E.7.12. [7.11] Toxic effects on livestock and pets

E.7.12.2.1. Administrative data

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.

E.7.12.2.2. Reference

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.510. 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 Select "Other company data" to characterise any unpublished information from a company other than a study report. Select "Grey literature" for any other unpublished information or "other:" and specify.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.

E.7.12.2.3. Data access

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.

E.7.12.2.4. Data protection claimed

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")

E.7.12.2.5. Cross-reference to same study

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.

E.7.12.2.6. Limit test

Indicate if the experiment was a limit test.

E.7.12.2.7. Test guideline

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.511. 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.

E.7.12.2.8. Principles of method if other than guideline

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).

E.7.12.2.9. GLP compliance

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.

E.7.12.2.10. Reason/justification of study

Briefly describe the reason and justification why toxicity testing with livestock or pets was done. For example, state that the test was required because the substance in question is used in spaces in which animals are housed, kept or transported or exposure is possible via drinking water or feedingstuffs. It should also be stated whether the purpose of the test was to establish an adequate margin of safety (rather than a NOEL of toxicity) and that non-lethal doses were selected (if so).

If the information presented is an estimation of toxic effects based on other available data (as should be indicated in field "Test result type", use either any of the specific fields (as far as possible) or include the information in fields "Remarks: method and test conditions", "Remarks: results" and/or "Remarks: any other information" as appropriate. This information may include data on adverse incidents in farm animals and pets.

E.7.12.2.11. Test material equivalent to submission substance identity

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".

E.7.12.2.12. Test material 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.512. 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.

E.7.12.2.13. Details on test material

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

E.7.12.2.14. Confidential details on test material

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

E.7.12.2.15. Species

Select name of species. If not available from picklist, select "other" and specify.

E.7.12.2.16. Sex

Select as appropriate.

E.7.12.2.17. Details on test animals and environmental conditions

Enter any details that could be relevant for evaluating this study summary. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

E.7.12.2.18. Route of exposure

Indicate to which route of exposure the information or description of experimenta study refers to.

E.7.12.2.19. Vehicle

Select the vehicle used. If not available from picklist, select "other" and specify. If no vehicle was used, select "unchanged (no vehicle)".

Note that some of the vehicles provided in this list are used for specific routes of administration only.

E.7.12.2.20. Details on exposure

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.

E.7.12.2.21. Analytical verification of doses or concentrations

Indicate whether the doses or concentrations were analytically verified.

E.7.12.2.22. Details on analytical verification of doses or concentrations

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.

E.7.12.2.23. Duration of treatment / exposure

Indicate duration in days, weeks or months, e.g. "5 days" or "10 weeks".

E.7.12.2.24. Frequency of treatment

Indicate the frequency of the administration of doses to the test animals (e.g., "once" or "daily injections" or "2 doses per day, 7 days per week"). Use of non-standard dosing regime (e.g. a five-day per week regime) should be justified.

E.7.12.2.25. Post exposure period

Indicate observation period (in days, weeks, months) after last exposure to the test material.

E.7.12.2.26. Doses / concentrations

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.513. 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.7.12.2.27. No. of animals per sex per dose

Enter value or specify if different number of animals were used per sex and/or dose level.

E.7.12.2.28. Control animals

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.

E.7.12.2.29. Further details on study design

Include any details on the study design including a brief description of the rationale for dose selection, animal assignment and selection of satellite groups including the duration of the post-exposure recovery period. 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.

E.7.12.2.30. Observations and examinations performed and frequency

Indicate if and which examinations were performed and the time schedule for those examinations. 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").

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.

E.7.12.2.31. Sacrifice and pathology

Indicate if and which examinations were performed. Also indicate the dose groups that were examined if not all. Note if not all collected tissues were examined. 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").

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.

E.7.12.2.32. Other examinations

Describe any other examinations.

E.7.12.2.33. Statistics

List parameters that were analysed and the statistical methods used; include a statement that the Reviewer considers the analyses used to be appropriate. If inappropriate, provide alternative/rationale.

E.7.12.2.34. Any other information on materials and methods incl. tables

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.

E.7.12.2.35. Clinical signs and mortality

Indicate whether any treatment-related effects were observed. In below field "Details on results", 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.