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.

SE07.01.01.0215

DATA SOURCE

[Data source]

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

SE07.01.01.0219

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'

SE07.01.01.0220

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 Select 'Other company data' to characterise any unpublished information from a company other than a study report. Select 'Grey literature' for any other unpublished information or 'other:' and specify.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

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE07.01.01.0221

Reference type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE07.01.01.0230

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_META_MAM>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE07.01.01.0240

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_META_MAM>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE07.01.01.0250

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_META_MAM>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE07.01.01.0260

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_META_MAM>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE07.01.01.0270

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_META_MAM>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE07.01.01.0280

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_META_MAM>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE07.01.01.0290

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_META_MAM>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE07.01.01.0300

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_META_MAM>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE07.01.01.0310

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_META_MAM>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE07.01.01.0320

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_META_MAM>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.01.0321

Data access

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.01.0330

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_META_MAM>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.01.01.0331

Data protection claimed

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.01.01.0340

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_META_MAM>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.01.01.0345

MATERIALS AND METHODS

[Materials and methods]

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

SE07.01.01.0350

Type of method

[Type of method]

Picklist Values:

in vivo || in vitro || other: || no data

Indicate if study was in vivo or in vitro test. If in vitro test, describe study design in field 'Any other information on materials and methods incl. tables'. If a specific template for in vitro assays is provided include the data in that template instead.

Indicator specifying whether study was in vivo or in vitro test.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:TYPE_INVIVO_INVITRO>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.01.0351

Type of method

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:TYPE_INVIVO_INVITRO>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.01.0359

Objective of study

[Objective of study]

Indicate the purpose of the study. The field is repeatable. Select the respective toxicokinetic aspect(s) investigated.

Indicator specifying the objectives of the study in terms of toxicokinetic aspects investigated, i.e. absorption, distribution, excretion, metabolism or toxicokinetics in general.

SE07.01.01.0360

Objective of study

[Objective of study]

Picklist Values:

absorption || distribution || excretion || metabolism || toxicokinetics || bioaccessibility || other: || no data

Indicate the purpose of the study. The field is repeatable. Select the respective toxicokinetic aspect(s) investigated.

Indicator specifying the objectives of the study in terms of toxicokinetic aspects investigated, i.e. absorption, distribution, excretion, metabolism or toxicokinetics in general.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:STUDY_OBJECTIVE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.01.0361

Objective of study

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:STUDY_OBJECTIVE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.01.0369

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'

SE07.01.01.0370

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_META_MAM>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE07.01.01.0380

Guideline

[Guideline]

Picklist Values:

OECD Guideline 417 (Toxicokinetics) || EU Method B.36 (Toxicokinetics) || EPA OPP 85-1 (Metabolism and Pharmacokinetics) || EPA OPPTS 870.7485 (Metabolism and Pharmacokinetics) || EPA OTS 798.7485 (Metabolism and Pharmacokinetics) || EPA OPPTS 870.8223 (Pharmacokinetic Test) || EPA OPPTS 870.8320 (Oral/dermal pharmacokinetics) || EPA OPPTS 870.8340 (Oral and Inhalation Pharmacokinetic Test) || EPA OPPTS 870.8360 (Pharmacokinetics of Isopropanol) || EPA OPPTS 870.8380 (Inhalation and Dermal Pharmacokinetics of Commercial Hexane) || EPA OPPTS 870.8500 (Toxicokinetic Test) || EPA OTS 795.2230 (Pharmacokinetic Test) || EPA OTS 795.2280 (Oral/Dermal Pharmacokinetics) || EPA OTS 795.2300 (Pharmacokinetic Test) || EPA OTS 795.2310 (Pharmacokinetics of Isopropanol) || EPA OTS 795.2320 (Inhalation and Dermal Pharmacokinetics of Commercial Hexane) || EPA OTS 795.2350 (Toxicokinetic Test) || OECD Series on Testing and Assessment No. 29 || 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_META_MAM>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE07.01.01.0381

Guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE07.01.01.0390

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_META_MAM>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE07.01.01.0391

Deviations from guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE07.01.01.0400

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_META_MAM>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.01.01.0410

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_META_MAM>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.01.01.0411

GLP compliance

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.01.01.0420

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_META_MAM>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE07.01.01.0429

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'

SE07.01.01.0430

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_META_MAM>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE07.01.01.0431

Identifier

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE07.01.01.0440

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_META_MAM>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE07.01.01.0445

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_META_MAM>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE07.01.01.0446

Test material form

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE07.01.01.0450

Radiolabelling

[Radiolabelling]

Picklist Values:

yes || no || other: || no data

Indicate if labelled or non-labelled test material was used. Details on labelled material to be described in field 'Details on test material'. In the supplementary remarks field, any further explanations can be provided, e.g. for indicating that both labelled and unlabelled substances were used.

Indication whether labelled or non-labelled test material was used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:RADIO_LABEL>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.01.01.0451

Radiolabelling

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:RADIO_LABEL>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.01.01.0455

Test materials

[Test materials]

Subheading of section 'Test materials'

SE07.01.01.0460

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_META_MAM>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.01.0470

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_META_MAM>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.01.0475

Test animals

[Test animals]

Subheading of section 'Test animals'

SE07.01.01.0480

Species

[Species]

Picklist Values:

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

Select name of species. For in vitro tests, indicate the species used as source of the test system. If not available from picklist, select 'other' and specify.

Organism used in the experiment. In the case of an in vitro study, the type of cell culture can be given after 'other:'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.01.0481

Species

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.01.0490

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>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:STRAIN>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.01.0491

Strain

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:STRAIN>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.01.0500

Sex

[Sex]

Picklist Values:

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

Select as appropriate. If different sexes were used in multiple test runs recorded in the same record, select 'male/female' and differentiate in field 'Doses / concentrations'.

Sex of the tested animals.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:SEX>

<i5:set>

<i5:LIST_BELOW_POP>

<i5:LIST_BELOW_POP>

SE07.01.01.0510

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:

- Individual metabolism cages: yes/no

- 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_META_MAM>

<i5:ORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.01.0515

Administration / exposure

[Administration / exposure]

Subheading of section 'Administration / exposure'

SE07.01.01.0520

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:ROUTE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.01.0521

Route of administration

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:ROUTE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.01.0530

Vehicle

[Vehicle]

Picklist Values:

unchanged (no vehicle) || acetone || 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 || 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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:VEHICLE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.01.01.0531

Vehicle

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:VEHICLE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.01.01.0540

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:

HOMOGENEITY AND STABILITY OF TEST MATERIAL:

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

GENERATION OF TEST ATMOSPHERE / CHAMPER DESCRIPTION

- Exposure apparatus:

- Method of holding animals in test chamber:

- Source and rate of air:

- Method of conditioning air:

- System of generating particulates/aerosols:

- Composition of vehicle (if applicable):

- Concentration of test material in vehicle (if applicable):

- Method of particle size determination:

- Treatment of exhaust air:

TEST ATMOSPHERE (if not tabulated)

- Particle size distribution:

- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):

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):

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 with optional selection of route-specific freetext template.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:EXP_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.01.0550

Duration and frequency of treatment / exposure

[Duration and frequency of treatment / exposure]

Indicate duration and frequency of application, e.g. 'single application' or 'multiple application: 14 days, 2 doses per day, 5 days per week'.

Description of duration and frequency of treatment / exposure, e.g. 'single application' or 'multiple application: 14 days, 2 doses per day, 5 days per week'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:EXP_PERIOD>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.01.01.0560

Doses / concentrations

[Doses / concentrations]

REMARKS:

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

Indicate the dose groups and state if the doses/concentrations were 'nominal in diet', 'actual ingested', 'nominal conc.', actual conc.' etc. and give both nominal and actual values as appropriate.

In case of a robust study summary or as requested by the regulatory programme, also provide 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.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:DOSES_CONCENTRATIONS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE07.01.01.0570

No. of animals per sex per dose

[No. of animals per sex per dose]

Enter value or specify according to dose if different number of animals per dose, e.g. '4 in each dose group with single application; 2 f and 4 m in multiple application group'.

In case of a robust study summary, include animal numbers per sex in table on animal assignment.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:NUMBER_ANIMALS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.01.01.0580

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.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.01.0581

Control animals

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.01.0590

Positive control

[Positive control]

Indicate if a positive control was used and if appropriate indicate purity, Lot/batch No.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:POS_CONTROL>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.01.01.0600

Details on study design

[Details on study design]

Freetext Templates:

- Dose selection rationale:

- Rationale for animal assignment (if not random):

Include further details on the study design including a brief description on dose selection and animal assignment rationale if appropriate. 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.

Further details on study design.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:STUDY_DESIGN_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.01.0610

Details on dosing and sampling

[Details on dosing and sampling]

Freetext Templates:

PHARMACOKINETIC STUDY (Absorption, distribution, excretion)

- Tissues and body fluids sampled (delete / add / specify): urine, faeces, blood, plasma, serum or other tissues, cage washes, bile

- Time and frequency of sampling:

- Other:

METABOLITE CHARACTERISATION STUDIES

- Tissues and body fluids sampled (delete / add / specify): urine, faeces, tissues, cage washes, bile

- Time and frequency of sampling:

- From how many animals: (samples pooled or not)

- Method type(s) for identification (e.g. GC-FID, GC-MS, HPLC-DAD, HPLC-MS-MS, HPLC-UV, Liquid scintillation counting, NMR, TLC)

- Limits of detection and quantification:

- Other:

TREATMENT FOR CLEAVAGE OF CONJUGATES (if applicable):

Include details on dosing and sampling. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

Details on dosing and sampling

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:DOSING_SAMPLING_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.01.0620

Statistics

[Statistics]

List parameters that were analysed by which test methods.

Indication of parameters analyzed and statistical tests performed.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE07.01.01.0630

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_META_MAM>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.01.01.0635

RESULTS AND DISCUSSION

[Results and discussions]

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

SE07.01.01.0640

Preliminary studies

[Preliminary studies]

Briefly describe the results of preliminary study or studies if any.

Description of the results of any preliminary study or studies.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:PRELIM_STUDIES>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.01.01.0641

Main ADME results

[Main ADME results]

Briefly describe the most relevant results with regard to absorption, distribution, metabolism, excretion and any other aspects related to toxicokinetics. Further details can be given in the below fields 'Details on absorption', 'Details on distribution in tissues', 'Details on excretion' and/or 'Any other information on results incl. tables'.

If required, copy block of fields to include several parameters.

Absorption: Include degree of absorption in %. In case of a robust study summary, include a relating excretion of radioactivity (in urine, feces, etc.) to sampling time.

Distribution: For each treatment group / study design or combined groups, describe levels of radioactivity measured at given time points in tissues/organs.

Excretion: For each treatment group / study design or combined groups, describe levels of radioactivity measured at given time points in tissues and excreta including total recovery.

SE07.01.01.0642

Type

[Type]

Picklist Values:

absorption || distribution || metabolism || excretion || other:

Select either 'absorption', 'distribution', 'metabolism', 'excretion' or 'other:' from drop-down list.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:ADME_RESULTS>

<i5:set>

<i5:PHRASEOTHER_TYPE>

<i5:TYPE>

SE07.01.01.0643

Type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:ADME_RESULTS>

<i5:set>

<i5:PHRASEOTHER_TYPE>

<i5:TYPE_TXT>

SE07.01.01.0644

Main ADME results

[Main ADME results]

Briefly describe the most relevant results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:ADME_RESULTS>

<i5:set>

<i5:RESULTS>

<i5:RESULTS>

SE07.01.01.0645

Pharmacokinetic studies

[Pharmacokinetic studies]

Subheading of section 'Pharmacokinetic studies'

SE07.01.01.0650

Details on absorption

[Details on absorption]

In case of a robust study summary, describe further details on absorption. As appropriate 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').

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

Brief description of details on absorption incl. degree of absorption in %. In case of a robust study summary, further details and reference to Table if included.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:ABSORPTION>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.01.01.0660

Details on distribution in tissues

[Details on distribution in tissues]

REMARKS:

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

In case of a robust study summary, describe further details on distribution. As appropriate 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').

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

Description of levels of radioactivity measured at given time points in tissues/organs. In case of a robust study summary, further details and reference to Table if included.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:DISTRIBUTION>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.01.01.0669

Transfer into organs

[Transfer into organs]

Indicate the transfer of the radiolabelled test substance into organs. Copy this block of fields for each transfer type and/or different test runs if applicable.

Heading of field block 'Transfer into organs'.

SE07.01.01.0670

Test No.

[Test No.]

Picklist Values:

#1 || #2 || #3 || #4 || #5 || #6 || #7 || #8 || #9 || #10

Select a consecutive test number from drop-down list if more than one test runs are reported.

Indication of a consecutive test number 1-n used to distinguish multiple test runs.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:TRANSFER>

<i5:set>

<i5:TEST_NO>

<i5:TEST_NO>

SE07.01.01.0680

Transfer type

[Transfer type]

Picklist Values:

blood/brain barrier || blood/placenta barrier || secretion via gastric mucosa || other:

Select type of transfer (e.g. 'blood/brain transfer') from picklist.

Indicator specifying the type of transfer into organs.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:TRANSFER>

<i5:set>

<i5:PHRASEOTHER_TYPE>

<i5:TYPE>

SE07.01.01.0681

Transfer type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:TRANSFER>

<i5:set>

<i5:PHRASEOTHER_TYPE>

<i5:TYPE_TXT>

SE07.01.01.0690

Observation

[Observation]

Picklist Values:

distinct transfer || slight transfer || no transfer detectable || not determined || other:

Select the qualitative description (e.g. 'distinct transfer') that characterises the observed transfer of radiolabelled test substance into the brain or spinal cord or into the placenta and on the secretion of radioactivity via the gastric mucosa, respectively. As appropriate, include quantitative data and/or any explanations in the supplementary remarks field.

Qualitative description (e.g. 'distinct transfer') that characterises the observed transfer of radiolabelled test substance into the respective organ.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:TRANSFER>

<i5:set>

<i5:PHRASEOTHER_OBSERVATION>

<i5:OBSERVATION>

SE07.01.01.0691

Observation

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:TRANSFER>

<i5:set>

<i5:PHRASEOTHER_OBSERVATION>

<i5:OBSERVATION_TXT>

SE07.01.01.0700

Detals on excretion

[Details on excretion]

REMARKS:

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

In case of a robust study summary, describe further details on excretion. As appropriate 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').

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

Description of levels of radioactivity measured at given time points in tissues and excreta including total recovery. In case of a robust study summary, further details and reference to Table if included.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:EXCRETION>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.01.01.0709

Toxicokinetic parameters

[Toxicokinetic parameters]

Select toxicokinetic parameter from picklist and enter the corresponding value(s) with unit in the related text field.

Examples: (i) Half-life 1st: 23.4 hrs (male, single administration study); (ii) C(time): 88 μg/l at 40 hrs

Copy this block of fields for each parameter. If multiple test runs are recorded, enter test numbers in subfield 'Test No.'.

Heading of field block 'Transfer into organs'.

SE07.01.01.0710

Test No.

[Test No.]

Picklist Values:

#1 || #2 || #3 || #4 || #5 || #6 || #7 || #8 || #9 || #10

Select a consecutive test number from drop-down list if more than one test runs are reported.

Indication of a consecutive test number 1-n used to distinguish multiple test runs.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:PARAMETER>

<i5:set>

<i5:TEST_NO>

<i5:TEST_NO>

SE07.01.01.0720

Parameter

[Toxicokinetic parameters]

Picklist Values:

Half-life 1st: || Half-life 2nd: || Half-life 3rd: || AUC: || Cmax: || C(time): || Tmax: || other:

Select parameter from drop-down list.

Explanations:

AUC: Area under the plasma (blood) level vs. time curve from zero up to a certain measured time point (specify the time);

Cmax: Maximum (peak) concentration;

C(time): Maximum concentration at a specified time after administration of a given dose;

Tmax: Time to reach peak or maximum concentration following administration

Repeatable field for selecting a toxicokinetic parameter type, e.g. Half-life 1st or Cmax, the values of which are to be entered in the related suppl. remarks field, together with explanations on the study group the result refers to as appropriate.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:PARAMETER>

<i5:set>

<i5:PHRASEOTHER_PARAMETER>

<i5:PARAMETER>

SE07.01.01.0721

Parameter

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:PARAMETER>

<i5:set>

<i5:PHRASEOTHER_PARAMETER>

<i5:PARAMETER_TXT>

SE07.01.01.0725

Metabolite characterisation studies

[Metabolite characterisation studies]

Subheading of section 'Metabolite characterisation studies'

SE07.01.01.0730

Metabolites identified

[Metabolites identified]

Picklist Values:

no || not measured || yes || no data

Indicate whether metabolites were identified.

Indicator that metabolites were identified or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:METABOLITES>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE07.01.01.0740

Details on metabolites

[Details on metabolites]

REMARKS:

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

List the metabolites identified, include percent of radioactive dose given, where they were identified, when, if applicable, how they were identified, if applicable, how much parent was present in the excreta.

In case of a robust study summary, 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').

When available, include summary of metabolic pathways and attach figures in field 'Attached background material'. Mention which are major vs. minor pathways. Attach the submitter's postulated pathway as a figure.

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

Details on metabolites with reference to a table if included.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:METABOLITES_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.01.01.0744

Bioaccessibility

[Bioaccessibility]

SE07.01.01.0745

Bioaccessibility testing results

[Bioaccessibility testing results]

Indicate the results of the bio-accessibility (or bio-availability) tests, if applicable.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:BIOACCESSIBILITY_RESULTS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.01.01.0750

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_META_MAM>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.01.01.0755

OVERALL REMARKS, ATTACHMENTS

[Overall remarks, attachments]

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

SE07.01.01.0760

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_META_MAM>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.01.01.0769

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'.

SE07.01.01.0770

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_META_MAM>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE07.01.01.0780

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_META_MAM>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE07.01.01.0789

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

SE07.01.01.0790

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_META_MAM>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE07.01.01.0792

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_META_MAM>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE07.01.01.0795

APPLICANT'S SUMMARY AND CONCLUSION

[Applicant's summary and conclusion]

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

SE07.01.01.0800

Interpretation of results

[Interpretation of results]

Picklist Values:

no bioaccumulation potential based on study results || low bioaccumulation potential based on study results || high bioaccumulation potential based on study results || bioaccumulation potential cannot be judged based on study results || other: || no data

Indicate overall interpretation of test results with regard to the bioaccumulation potential 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.

Indicate whether no or a low / high bioaccumulation potential can be concluded based on the study results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:INTERPRET_RS_SUBMITTER>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.01.01.0801

Interpretation of results

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_META_MAM>

<i5:INTERPRET_RS_SUBMITTER>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.01.01.0810

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_META_MAM>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.01.01.0820

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_META_MAM>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.01.01.0830

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_META_MAM>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>