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.

SE07.06.02.0215

DATA SOURCE

[Data source]

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

SE07.06.02.0219

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'

SE07.06.02.0220

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 Select 'Other company data' to characterise any unpublished information from a company other than a study report. Select 'Grey literature' for any other unpublished information or 'other:' and specify.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

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE07.06.02.0221

Reference type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE07.06.02.0230

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_GENETIC_IN_VIVO>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE07.06.02.0240

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_GENETIC_IN_VIVO>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE07.06.02.0250

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_GENETIC_IN_VIVO>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE07.06.02.0260

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_GENETIC_IN_VIVO>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE07.06.02.0270

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_GENETIC_IN_VIVO>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE07.06.02.0280

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_GENETIC_IN_VIVO>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE07.06.02.0290

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_GENETIC_IN_VIVO>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE07.06.02.0300

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_GENETIC_IN_VIVO>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE07.06.02.0310

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_GENETIC_IN_VIVO>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE07.06.02.0320

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_GENETIC_IN_VIVO>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.06.02.0321

Data access

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.06.02.0330

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_GENETIC_IN_VIVO>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.06.02.0331

Data protection claimed

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.06.02.0340

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_GENETIC_IN_VIVO>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.06.02.0345

MATERIALS AND METHODS

[Materials and methods]

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

SE07.06.02.0350

Type of genotoxicity

[Type of genotoxicity]

Picklist Values:

gene mutation || chromosome aberration || DNA damage and/or repair || genome mutation || other:

Indicate the type of genotoxicity adressed, i.e. gene mutation, chromosome aberration, DNA damage and/or repair or genome mutation.

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

Indicate the type of genotoxicity adressed, i.e. gene mutation, chromosome aberration, DNA damage and/or repair or genome mutation.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:GENOTOXICITY_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.06.02.0351

Type of genotoxicity

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:GENOTOXICITY_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.06.02.0360

Type of study

[Type of study]

Picklist Values:

Drosophila SLRL test || endogenous gene animal assay || mouse spot test || somatic mutation assay in Drosophila || transgenic animal mutagenicity assay || chromosome aberration assay || dominant lethal assay || heritable translocation assay || mammalian germ cell cytogenetic assay || micronucleus assay || inhibition of DNA-Synthesis || single cell gel/comet assay in rodents for detection of DNA damage || sister chromatid exchange assay || unscheduled DNA synthesis || other: || unspecified

Indicate the type of study.

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

Indicator specifying type of study; to be included if no guideline is indicated.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:STUDYTYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.06.02.0361

Type of study

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:STUDYTYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.06.02.0369

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'

SE07.06.02.0370

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_GENETIC_IN_VIVO>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE07.06.02.0380

Guideline

[Guideline]

Picklist Values:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test) || OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test) || OECD Guideline 477 (Genetic Toxicology: Sex-linked Recessive Lethal Test in Drosophila melanogaster) || OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test) || OECD Guideline 483 (Mammalian Spermatogonial Chromosome Aberration Test) || OECD Guideline 484 (Genetic Toxicology: Mouse Spot Test) || OECD Guideline 485 (Genetic Toxicology: Mouse Heritable Translocation Assay) || OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo) || EU Method B.11 (Mutagenicity - In Vivo Mammalian Bone-Marrow Chromosome Aberration Test) || EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test) || EU Method B.20 (Sex-linked Recessive Lethal Test in Drosophila melanogaster) || EU Method B.22 (Rodent Dominant Lethal Test) || EU Method B.23 (Mammalian Spermatogonial Chromosome Aberration Test) || EU Method B.24 (Mouse Spot Test) || EU Method B.25 (Mouse heritable translocation) || EU Method B.39 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells In Vivo) || EPA OPP 84-2 || EPA OPPTS 870.5195 (Mouse Biochemical Specific Locus Test) || EPA OPPTS 870.5200 (Mouse Visible Specific Locus Test) || EPA OPPTS 870.5275 (Sex-linked Recessive Lethal Test in Drosophila melanogaster) || EPA OPPTS 870.5380 (In Vivo Mammalian Cytogenetic Tests: Spermatogonial Chromosomal Aberrations) || EPA OPPTS 870.5385 (In Vivo Mammalian Cytogenetic Tests: Bone Marrow Chromosomal Analysis) || EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay) || EPA OPPTS 870.5450 (Rodent Dominant Lethal Assay) || EPA OPPTS 870.5460 (Rodent Heritable Translocation Assays) || EPA OPPTS 870.5915 (In Vivo Sister Chromatid Exchange Assay) || EPA OTS 798.5195 (Mouse Biochemical Specific Locus Test) || EPA OTS 798.5200 (Mouse Visible Specific Locus Test) || EPA OTS 798.5275 (Sex-linked Recessive Lethal Test in Drosophila melanogaster) || EPA OTS 798.5380 (In Vivo Mammalian Cytogenetic Tests: Spermatogonial Chromosomal Aberrations) || EPA OTS 798.5385 (In Vivo Mammalian Cytogenetic Tests: Bone Marrow Chromosomal Analysis) || EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay) || EPA OTS 798.5450 (Rodent Dominant Lethal Assay) || EPA OTS 798.5460 (Rodent Heritable Translocation Assays) || EPA OTS 798.5915 (In Vivo Sister Chromatid Exchange Assay) || JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals || 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_GENETIC_IN_VIVO>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE07.06.02.0381

Guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE07.06.02.0390

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_GENETIC_IN_VIVO>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE07.06.02.0391

Deviations from guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE07.06.02.0400

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_GENETIC_IN_VIVO>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.06.02.0410

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_GENETIC_IN_VIVO>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.06.02.0411

GLP compliance

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.06.02.0415

Test materials

[Test materials]

Subheading of section 'Test materials'

SE07.06.02.0420

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_GENETIC_IN_VIVO>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE07.06.02.0429

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'

SE07.06.02.0430

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_GENETIC_IN_VIVO>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE07.06.02.0431

Identifier

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE07.06.02.0440

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_GENETIC_IN_VIVO>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE07.06.02.0445

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_GENETIC_IN_VIVO>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE07.06.02.0446

Test material form

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE07.06.02.0450

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_GENETIC_IN_VIVO>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.06.02.0460

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_GENETIC_IN_VIVO>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.06.02.0465

Test animals

[Test animals]

Subheading of section 'Test animals'

SE07.06.02.0470

Species

[Species]

Picklist Values:

mouse || Drosophila melanogaster || 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>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.06.02.0471

Species

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.06.02.0480

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

The strain of the animal tested.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:STRAIN>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.06.02.0481

Strain

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:STRAIN>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.06.02.0490

Sex

[Sex]

Picklist Values:

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

Select as appropriate.

Sex of the tested animals.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:SEX>

<i5:set>

<i5:LIST_BELOW_POP>

<i5:LIST_BELOW_POP>

SE07.06.02.0500

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:

- Assigned to test groups randomly: [no/yes, under following basis: ]

- 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:

- 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_GENETIC_IN_VIVO>

<i5:ORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.06.02.0505

Administration / exposure

[Administration / exposure]

Subheading of section 'Administration / exposure'

SE07.06.02.0510

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 route of administration as appropriate, usually 'oral: gavage'. If another route was used, provide a justification and reasoning in field 'Details on exposure'. In the case of an inhalation study, also specify if 'nose only' or other.

Indicator how the chemical was administered to the test animals.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:ROUTE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.06.02.0511

Route of administration

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:ROUTE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.06.02.0520

Vehicle(s)

[Vehicle(s)]

Freetext Templates:

- Vehicle(s)/solvent(s) used: [none; no data; acetone; air; arachis oil; beeswax; carbowaxe; castor oil; cetosteryl alcohol; cetyl alcohol; 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; paraffin oil ; peanut oil; petrolatum; physiol. saline; poloxamer; polyethylene glycol; propylene glycol; silicone oil; sorbitan derivative; soya oil; theobroma oil; vegetable oil; water]

- Justification for choice of solvent/vehicle:

- Concentration of test material in vehicle:

- Amount of vehicle (if gavage or dermal):

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

- Lot/batch no. (if required):

- Purity:

Indicate whether vehicle(s)/solvent(s) was/were used and specify the substance(s) or state 'none' if no vehicle/solvent was used or 'no data' if not available from the study report or publication. Provide a justification for the choice of solvent/vehicle. Provide further details as appropriate.

Use freetext template and delete/add elements as appropriate. Note that the list of substances provided is not exhaustive.

Indication and identity of the vehicle(s)/solvent(s) used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:VEHICLE_TOX>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.06.02.0530

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: TYPE OF INHALATION EXPOSURE: nose only / head only / nose/head only / whole body / other: / no data

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

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

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_GENETIC_IN_VIVO>

<i5:EXP_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.06.02.0540

Duration of treatment / exposure

[Duration of treatment / exposure]

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

Exposure duration including unit.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:EXP_PERIOD>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.06.02.0550

Frequency of treatment

[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').

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_GENETIC_IN_VIVO>

<i5:FREQUENCY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.06.02.0560

Post exposure period

[Post exposure period]

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

Observation period after last exposure to the test chemical.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:POST_EXP_PERIOD>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.06.02.0569

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'.

SE07.06.02.0570

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. You may enter explanatory text, e.g., indicate if the study was a limit test..

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:DOSES>

<i5:set>

<i5:CONCENTRATIONS>

<i5:CONCENTRATIONS>

SE07.06.02.0580

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_GENETIC_IN_VIVO>

<i5:DOSES>

<i5:set>

<i5:PHRASEOTHER_BASIS>

<i5:BASIS>

SE07.06.02.0581

Basis

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:DOSES>

<i5:set>

<i5:PHRASEOTHER_BASIS>

<i5:BASIS_TXT>

SE07.06.02.0590

No. of animals per sex and 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 if different number of animals were used per sex and/or dose level or for the pilot, range-finding and main study.

For robust study summaries or as requested by the regulatory programme, also include a detailed table on the animal assignment in the rich text field 'Any other information on results incl. tables'. Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. '... see Table 1').

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:NUMBER_ANIMALS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.06.02.0599

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.

SE07.06.02.0600

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_GENETIC_IN_VIVO>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.06.02.0601

Control animals

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.06.02.0610

Positive control(s)

[Positive control(s)]

Freetext Templates:

none; no data; 2-acetylaminofluorene; 2-nitrofluorene; 3-methylcholanthrene; 4-nitroquinoline-N-oxide; 7,12-dimethylbenzanthracene; 9,10-dimethylbenzanthracene; 9-aminoacridine; benzo(a)pyrene; congo red; cumene hydroperoxide; cyclohexylamine; cyclophosphamide; cyclophosphamide; ethylmethanesulphonate; ethylmethanesulphonate; ethylnitrosurea; ethylnitrosurea; furylfuramide; ICR 191; methylmethanesulfonate; mitomycin C; mitomycin C; monomeric acrylamide; N-dimethylnitrosamine; N-ethyl-N-nitro-N-nitrosoguanidine; 2-nitrofluorene; 4-nitroquinoline 1-oxide; sodium azide; triethylenemelamine

- Justification for choice of positive control(s):

- Route of administration:

- Doses / concentrations:

Indicate what substance(s) was/were used as positive control(s) or state 'none' if no positive controls were used or 'no data' if not available from the study report or publication. If other than the reference substance(s) specified in the test guidelines was/were used include a brief justification. Also provide information on the route of administration and doses either under separate headings or in parentheses after the control substance(s) specified.

Use freetext template and delete/add elements as appropriate. Note that the list of substances provided is not exhaustive.

Indication of positive control(s), i.e. substances with known genotoxicity.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:POS_CONTROL>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.06.02.0615

Examinations

[Examinations]

Subheading of section 'Examinations'

SE07.06.02.0620

Tissues and cell types examined

[Tissues and cell types examined]

REMARKS:

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

Indicate tissues and cell types examined including the number of cells analysed per animal. Also note if examinations were not performed with tissues or cells from all animals studied.

For robust study summaries or as requested by the regulatory programme, also include a detailed table 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').

Description of tissues and cell types examined including number of cells analysed.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TISSUES_EXAM>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.06.02.0630

Details of tissue and slide preparation

[Details of tissue and slide preparation]

Freetext Templates:

CRITERIA FOR DOSE SELECTION:

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):

DETAILS OF SLIDE PREPARATION:

METHOD OF ANALYSIS:

OTHER:

Indicate any relevant details to characterise the test system and test protocol used. 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 study design.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TISSUE_PREP_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.06.02.0640

Evaluation criteria

[Evaluation criteria]

Describe the evaluation criteria used in the study to judge if a substance is positive.

Description of the evaluation criteria.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:EVALUATION_CRITERIA>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.06.02.0650

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE07.06.02.0660

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>

<i5:TO_GENETIC_IN_VIVO>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.06.02.0665

RESULTS AND DISCUSSION

[Results and discussions]

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

SE07.06.02.0669

Test results

[Test results]

Include the main test results in this block of fields. Multiply this block of fields as often as required, e.g. for recording different results for both sexes used.

For robust study summaries or as requested by the regulatory programme, also include a detailed table on the genotoxicity and toxicity results in the rich text field 'Any other information on results incl. tables'. Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. '... see Table 1').

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Heading of field block 'Test results'.

SE07.06.02.0670

Sex

[Sex]

Picklist Values:

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

Select from drop-down list.

Sex of the tested animals.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TEST_RS>

<i5:set>

<i5:SEX>

<i5:SEX>

SE07.06.02.0680

Genotoxicity

[Genotoxicity]

Picklist Values:

positive || ambiguous || negative || not determined || no data || other:

Indicate if there was evidence of genotoxicity. If result is considered positive or ambiguous, include dose(s) in the supplementary remarks field or representative table, e.g. predefined table or an excerpt from the study report.

Indicator specifying whether positive, negative or ambiguous results were seen for genotoxicity.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TEST_RS>

<i5:set>

<i5:PHRASEOTHER_GENOTOXICITY>

<i5:GENOTOXICITY>

SE07.06.02.0681

Genotoxicity

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TEST_RS>

<i5:set>

<i5:PHRASEOTHER_GENOTOXICITY>

<i5:GENOTOXICITY_TXT>

SE07.06.02.0690

Toxicity

[Toxicity]

Picklist Values:

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

Indicate whether signs of toxicity were observed or not. If yes, briefly describe the in life animal observations and the effects by dose in the supplementary remarks field (e.g. 'significantly decreased body weight gain in the high dose group). If necessary include further details in field 'Additional information on results'.

Indication whether signs of toxicity were observed.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TEST_RS>

<i5:set>

<i5:PHRASEOTHER_TOXICITY>

<i5:TOXICITY>

SE07.06.02.0691

Toxicity

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TEST_RS>

<i5:set>

<i5:PHRASEOTHER_TOXICITY>

<i5:TOXICITY_TXT>

SE07.06.02.0700

Vehicle controls valid

[Vehicle controls valid]

Picklist Values:

yes || no || not applicable || not examined || no data || other:

Indicate whether test with vehicle control(s) (i.e. without test substance, with/without solvent) is valid.

Indicator specifying whether test with vehicle control(s) is valid.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TEST_RS>

<i5:set>

<i5:PHRASEOTHER_VEH_CONTR_VALID>

<i5:VEH_CONTR_VALID>

SE07.06.02.0701

Vehicle controls valid

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TEST_RS>

<i5:set>

<i5:PHRASEOTHER_VEH_CONTR_VALID>

<i5:VEH_CONTR_VALID_TXT>

SE07.06.02.0710

Negative controls valid

[Negative controls valid]

Picklist Values:

yes || no || not applicable || not examined || no data || other:

Indicate whether test with true negative control(s) (i.e. substances with known lack of genotoxicity) is valid.

Indicator specifying whether test with true negative control(s) (i.e. substances with known lack of genotoxicity) is valid.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TEST_RS>

<i5:set>

<i5:PHRASEOTHER_NEG_CONTR_VALID>

<i5:NEG_CONTR_VALID>

SE07.06.02.0711

Negative controls valid

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TEST_RS>

<i5:set>

<i5:PHRASEOTHER_NEG_CONTR_VALID>

<i5:NEG_CONTR_VALID_TXT>

SE07.06.02.0720

Positive controls valid

[Positive controls valid]

Picklist Values:

yes || no || not applicable || not examined || no data || other:

Indicate whether test with positive control(s), i.e. substance(s) with known genotoxicity, is valid.

Indicator specifying whether test with positive control(s), i.e. substance(s) with known genotoxicity, is valid.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TEST_RS>

<i5:set>

<i5:PHRASEOTHER_POS_CONTR_VALID>

<i5:POS_CONTR_VALID>

SE07.06.02.0721

Positive controls valid

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:TEST_RS>

<i5:set>

<i5:PHRASEOTHER_POS_CONTR_VALID>

<i5:POS_CONTR_VALID_TXT>

SE07.06.02.0730

Additional information on results

[Additional information on results]

Freetext Templates:

RESULTS OF RANGE-FINDING STUDY

- Dose range:

- Solubility:

- Clinical signs of toxicity in test animals:

- Evidence of cytotoxicity in tissue analyzed:

- Rationale for exposure:

- Harvest times:

- High dose with and without activation:

- Other:

RESULTS OF DEFINITIVE STUDY

- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay):

- Induction of micronuclei (for Micronucleus assay):

- Ratio of PCE/NCE (for Micronucleus assay):

- Appropriateness of dose levels and route:

- Statistical evaluation:

Briefly describe the results of results of range-finding study if any. For the definitive study, provide further details on results. 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.

Particularly with comprehensive data, include a table and refer to respective table no. (use predefined table if any). Narrative accompanying such tabular data should address the toxicological significance of the results and not repeat what is presented in the table(s).

Note: Depending on the regulatory programme some form of a table may be mandatory. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Additional information on results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.06.02.0740

Any other information on results incl. tables

[Any other information on results incl. tables]

In this field, you can enter any other remarks on results. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: Both the 'Materials and methods' section and 'Results' section. In addition the fields 'Overall remarks' and 'Executive summary' allow rich text entry.

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>

<i5:TO_GENETIC_IN_VIVO>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.06.02.0745

OVERALL REMARKS, ATTACHMENTS

[Overall remarks, attachments]

Main heading under which 'Overall remarks, attachments' fields are subsumed.

SE07.06.02.0750

Remarks on results including tables and figures

[Remarks on results including tables and figures]

In this field, you can enter any overall remarks or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields 'Overall remarks' and 'Executive summary' allow rich text entry.

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>

<i5:TO_GENETIC_IN_VIVO>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.06.02.0759

Attached background material

[Attached background material]

Attach any background document that cannot be inserted in any rich text editor field, particularly image files (e.g. an image of a structural formula).

Copy this block of fields for attaching more than one file.

Heading of field block 'Attached document'.

SE07.06.02.0760

Attached document

[Attached document]

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

File name of document uploaded, i.e. attached. No restriction as to file type.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE07.06.02.0770

Remarks

[Remarks]

As appropriate, include remarks, e.g. a short description of the content of the attached document if the file name is not self-explanatory.

Remarks on attached document.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE07.06.02.0779

Attached full study report

[Attached full study report]

If required, an electronic copy of the full study report can be attached as WORD, pdf or other document type, which will not be integrated in any report, but must be handled as separate files.

Note: In the export administration you can indicate whether the attached files should be included in the data export or not.

Attached full study report

SE07.06.02.0780

Attached full study report

[Attached full study report]

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

Attached full study report

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE07.06.02.0782

Illustration (picture/graph)

[Illustration (picture/graph)]

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

Illustration (picture/graph)

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE07.06.02.0785

APPLICANT'S SUMMARY AND CONCLUSION

[Applicant's summary and conclusion]

Main heading under which generic 'Applicant's summary and conclusion' fields are subsumed.

SE07.06.02.0790

Interpretation of results

[Interpretation of results]

Picklist Values:

ambiguous || negative || positive || other: || no data

Indicate overall interpretation of test results as given in the study report or as concluded by the submitter. Use supplementary remarks field for indicating if conclusions originally reported were changed by submitter or for any other explanations.

Interpretation of test results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:INTERPRET_RS_SUBMITTER>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.06.02.0791

Interpretation of results

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:INTERPRET_RS_SUBMITTER>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.06.02.0800

Conclusions

[Conclusions]

Enter any conclusions if applicable.

Any conclusions either as adapted from the study report / publication or indicated by the submitter.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.06.02.0810

Executive summary

[Executive summary]

REMARKS:

Available predefined executive summary is shown below, at the end of this template. See also List of Predefined Executive Summaries in Annex 3.

If required by the respective national/regional programme, briefly summarise the relevant aspects of the study including the conclusions reached. If a specific format is prescribed, upload the respective freetext template if available from the drop-down list or copy it from the corresponding document.

Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Executive summary in which the relevant aspects of the study including the conclusions reached are briefly summarised.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.06.02.0820

Cross-reference to other study

[Cross-reference to other study]

A Cross-reference to other study or other studies can be included which are considered relevant in the interpretation of the test results, e.g. for supporting the conclusion that an effect observed was not substance-related. Indicate the respective chapter(s) and record ID(s) and enter relevant explanatory text.

Such cross-references may be useful if it is considered relevant to discuss other results at the summary level of a single study. It should be noted that the overall appraisal of results from different studies is normally done in the hazard or risk assessment.

Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.

A cross-reference to another study or other studies including explanatory text on why other results are relevant in the interpretation of the results of a given study, e.g. for supporting any conclusions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_GENETIC_IN_VIVO>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>