In the following, the online help texts for all data entry fields provided with any Endpoint summary record for this IUCLID section are listed. As to whether and to what extent endpoint summaries should be prepared, refer to the relevant guidance for the respective chemical programme, e.g., the Technical Guidance Document (TGD) on preparing the Chemical Safety Report under REACH in its most recent version.
For technical guidance on how to manage Endpoint summary records, see How to manage Endpoint summary records in sections 4 - 10, respectively. For details on data types, see What data types are available for input fields and how are they used?.
Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.
Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:
- Melting point: 54.6-55.8 °C at 1,013 hPa
- Water solubility: completely miscible
- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)
- Oxidation reduction potential: no data available
- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)
- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)
- Short-term toxicity to fish:
LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)
LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)
- Acute toxicity:
Dermal: LD50: > 2,000 mg/kg for rat (limit test)
- Genetic toxicity:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)
The field(s) under this heading (if provided) can be optionally completed in order to specify the key parameter(s) that may subsequently be used in the chemical safety assessment, classification and labelling or other. In order to enable the use of any specific software, only a minimum number of structured and hence, searchable fields are provided, in many cases only one.
Key parameters are intended to condense the data summarised in field "Full short description of relevant endpoint data" to one single numeric value or concluding remark (e.g. negative / positive) chosen from a drop-down list. Where a numeric field is provided, only a clear value can be entered, that is, no range and no less than or greater than qualifiers. Conversion to a predefined unit as indicated in the field label (e.g. mg/L) may be required.
If the key value is no clear number, but a range or preceded by <, <=, >, or >=, you may either leave this field empty or make up a value you consider most appropriate for the intended subsequent purpose. The rationale for any user-derived values should be described in field "Discussion" for the sake of transparency. Some non-exhaustive examples of user-derived parameters are as follows:
- Aquatic short-term L(E)C50 >100 mg/L (e.g. because only tested up to water solubility of the substance): it may be appropriate to assume 100 mg/L as worst case value.
- Aquatic long-term LOEC 1 mg/L (>10 and <20% effect): calculate NOEC as LOEC/2 and enter 0.5 mg/L in the field for NOEC.
- Acute oral LD50 >2000 mg/kg b.w. (because no LD50 was achieved in a limit test): enter 2000 mg/kg b.w.
In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.
If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.
Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.
Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:
- Melting point: 54.6-55.8 °C at 1,013 hPa
- Water solubility: completely miscible
- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)
- Oxidation reduction potential: no data available
- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)
- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)
- Short-term toxicity to fish:
LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)
LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)
- Acute toxicity:
Dermal: LD50: > 2,000 mg/kg for rat (limit test)
- Genetic toxicity:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)
The field(s) under this heading (if provided) can be optionally completed in order to specify the key parameter(s) that may subsequently be used in the chemical safety assessment, classification and labelling or other. In order to enable the use of any specific software, only a minimum number of structured and hence, searchable fields are provided, in many cases only one.
Key parameters are intended to condense the data summarised in field "Full short description of relevant endpoint data" to one single numeric value or concluding remark (e.g. negative / positive) chosen from a drop-down list. Where a numeric field is provided, only a clear value can be entered, that is, no range and no less than or greater than qualifiers. Conversion to a predefined unit as indicated in the field label (e.g. mg/L) may be required.
If the key value is no clear number, but a range or preceded by <, <=, >, or >=, you may either leave this field empty or make up a value you consider most appropriate for the intended subsequent purpose. The rationale for any user-derived values should be described in field "Discussion" for the sake of transparency. Some non-exhaustive examples of user-derived parameters are as follows:
- Aquatic short-term L(E)C50 >100 mg/L (e.g. because only tested up to water solubility of the substance): it may be appropriate to assume 100 mg/L as worst case value.
- Aquatic long-term LOEC 1 mg/L (>10 and <20% effect): calculate NOEC as LOEC/2 and enter 0.5 mg/L in the field for NOEC.
- Acute oral LD50 >2000 mg/kg b.w. (because no LD50 was achieved in a limit test): enter 2000 mg/kg b.w.
In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.
If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.
Enter a full short description of the most relevant endpoint data. This includes in principle the summary information that is compiled e.g. in the OECD Full SIDS Summary format or other endpoint summary formats. Provide only the most relevant details, which could be, depending on the cases, the test guideline used, test organism and exposure duration. Normally no reliability score needs to be indicated as it can be assumed that the studies identified are valid (reliability score 1 or 2). If this is not the case (for instance if the reliability of a published study cannot be assigned or if several less valid studies are used for a weight of evidence analysis), the reliability indicators should be specified.
Also several key studies can be referenced as applicable. However, the characterisation of the endpoint data should be kept as concise as possible. Examples of what could be entered here are as follows:
- Melting point: 54.6-55.8 °C at 1,013 hPa
- Water solubility: completely miscible
- pH: 6.9 (80 mg/l water) at 20°C (OECD TG105)
- Oxidation reduction potential: no data available
- Phototransformation in air: T1/2 = 9.32 x 10-2 yr (sensitizer: OH radical) (AOP Win v 1.86)
- Biodegradation in water: screening tests: Not readily biodegradable: 0 - 8% (BOD) in 28 days, 0 - 1% (HPLC) in 28 days (OECD TG 301C)
- Short-term toxicity to fish:
LC50 (96h) < 100 mg/l for Pimephales promelas (OECD TG 203)
LC50 (48h) = 3.2 mg/l for Oryzias latipes (OECD TG 203)
- Acute toxicity:
Dermal: LD50: > 2,000 mg/kg for rat (limit test)
- Genetic toxicity:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 100: positive with and without metabolic activation; TA 1535: positive without metabolic activation (equivalent to OECD TG 471)
In this rich text field, describe the assessment you have made for the given endpoint. Provide the rationale for the choice of the key study(ies) and the choice of the key parameter that, according to your judgement, characterise the endpoint. This includes a discussion of the key information identified and in some instances of studies which are considered to be unreliable, but give critical results. A discussion as to why they were discarded in favour of other studies should then be included. Vice versa, a weight of evidence analysis based on less reliable data or use of published data, the reliability of which cannot be judged because of limited reporting, should be justified.
If several studies were identified to be relevant for the assessment, discuss possible reasons for differing results if any, e.g. differences in purity / impurities of the test substance used, differences in the methods and test conditions, etc.
In the following, the online help texts for all data entry fields provided with any Endpoint study record for this IUCLID section are listed. For sections 4 to 10, these guidance notes are completely based on the so-called OECD Harmonised Templates (see Rationale behind IUCLID Endpoint Study Records - OECD harmonised templates in chapter chapter D.4.7.1 What is an Endpoint study record?)
IUCLID per se does not prescribe how detailed the study summaries should be recorded. Refer to the relevant guidance for the respective chemical regulatory programme thereof.
For technical guidance on how to manage Endpoint study records, see chapter D.4.7 How to manage Endpoint study records in sections 4 - 13. For details on data types, see chapter D.4.5 What data types are available for input fields and how are they used?
Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., "key study"), the type of result (e.g., "experimental study"), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.
Indicate the bibliographic reference of the study report or publication the study summary is based on. Always enter the primary reference in the first block of fields (i.e. Sort no. = 1), if there are more than one reference to be cited. Copy this block of fields for specifying any other references related to this record (e.g. report of a preliminary study or other documentation). If results of a study report have been published, indicate the full citation of that publication(s) in addition to the reference of the original study.
Table E.455. Field Descriptions
| Reference type | Indicate the type of reference, e.g. "Study report" or "Publication". Select "Other company data" to characterise any unpublished information from a company other than a study report. Select "Grey literature" for any other unpublished information or "other:" and specify. |
| Author(s) (or transferred reference) (Author) | For ease of sorting and searchability use following convention: Surname, Initial (Example 1: White D, Ruehl KJ, Borman SA & Little J. Example 2: Hartley M & Murray W (avoid unnecessary full-stops, commas)). If no individuals are cited as authors, enter name of company or organisation or "Anon." as appropriate. Note that the complete bibliographic reference may appear in this field after migration of unstructured data from existing databases. |
| Year | Enter year of study report or publication. For a study report this field should be completed to include it in any searches, regardless of whether the complete date is given in field "Report date". |
| Title | Include the title of the report. For publications, include the title of the article of a journal or article/chapter of a book (e.g. handbook). |
| Bibliographic source | Not relevant for any study report. For publications or any other literature source (grey literature) specify the following type of information: (i) Title of scientific journal or book (e.g. if handbook); (ii) Volume of journal; (iii) Editor, publisher, place of publication for books or articles in books; (iv) Pagination. Example 1 (journal): J. Agric. Food Chem. 38: 215-227 Example 2 (handbook): In: Lyman WJ (ed.) Handbook of chemical property estimation methods. Environmental behavior of organic compounds. McGraw-Hill Book Company 15.1-15.34, New York. |
| Testing laboratory | Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible. |
| Report no. | Specify the report number allocated by the testing laboratory. Note that any company-specific study number should be included in the respective field. |
| Owner company | Either manually enter the identity of the company who owns the data or select it from the picklist. In either case, editing is possible. |
| Company study no. | Specify any company study no. if there is such a number and if it is different from the report no. of the testing laboratory. Otherwise leave field empty. |
| Report date | Specify the complete date of the study report, e.g. "2005-05-12" for 12 May 2005. Note that subfield "Year" should be completed in any case for sorting and searching purposes. |
Select appropriate indication for data access. Enter "Not applicable" if the summary consists of information that is commonly accessible such as guidance on safe use.
Indicate as appropriate. Note: "yes" should be selected only if "Data submitter is data owner" or "Data submitter has Letter of Access". Options "yes, but willing to share" or "yes, but not willing to share" may be relevant for specific regulatory programmes where the submitter is requested to indicate whether he is willing to share studies (e.g. with vertebrates).
In the supplementary remarks field, include an explanation as appropriate, i.e. justification for denial of sharing the corresponding study or refer to a document attached that provides justification (e.g. "for justification see attached document X")
A cross-reference can be included to indicate that the same study is recorded in another record. Indicate the respective chapter and record ID and enter relevant explanatory text. This may be useful if specific endpoints of a given study are described in another chapter (e.g. results on reproduction toxicity in case of a combined repeated dose / reproduction toxicity study) or if more than one experiment is described by the same study report, but included in separate records.
Check with the relevant guidance document whether all the methodology details must be repeated or whether a cross-reference to the same study in another chapter may suffice.
Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.
Select appropriate test type. Note: This field may be redundant with the information given in field "Guideline", but is considered useful for searching reasons.
Indicate according to which test guideline the study was conducted. If no test guideline was explicitly followed, but the methodology used is equivalent or similar to a specific guideline, you can indicate so in the "Qualifier" subfield preceding the field "Guideline".
Copy this block of fields for specifying more than one guideline (e.g. US EPA in addition to OECD guideline).
Table E.456. Field Descriptions
| Qualifier | Select appropriate qualifier, i.e. - "according to" (if a given test guideline was followed); - "equivalent or similar to" (if no test guideline was explicitly followed, but the methodology is equivalent or similar to a specific guideline); - "no guideline followed" (if none of above qualifiers apply. If so, fill in field "Principles of method if other than guideline"); - "no guideline available" (if so, fill in field "Principles of method if other than guideline"). - "no guideline required" (if so, fill in field "Principles of method if other than guideline"). |
| Guideline | Select the applicable test guideline, e.g. "OECD Guideline xxx". If the test guideline used is not listed, choose "other guideline:" and specify the test guideline in the related text field. In this text field, you can also enter any remarks as applicable, particularly: - To include any other title of the test guideline draft used, a subtitle, another version or update number and the year of update (For instance, different titles and/or numbers may exist for a given EU test guideline.); - To indicate if a the study was performed prior to the adoption of the test guideline specified; - To indicate if the methodology used was based on an extension of the test guideline specified. |
| Deviations from guideline (Deviations) | For robust study summaries or as requested by the regulatory programme, indicate if there are any deviations from the test guideline specified. If "yes" is selected, only briefly state relevant deviations in the supplementary remarks field (e.g. "other species used"); details should be described in the respective fields of the section MATERIALS AND METHODS. |
If no guideline was followed, include a description of the principles of the test protocol or estimated method used in the study. Details should be entered in appropriate distinct fields of section MATERIALS AND METHODS if available. Also provide a justification for using this method if appropriate.
If an estimation method was used (to be indicated in field "Test result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s).
Indicate whether the study was conducted following Good Laboratory Practice or not. Select "yes (incl. certificate)" if a GLP certificate of a test facility is available. Select "yes" if a GLP compliance statement is available, but no information on a GLP certificate. You can give an explanation in the supplementary remarks field, e.g. for explaining why GLP was not complied with or for specifying which (national) GLP was followed.
Indicate if the test material used in the study is equivalent to the submission substance identity. If "yes" is selected, the corresponding identity is automatically entered in the subsequent block of fields "Test material identity".
If "no" is selected, identify the test material in the subsequent block of fields "Test material identity". In this case, also make sure that the information entered in field "Study result type" is consistent, i.e. "read-across from supporting substance (structural analogue or surrogate)".
NOTE: If a completed record is used for another submission, you may have to update both fields "Study result type" and "Test material equivalent to submission substance identity".
If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.
If another than the submission substance identity was selected erraneously, go back to field "Test material equivalent to submission substance identity" and select "yes". This will prompt automatic entry of the respective identifiers.
Table E.457. Field Descriptions
| Identifier | Select an appropriate identifier from drop-down list, e.g. "CAS number". Use "Other:" and specify, if identity according to a standard identifier is not known or if an additional chemical name or number is provided. |
| Identity | Select the corresponding substance identity from drop-down list or enter manually if the identity is not available from the list or if no list is provided for the type of identifier selected. |
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Note that any information that can be claimed confidential should be included in the subsequent field "Confidential details on test material".
Explanations:
- Name of test material (as cited in study report): only if different from any other identifiers provided in the preceding fields.
- Molecular formula (if other than submission substance): specify
- Molecular weight (if other than submission substance): specify
- Smiles notation (if other than submission substance): provide if available
- InChl (if other than submission substance): provide if available
- Structural formula attached as image file (if other than submission substance): see Fig.: only if different from submission substance. Indicate Fig. no. if a file is attached in field "Attached document", e.g. state "see Fig. 1".
- Substance type: indicate whether pure active substance, technical product, formulation or other.
- Physical state: indicate "gas", "solid" or "liquid" only if different from submission substance or if substance can occur in different physical states.
- Analytical purity: specify in %
- Impurities (identity and concentrations): specify
- Composition of the test material, percentage of components: specify if applicable
- Isomers composition: specify if applicable
- Purity test date: provide if available
- Lot/batch No.: provide if available
- Expiration date of the lot/batch: provide if available
- Radiochemical purity (if radiolabelling): specify if applicable
- Specific activity (if radiolabelling): specify if applicable
- Locations of the label (if radiolabelling): specify if applicable
- Expiration date of radiochemical substance (if radiolabelling): specify if applicable
- Storage condition of test substance: specify if applicable
- Stability under test conditions: indicate if available
Enter any confidential information on the test material in this separate field. Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Explanations:
- Analytical purity: specify in %
- Impurities (identity and concentrations): specify
- Composition of the test material, percentage of components: specify if applicable
- Purity test date: provide if available
- Lot/batch No.: : provide if available
- Expiration date of the lot/batch: : provide if available
- Isomers composition: specify if applicable
Select strain as appropriate. If not available from picklist, select "other" and specify.
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Explanations:
- Diet: Describe type of diet (e.g. conventional laboratory diet / caloric restriction) and whether it was provided ad libitum.
- Water: Describe type (e.g. drinking water) and whether it was provided ad libitum.
- IN-LIFE DATES: If required, specify the in-life dates (i.e. the phase of a study following treatment in which the test system is alive/growing).
Select as appropriate. If not available from picklist, select "other" and specify.
If route of administration is "inhalation", indicate type of inhalation exposure, e.g. "nose only". Any remarks can be entered in the supplementary remarks subfield.
Select "unchanged (no vehicle)" if none was used or select vehicle used if any. If not available from picklist, select "other" and specify.
Note that some of the vehicles provided in this list are used for specific routes of administration only.
Select freetext template for the respective route of administration and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Briefly describe the mating procedure.
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate whether the doses or concentrations were analytically verified.
For robust study summaries or as requested by the regulatory programme, include a short description on the method of analysis in the supplementary remarks field. If any problems occurred in any of these procedures, then they should be reported in more detail. If this could have affected the veracity or conclusions of the study, discuss this in field "Rationale for reliability incl. deficiences".
Further route-dependent information to be included:
- For oral studies: State whether the analytical data indicated that the variance between nominal and actual dosage (if diet is route of administration) or concentrations (for drinking water study) was acceptable.
If diet is the route of administration, briefly record when and at what dose levels the dosage analyses were made and include the results (range of values) of (i) Homogeneity analysis, (ii) Stability analysis and (iii) Concentration analysis.It may be appropriate to include a cross-reference to another study in which stability analysis was performed and reported. If so, a justification should also be included briefly explaining the rationale of referring to another study.
- For inhalation studies: State whether the analytical data indicated that the variance between nominal and actual concentrations was acceptable.
- For dermal studies: State whether the analytical data indicated that the variance between nominal and actual concentrations of the test substance in the vehicle was acceptable.
Indicate duration of treatment or exposure (with unit) for each reproductive phase and generation,
e.g.
(P) Males: [...] days/weeks before mating.
(P) Females: [...] days/weeks before mating, [...] days/weeks during mating, [...] days/weeks during resulting pregnancies, [...] days/weeks through weaning of their F1 offspring.
(F1) Males: [...] days/weeks at weaning, during growth into adulthood, mating and production of an F2 generation, until weaning of the F2 generation.
(F1) Females: [...] days/weeks at weaning, during growth into adulthood, mating and production of an F2 generation, until weaning of the F2 generation.
Indicate the frequency of the administration of doses to the test animals (e.g., "daily, 7 days each week"). Use of non-standard dosing regime (e.g. a five-day per week regime) should be justified.
Briefly describe the study schedule as far as not indicated under "Duration of treatment / exposure".
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
If necessary expand the information with corresponding data on F2 animals if applicable.
Indicate the dose or concentration levels applied and the basis of quantity used. Copy this block of fields if the dose/concentration levels were determined on more than one basis of quantity as appropriate.
Table E.458. Field Descriptions
| Doses / concentrations (no label) | Indicate the doses or concentrations including unit applied to the test animals, e.g. 0, 112, 220, 523 mg/kg bw/day (P and F1, m/f)" or "0, 112, 220, 523 mg/kg bw/day (P, m); 0, 87, 198, 477 mg/kg bw/day (P, f)". You may enter explanatory text. |
| Basis | Indicate whether doses/concentrations are based on nominal or actually ingested or analytically measured values. In the supplementary remarks field provide further details as appropriate. |
Indicate number of animals used per dose group, e.g. [#] (P) males caged with [#] (P) females; [#] (F1) males, [#] (F1) females.
For robust study summaries or as requested by the regulatory programme, also include a detailed table on the animal assignment in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").
Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate whether and what type of concurrent control groups were used. If not available from picklist, select "other" and specify. Copy field if more than one type of control was used.
Include any details on the study design including a brief description on dose selection and animal assignment rationale if appropriate. As appropriate state study type(s) and briefly describe the results from range-finding or other studies used as basis for dose selection. More comprehensive details may be attached.
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate if a positive control was used and if necessary indicate purity, Lot/batch No.
Indicate which clinical examinations were performed in the parental animals and the time schedule for those examinations. State if any examination was not performed and with what parental generation as applicable. Also indicate the dose groups that were examined if not all. As appropriate include detailed table(s) in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").
If the study is a combined repeated dose toxicity / reproduction toxicity study or includes a developmental neurotoxicity part, include a note in field "Cross-reference to same study" and describe these study parts separately in the respective data point entry form(s), i.e. "Repeated dose toxicity (route x)" or "Neurotoxicity".
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate whether and how [e.g., vaginal smear] and for how long [x cycles or x weeks] the estrous cyclicity was determined.
Indicate which sperm parameters were examined. State if any examination was not performed and with what parental generation as applicable. Also indicate the dose groups that were examined if not all.
Indicate which litter observations were made. State if any examination was not performed and with what generation as applicable. Also indicate the dose groups that were examined if not all.
In parentheses, include the time of observation (lactation day), e.g. (Day 0). As an alternative option, include detailed table(s) in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate when the surviving parental males/females were sacrificed and the postmortem examinations performed. Use freetext template and delete/add elements as appropriate. As an alternative option, include detailed table(s) in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").
Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate details on gross pathological and histopathological examinations. Also indicate those dose groups which were examined if not all. Use freetext template and delete/add elements as appropriate. As an alternative option or in addition, include a table and refer to respective table no. (use predefined table if any).
Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
List parameters that were analyzed by which test methods. Indicate whether these are appropriate.
Note: General statistical assumptions need not be stated unless there are deviations from generally applied techniques. Animals excluded from analyses should be in table footnotes.
Describe which reproductive indices were calculated from breeding and parturition records of animals in the study. Include formulas or descriptions as provided in the study report.
Describe which viability indices were calculated from lactation records of litters in the study. Include formulas or descriptions as provided in the study report.
In this field, you can enter any information on materials and methods, for which no distinct field is available, or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.
Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.
Record effect levels, based on different endpoints and/or separated for each generation and/or sex. Copy this block of fields as appropriate.
Table E.459. Field Descriptions
| Endpoint | Select type of endpoint, normally NOAEC or LOAEC. If adverse effects were observed at the highest dose tested, select "no NOAEC identified". If a benchmark dose / concentration was calculated, select appropriate BMC indicator (e.g. "BMC05" or "BMC:" and specify in the related text field). If the critical effects at a specific dose or concentration level are reported only, select "dose. level:" or "conc. level:" and specify. |
| Generation | Select the generation (e.g. "P") the effect level refers to. |
| Sex | Select from drop-down list. |
| Effect level | Enter a numeric value or a range of numeric values according to following conventions: (i) In the first numeric field, enter a single value (Qualifier subfield left blank) or a value if preceded by ">", ">=" or "ca." (e.g. "20", "ca. 20", ">20"). (ii) In the second numeric field, enter a single value if preceded by "<" or "<=". (iii) Use both numeric fields and, as required, the lower and upper qualifier field to enter a range of numeric values (e.g. "2 - 8" or ">2 <8"). |
| Unit of dose (no label) | Select unit of dose or concentration as appropriate. |
| Basis for effect level / Remarks | Indicate the parameter(s) used to establish the given effect level. If necessary, give further details, e.g. "histopathology: liver enlargment" or "fertility index". Delete any elements in the predefined freetext that do not apply. This subfield can also be used to enter any other explanations, e.g. for indicating that the effect level provided was derived by the notifier or for indicating "NOAEL = highest dose tested" if applicable. |
Indicate whether any treatment-related effects were observed. In below field "Details on results (parental animals)", describe the effects for each parental generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (parental animals)", describe the effects for each parental generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (parental animals)", describe the effects for each parental generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (parental animals)", describe the effects for each parental generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (parental animals)", describe the effects for each parental generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Water consumption may not be specifically requested under the respective test guideline, unless the substance was administered in the drinking water.
Indicate whether any treatment-related effects were observed. In below field "Details on results (parental animals)", describe the effects for each parental generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (parental animals)", describe the effects for each parental generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (parental animals)", describe the effects for each parental generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (parental animals)", describe the effects for each parental generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Describe the effects for each parental generation by dose and sex for each of the previous fields answered "yes". If answered "no effects", you may provide any further explanations, e.g. stating that effects were observed, but considered negligible and not of biological or statistical significance (to be explained why).
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Relate treatment-related findings to any histological findings where appropriate.
Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).
Explanations:
- CLINICAL SIGNS AND MORTALITY (PARENTAL ANIMALS): Describe gross observations for behaviour and appearance ("cage-side observations"). Note when signs were first observed and if they were reversible. For mortalities indicate the cause of death.
- BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS): Include selected group mean body weights and food consumption values for pregnant or nursing dams as summarised in the report. Present/discuss findings during gestation and lactation for each generation. If data are tabulated, split data into more than one table as appropriate.
- TEST SUBSTANCE INTAKE (PARENTAL ANIMALS): Include the doses expressed as mean daily mg test substance/kg bw during the pre-mating period (specify the # of weeks) based on food consumption (or drinking water consumption if drinking water study), body weight and dietary analyses results (if any). Indicate whether the values for the [P or F1] generation are considered to be representative of the test substance intake for the entire study. Likewise, indicate the test substance intake during pregnancy and during the lactation periods.
- REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS): Summarise, for each generation, any biologically relevant effects on the estrous cycle, i.e. length and periodicity, based on the results from the evaluation of vaginal smears (describe).
- REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS): Summarise, for each generation, any biologically relevant effects on sperm parameters, i.e. testis weight, epididymis weight, daily sperm production, sperm count in testes, sperm count in epididymides, enumeration of cauda epididymal sperm reserve, sperm motility, sperm morphology, other.
- REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS): Summarise any biologically relevant effects on reproductive performance for each generation and sex. Any table included should be based on report content and include any calculated reproductive indices.
- ORGAN WEIGHTS (PARENTAL ANIMALS): Give absolute and relative organ weight changes as appropriate; relate to any histological findings.
- GROSS PATHOLOGY (PARENTAL ANIMALS): State treatment-related findings and relate with other findings as appropriate.
- HISTOPATHOLOGY (PARENTAL ANIMALS): State treatment-related findings and relate with other findings as appropriate.
- OTHER FINDINGS (PARENTAL ANIMALS): Describe the results of any other examinations or include a cross-reference in field "Cross-reference to same study" to indicate that specific results of the same study are described in another chapter.
Indicate whether any treatment-related effects were observed. In below field "Details on results (offspring)", describe the effects for each generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (offspring)", describe the effects for each generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (offspring)", describe the effects for each generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (offspring)", describe the effects for each generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (offspring)", describe the effects for each generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (offspring)", describe the effects for each generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Indicate whether any treatment-related effects were observed. In below field "Details on results (offspring)", describe the effects for each generation by dose and sex (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Describe the effects for each generation by dose and sex for each of the previous fields answered "yes". If answered "no effects", you may provide any further explanations, e.g. stating that effects were observed, but considered negligible.
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Relate treatment-related findings to any histological findings where appropriate.
Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).
NOTE: Depending on the regulatory programme some form of a table(s) may be mandatory.
Explanations:
- VIABILITY (OFFSPRING): Describe mean litter size and viability (survival) results from pups during lactation, sex ratio. Also describe anogenital distance results, if measured.
- CLINICAL SIGNS (OFFSPRING): Describe any clinical observations of offspring during lactation.
- BODY WEIGHT (OFFSPRING): Describe offspring body weights and selected mean pup body weight data. Separate data for selected lactation days by generation (F1 and F2).
- SEXUAL MATURATION (OFFSPRING): Describe biologically relevant effects on vaginal opening and preputial separation and other effects on sexual maturation.
- ORGAN WEIGHTS (OFFSPRING): Give absolute and relative organ weight changes as appropriate; relate to any histological findings.
- GROSS PATHOLOGY (OFFSPRING): State treatment-related findings and relate with other findings as appropriate. It is recommended to tabulate treatment-related findings and limit text to integration of findings and highlights.
- HISTOPATHOLOGY (OFFSPRING): State treatment-related findings and relate with other findings as appropriate. It is recommended to tabulate treatment-related findings and limit text to integration of findings and highlights.
- OTHER FINDINGS (OFFSPRING): Describe the results of any other examinations or include a cross-reference in field "Cross-reference to same study" to indicate that specific results of the same study are described in another chapter.
In this field, you can enter any other remarks on results. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.
Note: Both the "Materials and methods" section and "Results" section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.
In this field, you can enter any overall remarks or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.
Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.
Attach any background document that cannot be inserted in any rich text editor field, particularly image files (e.g. an image of a structural formula).
Copy this block of fields for attaching more than one file.
Table E.460. Field Descriptions
| Attached document | Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document. |
| Remarks | As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory. |
If required, an electronic copy of the full study report can be attached as WORD, pdf or other document type, which will not be integrated in any report, but must be handled as separate files.
Note: In the export administration you can indicate whether the attached files should be included in the data export or not.
If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the conclusions reached. If a specific format is prescribed, upload the respective freetext template if available from the drop-down list or copy it from the corresponding document.
Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
A Cross-reference to other study or other studies can be included which are considered relevant in the interpretation of the test results, e.g. for supporting the conclusion that an effect observed was not substance-related. Indicate the respective chapter(s) and record ID(s) and enter relevant explanatory text.
Such cross-references may be useful if it is considered relevant to discuss other results at the summary level of a single study. It should be noted that the overall appraisal of results from different studies is normally done in the hazard or risk assessment.
Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.
In the following, the online help texts for all data entry fields provided with any Endpoint study record for this IUCLID section are listed. For sections 4 to 10, these guidance notes are completely based on the so-called OECD Harmonised Templates (see Rationale behind IUCLID Endpoint Study Records - OECD harmonised templates in chapter chapter D.4.7.1 What is an Endpoint study record?)
IUCLID per se does not prescribe how detailed the study summaries should be recorded. Refer to the relevant guidance for the respective chemical regulatory programme thereof.
For technical guidance on how to manage Endpoint study records, see chapter D.4.7 How to manage Endpoint study records in sections 4 - 13. For details on data types, see chapter D.4.5 What data types are available for input fields and how are they used?
Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., "key study"), the type of result (e.g., "experimental study"), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.
Indicate the bibliographic reference of the study report or publication the study summary is based on. Always enter the primary reference in the first block of fields (i.e. Sort no. = 1), if there are more than one reference to be cited. Copy this block of fields for specifying any other references related to this record (e.g. report of a preliminary study or other documentation). If results of a study report have been published, indicate the full citation of that publication(s) in addition to the reference of the original study.
Table E.461. Field Descriptions
| Reference type | Indicate the type of reference, e.g. "Study report" or "Publication". Select "Other company data" to characterise any unpublished information from a company other than a study report. Select "Grey literature" for any other unpublished information or "other:" and specify. |
| Author(s) (or transferred reference) (Author) | For ease of sorting and searchability use following convention: Surname, Initial (Example 1: White D, Ruehl KJ, Borman SA & Little J. Example 2: Hartley M & Murray W (avoid unnecessary full-stops, commas)). If no individuals are cited as authors, enter name of company or organisation or "Anon." as appropriate. Note that the complete bibliographic reference may appear in this field after migration of unstructured data from existing databases. |
| Year | Enter year of study report or publication. For a study report this field should be completed to include it in any searches, regardless of whether the complete date is given in field "Report date". |
| Title | Include the title of the report. For publications, include the title of the article of a journal or article/chapter of a book (e.g. handbook). |
| Bibliographic source | Not relevant for any study report. For publications or any other literature source (grey literature) specify the following type of information: (i) Title of scientific journal or book (e.g. if handbook); (ii) Volume of journal; (iii) Editor, publisher, place of publication for books or articles in books; (iv) Pagination. Example 1 (journal): J. Agric. Food Chem. 38: 215-227 Example 2 (handbook): In: Lyman WJ (ed.) Handbook of chemical property estimation methods. Environmental behavior of organic compounds. McGraw-Hill Book Company 15.1-15.34, New York. |
| Testing laboratory | Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible. |
| Report no. | Specify the report number allocated by the testing laboratory. Note that any company-specific study number should be included in the respective field. |
| Owner company | Either manually enter the identity of the company who owns the data or select it from the picklist. In either case, editing is possible. |
| Company study no. | Specify any company study no. if there is such a number and if it is different from the report no. of the testing laboratory. Otherwise leave field empty. |
| Report date | Specify the complete date of the study report, e.g. "2005-05-12" for 12 May 2005. Note that subfield "Year" should be completed in any case for sorting and searching purposes. |
Select appropriate indication for data access. Enter "Not applicable" if the summary consists of information that is commonly accessible such as guidance on safe use.
Indicate as appropriate. Note: "yes" should be selected only if "Data submitter is data owner" or "Data submitter has Letter of Access". Options "yes, but willing to share" or "yes, but not willing to share" may be relevant for specific regulatory programmes where the submitter is requested to indicate whether he is willing to share studies (e.g. with vertebrates).
In the supplementary remarks field, include an explanation as appropriate, i.e. justification for denial of sharing the corresponding study or refer to a document attached that provides justification (e.g. "for justification see attached document X")
A cross-reference can be included to indicate that the same study is recorded in another record. Indicate the respective chapter and record ID and enter relevant explanatory text. This may be useful if specific endpoints of a given study are described in another chapter (e.g. results on reproduction toxicity in case of a combined repeated dose / reproduction toxicity study) or if more than one experiment is described by the same study report, but included in separate records.
Check with the relevant guidance document whether all the methodology details must be repeated or whether a cross-reference to the same study in another chapter may suffice.
Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.
Indicate according to which test guideline the study was conducted. If no test guideline was explicitly followed, but the methodology used is equivalent or similar to a specific guideline, you can indicate so in the "Qualifier" subfield preceding the field "Guideline".
Copy this block of fields for specifying more than one guideline (e.g. US EPA in addition to OECD guideline).
Table E.462. Field Descriptions
| Qualifier | Select appropriate qualifier, i.e. - "according to" (if a given test guideline was followed); - "equivalent or similar to" (if no test guideline was explicitly followed, but the methodology is equivalent or similar to a specific guideline); - "no guideline followed" (if none of above qualifiers apply. If so, fill in field "Principles of method if other than guideline"); - "no guideline available" (if so, fill in field "Principles of method if other than guideline"). - "no guideline required" (if so, fill in field "Principles of method if other than guideline"). |
| Guideline | Select the applicable test guideline, e.g. "OECD Guideline xxx". If the test guideline used is not listed, choose "other guideline:" and specify the test guideline in the related text field. In this text field, you can also enter any remarks as applicable, particularly: - To include any other title of the test guideline draft used, a subtitle, another version or update number and the year of update (For instance, different titles and/or numbers may exist for a given EU test guideline.); - To indicate if a the study was performed prior to the adoption of the test guideline specified; - To indicate if the methodology used was based on an extension of the test guideline specified. |
| Deviations from guideline (Deviations) | For robust study summaries or as requested by the regulatory programme, indicate if there are any deviations from the test guideline specified. If "yes" is selected, only briefly state relevant deviations in the supplementary remarks field (e.g. "other species used"); details should be described in the respective fields of the section MATERIALS AND METHODS. |
If no guideline was followed, include a description of the principles of the test protocol or estimated method used in the study. Details should be entered in appropriate distinct fields of section MATERIALS AND METHODS if available. Also provide a justification for using this method if appropriate.
If an estimation method was used (to be indicated in field "Test result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s).
Indicate whether the study was conducted following Good Laboratory Practice or not. Select "yes (incl. certificate)" if a GLP certificate of a test facility is available. Select "yes" if a GLP compliance statement is available, but no information on a GLP certificate. You can give an explanation in the supplementary remarks field, e.g. for explaining why GLP was not complied with or for specifying which (national) GLP was followed.
Indicate if the test material used in the study is equivalent to the submission substance identity. If "yes" is selected, the corresponding identity is automatically entered in the subsequent block of fields "Test material identity".
If "no" is selected, identify the test material in the subsequent block of fields "Test material identity". In this case, also make sure that the information entered in field "Study result type" is consistent, i.e. "read-across from supporting substance (structural analogue or surrogate)".
NOTE: If a completed record is used for another submission, you may have to update both fields "Study result type" and "Test material equivalent to submission substance identity".
If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.
If another than the submission substance identity was selected erraneously, go back to field "Test material equivalent to submission substance identity" and select "yes". This will prompt automatic entry of the respective identifiers.
Table E.463. Field Descriptions
| Identifier | Select an appropriate identifier from drop-down list, e.g. "CAS number". Use "Other:" and specify, if identity according to a standard identifier is not known or if an additional chemical name or number is provided. |
| Identity | Select the corresponding substance identity from drop-down list or enter manually if the identity is not available from the list or if no list is provided for the type of identifier selected. |
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Note that any information that can be claimed confidential should be included in the subsequent field "Confidential details on test material".
Explanations:
- Name of test material (as cited in study report): only if different from any other identifiers provided in the preceding fields.
- Molecular formula (if other than submission substance): specify
- Molecular weight (if other than submission substance): specify
- Smiles notation (if other than submission substance): provide if available
- InChl (if other than submission substance): provide if available
- Structural formula attached as image file (if other than submission substance): see Fig.: only if different from submission substance. Indicate Fig. no. if a file is attached in field "Attached document", e.g. state "see Fig. 1".
- Substance type: indicate whether pure active substance, technical product, formulation or other.
- Physical state: indicate "gas", "solid" or "liquid" only if different from submission substance or if substance can occur in different physical states.
- Analytical purity: specify in %
- Impurities (identity and concentrations): specify
- Composition of the test material, percentage of components: specify if applicable
- Isomers composition: specify if applicable
- Purity test date: provide if available
- Lot/batch No.: provide if available
- Expiration date of the lot/batch: provide if available
- Radiochemical purity (if radiolabelling): specify if applicable
- Specific activity (if radiolabelling): specify if applicable
- Locations of the label (if radiolabelling): specify if applicable
- Expiration date of radiochemical substance (if radiolabelling): specify if applicable
- Storage condition of test substance: specify if applicable
- Stability under test conditions: indicate if available
Enter any confidential information on the test material in this separate field. Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Explanations:
- Analytical purity: specify in %
- Impurities (identity and concentrations): specify
- Composition of the test material, percentage of components: specify if applicable
- Purity test date: provide if available
- Lot/batch No.: : provide if available
- Expiration date of the lot/batch: : provide if available
- Isomers composition: specify if applicable
Select strain as appropriate. If not available from picklist, select "other" and specify.
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Explanations:
- Housing: describe housing conditions. Indicate whether individual metabolism cages were used.
- Diet: Describe type of diet (e.g. conventional laboratory diet / caloric restriction) and whether it was provided ad libitum.
- Water: Describe type (e.g. drinking water) and whether it was provided ad libitum.
- IN-LIFE DATES: If required, specify the in-life dates (i.e. the phase of a study following treatment in which the test system is alive/growing).
Select as appropriate. If not available from picklist, select "other" and specify.
If route of administration is "inhalation", indicate type of inhalation exposure, e.g. "nose only". Any remarks can be entered in the supplementary remarks subfield.
Select "unchanged (no vehicle)" if none was used or select vehicle used if any. If not available from picklist, select "other" and specify.
Note that some of the vehicles provided in this list are used for specific routes of administration only.
Select freetext template for the respective route of administration and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate whether the doses or concentrations were analytically verified.
For robust study summaries or as requested by the regulatory programme, include a short description on the method of analysis in the supplementary remarks field. If any problems occurred in any of these procedures, then they should be reported in more detail. If this could have affected the veracity or conclusions of the study, discuss this in field "Rationale for reliability incl. deficiences".
Further route-dependent information to be included:
- For oral studies: State whether the analytical data indicated that the variance between nominal and actual dosage (if diet is route of administration) or concentrations (for drinking water study) was acceptable.
If diet is the route of administration, briefly record when and at what dose levels the dosage analyses were made and include the results (range of values) of (i) Homogeneity analysis, (ii) Stability analysis and (iii) Concentration analysis.It may be appropriate to include a cross-reference to another study in which stability analysis was performed and reported. If so, a justification should also be included briefly explaining the rationale of referring to another study.
- For inhalation studies: State whether the analytical data indicated that the variance between nominal and actual concentrations was acceptable.
- For dermal studies: State whether the analytical data indicated that the variance between nominal and actual concentrations of the test substance in the vehicle was acceptable.
Briefly describe the mating procedure.
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate duration of administration / exposure in days of pregnancy counting from day 0 of pregnancy, i.e. 6-14 days pc, 6-17 days pc, 6-18 days pc or other.
In the case of an inhalation or dermal study include the daily exposure duration, e.g. "4 hours per day". Use of non-standard dosing regime should be justified.
Indicate the dose or concentration levels applied and the basis of quantity used. Copy this block of fields if the dose/concentration levels were determined on more than one basis of quantity as appropriate.
Table E.464. Field Descriptions
| Doses / concentrations (no label) | Indicate the doses or concentrations including unit applied to the test animals, e.g. 0, 112, 220, 523 mg/kg bw/day. You may enter explanatory text. |
| Basis | Indicate whether doses/concentrations are based on nominal or actually ingested or analytically measured values. In the supplementary remarks field provide further details as appropriate, e.g. state whether dosing was based on body weight on the most recent body weight determination or on a specific gestation day. |
Enter number of females per dose, e.g. "20" or specify according to dose if different numbers were used and explain why.
For robust study summaries or as requested by the regulatory programme, also include a detailed table on the animal assignment in the rich text field "Any other information on results incl. tables". Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. "... see Table 1").
Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate whether and what type of concurrent control groups were used. If not available from picklist, select "other" and specify. Copy field if more than one type of control was used.
Include any further details on the study design including a brief description on dose selection and animal assignment rationale if appropriate. Use data from range-finding study if available. More comprehensive details may be attached.
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate if and which examinations were performed in the dams and the time schedule for those examinations. Also indicate the dose groups that were examined if not all. When tabulating parameters examined, refer to respective table no.
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate if ovaries and uterine contents were examined and the type of examinations.
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate if and which examinations were performed in the fetuses. Describe in detail, i.e. external, soft tissue and skeletal eaminations, including assignment of fetuses and standard/non-standard methodologies used. Indicate how many per litter were used, i.e. all, half, a distinct number, or any other. When tabulating parameters examined, refer to respective table no.
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
List parameters that were analyzed by which test methods. Indicate whether these are appropriate. Differentiate between parametric and non-parametric analysis.
Note: General statistical assumptions need not be stated unless there are deviations from generally applied techniques. Animals excluded from analyses should be in table footnotes.
Describe which indices were calculated from cesarean section records of animals in the study. Include formulas or descriptions as provided in the study report.
Describe whether historical control data were provided to allow comparison with concurrent controls. State source of data and what data were included.
In this field, you can enter any information on materials and methods, for which no distinct field is available, or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.
Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.
Record effect levels, based on different endpoints and effect types (i.e. maternal toxicity, developmental toxicity). Copy this block of fields as appropriate.
Table E.465. Field Descriptions
| Endpoint | Select type of endpoint, normally NOAEC or LOAEC. If adverse effects were observed at the highest dose tested, select "no NOAEC identified". If a benchmark dose / concentration was calculated, select appropriate BMC indicator (e.g. "BMC05" or "BMC:" and specify in the related text field). If the critical effects at a specific dose or concentration level are reported only, select "dose. level:" or "conc. level:" and specify. |
| Effect type | Select the effect type (e.g. "maternal toxicity") the effect level refers to. |
| Effect level | Enter a numeric value or a range of numeric values according to following conventions: (i) In the first numeric field, enter a single value (Qualifier subfield left blank) or a value if preceded by ">", ">=" or "ca." (e.g. "20", "ca. 20", ">20"). (ii) In the second numeric field, enter a single value if preceded by "<" or "<=". (iii) Use both numeric fields and, as required, the lower and upper qualifier field to enter a range of numeric values (e.g. "2 - 8" or ">2 <8"). |
| Unit of dose (no label) | Select unit of dose or concentration as appropriate. |
| Basis for effect level / Remarks | Indicate the parameter(s) used to establish the given effect level. If necessary, give further details, e.g. "histopathology: liver enlargment". Select freetext template either for Maternal toxicity or Developmental toxicity. Delete any elements in the predefined freetext that do not apply. This subfield can also be used to enter any other explanations, e.g. for indicating that the effect level provided was derived by the notifier or for indicating "NOAEL = highest dose tested" if applicable. |
Indicate whether any treatment-related maternal effects were observed. In below field "Details on maternal toxic effects", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Describe the effects if previous field answered "yes". If answered "no effects", you may provide any further explanations, e.g. stating that effects were observed, but considered negligible and not of biological or statistical significance (to be explained why).
Include data on mortality, clinical observations, body weight gain, food consumption, gross pathology, cesarean section observations, other.
Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).
NOTE: Depending on the regulatory programme some form of a table(s) may be mandatory. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate whether any treatment-related developmental effects were observed. In below field "Details on embryotoxic / teratogenic effects", describe the effects by dose (if "yes") or provide any further explanation (if "no effects"), e.g. stating that effects were observed, but considered negligible.
Select "not examined" or "no data" as applicable.
Describe the effects if previous field answered "yes". If answered "no effects", you may provide any further explanations, e.g. stating that effects were observed, but considered negligible and not of biological or statistical significance (to be explained why).
Include data on findings from external, visceral and skeletal examinations. Present variations and malformations (or other classifications of anomalies) separately; give the total visceral, skeletal and visceral alterations when applicable.
Particularly with comprehensive data, include a table in the rich text field "Any other information on results incl. tables" and refer to respective table no., e.g. "see Table 1" (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).
NOTE: Depending on the regulatory programme some form of a table(s) may be mandatory. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
In this field, you can enter any other remarks on results. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.
Note: Both the "Materials and methods" section and "Results" section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.
In this field, you can enter any overall remarks or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.
Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.
Attach any background document that cannot be inserted in any rich text editor field, particularly image files (e.g. an image of a structural formula).
Copy this block of fields for attaching more than one file.
Table E.466. Field Descriptions
| Attached document | Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document. |
| Remarks | As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory. |
If required, an electronic copy of the full study report can be attached as WORD, pdf or other document type, which will not be integrated in any report, but must be handled as separate files.
Note: In the export administration you can indicate whether the attached files should be included in the data export or not.
If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the conclusions reached. If a specific format is prescribed, upload the respective freetext template if available from the drop-down list or copy it from the corresponding document.
Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
A Cross-reference to other study or other studies can be included which are considered relevant in the interpretation of the test results, e.g. for supporting the conclusion that an effect observed was not substance-related. Indicate the respective chapter(s) and record ID(s) and enter relevant explanatory text.
Such cross-references may be useful if it is considered relevant to discuss other results at the summary level of a single study. It should be noted that the overall appraisal of results from different studies is normally done in the hazard or risk assessment.
Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.
In the following, the online help texts for all data entry fields provided with any Endpoint study record for this IUCLID section are listed. For sections 4 to 10, these guidance notes are completely based on the so-called OECD Harmonised Templates (see Rationale behind IUCLID Endpoint Study Records - OECD harmonised templates in chapter chapter D.4.7.1 What is an Endpoint study record?)
IUCLID per se does not prescribe how detailed the study summaries should be recorded. Refer to the relevant guidance for the respective chemical regulatory programme thereof.
For technical guidance on how to manage Endpoint study records, see chapter D.4.7 How to manage Endpoint study records in sections 4 - 13. For details on data types, see chapter D.4.5 What data types are available for input fields and how are they used?
Under this main heading, fields are subsumed for identifying the purpose of the record (e.g., "key study"), the type of result (e.g., "experimental study"), data waiving indication (if any), reliability indication, and flags for indicating the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterise the relevance of a study summary and are therefore displayed on top of each Endpoint Study Record. For detailed guidance, refer to chapter D.4.7.7.1 Administrative data.
Indicate the bibliographic reference of the study report or publication the study summary is based on. Always enter the primary reference in the first block of fields (i.e. Sort no. = 1), if there are more than one reference to be cited. Copy this block of fields for specifying any other references related to this record (e.g. report of a preliminary study or other documentation). If results of a study report have been published, indicate the full citation of that publication(s) in addition to the reference of the original study.
Table E.467. Field Descriptions
| Reference type | Indicate the type of reference, e.g. "Study report" or "Publication". Select "Other company data" to characterise any unpublished information from a company other than a study report. Select "Grey literature" for any other unpublished information or "other:" and specify. |
| Author(s) (or transferred reference) (Author) | For ease of sorting and searchability use following convention: Surname, Initial (Example 1: White D, Ruehl KJ, Borman SA & Little J. Example 2: Hartley M & Murray W (avoid unnecessary full-stops, commas)). If no individuals are cited as authors, enter name of company or organisation or "Anon." as appropriate. Note that the complete bibliographic reference may appear in this field after migration of unstructured data from existing databases. |
| Year | Enter year of study report or publication. For a study report this field should be completed to include it in any searches, regardless of whether the complete date is given in field "Report date". |
| Title | Include the title of the report. For publications, include the title of the article of a journal or article/chapter of a book (e.g. handbook). |
| Bibliographic source | Not relevant for any study report. For publications or any other literature source (grey literature) specify the following type of information: (i) Title of scientific journal or book (e.g. if handbook); (ii) Volume of journal; (iii) Editor, publisher, place of publication for books or articles in books; (iv) Pagination. Example 1 (journal): J. Agric. Food Chem. 38: 215-227 Example 2 (handbook): In: Lyman WJ (ed.) Handbook of chemical property estimation methods. Environmental behavior of organic compounds. McGraw-Hill Book Company 15.1-15.34, New York. |
| Testing laboratory | Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible. |
| Report no. | Specify the report number allocated by the testing laboratory. Note that any company-specific study number should be included in the respective field. |
| Owner company | Either manually enter the identity of the company who owns the data or select it from the picklist. In either case, editing is possible. |
| Company study no. | Specify any company study no. if there is such a number and if it is different from the report no. of the testing laboratory. Otherwise leave field empty. |
| Report date | Specify the complete date of the study report, e.g. "2005-05-12" for 12 May 2005. Note that subfield "Year" should be completed in any case for sorting and searching purposes. |
Select appropriate indication for data access. Enter "Not applicable" if the summary consists of information that is commonly accessible such as guidance on safe use.
Indicate as appropriate. Note: "yes" should be selected only if "Data submitter is data owner" or "Data submitter has Letter of Access". Options "yes, but willing to share" or "yes, but not willing to share" may be relevant for specific regulatory programmes where the submitter is requested to indicate whether he is willing to share studies (e.g. with vertebrates).
In the supplementary remarks field, include an explanation as appropriate, i.e. justification for denial of sharing the corresponding study or refer to a document attached that provides justification (e.g. "for justification see attached document X")
A cross-reference can be included to indicate that the same study is recorded in another record. Indicate the respective chapter and record ID and enter relevant explanatory text. This may be useful if specific endpoints of a given study are described in another chapter (e.g. results on reproduction toxicity in case of a combined repeated dose / reproduction toxicity study) or if more than one experiment is described by the same study report, but included in separate records.
Check with the relevant guidance document whether all the methodology details must be repeated or whether a cross-reference to the same study in another chapter may suffice.
Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.
Indicate if study was in vivo or in vitro test. If in vitro test, describe study design in field "Any other information on materials and methods incl. tables". If a specific template for in vitro assays is provided include the data in that template instead.
Indicate according to which test guideline the study was conducted. If no test guideline was explicitly followed, but the methodology used is equivalent or similar to a specific guideline, you can indicate so in the "Qualifier" subfield preceding the field "Guideline".
Copy this block of fields for specifying more than one guideline (e.g. US EPA in addition to OECD guideline).
Table E.468. Field Descriptions
| Qualifier | Select appropriate qualifier, i.e. - "according to" (if a given test guideline was followed); - "equivalent or similar to" (if no test guideline was explicitly followed, but the methodology is equivalent or similar to a specific guideline); - "no guideline followed" (if none of above qualifiers apply. If so, fill in field "Principles of method if other than guideline"); - "no guideline available" (if so, fill in field "Principles of method if other than guideline"). - "no guideline required" (if so, fill in field "Principles of method if other than guideline"). |
| Guideline | Select the applicable test guideline, e.g. "OECD Guideline xxx". If the test guideline used is not listed, choose "other guideline:" and specify the test guideline in the related text field. In this text field, you can also enter any remarks as applicable, particularly: - To include any other title of the test guideline draft used, a subtitle, another version or update number and the year of update (For instance, different titles and/or numbers may exist for a given EU test guideline.); - To indicate if a the study was performed prior to the adoption of the test guideline specified; - To indicate if the methodology used was based on an extension of the test guideline specified. |
| Deviations from guideline (Deviations) | For robust study summaries or as requested by the regulatory programme, indicate if there are any deviations from the test guideline specified. If "yes" is selected, only briefly state relevant deviations in the supplementary remarks field (e.g. "other species used"); details should be described in the respective fields of the section MATERIALS AND METHODS. |
If no guideline was followed, include a description of the principles of the test protocol or estimated method used in the study. Details should be entered in appropriate distinct fields of section MATERIALS AND METHODS if available. Also provide a justification for using this method if appropriate.
If an estimation method was used (to be indicated in field "Test result type") state the equation(s) and/or computer software or other methods applied to calculate the value(s).
Indicate whether the study was conducted following Good Laboratory Practice or not. Select "yes (incl. certificate)" if a GLP certificate of a test facility is available. Select "yes" if a GLP compliance statement is available, but no information on a GLP certificate. You can give an explanation in the supplementary remarks field, e.g. for explaining why GLP was not complied with or for specifying which (national) GLP was followed.
Indicate if the test material used in the study is equivalent to the submission substance identity. If "yes" is selected, the corresponding identity is automatically entered in the subsequent block of fields "Test material identity".
If "no" is selected, identify the test material in the subsequent block of fields "Test material identity". In this case, also make sure that the information entered in field "Study result type" is consistent, i.e. "read-across from supporting substance (structural analogue or surrogate)".
NOTE: If a completed record is used for another submission, you may have to update both fields "Study result type" and "Test material equivalent to submission substance identity".
If the identity of the test material used for this study is not included in this block of fields automatically, indicate the identity for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.
If another than the submission substance identity was selected erraneously, go back to field "Test material equivalent to submission substance identity" and select "yes". This will prompt automatic entry of the respective identifiers.
Table E.469. Field Descriptions
| Identifier | Select an appropriate identifier from drop-down list, e.g. "CAS number". Use "Other:" and specify, if identity according to a standard identifier is not known or if an additional chemical name or number is provided. |
| Identity | Select the corresponding substance identity from drop-down list or enter manually if the identity is not available from the list or if no list is provided for the type of identifier selected. |
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Note that any information that can be claimed confidential should be included in the subsequent field "Confidential details on test material".
Explanations:
- Name of test material (as cited in study report): only if different from any other identifiers provided in the preceding fields.
- Molecular formula (if other than submission substance): specify
- Molecular weight (if other than submission substance): specify
- Smiles notation (if other than submission substance): provide if available
- InChl (if other than submission substance): provide if available
- Structural formula attached as image file (if other than submission substance): see Fig.: only if different from submission substance. Indicate Fig. no. if a file is attached in field "Attached document", e.g. state "see Fig. 1".
- Substance type: indicate whether pure active substance, technical product, formulation or other.
- Physical state: indicate "gas", "solid" or "liquid" only if different from submission substance or if substance can occur in different physical states.
- Analytical purity: specify in %
- Impurities (identity and concentrations): specify
- Composition of the test material, percentage of components: specify if applicable
- Isomers composition: specify if applicable
- Purity test date: provide if available
- Lot/batch No.: provide if available
- Expiration date of the lot/batch: provide if available
- Radiochemical purity (if radiolabelling): specify if applicable
- Specific activity (if radiolabelling): specify if applicable
- Locations of the label (if radiolabelling): specify if applicable
- Expiration date of radiochemical substance (if radiolabelling): specify if applicable
- Storage condition of test substance: specify if applicable
- Stability under test conditions: indicate if available
Enter any confidential information on the test material in this separate field. Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Explanations:
- Analytical purity: specify in %
- Impurities (identity and concentrations): specify
- Composition of the test material, percentage of components: specify if applicable
- Purity test date: provide if available
- Lot/batch No.: : provide if available
- Expiration date of the lot/batch: : provide if available
- Isomers composition: specify if applicable
Select strain as appropriate. If not available from picklist, select "other" and specify.
Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Explanations:
- Diet: Describe type of diet (e.g. conventional laboratory diet / caloric restriction) and whether it was provided ad libitum.
- Water: Describe type (e.g. drinking water) and whether it was provided ad libitum.
- IN-LIFE DATES: If required, specify the in-life dates (i.e. the phase of a study following treatment in which the test system is alive/growing).
Select as appropriate. If not available from picklist, select "other" and specify.
If route of administration is "inhalation", indicate type of inhalation exposure, e.g. "nose only". Any remarks can be entered in the supplementary remarks subfield.
Select "unchanged (no vehicle)" if none was used or select vehicle used if any. If not available from picklist, select "other" and specify.
Note that some of the vehicles provided in this list are used for specific routes of administration only.
Select freetext template for the respective route of administration and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
Indicate whether the doses or concentrations were analytically verified.
For robust study summaries or as requested by the regulatory programme, include a short description on the method of analysis in the supplementary remarks field. If any problems occurred in any of these procedures, then they should be reported in more detail. If this could have affected the veracity or conclusions of the study, discuss this in field "Rationale for reliability incl. deficiences".
Further route-dependent information to be included:
- For oral studies: State whether the analytical data indicated that the variance between nominal and actual dosage (if diet is route of administration) or concentrations (for drinking water study) was acceptable.
If diet is the route of administration, briefly record when and at what dose levels the dosage analyses were made and include the results (range of values) of (i) Homogeneity analysis, (ii) Stability analysis and (iii) Concentration analysis.It may be appropriate to include a cross-reference to another study in which stability analysis was performed and reported. If so, a justification should also be included briefly explaining the rationale of referring to another study.
- For inhalation studies: State whether the analytical data indicated that the variance between nominal and actual concentrations was acceptable.
- For dermal studies: State whether the analytical data indicated that the variance between nominal and actual concentrations of the test substance in the vehicle was acceptable.
Indicate duration of administration / exposure in days of pregnancy counting from day 0 of pregnancy, i.e. 6-14 days pc, 6-17 days pc, 6-18 days pc or other.
Indicate the frequency of the administration of doses to the test animals (e.g., "daily, 7 days each week"). Use of non-standard dosing regime (e.g. a five-day per week regime) should be justified.
Indicate the dose or concentration levels applied and the basis of quantity used. Copy this block of fields if the dose/concentration levels were determined on more than one basis of quantity as appropriate.
Table E.470. Field Descriptions
| Doses / concentrations (no label) | Indicate the doses or concentrations including unit applied to the test animals, e.g. 0, 112, 220, 523 mg/kg bw/day. You may enter explanatory text. |
| Basis | Indicate whether doses/concentrations are based on nominal or actually ingested or analytically measured values. In the supplementary remarks field provide further details as appropriate, e.g. state whether dosing was based on body weight on the most recent body weight determination or on a specific gestation day. |
Depending on type of study specify either number of dams or number of males and females.
Indicate whether and what type of concurrent control groups were used. If not available from picklist, select "other" and specify. Copy field if more than one type of control was used.
Give details on the study design. As an option you may include an excerpt from the study report.
In this field, you can enter any information on materials and methods, for which no distinct field is available, or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.
Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.
Record effect levels, based on different endpoints and/or separated for each generation and/or sex. Copy this block of fields as appropriate.
Table E.471. Field Descriptions
| Endpoint | Select type of endpoint, normally NOAEL/NOAEC or LOAEL/LOAEC. If adverse effects were observed at the highest dose tested, select "no NOAEL identified" or "no NOAEC identified". If a benchmark dose / concentration was calculated, select "BMD" or "BMC" and specify (e.g. "10% response") in the supplementary remarks field. If the critical effects at a specific concentration level are reported only, select "dose level" or "conc. level" and specify in the supplementary remarks field. |
| Effect level | Enter a numeric value or a range of numeric values according to following conventions: (i) In the first numeric field, enter a single value (Qualifier subfield left blank) or a value if preceded by ">", ">=" or "ca." (e.g. "20", "ca. 20", ">20"). (ii) In the second numeric field, enter a single value if preceded by "<" or "<=". (iii) Use both numeric fields and, as required, the lower and upper qualifier field to enter a range of numeric values (e.g. "2 - 8" or ">2 <8"). |
| Unit of dose (no label) | Select unit of dose or concentration as appropriate. |
| Sex | Select from drop-down list. |
| Basis for effect level / Remarks | Indicate the parameter(s) used to establish the given effect level. |
In this field, you can enter any other remarks on results. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.
Note: Both the "Materials and methods" section and "Results" section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.
In this field, you can enter any overall remarks or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.
Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields "Overall remarks" and "Executive summary" allow rich text entry.
Attach any background document that cannot be inserted in any rich text editor field, particularly image files (e.g. an image of a structural formula).
Copy this block of fields for attaching more than one file.
Table E.472. Field Descriptions
| Attached document | Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document. |
| Remarks | As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory. |
If required, an electronic copy of the full study report can be attached as WORD, pdf or other document type, which will not be integrated in any report, but must be handled as separate files.
Note: In the export administration you can indicate whether the attached files should be included in the data export or not.
If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the conclusions reached. If a specific format is prescribed, upload the respective freetext template if available from the drop-down list or copy it from the corresponding document.
Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.
A Cross-reference to other study or other studies can be included which are considered relevant in the interpretation of the test results, e.g. for supporting the conclusion that an effect observed was not substance-related. Indicate the respective chapter(s) and record ID(s) and enter relevant explanatory text.
Such cross-references may be useful if it is considered relevant to discuss other results at the summary level of a single study. It should be noted that the overall appraisal of results from different studies is normally done in the hazard or risk assessment.
Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.