ADMINISTRATIVE DATA

REMARKS:

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 may therefore be displayed on top of each template. For detailed guidance, refer to Administrative data.

SE07.09.01.0215

DATA SOURCE

[Data source]

Main heading under which generic 'Data source' fields are subsumed.

SE07.09.01.0219

Reference

[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.

Heading of field block 'Reference'

SE07.09.01.0220

Reference type

[Reference type]

Picklist Values:

study report || other company data || publication || review article or handbook || secondary source || grey literature || other:

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 Select 'Other company data' to characterise any unpublished information from a company other than a study report. Select 'Grey literature' for any other unpublished information or 'other:' and specify.

Indicator specifying the type of reference, e.g. 'Study report' or 'Publication'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE07.09.01.0221

Reference type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE07.09.01.0230

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.

Name(s) of author(s) of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE07.09.01.0240

Year

[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'.

Year of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE07.09.01.0250

Title

[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).

Title of a study report or title of published article of journal or book (e.g. handbook).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE07.09.01.0260

Bibliographic source

[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.

Bibliographic source of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE07.09.01.0270

Testing laboratory

[Testing laboratory]

Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible.

Name of the testing laboratory.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE07.09.01.0280

Report no.

[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.

Report number allocated by the testing laboratory.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE07.09.01.0290

Owner company

[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.

Identity of the sponsor company who owns the study report.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE07.09.01.0300

Company study no.

[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.

Company-specific study number.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE07.09.01.0310

Report date

[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.

Complete date of the study report.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE07.09.01.0320

Data access

[Data access]

Picklist Values:

data submitter is data owner || data submitter has Letter of Access || data no longer protected || data published || not applicable || other:

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.

Indication for data access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.09.01.0321

Data access

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.01.0330

Data protection claimed

[Data protection claimed]

Picklist Values:

yes || yes, but willing to share || yes, but not willing to share

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')

Indication if data protection is claimed by the submitter who has to be data owner or have letter of access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.09.01.0331

Data protection claimed

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.09.01.0340

Cross-reference to same study

[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.

Indication that the same study is described in another study summary / chapter of the data set.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.09.01.0345

MATERIALS AND METHODS

[Materials and methods]

Main heading under which generic 'Materials and methods' fields are subsumed.

SE07.09.01.0350

Test type

[Test type]

Picklist Values:

acute || subacute || subchronic || chronic || developmental || other:

Select appropriate test type. Note: This field may be redundant with the information given in field 'Guideline', but is considered useful for searching reasons.

Indicator showing whether the study was an acute, subacute, subchronic or chronic or other.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:TESTTYPE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.09.01.0351

Test type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:TESTTYPE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.01.0360

Limit test

[Limit test]

Picklist Values:

yes || no

Indicate if the experiment was a limit test.

An indicator that the experiment was a limit test.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:LIMIT_TEST>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE07.09.01.0369

Test guideline

[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).

Heading of field block 'Guideline'

SE07.09.01.0370

Qualifier

[Qualifier]

Picklist Values:

according to || equivalent or similar to || no guideline followed || no guideline available || no guideline required

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').

An indicator signifying how strict the guideline given in the subsequent field 'Guideline' was followed or whether no guideline was used or available/required.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE07.09.01.0380

Guideline

[Guideline]

Picklist Values:

OECD Guideline 418 (Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure) || OECD Guideline 419 (Delayed Neurotoxicity of Organophosphorus Substances: 28-Day Repeated Dose Study) || OECD Guideline 424 (Neurotoxicity Study in Rodents) || OECD Guideline 426 (Developmental Neurotoxicity Study) || EU Method B.37 (Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure) || EU Method B.38 (Delayed Neurotoxicity of Organophosphorus Substances 28-Day Repeated Dose Study) || EU Method B.43 (Neurotoxicity Study in Rodents) || EPA OPP 81-7 (Delayed Neurotoxicity of Organophosphorus Substances Following Acute and 28-Day Exposure) || EPA OPP 81-8 (Neurotoxicity Screening Battery) || EPA OPP 83-6 (Developmental Neurotoxicity Study) || EPA OPP 85-5 (Schedule-Controlled Neurotoxicity Study) || EPA OPP 85-6 (Peripheral Nerve Function) || EPA OPPTS 870.3600 (Inhalation Developmental Toxicity Screen) || EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study) || EPA OPPTS 870.6100 (Acute and 28-Day Delayed Neurotoxicity of Organophosphorus Substances) || EPA OPPTS 870.6200 (Neurotoxicity Screening Battery) || EPA OPPTS 870.6300 (Developmental Neurotoxicity Study) || EPA OPPTS 870.6500 (Schedule-Controlled Neurotoxicity Study) || EPA OPPTS 870.6850 (Peripheral Nerve Function) || EPA OPPTS 870.6855 (Neurophysiology: Sensory Evoked Potentials) || EPA OTS 795.2500 (Developmental Neurotoxicity Screen) || EPA OTS 798.6050 (Neurotoxicity Screening Battery) || EPA OTS 798.6450 (Acute and 28-Day Delayed Neurotoxicity of Organophosphorus Substances) || EPA OTS 798.6500 (Schedule-Controlled Neurotoxicity Study) || EPA OTS 798.6540 (Acute and 28-Day Delayed Neurotoxicity of Organophosphorus Substances) || EPA OTS 798.6560 (Acute and 28-Day Delayed Neurotoxicity of Organophosphorus Substances) || EPA OTS 798.6850 (Peripheral Nerve Function) || EPA OTS 798.6855 (Neurophysiology: Sensory Evoked Potentials) || other 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.

The name of the guideline followed in performing the study or to which the method used can be compared. Also indication if no guideline was used, available or required. In supplementary remarks field indication of guideline version, or title if deviating from the picklist value, or of additional test guidelines cited.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE07.09.01.0381

Guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE07.09.01.0390

Deviations from guideline

[Deviations]

Picklist Values:

yes || no || no data || not applicable

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.

Indication that a study contains deviations from the standard test protocol.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE07.09.01.0391

Deviations from guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE07.09.01.0400

Principles of method if other than guideline

[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 'Study result type') state the equation(s) and/or computer software or other methods applied to calculate the value(s).

Description of the test protocol or estimated method used in the study, if other than a guideline, and justification for using this method if appropriate.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.09.01.0410

GLP compliance

[GLP compliance]

Picklist Values:

yes (incl. certificate) || yes || no || no data

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.

Indication whether a GLP certificate or compliance statement is available.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.01.0411

GLP compliance

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.01.0415

Test materials

[Test materials]

Subheading of section 'Test materials'

SE07.09.01.0420

Test material equivalent to submission substance identity

[Identity of test material same as for substance defined in section 1 (if not read-across)]

Picklist Values:

yes || no

Select 'yes' or 'no' from the drop-down list for indicating that the identity of the test material is the same or is not the same, respectively, as for substance defined in section 1 (General information). In addition, the identity of the test material should be specified in the subsequent block of fields 'Test material identity'.

NOTE: You cannot update this field, if a completed record is copied to another submission substance as reference. Therefore, in case of read-across the indication of 'yes' is not relevant.

Indicator showing whether the test material used is equivalent to the submission substance identity.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE07.09.01.0429

Test material identity

[Test material identity]

Indicate the identity of the test material for one or more appropriate identifiers, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields as appropriate.

NOTE: In order to avoid confusion on the test material identity it is highly recommended to enter at least one substance identifier, regardless of what has been entered in field 'Identity of test material same as for substance defined in section 1 (if not read-across)'.

Heading of field block 'Test material identity'

SE07.09.01.0430

Identifier

[Identifier]

Picklist Values:

CAS name || CAS number || Common name || EC name || EC number || IUPAC name || TSCA name || other:

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.

Indicator specifying the type of chemical identifier, e.g. CAS name.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE07.09.01.0431

Identifier

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE07.09.01.0440

Identity

[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.

Identity of the chemical substance used in the study or referred to in the record.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE07.09.01.0445

Physical form

[Test material form]

Picklist Values:

aerosol || compact || crystalline || dispersion || fibre || filaments || flakes || liquified gas || nanomaterial || particulates || paste || pellets || powder || refrigerated liquid || suspension || viscous || other: || no data

Select the test material form from the drop-down list. If the form of the test chemical is not available in the list, select 'other:' and specify in the adjacent field. If the test material form is unknown, select 'no data'.

Form of the substance, i.e. powder, crystalline, compact, viscous, etc.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE07.09.01.0446

Test material form

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE07.09.01.0450

Details on test material

[Details on test material]

Freetext Templates:

- Name of test material (as cited in study report):

- Molecular formula (if other than submission substance):

- Molecular weight (if other than submission substance):

- Smiles notation (if other than submission substance):

- InChl (if other than submission substance):

- Structural formula attached as image file (if other than submission substance): see Fig.

- Substance type:

- Physical state:

- Analytical purity:

- Impurities (identity and concentrations):

- Composition of test material, percentage of components:

- Isomers composition:

- Purity test date:

- Lot/batch No.:

- Expiration date of the lot/batch:

- Radiochemical purity (if radiolabelling):

- Specific activity (if radiolabelling):

- Locations of the label (if radiolabelling):

- Expiration date of radiochemical substance (if radiolabelling):

- Stability under test conditions:

- Storage condition of test material:

- Other:

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

Details on description and specification of the actual test material.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.01.0460

Confidential details on test material

[Confidential details on test material]

Freetext Templates:

- Analytical purity:

- Impurities (identity and concentrations):

- Composition of test material, percentage of components:

- Purity test date:

- Lot/batch No.:

- Expiration date of the lot/batch:

- Isomers composition:

- Other:

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

Confidential details on the actual test material.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.01.0465

Test animals

[Test animals]

Subheading of section 'Test animals'

SE07.09.01.0470

Species

[Species]

Picklist Values:

mouse || rat || cat || cattle || dog || gerbil || guinea pig || hamster || hamster, Armenian || hamster, Chinese || hamster, Syrian || hen || miniature swine || monkey || pig || primate || rabbit || sheep || other:

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

Organism/cell culture used in the experiment.

<i5:EndpointStudyRecord>

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<i5:TO_NEUROTOX>

<i5:ORGANISM>

<i5:set>

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<i5:LIST_POP>

SE07.09.01.0471

Species

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.01.0480

Strain

[Strain]

Picklist Values:

Sencar || Zucker || Beagle || Abyssinian || Dunkin-Hartley || Hartley || Peruvian || Pirbright-Hartley || Shorthair || Macaca fascicularis || Marmoset || Mulatta arctoides || AKR || B6C3F1 || Balb/c || C3H || C57BL || CAF1 || CB6F1 || CBA || CD-1 || CF-1 || DBA || DBF1 || FVB || ICL-ICR || ICR || NMRI || Nude Balb/cAnN || Nude CD-1 || Tif:MAGf || SIV 50 || SKH/HR1 || Strain A || Swiss || Swiss Webster || Angora || Belgian Hare || Californian || Chinchilla || Dutch || Flemish Giant || Himalayan || New Zealand Black || New Zealand Red || New Zealand White || Polish || San Juan || Vienna White || Brown Norway || Crj: CD(SD) || Fischer 344 || Fischer 344/DuCrj || Lewis || Long-Evans || Osborne-Mendel || Sherman || Sprague-Dawley || Wistar || Wistar Kyoto (WKY) || other: || no data

Select strain as appropriate. If not available from picklist, select 'other' and specify.

The strain of the animal tested.

<i5:EndpointStudyRecord>

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<i5:STRAIN>

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<i5:LIST_POP>

SE07.09.01.0481

Strain

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:STRAIN>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.01.0490

Sex

[Sex]

Picklist Values:

female || male || male/female || no data

Select as appropriate.

Sex of the tested animals.

<i5:EndpointStudyRecord>

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<i5:TO_NEUROTOX>

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SE07.09.01.0500

Details on test animals and environmental conditions

[Details on test animals and environmental conditions]

Freetext Templates:

TEST ANIMALS

- Source:

- Age at study initiation:

- Weight at study initiation:

- Fasting period before study:

- Housing:

- Diet (e.g. ad libitum):

- Water (e.g. ad libitum):

- Acclimation period:

ENVIRONMENTAL CONDITIONS

- Temperature (°C):

- Humidity (%):

- Air changes (per hr):

- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

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).

Details on test organisms and environmental conditions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

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<i5:set>

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SE07.09.01.0505

Administration / exposure

[Administration / exposure]

Subheading of section 'Administration / exposure'

SE07.09.01.0510

Route of administration

[Route of administration]

Picklist Values:

oral: gavage || oral: capsule || oral: feed || oral: drinking water || oral: unspecified || inhalation: aerosol || inhalation: dust || inhalation: gas || inhalation: vapour || inhalation || dermal || implantation || infusion || intramuscular || intraperitoneal || intratracheal || intravenous || subcutaneous || other:

Select as appropriate. If not available from picklist, select 'other' and specify.

Indicator how the chemical was administered to the test animals.

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<i5:LIST_POP>

SE07.09.01.0511

Route of administration

[no label]

<i5:EndpointStudyRecord>

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<i5:TO_NEUROTOX>

<i5:ROUTE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.01.0520

Vehicle

[Vehicle]

Picklist Values:

unchanged (no vehicle) || acetone || air || arachis oil || beeswax || carbowaxe || castor oil || cetosteryl alcohol || cetyl alcohol || clean air || CMC (carboxymethyl cellulose) || coconut oil || corn oil || cotton seed oil || DMSO || ethanol || glycerol ester || glycolester || hydrogenated vegetable oil || lecithin || macrogel ester || maize oil || olive oil || oxygen || paraffin oil || peanut oil || petrolatum || physiol. saline || poloxamer || polyethylene glycol || propylene glycol || silicone oil || sorbitan derivative || soya oil || theobroma oil || vegetable oil || water || other: || no data

Select 'unchanged (no vehicle)' if none was used or select vehicle used if any. If not available from picklist, select 'other' and specify. Further information can be given in the supplementary remarks field.

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

Identity of the vehicle used.

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<i5:LIST_POP_FIX>

SE07.09.01.0521

Vehicle

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:VEHICLE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.09.01.0530

Details on exposure

[Details on exposure]

Freetext Templates:

PREPARATION OF DOSING SOLUTIONS:

DIET PREPARATION

- Rate of preparation of diet (frequency):

- Mixing appropriate amounts with (Type of food):

- Storage temperature of food:

VEHICLE

- Justification for use and choice of vehicle (if other than water):

- Concentration in vehicle:

- Amount of vehicle (if gavage):

- Lot/batch no. (if required):

- Purity:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Exposure apparatus:

- Method of holding animals in test chamber:

- Source and rate of air:

- Method of conditioning air:

- System of generating particulates/aerosols:

- Temperature, humidity, pressure in air chamber:

- Air flow rate:

- Air change rate:

- Method of particle size determination:

- Treatment of exhaust air:

TEST ATMOSPHERE

- Brief description of analytical method used:

- Samples taken from breathing zone: yes/no

VEHICLE (if applicable)

- Justification for use and choice of vehicle:

- Composition of vehicle:

- Type and concentration of dispersant aid (if powder):

- Concentration of test material in vehicle:

- Lot/batch no. of vehicle (if required):

- Purity of vehicle:

TEST SITE

- Area of exposure:

- % coverage:

- Type of wrap if used:

- Time intervals for shavings or clipplings:

REMOVAL OF TEST SUBSTANCE

- Washing (if done):

- Time after start of exposure:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit):

- Concentration (if solution):

- Constant volume or concentration used: yes/no

- For solids, paste formed: yes/no

VEHICLE

- Justification for use and choice of vehicle (if other than water):

- Amount(s) applied (volume or weight with unit):

- Concentration (if solution):

- Lot/batch no. (if required):

- Purity:

USE OF RESTRAINERS FOR PREVENTING INGESTION: yes/no

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.

Details on exposure.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:EXP_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.01.0540

Analytical verification of doses or concentrations

[Analytical verification of doses or concentrations]

Picklist Values:

yes || no || no data

Indicate whether the doses or concentrations were analytically verified.

Indicator whether doses or concentrations were analytically verified.

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<i5:scientificPart>

<i5:TO_NEUROTOX>

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<i5:LIST_BELOW_SEL>

SE07.09.01.0550

Details on analytical verification of doses or concentrations

[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. deficiencies'.

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.

Details on analytical verification of doses or concentrations

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<i5:TO_NEUROTOX>

<i5:ANALYT_VERIF_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.09.01.0560

Details on mating procedure (for developmental toxicity study)

[Details on mating procedure (for developmental toxicity study)]

Freetext Templates:

- Impregnation procedure: [artificial insemination / purchased timed pregnant / cohoused]

- If cohoused:

- M/F ratio per cage:

- Length of cohabitation:

- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.

- Further matings after two unsuccessful attempts: [no / yes (explain)]

- Verification of same strain and source of both sexes: [yes / no (explain)]

- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy

- Any other deviations from standard protocol:

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.

Details on mating procedure

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:MATING_PROCEDURES_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.01.0570

Duration of treatment / exposure

[Duration of treatment / exposure]

Indicate duration in days, weeks or months, e.g. '28 days' or '18 months'.

Exposure duration including unit.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:EXP_PERIOD>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.09.01.0580

Frequency of treatment

[Frequency of treatment]

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.

Description of the administration of doses to the test animals (e.g., n doses per day, n days per week).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:FREQUENCY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.09.01.0589

Doses / concentrations

[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.

Heading of field block 'Doses / concentrations'.

SE07.09.01.0590

Doses / concentrations

[Doses / concentrations]

Indicate the doses or concentrations including unit applied to the test animals, e.g. '0, 112, 220, 523 mg/kg bw/day (m/f)' or '0, 112, 220, 523 mg/kg bw/day (m); 0, 87, 198, 477 mg/kg bw/day (f)'. You may enter explanatory text.

Dose(s) or concentration(s) tested/administered including unit.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:DOSES>

<i5:set>

<i5:CONCENTRATIONS>

<i5:CONCENTRATIONS>

SE07.09.01.0600

Basis

[Basis]

Picklist Values:

nominal in diet || nominal in water || actual ingested || nominal conc. || analytical conc. || other: || no data

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.

Indicator showing whether the doses/concentrations given are based on nominal or actually ingested values or nominal or analytical concentrations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:DOSES>

<i5:set>

<i5:PHRASEOTHER_BASIS>

<i5:BASIS>

SE07.09.01.0601

Basis

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:DOSES>

<i5:set>

<i5:PHRASEOTHER_BASIS>

<i5:BASIS_TXT>

SE07.09.01.0610

No. of animals per dose group

[No. of animals per sex per dose]

REMARKS:

Available predefined table(s) are displayed below, after this template. See also List of Predefined Tables in Annex 2.

Enter value or specify according to dose if different number of animals per dose or test, e.g. '10 in each dose group of FOB'.

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').

For a developmental neurotoxicity study it should be noted: The method of animal assignment should have minimized potential problems related to litter effects, i.e., by using one pup/sex/litter (or one measure/litter, e.g., mean body weight for each litter).

When allocating animals to FOB and motor activity testing, the same individual animals should have been evaluated at all scheduled time points.

For the selection of animals and testing paradigms for cognitive (learning and memory) assessment, it is important to ensure that tasks were selected and/or animals allocated so that comparable assessments of learning were made at both times, i.e., shortly after PND 21 and around PND 60. Indicate whether the same or different animals were used for assessments at the weanling and adult ages. In general, the use of separate animals at the two time points is preferred, because for many tasks, initial learning (PND 21) may confound later (PND 60) assessment of learning. If the same animals were used at both times, different tasks would likely have been necessary. The selection of the test for assessing learning should have been adequately justified regardless of whether the same or a different task was used.

The number of organisms dosed at each dose level of the study.

<i5:EndpointStudyRecord>

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<i5:TO_NEUROTOX>

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SE07.09.01.0619

Control animals

[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.

Indication whether and what type of concurrent control groups were used.

SE07.09.01.0620

Control animals

[Control animals]

Picklist Values:

yes || yes, concurrent no treatment || yes, concurrent vehicle || yes, plain diet || yes, sham-exposed || yes, historical || no || no data || other:

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.

Indication whether and what type of concurrent control groups were used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.09.01.0621

Control animals

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.01.0630

Further details on study design

[Further details on study design]

Freetext Templates:

- Dose selection rationale:

- Rationale for animal assignment (if not random):

- Rationale for selecting satellite groups:

- Post-exposure recovery period in satellite groups:

- Other:

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.

For a developmental neurotoxicity study it should be noted: Dose selection rationale should be discussed, including information from the prenatal developmental or two-generation reproduction studies, if applicable. Any pilot study data (including biomarker data, such as cholinesterase activity) or pharmacokinetic data (e.g., milk or blood levels of test substance, or data that established time of peak effect) should be described in detail. If these data were submitted in a separate study report, the methods and results (including detailed tables of analytical results) should be presented in a separate record (include a reference in field 'Cross-reference to same study' or 'Cross-reference to other study' as applicable); alternatively, they could be appended to this record.

Further details on study design.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:STUDY_DESIGN_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.01.0635

Examinations

[Examinations]

Subheading of section 'Examinations'

SE07.09.01.0640

Observations and clinical examinations

[Observations and clinical examinations performed and frequency]

Freetext Templates:

CAGE SIDE OBSERVATIONS: Yes / No / No data

- Time schedule:

- Cage side observations checked in table [No.?] were included.

DETAILED CLINICAL OBSERVATIONS: Yes / No / No data

- Time schedule:

BODY WEIGHT: Yes / No / No data

- Time schedule for examinations:

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):

- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data

- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data

- Time schedule for examinations:

OPHTHALMOSCOPIC EXAMINATION: Yes / No / No data

- Time schedule for examinations:

- Dose groups that were examined:

OTHER:

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. When tabulating parameters examined, refer to respective table no.

If other observations (e.g. haematology) are reported in another study summary (e.g. repeated dose toxicity), include a note in field 'Cross-reference to same study' and refer to that summary.

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.

Details on clinical examinations performed and frequency.

<i5:EndpointStudyRecord>

<i5:scientificPart>

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SE07.09.01.0650

Specific biochemical examinations

[Specific biochemical examinations]

Freetext Templates:

NEUROPATHY TARGET ESTERASE (NTE) ACTIVITY: Yes / No / No data

- Time schedule for examinations:

- How many animals:

- Method of sample collection and processing:

- Tissues used:

- Animals fasted: Yes / No / No data

- Description of methodology for NTE determination:

- Other:

CHOLINESTERASE ACTIVITY: Yes / No / No data

- Time schedule for examinations:

- How many animals:

- Method of sample collection and processing:

- Tissues used:

- Animals fasted: Yes / No / No data

- Description of methodology for NTE determination:

- Other:

OTHER:

If specific biochemical determinations were made, provide details on the sampling, the tissues tested (e.g. plasma, whole blood, RBCs, brain (whole brain or regions)) and methodology. When tabulating parameters examined, refer to respective table no.

Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). 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.

Details on specific biochemical examinations, i.e. neuropathy target esterase and cholinesterase activity.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:EXAM_BIOCHEMISTRY>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.01.0660

Neurobehavioural examinations performed and frequency

[Neurobehavioural examinations performed and frequency]

Freetext Templates:

FUNCTIONAL OBSERVATIONAL BATTERY: Yes / No / No data

- Parameters checked in table [No.?] were examined.

- Description of procedures:

- Minimization of bias:

- Same technicians used throughout testing: Yes / No / No data

- Technicians were blind to treatment status of animals: Yes / No / No data

- Site of testing:

- Time schedule for examinations:

- Environmental conditions:

- Noise level:

- Other:

- Scoring criteria (if any):

- Duration of observation period for open field observations:

- Description of equipment where required:

Additional information for developmental neurotoxicity study:

- Number of offspring/sex/group examined on postnatal days (unless given in animal assignment table) outside the home cage:

- Description of procedures used for each age at which offspring were examined: [adjustments for developmental age / other: ]

- Same offspring evaluated at each time point: [no (describe/justify) / yes]

- Same parameters assessed in the maternal FOB examined for offspring:

LOCOMOTOR ACTIVITY: Yes / No / No data

- Replicates used:

- Type of equipment used:

- Length of session, number and length of subsessions:

- Parameters measured:

- Total activity:

- Ambulatory activity:

- Large movements:

- Small movements

- Other:

Additional information for developmental neurotoxicity study:

- Number and age of offspring/sex/group examined (unless given in animal assignment table) and days of evaluation:

- Description of procedures used for each age at which offspring were examined: [adjustments for developmental age / other: ]

- Same offspring evaluated at each preweaning time point: [no (describe/justify) / yes]

- Same parameters assessed in the maternal FOB examined for offspring:

Additional testing required for developmental neurotoxicity studies:

AUDITORY STARTLE REFLEX HABITUATION: Yes / No / No data

- Number of animals: [..] offspring per sex and dose

- Days of testing: postnatal days [..] and [..]

- Same offspring evaluated at each preweaning time point: [no (describe/justify) / yes]

- Exact age:

- Type of equipment used:

- Environmental conditions:

- Number of trials performed:

- Length (msec) and intensity (dB) of sound:

- Length of interval between trials:

- Other procedural details:

LEARNING AND MEMORY TESTING: Yes / No / No data

(1) Overall testing design

- Number of animals: [..] offspring per sex and dose

- Days of testing:

- Evaluation of both short and long term recall: [yes/no]

(2) Equipment used

- Type of equipment (including manufacturer, if available):

- Environmental conditions:

(3) Testing and training procedures

- Number of trials per day:

- Number of days of testing:

- Changes across days:

- Inter-trial intervals:

- Stimulus parameters:

- Use of cut-off times or error correction procedures:

- Definition of errors:

- Learning criteria:

(4) Control procedures

- Swim speed in straight alley:

- Swimming angle development:

(5) Performance measures

- Number of errors or trials to criterion:

- Time or latency to reach goal:

- Performance on 'probe trials':

Provide details on the neurobehavioural examinations performed and frequency. Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). 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.

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).

Details on neurobehavioural examinations performed and frequency.

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SE07.09.01.0670

Sacrifice and (histo)pathology

[Sacrifice and (histo)pathology]

Freetext Templates:

- Time point of sacrifice:

- Number of animals sacrificed:

- Parameters measured:

- Brain weight:

- Length and width of brain:

- Other:

- Procedures for perfusion:

- Number of animals perfused:

- Tissues evaluated: Parameters checked in table [No.?] were examined.

- Type of staining:

- Methodology of preparation of sections:

- Thickness:

- Embedding media:

- Number of sections:

- Number of animals evaluated from each sex and treatment group:

MATERNAL ANIMALS

- Time point of sacrifice or discard without postmortem examination:

- Method of sacrifice:

- Description of any postmortem evaluations conducted:

- Necropsy:

- Brain weight:

- Other organ weights:

- Histopathology:

- Other:

OFFSPRING

- Time point of sacrifice of offspring selected for brain weight or neuropathological evaluation: postnatal day [# ] or [# ]

- Description of postmortem examinations:

- At postnatal day 11 [or 22], ten pups/sex/group were selected for brain weight measurements [describe specifics, e.g., whole brain, forebrain, and hindbrain, whether brain was weighed pre- or post-fixation].

- The brains from [# ] of these pups/sex/group were immersion fixed and embedded in paraffin, blocked, sectioned, and stained with hematoxylin and eosin. [Adjust procedures as necessary if pups are sacrificed on PND 22; it is preferred that PND 22 pups be perfusion-fixed.]

- Histopathological examination was performed on tissues from control and high-dose pups.

- Detailed morphometric evaluation of the neocortex, hippocampus, and cerebellum [add other regions, if examined] was conducted. [Provide details of blocking, sectioning, and staining procedures and how far each dose group was processed. Describe specific morphometric measures taken. Describe qualitative or quantitative evaluation of low- and mid-dose groups, if conducted.]

- On postnatal day [#] [insert exact age], [# ] animals/sex/group were euthanized and perfused with [identify perfusion fixative] for brain weight measurements and/or neuropathology. Brains from these animals were weighed [and measured for length and width] [describe any other specifics].

- From [# ] of these animals/sex/group, the following central and peripheral nervous tissues (X) were dissected, preserved in paraffin (CNS tissues) or plastic (PNS tissues), blocked, sectioned, and stained with hematoxylin and eosin.

- Histopathological evaluation was performed on tissues from males and females in the control and high dose groups.

- Detailed morphometric evaluation of the neocortex, hippocampus, and cerebellum [add other regions, if examined] was conducted. [Provide details of blocking, sectioning, and staining procedures, including any additional stains used. Describe specific morphometric measures taken. Describe qualitative or quantitative evaluation of low- and mid-dose groups, if conducted.]

Indicate details on gross pathological and histopathological examinations. Also indicate those dose groups which were examined.

Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). 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.

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).

Specific guidance for acute or subchronic neurotoxicity:

Indicate when and how were animals sacrificed, how many were perfused, what parameters were measured (e.g. brain weight, length and width), what were the procedures for perfusion, what tissues were evaluated, what type of staining was used, how were sections prepared (thickness, embedding media, number of sections). How many animals from each sex and treatment group were evaluated?

Specific guidance for developmental neurotoxicity studies: see freetext template.

Tables are optional, particularly for postmortem examinations of the offspring and the specific morphometric measures taken.

Further details on sacrifice and pathology

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SE07.09.01.0680

Litter observations (for developmental neurotoxicity study)

[Litter observations]

Freetext Templates:

DEVELOPMENTAL LANDMARKS

- Beginning on postnatal day [#], male offspring were examined daily for balanopreputial separation.

- Beginning on postnatal day [#], female offspring were examined daily for vaginal patency. The age of onset was recorded.

- Detailed description of any other developmental landmarks (if included in the study report):

Developmental landmark [....]:

- Postnatal day(s) of pup examination:

- Number of offspring assigned to evaluation:

- Evaluation criteria:

Developmental landmark [....]:

- Postnatal day(s) of pup examination:

- Number of offspring assigned to evaluation:

- Evaluation criteria:

POSTWEANING OBSERVATIONS

- After weaning on postnatal day 21, offspring were examined twice daily for mortality, and cage-side observations were conducted once daily.

- Individual offspring body weight data were recorded weekly [biweekly].

- [Indicate any additional body weight records, e.g. on the day that vaginal opening or preputial separation was achieved.

LITTER OBSERVATIONS

- The day of completion of parturition was designated as lactation day (postnatal day) 0.

- Live pups were counted, sexed and weighed individually for each litter on postnatal days [0, 4, 11, 17, and 21].

- Daily throughout lactation, offspring were examined cage-side for gross signs of mortality or morbidity.

- Any gross signs of toxicity in the offspring were recorded as they were observed, including the time of onset, degree, and duration.

For developmental neurotoxicity studies, indicate the relevant developmental landmarks and details on postweaning and litter observations. Use freetext template and delete/add elements as appropriate (e.g. delete items on NTE activity if not applicable). 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.

Specific guidance on DEVELOPMENTAL LANDMARKS: If other developmental landmarks than those specified in the guideline are included in the study report, a detailed description of any developmental landmarks evaluated is MANDATORY, e.g. , e.g., eye opening, pinna unfolding, incisor eruption, etc.

Further details on litter observations (for developmental neurotoxicity study)

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SE07.09.01.0690

Pharmacokinetic data

[Pharmacokinetic data]

For developmental neurotoxicity studies, provide pharmacokinetic data. If applicable] Measures of [list parameters examined, e.g., test substance and metabolites in milk or in maternal, fetal, or pup blood] were determined in [Provide study identification, source of the animals (e.g., were they part of a range-finding or companion study?). Describe how many animals of each age group at each time point, how often, at what age for offspring. Indicate specifics of sample collection and processing; describe analytical methods used.

Indication of parameters analyzed and statistical tests performed.

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SE07.09.01.0700

Other examinations

[Other examinations]

Describe any other examinations.

Description of other examinations.

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SE07.09.01.0710

Positive control

[Positive control]

Briefly describe the positive control data cited, and its acceptability for use with the current study.

For positive control data to be acceptable, it must demonstrate the sensitivity of the test method to detect changes in the measured parameters. These data do not have to be from studies using prenatal exposures. However, the laboratory must demonstrate competence in evaluation of effects in neonatal animals perinatally exposed to chemicals and establish test norms for the appropriate age group. For observational measures, the data should demonstrate the ability to detect major neurotoxic endpoints, including limb weakness, paralysis, tremor, and autonomic signs; motor activity positive control data should demonstrate the ability to detect both increases and decreases in motor activity; pathology positive control data should demonstrate the ability to detect central and peripheral nervous system pathology (separate groups may be used to demonstrate each type of pathology, for example, acrylamide for peripheral nervous system pathology and trimethyl tin for central nervous system pathology).

The methods should be completely described, and must be the same as those used in the study being evaluated (for example, the same equipment should be used, motor activity sessions should be of the same duration, the observation arena should be the same, the same sections should be evaluated for neuropathology, using the same types of stains, etc.), and preferably the same personnel should have conducted the testing. The data presentation should be complete enough to evaluate the sensitivity of the method, including individual data and measures of variability. Statistical evaluations used to demonstrate sensitivity should also be the same as those used in the study being evaluated. The number of animals per test group should not be greater than that used in the study under evaluation. Positive control data should also demonstrate inter-observer reliability for the FOB (i.e., the same results should be seen regardless of who is doing the observations). The positive control data should have been collected within a reasonable time frame before the current study, e.g., the last few years. New data should also be collected when observational personnel or other critical laboratory elements change.

Indication if a positive control was used and if appropriate indication of purity, Lot/batch No.

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<i5:TEXT_INT>

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SE07.09.01.0720

Statistics

[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.

Indication of parameters analyzed and statistical tests performed.

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<i5:STATISTICS>

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<i5:TEXT_INT>

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SE07.09.01.0730

Any other information on materials and methods incl. tables

[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.

Rich text editor field for creating formatted text and tables or inserting and editing any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

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<i5:RICHTEXT_BELOW>

SE07.09.01.0735

RESULTS AND DISCUSSION

[Results and discussions]

Main heading under which generic 'Results and discussion' fields are subsumed.

SE07.09.01.0739

Effect levels

[Effect levels]

Record effect levels, based on different endpoints and/or separated for each generation (if applicable) and/or sex. Copy this block of fields as appropriate.

Heading of field block 'Other effect levels'.

SE07.09.01.0740

Endpoint

[Endpoint]

Picklist Values:

no NOAEC identified || no NOAEL identified || NOAEC || NOAEL || NOEC || NOEL || LOAEC || LOAEL || LOEC || LOEL || BMD05 || BMDL05 || BMDL10 || BMD: || BMC05 || BMCL05 || BMCL10 || BMC: || dose level: || conc. level: || other:

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.

Type of endpoint (e.g. NOAEL) to which the data entered in this field block relate.

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<i5:TO_NEUROTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT>

SE07.09.01.0741

Endpoint

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT_TXT>

SE07.09.01.0750

Generation (if applicable)

[Generation (if applicable)]

Picklist Values:

maternal || offspring || other:

For developmental neurotoxicity study, select the generation (i.e. 'maternal' or 'offspring'). If not applicable, leave this subfield empty.

Type of generation (i.e. maternal or offspring) to which the data entered in this field block relate.

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<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:EFFLEVEL>

<i5:set>

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<i5:GENERATION>

SE07.09.01.0751

Generation (if applicable)

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_GENERATION>

<i5:GENERATION_TXT>

SE07.09.01.0760

Sex

[Sex]

Picklist Values:

female || male || male/female || no data

Select from drop-down list.

Sex of the tested animals.

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<i5:SEX>

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SE07.09.01.0770

Effect level

[Effect level]

Picklist Values:

> || >= || ca.

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').

Effect concentration: Lower qualifier field providing a list with following operators: >, >=, and ca.

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<i5:LOQUALIFIER>

SE07.09.01.0780

Effect level

[no label]

Effect concentration: Lower numeric field for entering a numeric value preceded either by no operator, '>', '>=' or 'ca.' (e.g. '20', '>20', '>=20', '20')

<i5:EndpointStudyRecord>

<i5:scientificPart>

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<i5:LOVALUE>

SE07.09.01.0790

Effect level

[no label]

Picklist Values:

< || <= || ca.

Effect concentration: Upper qualifier field providing a list with following operators: <, <=, and ca.

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<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:EFFLEVEL>

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SE07.09.01.0800

Effect level

[no label]

Effect concentration: Upper numeric field for entering a numeric value only if either a lower value is already entered to specify a numeric range or if the numeric value is preceded by either operator '<' or '<='.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

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<i5:set>

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SE07.09.01.0810

Unit of dose

[Effect levels]

Picklist Values:

mg/kg bw/day (nominal) || mg/kg bw/day (actual dose received) || mg/kg bw/day || mg/kg diet || mg/L drinking water || mg/kg bw (total dose) || mg/L air || mg/L air (nominal) || mg/L air (analytical) || mg/m³ air || mg/m³ air (nominal) || mg/m³ air (analytical) || ppm || ppm (nominal) || ppm (analytical) || other:

Select unit of dose or concentration as appropriate.

Unit of effect level.

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<i5:EFFLEVEL>

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<i5:UNIT>

SE07.09.01.0811

Unit of dose

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT_TXT>

SE07.09.01.0812

Effect concentration type

[Based on]

Picklist Values:

test mat. || act. ingr. || element || dissolved || labile/free || other: || no data

Indicate whether the dose/concentration is based on the test material (test mat.), active ingredient (act. ingr.), element, dissolved (if inorganic non-metal), labile/free (if metal) or other (specify). Further information can be given in the supplementary remarks field.

Leave blank or select 'no data' if type is not known.

Heading of field block 'Other effect levels'.

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<i5:EFF_CONC_TYPE>

SE07.09.01.0813

Effect concentration type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_EFF_CONC_TYPE>

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SE07.09.01.0820

Basis for effect level / Remarks

[Basis for effect level / Remarks]

Freetext Templates:

overall effects

no data; neurobehaviour; neuropathology; neurochemistry; neurochemistry (plasma cholinesterase inhibition); neurochemistry (erythrocyte cholinesterase inhibition); neurochemistry (brain cholinesterase inhibition); electrophysiology; other:

Indicate the parameter(s) used to establish the given effect level. If necessary, give further details. 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.

Effect parameter or parameters, which the results given relate to.

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SE07.09.01.0825

Observations

[Results of examinations]

Subheading of section 'Observations'

SE07.09.01.0830

Clinical signs and mortality

[Clinical signs and mortality]

Picklist Values:

yes || no effects || not examined || no data

Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, 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.

Indication whether mortality or clinical signs were observed or not.

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<i5:LIST_SEL_FIX>

SE07.09.01.0831

Clinical signs and mortality

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:OBSERV_CLIN_SIGNS>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.01.0840

Body weight and weight gain

[Body weight and weight gain]

Picklist Values:

yes || no effects || not examined || no data

Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, 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.

Indication whether effects were observed on body weight and weight gain or not.

<i5:EndpointStudyRecord>

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<i5:TO_NEUROTOX>

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<i5:set>

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<i5:LIST_SEL_FIX>

SE07.09.01.0841

Body weight and weight gain

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:OBSERV_BODYWEIGHT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.01.0850

Food consumption and compound intake (if feeding study)

[Food consumption and compound intake (if feeding study)]

Picklist Values:

yes || no effects || not examined || no data

Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, 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.

Indication whether effects were observed on food consumption or not.

<i5:EndpointStudyRecord>

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<i5:TO_NEUROTOX>

<i5:OBSERV_FOOD_CONSUM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.01.0851

Food consumption and compound intake (if feeding study)

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:OBSERV_FOOD_CONSUM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.01.0860

Food efficiency

[Food efficiency]

Picklist Values:

yes || no effects || not examined || no data

Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, 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.

Indication whether effects were observed on food efficiency or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:OBSERV_FOOD_EFFICIENCY>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.01.0861

Food efficiency

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:OBSERV_FOOD_EFFICIENCY>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.01.0870

Water consumption and compound intake (if drinking water study)

[Water consumption and compound intake (if drinking water study)]

Picklist Values:

yes || no effects || not examined || no data

Indicate whether any treatment-related effects were observed. In the supplementary remarks field related to this list field, 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.

Indication whether effects were observed on water consumption or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_NEUROTOX>

<i5:OBSERV_WATER_CONSUM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.01.0871

Water consumption and compound intake (if drinking water study)

[no label]