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.

SE05.03.02.0215

DATA SOURCE

[Data source]

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

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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'

SE05.03.02.0220

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 Select 'Other company data' to characterise any unpublished information from a company other than a study report. Select 'Grey literature' for any other unpublished information or 'other:' and specify.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

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE05.03.02.0221

Reference type

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE05.03.02.0230

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:EN_BIOACCU_TERR>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE05.03.02.0240

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:EN_BIOACCU_TERR>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE05.03.02.0250

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:EN_BIOACCU_TERR>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE05.03.02.0260

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:EN_BIOACCU_TERR>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE05.03.02.0270

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:EN_BIOACCU_TERR>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE05.03.02.0280

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:EN_BIOACCU_TERR>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE05.03.02.0290

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:EN_BIOACCU_TERR>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE05.03.02.0300

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:EN_BIOACCU_TERR>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE05.03.02.0310

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:EN_BIOACCU_TERR>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE05.03.02.0320

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:EN_BIOACCU_TERR>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE05.03.02.0321

Data access

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE05.03.02.0330

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:EN_BIOACCU_TERR>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE05.03.02.0331

Data protection claimed

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE05.03.02.0340

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:EN_BIOACCU_TERR>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.02.0345

MATERIALS AND METHODS

[Materials and methods]

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

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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'

SE05.03.02.0350

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:EN_BIOACCU_TERR>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE05.03.02.0360

Guideline

[Guideline]

Picklist Values:

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:EN_BIOACCU_TERR>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE05.03.02.0361

Guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE05.03.02.0370

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:EN_BIOACCU_TERR>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE05.03.02.0371

Deviations from guideline

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE05.03.02.0380

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:EN_BIOACCU_TERR>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE05.03.02.0390

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:EN_BIOACCU_TERR>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE05.03.02.0391

GLP compliance

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE05.03.02.0395

Test materials

[Test materials]

Subheading of section 'Test materials'

SE05.03.02.0400

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:EN_BIOACCU_TERR>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.03.02.0409

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'

SE05.03.02.0410

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:EN_BIOACCU_TERR>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE05.03.02.0411

Identifier

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE05.03.02.0420

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:EN_BIOACCU_TERR>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE05.03.02.0425

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:EN_BIOACCU_TERR>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE05.03.02.0426

Test material form

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE05.03.02.0430

Radiolabelling

[Radiolabelling]

Picklist Values:

no || yes || 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'.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:RADIO_LABEL>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.03.02.0440

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:EN_BIOACCU_TERR>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.02.0450

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:EN_BIOACCU_TERR>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.02.0460

Details on properties of test surrogate or analogue material

[Details on properties of test surrogate or analogue material]

Freetext Templates:

PHYSICO-CHEMICAL PROPERTIES

- Vapour pressure:

- Water solubility:

- Henry's Law constant:

- log Pow:

- pKa:

- log Koc:

- Base or acid catalysis of test material:

- UV absorption:

- Stability of test material at room temperature:

OTHER PROPERTIES (if relevant for this endpoint)

ONLY if another substance, i.e. analogue or surrogate (e.g. degradation/transformation product) was used as test material, enter any relevant details on the properties of this substance that may possibly affect the test performance, particularly physico-chemical properties.

Use freetext template and delete/add elements as appropriate.

Note that the physico-chemical properties of the substance for which the submission is made should be recorded in the corresponding templates and therefore need not be repeated here. Nevertheless, the possible influence of any physico-chemical properties should be indicated / discussed in appropriate fields, particularly in fields 'Details on test conditions' and 'Details on results'. This holds also true if any property of the substance is different in the test medium as compared to the data recorded in the section on physico-chemical properties, e.g. lower water solubility.

Details on properties of test material, particularly physico-chemical properties. Relevant if an analogue or surrogate was used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:PROPERTIES_TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.02.0465

Study design

[Study design]

Subheading of section 'Study design'

SE05.03.02.0470

Details on sampling

[Details on sampling]

Freetext Templates:

- Sampling intervals/frequency for test organisms:

- Sampling intervals/frequency for test medium samples:

- Sample storage conditions before analysis:

- Details on sampling and analysis of test organisms and test media samples (e.g. sample preparation, analytical methods):

Enter details on sampling. Use freetext template as appropriate and delete/add elements as appropriate.

Details on sampling.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:SAMPLING_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.02.0480

Details on analytical methods

[Details on analytical methods]

Freetext Templates:

DETAILS ON PRETREATMENT

- Centrifugation:

- Filtration:

- Digestion (acid used, method: e.g. micro-oven):

- Extraction (solvent used, method: e.g. solid/liquid by soxhlet or ASE):

- Total 14C measurement:

- Clean up method: e.g. chemical used for chemistry method (Cu, Hg, ...) or phase and solvent used for SPE method:

- Derivatisation method if used:

- Concentration (method):

IDENTIFICATION AND QUANTIFICATION OF TEST SUBSTANCE/PRODUCT

- Separation method (e.g. HPLC, GC):

- Conditions (column, mobile phase, etc.):

- Detection method (e.g. ECD, UV, MS, ICP-AES, ICP-MS):

- Detection limits (LOD, LOQ) (indicate method of determination/calculation):

- Reproducibility in % (indicate method of evaluation; should be given for stated concentration levels):

- Linearity range:

- Internal or external calibration:

- Extraction recovery (indicate if results are corrected or not for recoveries):

- Method of confirmation of identity of measured compound:

Enter any details on the analytical methods used. Use freetext template and delete/add elements as appropriate. Specify treatment of animal and soil samples, including details of preparation, storage, extraction and analytical procedures (and precision) for the test substance and lipid content (if measured).

Copy any subheading(s) for the different matrices as appropriate.

Details on the analytical method used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:ANALYT_METHOD_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.02.0490

Vehicle

[Vehicle]

Picklist Values:

yes || no || no data

Indicate whether vehicle was used to emulsify or mix the experimental test material to enhance its solubility. If yes, specify in field 'Details on preparation and application of test substrate'.

Indicator that a chemical was used to emulsify or mix the experimental test material to enhance its solubility.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:VEHICLE_FATE>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.03.02.0500

Details on preparation and application of test substrate

[Details on preparation and application of test substrate]

Freetext Templates:

- Method of application to filter paper (if used):

- Method of mixing into soil (if used):

- Method of application to soil surface (if used):

- Controls:

- Chemical name of vehicle (organic solvent, emulsifier or dispersant):

- Concentration of vehicle in test medium (stock solution and final test solution):

- Evaporation of vehicle before use:

Enter any details that could be relevant for evaluating this study summary. Use freetext template as appropriate.

Additional details on preparation and application of test substrate

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:TESTSUBSTRATE_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.02.0505

Test organisms

[Test organisms]

Subheading of section 'Test organisms'

SE05.03.02.0510

Test organisms (species)

[Test organisms (species)]

Picklist Values:

Aleochara bilineata || Aleochara sp. || Bembidion lampros || Bembidion sp. || Caenorhabditis elegans || Caenorhabditis sp. || Eisenia fetida || Eisenia sp. || Enchytraeus albidus || Enchytraeus globuliferus || Enchytraeus sp. || Folsomia candida || Folsomia sp. || Hypoaspis aculeifer || Lumbricus rubellus || Lumbricus sp. || Monhystera disjuncta || Monhystera sp. || Oniscus assellus || Oniscus sp. || Onychiurus armatus || Onychiurus sp. || Orchesella cincta || Orchesella sp. || Panagrellus redivivus || Panagrellus sp. || Pardosa sp. || Poecilus cupreus || Porcellus scaber || Porcellus sp. || Pterostichus cupreus || Pterostichus sp. || Rhabditis oxycerca || Rhabditis sp. || Tomocerus sp. || Trachelipus rathkii || Trachelipus sp. || other:

Select species from picklist. If not available, select 'other' and enter name of organism (species).

The test species or organism in an experimental study.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE05.03.02.0511

Test organisms (species)

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE05.03.02.0520

Details on test organisms

[Details on test organisms]

Freetext Templates:

TEST ORGANISM

- Common name:

- Source:

- Age at test initiation (mean and range, SD):

- Weight at test initiation (mean and range, SD):

ACCLIMATION

- Acclimation period:

- Acclimation conditions (same as test or not):

- Health during acclimation (any mortality observed):

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

Details on test organisms and acclimation.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:ORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.02.0530

Exposure / uptake duration

[Total exposure / uptake duration]

Picklist Values:

> || >= || ca.

Enter a numeric value or a range of numeric values according to following conventions:

(i) In the first numeric field, enter a single value (Qualifier subfield left blank) or a value if preceded by '>', '>=' or 'ca.' (e.g. '20', 'ca. 20', '>20').

(ii) In the second numeric field, enter a single value if preceded by '<' or '<='.

(iii) Use both numeric fields and, as required, the lower and upper qualifier field to enter a range of numeric values (e.g. '2 - 8' or '>2 <8').

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.03.02.0540

Exposure / uptake duration

[no label]

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.03.02.0550

Exposure / uptake duration

[no label]

Picklist Values:

< || <= || ca.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.03.02.0560

Exposure / uptake duration

[no label]

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.03.02.0570

Unit

[Total exposure / uptake duration]

Picklist Values:

min || h || d || wk

Select from drop-down list.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE05.03.02.0580

Depuration duration

[Total depuration duration]

Picklist Values:

> || >= || ca.

Enter a numeric value or a range of numeric values according to following conventions:

(i) In the first numeric field, enter a single value (Qualifier subfield left blank) or a value if preceded by '>', '>=' or 'ca.' (e.g. '20', 'ca. 20', '>20').

(ii) In the second numeric field, enter a single value if preceded by '<' or '<='.

(iii) Use both numeric fields and, as required, the lower and upper qualifier field to enter a range of numeric values (e.g. '2 - 8' or '>2 <8').

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DEPUR_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.03.02.0590

Depuration duration

[no label]

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DEPUR_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.03.02.0600

Depuration duration

[no label]

Picklist Values:

< || <= || ca.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DEPUR_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.03.02.0610

Depuration duration

[no label]

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DEPUR_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.03.02.0620

Unit

[Total depuration duration]

Picklist Values:

min || h || d || wk

Select from drop-down list.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DEPUR_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE05.03.02.0630

Nominal and measured concentrations

[Nominal and measured concentrations]

List nominal and, if available, measured test concentrations in soil and the measured concentrations in tissues (with unit, i.e. mg/kg soil d.w., g/kg soil d.w., g/ha d.w., kg/ha d.w. or other). As appropriate tabulate the data and refer to Table No. (use predefined table if any).

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

Nominal and measured concentrations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:NOM_MEAS_CONC>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.02.0635

Test conditions

[Test conditions]

Subheading of section 'Test conditions'

SE05.03.02.0640

Test temperature

[Test temperature]

Indicate test temperature values measured during test. Include range, mean, standard deviation and unit. As appropriate state the location and type of measurement (e.g. continuous monitoring). Alternatively refer to table (e.g. 'see table no. 2') if the test conditions are presented in tabular form in the rich text editor field.

The temperature used in the experimental determination of the test value.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:TEST_TEMP>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.02.0650

pH

[pH]

Indicate pH values measured during test. Include range, mean, standard deviation and unit. Alternatively refer to table (e.g. 'see table no. 2') if the test conditions are presented in tabular form in the rich text editor field.

The pH value applicable to the measured or estimated test value or mean or range.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:PH>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.02.0660

Moisture

[Moisture]

Indicate the soil humidity in % moisture content or g water/100g soil dry weight measured during test. Include range, mean, standard deviation and unit. Alternatively refer to table (e.g. 'see table no. 2') if the test conditions are presented in tabular form in the rich text editor field.

Indication of soil humidity in % moisture content or g water/100g soil dry weight.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:HUMIDITY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.02.0670

TOC

[TOC]

Indicate TOC (total organic carbon) values measured during test. Include range, mean, standard deviation and unit. Alternatively refer to table (e.g. 'see table no. 2') if the test conditions are presented in tabular form in the rich text editor field.

The TOC value applicable to the measured or estimated test value or mean or range.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:TOC>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.02.0680

Details on test conditions

[Details on test conditions]

Freetext Templates:

TEST SYSTEM

- Test container (material, size):

- Amount of soil or substrate:

- No. of organisms per container (treatment):

- No. of replicates per treatment group:

- No. of replicates per control / vehicle control:

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)

- Geographical reference of sampling site (latitude, longitude):

- History of site:

- Vegetation cover:

- Treatments with pesticides or fertilizers:

- Accidental contamination:

- Other:

- Depth of sampling:

- Soil texture

- % sand:

- % silt:

- % clay:

- Soil taxonomic classification:

- Soil classification system:

- Composition (if artificial substrate):

- pH water:

- pH soil:

- Organic carbon (%):

- Moisture (%):

- Maximum water holding capacity (in % dry weight):

- Stability and homogeneity of test material in the medium:

OTHER TEST CONDITIONS

- Adjustment of pH:

- Photoperiod:

- Light intensity:

VEHICLE CONTROL PERFORMED: yes/no

RANGE-FINDING / PRELIMINARY STUDY

- Test concentrations:

- Results used to determine the conditions for the definitive study:

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 test conditions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:TESTCONDIT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.02.0690

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:EN_BIOACCU_TERR>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.03.02.0695

RESULTS AND DISCUSSION

[Results and discussions]

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

SE05.03.02.0699

Lipid content of test organisms

[Lipid content]

Indicate the lipid content of test organisms with unit. If appropriate specify the time point at which the measurement was made, e.g. start or end of experiment.

Copy this block of fields for specifying the lipid content ratio in % if required.

Heading of field block 'Lipid content of test organisms'

SE05.03.02.0700

Lipid content

[Lipid content]

Picklist Values:

> || >= || ca.

Enter a numeric value or a range of numeric values according to following conventions:

(i) In the first numeric field, enter a single value (Qualifier subfield left blank) or a value if preceded by '>', '>=' or 'ca.' (e.g. '20', 'ca. 20', '>20').

(ii) In the second numeric field, enter a single value if preceded by '<' or '<='.

(iii) Use both numeric fields and, as required, the lower and upper qualifier field to enter a range of numeric values (e.g. '2 - 8' or '>2 <8').

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.03.02.0710

Lipid content

[no label]

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.03.02.0720

Lipid content

[no label]

Picklist Values:

< || <= || ca.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.03.02.0730

Lipid content

[no label]

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.03.02.0740

Unit of lipid content

[Lipid content]

Picklist Values:

µg/kg bw d.w. || mg/kg bw d.w. || µg/kg bw w.w. || mg/kg bw w.w. || % || other:

Select from drop-down list.

Unit of lipid content.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE05.03.02.0741

Unit of lipid content

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT_TXT>

SE05.03.02.0750

Time point

[Time point]

Picklist Values:

start of exposure || end of exposure || other:

Select from drop-down list.

Time point at which the lipid content was determined.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PHRASEOTHER_TIME>

<i5:TIME>

SE05.03.02.0751

Time point

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PHRASEOTHER_TIME>

<i5:TIME_TXT>

SE05.03.02.0760

Remarks

[Remarks]

Enter any remarks related to the recorded values as appropriate.

Remarks on lipid content

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:LIPID_CONTENT>

<i5:set>

<i5:REM>

<i5:REM>

SE05.03.02.0769

Bioconcentration factor (BCF)

[Bioconcentration factor]

This repeatable block of fields allows to report the steady-state BSAF (biota-to-soil accumulation factor) and/or BCF (bioconcentration factor, where pore water is the basis). Copy this block of fields if more than one value should be entered, e.g. kinetic bioconcentration factors expressed in relation to the whole body, the total lipid content or specific tissues of the test organisms.

Heading of field block 'Bioconcentration factor'

SE05.03.02.0770

Type of bioconcentration factor

[Type]

Picklist Values:

BCF || BSAF

Indicate the reported bioconcentration factor, i.e. either the steady-state BSAF (biota-to-soil accumulation factor) or BCF (bioconcentration factor, where pore water is the basis).

Type of bioconcentration factor, i.e. BCF or BSAF.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:BSAF_TYPE>

<i5:BSAF_TYPE>

SE05.03.02.0780

Bioconcentration factor

[Value]

Picklist Values:

> || >= || ca.

Enter a numeric value or a range of numeric values according to following conventions:

(i) In the first numeric field, enter a single value (Qualifier subfield left blank) or a value if preceded by '>', '>=' or 'ca.' (e.g. '20', 'ca. 20', '>20').

(ii) In the second numeric field, enter a single value if preceded by '<' or '<='.

(iii) Use both numeric fields and, as required, the lower and upper qualifier field to enter a range of numeric values (e.g. '2 - 8' or '>2 <8').

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:PRECISION_BSAF_LOQUALIFIER>

<i5:BSAF_LOQUALIFIER>

SE05.03.02.0790

Bioconcentration factor

[no label]

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:PRECISION_BSAF_LOQUALIFIER>

<i5:BSAF_LOVALUE>

SE05.03.02.0800

Bioconcentration factor

[no label]

Picklist Values:

< || <= || ca.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:PRECISION_BSAF_LOQUALIFIER>

<i5:BSAF_UPQUALIFIER>

SE05.03.02.0810

Bioconcentration factor

[no label]

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:PRECISION_BSAF_LOQUALIFIER>

<i5:BSAF_UPVALUE>

SE05.03.02.0811

Unit

[Bioconcentration factor]

Picklist Values:

dimensionless || L/kg || m³/kg || other:

Select from drop-down list.

Heading of field block 'Bioconcentration factor'

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:PRECISION_BSAF_LOQUALIFIER>

<i5:BSAF_UNIT>

SE05.03.02.0812

Unit

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:PRECISION_BSAF_LOQUALIFIER>

<i5:BSAF_UNIT_TXT>

SE05.03.02.0820

Basis for BCF

[Basis]

Picklist Values:

whole body w.w. || whole body d.w. || organ w.w. || organ d.w. || edible fraction || non-edible fraction || normalised lipid fraction || total lipid content || no data || other:

From drop-down list, select the basis for the BCF, i.e. expressed in relation to the whole body, the total lipid content or specific tissues of the test organisms (w.w. = wet weight; d.w. = dry weight).

'Indication of the body parts including their moisture condition the BCF is based on (w.w. = wet weight; d.w. = dry weight).'

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:PHRASEOTHER_BASIS>

<i5:BASIS>

SE05.03.02.0821

Basis for BCF

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:PHRASEOTHER_BASIS>

<i5:BASIS_TXT>

SE05.03.02.0830

Time of plateau

[Time of plateau]

If applicable, indicate time at which plateau was reached (for tissue concentration).

Numeric value of time at which plateau was reached (for tissue concentration).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:VALUEUNIT_PLATEAU_VALUE>

<i5:PLATEAU_VALUE>

SE05.03.02.0840

Unit

[Bioconcentration factor]

Picklist Values:

min || h || d || wk

Select from drop-down list.

Unit of depuration duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:VALUEUNIT_PLATEAU_VALUE>

<i5:PLATEAU_UNIT>

SE05.03.02.0850

Calculation basis

[Calculation basis]

Picklist Values:

steady state || kinetic || other:

If the BCF was not calculated at steady state, select 'kinetic:' and briefly specify using the supplementary remarks field (e.g. 'kinetic: steady state at 80% of equilibrium).

Indicator specifying whether bioconcentration factor was calculated based on steady state or kinetic conditions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:PHRASEOTHER_CALC_BASE>

<i5:CALC_BASE>

SE05.03.02.0851

Calculation basis

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:PHRASEOTHER_CALC_BASE>

<i5:CALC_BASE_TXT>

SE05.03.02.0860

Remarks

[Remarks]

Enter any remarks related to the recorded values as appropriate, e.g. for indicating if BCF is based on parent compound instead of radioactivity.

Remarks on BCF

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:BCF>

<i5:set>

<i5:REM>

<i5:REM>

SE05.03.02.0869

Depuration

[Depuration]

Indicate if clearance of test substance or metabolites from test organisms was observed; give depuration time required for clearance of 50% (DT50), 90% (DT90) and or any other percent of residues

Heading of field block 'Depuration'

SE05.03.02.0870

Elimination

[Elimination]

Picklist Values:

yes || no || no data

Indicate whether elimination of test substance or metabolites occurred or not.

Indicator specifying whether elimination of test substance or metabolites occurred or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DEPURATION>

<i5:set>

<i5:INDICATOR>

<i5:INDICATOR>

SE05.03.02.0880

Endpoint

[Endpoint]

Picklist Values:

DT50 || DT90 || other:

Indicate to which endpoint type the effect concentration refers, , e.g. DT50.

Endpoint type, e.g. DT50, to which the effect concentration refers.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DEPURATION>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT>

SE05.03.02.0881

Endpoint

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DEPURATION>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT_TXT>

SE05.03.02.0890

Depuration time (DT)

[Depuration time (DT)]

Enter numeric value.

Numeric value of depuration time endpoint.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DEPURATION>

<i5:set>

<i5:VALUEUNIT_TIME_VALUE>

<i5:TIME_VALUE>

SE05.03.02.0900

Unit

[Depuration]

Picklist Values:

min || h || d || wk

Select from drop-down list.

Unit of depuration time

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:DEPURATION>

<i5:set>

<i5:VALUEUNIT_TIME_VALUE>

<i5:TIME_UNIT>

SE05.03.02.0910

Kinetic parameters

[Kinetic parameters]

Freetext Templates:

- Uptake rate constant:

- Depuration rate constant:

- Indication of bi- or multiphasic kinetics:

- Computation / data analysis:

Give values (including 95 % confidence limits and standard deviations) for the uptake and depuration rate constants (all expressed in relation to whole body, total lipid content or specific tissues of the test organisms); give relevant details on computation/data analysis.

Kinetic parameters, i.e. uptake and depuration rate constants and details on computation/data analysis.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:KINETIC_PARAMETERS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.02.0920

Metabolites

[Metabolites]

If identified, table(s) with data on any metabolites of the test substance accumulated in test organisms (total), specific tissues thereof (e.g. lipid) should be included (at least those, accounting for > 10 % of residues).

Data on metabolites

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:METABOLITES>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE05.03.02.0930

Details on results

[Details on results]

Freetext Templates:

- Mortality of test organisms:

- Behavioural abnormalities:

- Observations on body length and weight:

- Other biological observations:

- Mortality and/or behavioural abnormalities of control:

- Loss of test substance during test period:

- Results with vehicle control:

Report any other relevant results using freetext template as appropriate. Indicate any results related to the chemical properties of the test material. Compare the results for the test substance with that for the reference substance.

Additional information on results

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.02.0940

Reported statistics

[Reported statistics]

Indicate the parameters analysed, the statistical method used and the statistical test performed.

Indication of parameters analyzed, the statistical method used and the statistical test performed.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE05.03.02.0950

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:EN_BIOACCU_TERR>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.03.02.0955

OVERALL REMARKS, ATTACHMENTS

[Overall remarks, attachments]

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

SE05.03.02.0960

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:EN_BIOACCU_TERR>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.03.02.0969

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'.

SE05.03.02.0970

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:EN_BIOACCU_TERR>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE05.03.02.0980

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:EN_BIOACCU_TERR>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE05.03.02.0989

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

SE05.03.02.0990

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:EN_BIOACCU_TERR>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE05.03.02.0992

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:EN_BIOACCU_TERR>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE05.03.02.0995

APPLICANT'S SUMMARY AND CONCLUSION

[Applicant's summary and conclusion]

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

SE05.03.02.1000

Validity criteria fulfilled

[Validity criteria fulfilled]

Picklist Values:

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

Indicate whether validity criteria given by test guideline have been fulfilled or not. Use supplementary remarks field for indicating the criteria and entering remarks. Clearly indicate if the criteria used are not consistent with those given by the test guideline. If so, give justification in field 'Rationale for reliability incl. deficiencies' as to why this study summary is considered reliable.

Indication of validity criteria and whether they have been fulfilled or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE05.03.02.1001

Validity criteria fulfilled

[no label]

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCU_TERR>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE05.03.02.1010

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:EN_BIOACCU_TERR>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE05.03.02.1020

Executive summary

[Executive summary]

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:EN_BIOACCU_TERR>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.03.02.1030

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:EN_BIOACCU_TERR>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>