OECD Template #32: Bioaccumulation: aquatic / sediment (Version 2-June 2012)

The following table gives a detailed description of the type of information prompted for by the data entry fields. Elements provided to guide the user include predefined picklist phrases, freetext templates and context-sensitive help texts. In addition, technical elements are provided, i.e. field and data types, explanations for use in Data Element Dictionary (DED) and the xml schema. The conventions used are explained in part 'Introduction and Format of OECD Harmonised Templates'.

Field number

Field description

[Field label]

  1. Field type
  2. Data type
  3. Group ID
  4. Max occ.
  5. Detail level
  6. Picklist code

Remarks, Picklist, Freetext template

Help text

Explanation for use in Data Element Dictionary (DED)

XML Schema

 

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.

 

 

 

SE05.03.01.0215

DATA SOURCE

[Data source]

  1. HEAD-1
  2. Heading level 1
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

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

 

SE05.03.01.0219

Reference

[Reference]

  1. HEAD BLOCK
  2. Block label
  3. g242
  4. 10
  5. 1
  6. [N/A]

 

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'

 

SE05.03.01.0220

Reference type

[Reference type]

  1. LIST-OPEN
  2. STRING/255
  3. g242
  4. 1
  5. 1
  6. Z31

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_BIOACCUMULATION>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE05.03.01.0221

Reference type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g242
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE05.03.01.0230

Author(s) (or transferred reference)

[Author]

  1. TEXT
  2. STRING/2000
  3. g242
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE05.03.01.0240

Year

[Year]

  1. YEAR
  2. NUMBER/4/###0
  3. g242
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE05.03.01.0250

Title

[Title]

  1. TEXT
  2. STRING/255
  3. g242
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE05.03.01.0260

Bibliographic source

[Bibliographic source]

  1. TEXT
  2. STRING/255
  3. g242
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE05.03.01.0270

Testing laboratory

[Testing laboratory]

  1. TEXT
  2. STRING/255
  3. g242
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE05.03.01.0280

Report no.

[Report no.]

  1. TEXT
  2. STRING/255
  3. g242
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE05.03.01.0290

Owner company

[Owner company]

  1. TEXT
  2. STRING/255
  3. g242
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE05.03.01.0300

Company study no.

[Company study no.]

  1. TEXT
  2. STRING/255
  3. g242
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE05.03.01.0310

Report date

[Report date]

  1. DATE
  2. DATE/255
  3. g242
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE05.03.01.0320

Data access

[Data access]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z03

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_BIOACCUMULATION>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE05.03.01.0321

Data access

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE05.03.01.0330

Data protection claimed

[Data protection claimed]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z30

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_BIOACCUMULATION>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE05.03.01.0331

Data protection claimed

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE05.03.01.0340

Cross-reference to same study

[Cross-reference to same study]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.01.0345

MATERIALS AND METHODS

[Materials and methods]

  1. HEAD-1
  2. Heading level 1
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

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

 

SE05.03.01.0349

Test guideline

[Test guideline]

  1. HEAD BLOCK
  2. Block label
  3. g243
  4. 5
  5. 1
  6. [N/A]

 

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'

 

SE05.03.01.0350

Qualifier

[Qualifier]

  1. LIST-CLOSED
  2. STRING/255
  3. g243
  4. 1
  5. 1
  6. Z06

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_BIOACCUMULATION>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE05.03.01.0360

Guideline

[Guideline]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g243
  4. 1
  5. 1
  6. F34

Picklist Values:

OECD Guideline 305 (Bioconcentration: Flow-through Fish Test) || OECD Guideline 305 A (Bioaccumulation: Sequential Static Fish Test) || OECD Guideline 305 B (Bioaccumulation: Semi-static Fish Test) || OECD Guideline 305 C (Bioaccumulation: Test for the Degree of Bioconcentration in Fish) || OECD Guideline 305 D (Bioaccumulation: Static Fish Test) || OECD Guideline 305 E (Bioaccumulation: Flow-through Fish Test) || EU Method C.13 (Bioconcentration: Flow-through fish test) || EPA OPP 165-4 (Laboratory Studies of Pesticide Accumulation in Fish) || EPA OPP 72-6 (Aquatic Organism Accumulation Tests) || EPA OPPTS 850.1710 (Oyster Bioconcentration Test) || EPA OPPTS 850.1730 (Fish BioconcentrationTest) || EPA OPPTS 850.1850 (Aquatic Food Chain Transfer) || EPA OTS 797.1520 (Fish Bioconcentration Test-Rainbow Trout) || EPA OTS 797.1830 (Oyster Bioconcentration Test) || EPA 600/R-94/024 (Methods for measuring the toxicity and bioaccumulation of sediment-associated contaminants with freshwater invertebrates) || ASTM E1688-95 (Standard guide for determination of bioaccumulation of sediment-associated contaminants by benthic invertebrates) || 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_BIOACCUMULATION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE05.03.01.0361

Guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g243
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE05.03.01.0370

Deviations from guideline

[Deviations]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g243
  4. 1
  5. 1
  6. Z08

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_BIOACCUMULATION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE05.03.01.0371

Deviations from guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g243
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE05.03.01.0380

Principles of method if other than guideline

[Principles of method if other than guideline]

  1. TEXTAREA
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE05.03.01.0390

GLP compliance

[GLP compliance]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z40

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_BIOACCUMULATION>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE05.03.01.0391

GLP compliance

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE05.03.01.0395

Test materials

[Test materials]

  1. HEAD-2
  2. Heading level 2
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Subheading of section 'Test materials'

 

SE05.03.01.0400

Test material equivalent to submission substance identity

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

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z38

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_BIOACCUMULATION>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.03.01.0409

Test material identity

[Test material identity]

  1. HEAD BLOCK
  2. Block label
  3. g244
  4. 10
  5. 1
  6. [N/A]

 

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'

 

SE05.03.01.0410

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g244
  4. 1
  5. 1
  6. Z39

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_BIOACCUMULATION>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE05.03.01.0411

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g244
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE05.03.01.0420

Identity

[Identity]

  1. TEXT
  2. STRING/2000
  3. g244
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE05.03.01.0425

Physical form

[Test material form]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. A101

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_BIOACCUMULATION>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE05.03.01.0426

Test material form

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE05.03.01.0430

Radiolabelling

[Radiolabelling]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. F14

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_BIOACCUMULATION>

<i5:RADIO_LABEL>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.03.01.0440

Details on test material

[Details on test material]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

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_BIOACCUMULATION>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.01.0450

Confidential details on test material

[Confidential details on test material]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 3
  6. [N/A]

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_BIOACCUMULATION>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.01.0460

Details on properties of test surrogate or analogue material

[Details on properties of test surrogate or analogue material]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

Freetext Templates:

PHYSICO-CHEMICAL PROPERTIES

- Vapour pressure:

- Water solubility:

- Henry's Law constant:

- log Pow:

- pKa:

- Base or acid catalysis of test material:

- UV absorption:

- Stability of test material at room temperature:

OTHER PROPERTIES (if relevant for this endpoint)

- Phototransformation in water:

- Ready biodegradability (where appropriate):

- Acute toxicity to fish (species, duration, LC50, type and concentration of vehicle if used):

- Other:

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_BIOACCUMULATION>

<i5:PROPERTIES_TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.01.0470

Details on sampling

[Details on sampling]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

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. For sediment study, distinguish between sampling of sediment, pore water, and overlying water.

Details on sampling.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:SAMPLING_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.01.0480

Details on analytical methods

[Details on analytical methods]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

Freetext Templates:

DETAILS ON PRETREATMENT

- Centrifugation:

- Filtration:

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

- Extraction (solvent used, method: e.g. liquid-liquid, SPE):

- 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):

- Recovery ratio of test material from water vs. fish samples:

- 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 fish and water 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_BIOACCUMULATION>

<i5:ANALYT_METHOD_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.01.0490

Vehicle

[Vehicle]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. A03

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 test solutions'.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:VEHICLE_FATE>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.03.01.0500

Details on test solutions

[Details on preparation of test solutions or sediment]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

Freetext Templates:

PREPARATION OF SPIKED SEDIMENT

- Pooling or mixing of different substrates:

- Method of mixing:

- Details of spiking:

- Equilibration time:

- Equilibration conditions:

- 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:

PREPARATION OF SPIKED WATER

- Details of spiking:

- Controls:

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

- Concentration of vehicle in final test solution: PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

- Method:

- Controls:

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

- Concentration of vehicle in test medium (stock solution and final test solution(s) at different concentrations and in control(s)):

- Evidence of undissolved material (e.g. precipitate, surface film, etc):

Select freetext template for the respective type of study (i.e. aquatic or sediment) and delete/add elements as appropriate.

Additional details describing the characteristics of the test and reference material.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:TESTSOLUTIONS_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.01.0505

Test organisms

[Test organisms]

  1. HEAD-2
  2. Heading level 2
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Subheading of section 'Test organisms'

 

SE05.03.01.0510

Test organisms (species)

[Test organisms (species)]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E147

Picklist Values:

Alburnus albidus costa || Alburnus alburnus || Alburnus lucidus || Alburnus sp. || Alosa pseudobarengus || Anchoa mitchilli || Anguilla anguilla || Anguilla japonica || Anguilla rostrata || Anguilla sp. || Barbus barbus || Brachydanio rerio (new name: Danio rerio) || Brevoortia patronus || Brevoortia tyrannus || Carassius auratus || Carassius carassius || Carassius sp. || Carassius vulgaris || Catostomus commersoni || Centropomus undecimalis || Centropristis striata || Clupea harengus || Colisa fasciatus || Coregonus artedii || Coregonus clupeaformis || Ctenopharyngodon idella || Cymatogaster aggregata || Cynoscion nebulosus || Cyprinodon sp. || Cyprinodon variegatus || Cyprinus auratus || Cyprinus carassius || Cyprinus carpio || Cyprinus sp. || Danio rerio || Danio rerio (reported as Brachydanio rerio) || Dorosoma petenese || Esox lucius || Esox masquinongi || Esox niger || Esox sp. || Fundulus confluentus || Fundulus diaphanus || Fundulus grandis || Fundulus heteroclitus || Fundulus jenkinsi || Fundulus lucidae || Fundulus majalis || Fundulus similis || Fundulus sp. || Gadus morrhua || Gambusia affinis || Gasterosteus aculeatus || Gaus mexlaughs || Harengula pensacolae || Ictalurus catus || Ictalurus furcatus || Ictalurus melas || Ictalurus natalis || Ictalurus nebulosus || Ictalurus punctatus || Ictalurus sp. || Idus idus || Jordanella floridae || Lagodon rhomboides || Lebistes reticulatus || Leiostomus xanthurus || Lepomis auritus || Lepomis cyanellus || Lepomis gibbosus || Lepomis humilis || Lepomis macrochirus || Lepomis microlophus || Lepomis pallidus || Lepomis sp. || Leuciscus cephalus cabeda rissa || Leuciscus idus || Leuciscus idus melanotus || Leuciscus rutilus || Leuciscus sp. || Limanda aspera || Limanda limanda || Limanda sp. || Menidia beryllina || Menidia menidia || Menidia peninsulae || Menidia sp. || Micropogon undulatus || Micropterus dolomieui || Micropterus salmoides || Micropterus sp. || Misgurnus anguillicaudatus || Morone chrysops || Morone saxatilis || Morone sp. || Mugil cephalus || Mugil curema || Mugil sp. || Notropis atherinoides || Oncorhynchus gorbuscha || Oncorhynchus keta || Oncorhynchus kisutch || Oncorhynchus mykiss || Oncorhynchus mykiss (reported as Salmo gairdneri) || Oncorhynchus nerka || Oncorhynchus nerka kennerlyi || Oncorhynchus sp. || Oncorhynchus tschawytscha || Oryzias latipes || Osmerus mordax || Parophrys vetulus || Perca flavescens || Perca fluviatilis || Perca sp. || Petromyzon fluviatilis || Petromyzon marinus || Petromyzon sp. || Phoxinus laevis || Phoxinus phoxinus || Phoxinus sp. || Pimephales notatus || Pimephales promelas || Pimephales sp. || Platypoecilus maculatus || Pleuronectes platessa || Poecilia latipinna || Poecilia reticulata || Poecilia sp. || Pogonias cromis || Pomatomus saltatrix || Pomoxis annularis || Pomoxis nigromaculatus || Prosopium williamsoni || Pseudopleuronectes americanus || Ptychocheilus oregonensis || Rasbora heteromorpha || Rhodeus sericeus || Roccus americanus || Rutilus rutilus || Salmo aquabonita || Salmo clarki || Salmo gairdneri (new name: Oncorhynchus mykiss) || Salmo irideus || Salmo salar || Salmo sp. || Salmo trutta || Salvelinus alpinus || Salvelinus fontinalis || Salvelinus malma || Salvelinus namaycush || Salvelinus sp. || Sardinops sagax || Sarotherodon mossambicus || Scardinius erythrophthalmus || Sciaenops ocellata || Semolitus atromaculatus || Sphaeroidus maculatus || Stizostedion canadense || Stizostedion v. vitreum || Tinca sp..........

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_BIOACCUMULATION>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE05.03.01.0511

Test organisms (species)

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE05.03.01.0520

Details on test organisms

[Details on test organisms]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

Freetext Templates:

TEST ORGANISM

- Common name:

- Strain:

- Source:

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

- Length at study initiation (length definition, mean, range and SD):

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

- Weight at termination (mean and range, SD):

- Method of breeding:

- Health status:

- Description of housing/holding area:

- Feeding during test

- Food type:

- Amount:

- Frequency:

ACCLIMATION

- Acclimation period:

- Acclimation conditions (same as test or not):

- Type and amount of food:

- Feeding frequency:

- Health during acclimation (any mortality observed):

Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Details on test organisms and acclimation.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:ORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.01.0525

Study design

[Study design]

  1. HEAD-2
  2. Heading level 2
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Subheading of section 'Study design'

 

SE05.03.01.0530

Route of exposure

[Route of exposure]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. F142

Picklist Values:

aqueous || sediment || feed || other:

Indicate if exposure was to aquatic medium, sediment or through feed (i.e. dietary exposure).

Indicator showing whether medium was supplied in a static, semi-static or flow-through way.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:ROUTE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE05.03.01.0531

Route of exposure

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:ROUTE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE05.03.01.0540

Type of sediment (if sediment study)

[Type of sediment (if sediment study)]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E133

Picklist Values:

natural sediment || artificial sediment || no data

Indicate whether natural or formulated sediment was used as substrate

Indicator specifying the type of substrate for exposure

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:SEDIMENT_TYPE>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.03.01.0550

Test type

[Test type]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. F122

Picklist Values:

static || semi-static || flow-through || field study || other: || no data

Select appropriate test type.

Indicator showing whether medium was supplied in a static, semi-static or flow-through way.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:TESTTYPE_BIOACCUMULATION>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE05.03.01.0551

Test type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:TESTTYPE_BIOACCUMULATION>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE05.03.01.0560

Water media type

[Water media type]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E102

Picklist Values:

freshwater || saltwater || brackish water || no data

Indicate whether organisms were tested in fresh-/salt- or brackish/estuarine water.

Indicator specifying whether organisms were tested in fresh-/salt- or brackish/estuarine water.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:WATERTYPE>

<i5:set>

<i5:LIST_BELOW_POP>

<i5:LIST_BELOW_POP>

SE05.03.01.0570

Exposure / uptake duration

[Total exposure / uptake duration]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. A02-1

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.03.01.0580

Exposure / uptake duration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Exposure duration or range: 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_BIOACCUMULATION>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.03.01.0590

Exposure / uptake duration

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.03.01.0600

Exposure / uptake duration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Exposure duration or range: 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_BIOACCUMULATION>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.03.01.0610

Unit

[Total exposure / uptake duration]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E04

Picklist Values:

min || h || d || wk

Select from drop-down list.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE05.03.01.0620

Depuration duration

[Total depuration duration]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. A02-1

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_BIOACCUMULATION>

<i5:DEPUR_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.03.01.0630

Depuration duration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

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_BIOACCUMULATION>

<i5:DEPUR_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.03.01.0640

Depuration duration

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:DEPUR_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.03.01.0650

Depuration duration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

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_BIOACCUMULATION>

<i5:DEPUR_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.03.01.0660

Unit

[Total depuration duration]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E04

Picklist Values:

min || h || d || wk

Select from drop-down list.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:DEPUR_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE05.03.01.0665

Test conditions

[Test conditions]

  1. HEAD-2
  2. Heading level 2
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

Subheading of section 'Test conditions'

 

SE05.03.01.0670

Hardness

[Hardness]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

 

For freshwater tests, indicate water hardness as mg/l calcium carbonate equivalent 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 concentration of calcium and magnesium ions in water, measured as mg/L calcium carbonate equivalent.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:HARDNESS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.01.0680

Test temperature

[Test temperature]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

 

Indicate test temperature values measured during test. Include range, mean, standard deviation and unit. As appropriate state the location (e.g. water bath, test chambers) 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_BIOACCUMULATION>

<i5:TEST_TEMP>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.01.0690

pH

[pH]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:PH>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.01.0700

Dissolved oxygen

[Dissolved oxygen]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

 

Indicate dissolved oxygen 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 amount of soluble oxygen in water including mean or range.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:DISS_OXYGEN>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.01.0710

TOC

[TOC]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:TOC>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.01.0720

Salinity

[Salinity]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

 

For marine studies, indicate salinity 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 salinity used in the experimental determination of the test value.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:SALINITY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.01.0730

Nominal and measured concentrations

[Nominal and measured concentrations]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

REMARKS:

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

List nominal and, if available, measured test concentrations (with unit, i.e. µg/l, mg/l, g/l, mmol/l, mol/l, µmol/l or other) for all sampling times. As appropriate tabulate nominal vs. measured concentrations; include table(s) in the rich text field 'Any other information on results incl. tables'. Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. '... see Table 1').

Use alternative predefined tables if data for both the technical end product and the active ingredient are to be recorded.

If exposure is through diet, provide the nominal and measured dietary concentrations and the doses applied.

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

Nominal and, if available, measured test concentrations (with unit) and/or reference to table.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:NOM_MEAS_CONC>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.03.01.0740

Details on test conditions

[Details on test conditions]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

Freetext Templates:

TEST SYSTEM

- Test vessel:

- Type (delete if not applicable): open / closed

- Material, size, headspace, fill volume:

- Aeration:

- Type of flow-through (e.g. peristaltic or proportional diluter):

- Renewal rate of test solution (frequency/flow rate):

- No. of organisms per vessel:

- No. of vessels per concentration (replicates):

- No. of vessels per control / vehicle control (replicates):

- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water:

- Particulate matter:

- Metals:

- Pesticides:

- Chlorine:

- Alkalinity:

- Ca/mg ratio:

- Conductance:

- Holding medium different from test medium:

- Intervals of water quality measurement:

- Intervals of test medium replacement:

OTHER TEST CONDITIONS

- Adjustment of pH:

- Photoperiod:

- Light intensity:

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_BIOACCUMULATION>

<i5:TESTCONDIT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.01.0750

Reference substance (positive control)

[Reference substance (positive control)]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 2
  6. Z36

Picklist Values:

yes || no || no data || not required

Indicate if a positive control was tested, i.e. a reference substance with known bioaccumulation potential. If yes, include the identity of the substance(s) and the concentrations in the supplementary remarks field.

Indicator specifying whether reference substance(s) was/were tested and identity and concentrations in supplementary remarks field.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE05.03.01.0751

Reference substance (positive control)

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE05.03.01.0760

Details on estimation of bioconcentration

[Details on estimation of bioconcentration]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

Freetext Templates:

BASIS INFORMATION

- Measured/calculated logPow:

- Results from toxicokinetic study:

- Results from residue study:

- Monitoring data:

BASIS FOR CALCULATION OF BCF

- Estimation software:

- Result based on measured log Pow of:

- Result based on calculated log Pow of:

If the intrinsic potential of the test substance for bioconcentration was estimated, indicate physico-chemical properties, experimental toxicokinetic/residue studies or monitoring data the bioconcentration potential was based on.

Indicate the applied software (e.g. BCFWIN, v 2.13) and the basis for BCF calculation (e.g. measured log Pow).

Details on estimation of bioconcentration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:ESTIMATION_BCF_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.01.0770

Any other information on materials and methods incl. tables

[Any other information on materials and methods incl. tables]

  1. RICHTEXT
  2. STRING/256000
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.03.01.0775

RESULTS AND DISCUSSION

[Results and discussions]

  1. HEAD-1
  2. Heading level 1
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

 

 

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

 

SE05.03.01.0779

Lipid content of test organisms

[Lipid content]

  1. HEAD BLOCK
  2. Block label
  3. g245
  4. 10
  5. 2
  6. [N/A]

 

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'

 

SE05.03.01.0780

Lipid content

[Lipid content]

  1. LIST-CLOSED
  2. STRING/255
  3. g245
  4. 1
  5. 2
  6. A02-1

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_BIOACCUMULATION>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.03.01.0790

Lipid content

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g245
  4. 1
  5. 2
  6. [N/A]

 

 

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_BIOACCUMULATION>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.03.01.0800

Lipid content

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g245
  4. 1
  5. 2
  6. A02-2

Picklist Values:

< || <= || ca.

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.03.01.0810

Lipid content

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g245
  4. 1
  5. 2
  6. [N/A]

 

 

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_BIOACCUMULATION>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.03.01.0820

Unit of lipid content

[Lipid content]

  1. LIST-OPEN
  2. STRING/255
  3. g245
  4. 1
  5. 2
  6. F119

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_BIOACCUMULATION>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE05.03.01.0821

Unit of lipid content

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g245
  4. 1
  5. 2
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT_TXT>

SE05.03.01.0830

Time point

[Time point]

  1. LIST-OPEN
  2. STRING/255
  3. g245
  4. 1
  5. 2
  6. F138

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_BIOACCUMULATION>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PHRASEOTHER_TIME>

<i5:TIME>

SE05.03.01.0831

Time point

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g245
  4. 1
  5. 2
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:LIPID_CONTENT>

<i5:set>

<i5:PHRASEOTHER_TIME>

<i5:TIME_TXT>

SE05.03.01.0840

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g245
  4. 1
  5. 2
  6. [N/A]

 

Enter any remarks related to the recorded values as appropriate.

Remarks on lipid content

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:LIPID_CONTENT>

<i5:set>

<i5:REM>

<i5:REM>

SE05.03.01.0849

Bioaccumulation factor

[Bioaccumulation factor]

  1. HEAD BLOCK
  2. Block label
  3. g246
  4. 10
  5. 1
  6. [N/A]

REMARKS:

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

This repeatable block of fields allows to report the steady-state BCFs and/or the kinetic BCFk.

As appropriate or requested by the regulatory programme include table(s) in the rich text field 'Any other information on results incl. tables' showing the BCFs measured at different time points and concentrations in the water. 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').

Heading of field block 'Bioconcentration factor'

 

SE05.03.01.0850

Concentration in environment / dose level

[Conc. in environment / dose]

  1. TEXT
  2. STRING/255
  3. g246
  4. 1
  5. 1
  6. [N/A]

REMARKS:

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

Give the concentration in surrounding water (and/or sediment, if sediment study) or the dose level applied (if feeding study). If more than one concentration or dose was tested for which different bioaccumulation factors are reported, e.g. for high and low concentration levels, multiply this block of fields and indicate nominal and, if available, measured test concentration(s) (with unit, i.e. µg/l, mg/l, g/l, mmol/l, mol/l, µmol/l, ng/kg, µg/kg or mg/kg sediment dw or other).

Nominal and, if available, measured test concentration(s) the bioaccumulation factor refers to.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:CONCLEVEL>

<i5:CONCLEVEL>

SE05.03.01.0860

Type of bioaccumulation factor

[Type]

  1. LIST-OPEN
  2. STRING/255
  3. g246
  4. 1
  5. 1
  6. F141

REMARKS:

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

Picklist Values:

BCF || BAF || BSAF || BMF || other:

Indicate the reported bioconcentration factor, i.e. either BCF (bioconcentration factor which accounts for substance intake from the surrounding water only), BFA (bioaccumulation factor which accounts for substance intake from both food and surrounding water), BSAF (biota-sediment accumulation factor), BMF (biomagnification factor, i.e. the ratio between the relative concentration in a predatory animal and the concentration in (part of) its prey) or other (to be specified).

Type of bioconcentration factor, i.e. BCF, BFA, BSFA, BMF or other.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PHRASEOTHER_TYPE>

<i5:TYPE>

SE05.03.01.0861

Type of bioaccumulation factor

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g246
  4. 1
  5. 1
  6. [N/A]

REMARKS:

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

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PHRASEOTHER_TYPE>

<i5:TYPE_TXT>

SE05.03.01.0870

Bioaccumulation value

[Value]

  1. LIST-CLOSED
  2. STRING/255
  3. g246
  4. 1
  5. 1
  6. A02-1

REMARKS:

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

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_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.03.01.0880

Bioaccumulation value

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g246
  4. 1
  5. 1
  6. [N/A]

REMARKS:

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

 

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_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.03.01.0890

Bioaccumulation value

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g246
  4. 1
  5. 1
  6. A02-2

REMARKS:

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

Picklist Values:

< || <= || ca.

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.03.01.0900

Bioaccumulation value

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g246
  4. 1
  5. 1
  6. [N/A]

REMARKS:

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

 

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_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.03.01.0901

Unit

[Bioaccumulation factor]

  1. LIST-OPEN
  2. STRING/255
  3. g246
  4. 1
  5. 2
  6. TD330

REMARKS:

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

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_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE05.03.01.0902

Unit

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g246
  4. 1
  5. 2
  6. [N/A]

REMARKS:

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

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT_TXT>

SE05.03.01.0910

Basis of bioaccumulation factor

[Basis]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g246
  4. 1
  5. 1
  6. F120

REMARKS:

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

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_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PHRASEOTHER_BASIS>

<i5:BASIS>

SE05.03.01.0911

Basis of bioaccumulation factor

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g246
  4. 1
  5. 1
  6. [N/A]

REMARKS:

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

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PHRASEOTHER_BASIS>

<i5:BASIS_TXT>

SE05.03.01.0920

Time of plateau

[Time of plateau]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g246
  4. 1
  5. 1
  6. [N/A]

REMARKS:

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

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_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:VALUEUNIT_PLATEAU_VALUE>

<i5:PLATEAU_VALUE>

SE05.03.01.0930

Unit

[Bioaccumulation factor]

  1. LIST-CLOSED
  2. STRING/255
  3. g246
  4. 1
  5. 1
  6. E04

REMARKS:

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

Picklist Values:

min || h || d || wk

Select from drop-down list.

Unit of depuration duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:VALUEUNIT_PLATEAU_VALUE>

<i5:PLATEAU_UNIT>

SE05.03.01.0940

Calculation basis

[Calculation basis]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g246
  4. 1
  5. 1
  6. F121

REMARKS:

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

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_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PHRASEOTHER_CALC_BASE>

<i5:CALC_BASE>

SE05.03.01.0941

Calculation basis

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g246
  4. 1
  5. 1
  6. [N/A]

REMARKS:

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

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:PHRASEOTHER_CALC_BASE>

<i5:CALC_BASE_TXT>

SE05.03.01.0950

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g246
  4. 1
  5. 1
  6. [N/A]

REMARKS:

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

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_BIOACCUMULATION>

<i5:BCF>

<i5:set>

<i5:REM>

<i5:REM>

SE05.03.01.0959

Depuration

[Depuration]

  1. HEAD BLOCK
  2. Block label
  3. g247
  4. 10
  5. 1
  6. [N/A]

 

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'

 

SE05.03.01.0960

Elimination

[Elimination]

  1. LIST-CLOSED
  2. STRING/255
  3. g247
  4. 1
  5. 1
  6. A03

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_BIOACCUMULATION>

<i5:DEPURATION>

<i5:set>

<i5:INDICATOR>

<i5:INDICATOR>

SE05.03.01.0970

Endpoint

[Endpoint]

  1. LIST-OPEN
  2. STRING/255
  3. g247
  4. 1
  5. 1
  6. F123

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_BIOACCUMULATION>

<i5:DEPURATION>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT>

SE05.03.01.0971

Endpoint

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g247
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:DEPURATION>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT_TXT>

SE05.03.01.0980

Depuration time (DT)

[Depuration time (DT)]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g247
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Numeric value of depuration time endpoint.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:DEPURATION>

<i5:set>

<i5:VALUEUNIT_TIME_VALUE>

<i5:TIME_VALUE>

SE05.03.01.0990

Unit

[Depuration]

  1. LIST-CLOSED
  2. STRING/255
  3. g247
  4. 1
  5. 1
  6. E04

Picklist Values:

min || h || d || wk

Select from drop-down list.

Unit of depuration time

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:DEPURATION>

<i5:set>

<i5:VALUEUNIT_TIME_VALUE>

<i5:TIME_UNIT>

SE05.03.01.1000

Kinetic parameters

[Kinetic parameters]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

Freetext Templates:

- Uptake rate constant (k1):

- Depuration (loss) rate constant (k2):

- 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_BIOACCUMULATION>

<i5:KINETIC_PARAMETERS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.01.1010

Metabolites

[Metabolites]

  1. TEXTAREA
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

REMARKS:

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

If identified, include table(s) in the rich text field 'Any other information on results incl. tables' with data on any metabolites of the test substance accumulated in test organisms (total) and specific tissues thereof (e.g. lipid) (at least those, accounting for > 10 % of residues). 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').

Data on metabolites

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:METABOLITES>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE05.03.01.1020

Results with reference substance (positive control)

[Results with reference substance (positive control)]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

 

If reference substance(s) was/were tested, indicate whether the results with it/them are valid.

Indication whether the results with the reference substance(s) are valid.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EN_BIOACCUMULATION>

<i5:RS_REF_SUBSTANCE>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE05.03.01.1030

Details on results

[Details on results]

  1. TEXT-TEMPL
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

Freetext Templates:

- Mortality of test organisms:

- Behavioural abnormalities:

- Observations on body length and weight:

- Other biological observations:

- Organ specific bioaccumulation:

- Bound residues forming a plateau:

- 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_BIOACCUMULATION>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.03.01.1040

Reported statistics

[Reported statistics]

  1. TEXTAREA
  2. STRING/2000
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]

 

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_BIOACCUMULATION>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE05.03.01.1050