OECD Template #42: Long-term toxicity to fish (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.

 

 

 

SE06.01.02.0215

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.

 

SE06.01.02.0219

Reference

[Reference]

  1. HEAD BLOCK
  2. Block label
  3. g307
  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'

 

SE06.01.02.0220

Reference type

[Reference type]

  1. LIST-OPEN
  2. STRING/255
  3. g307
  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:EC_CHRONFISHTOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE06.01.02.0221

Reference type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g307
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE06.01.02.0230

Author(s) (or transferred reference)

[Author]

  1. TEXT
  2. STRING/2000
  3. g307
  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:EC_CHRONFISHTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE06.01.02.0240

Year

[Year]

  1. YEAR
  2. NUMBER/4/###0
  3. g307
  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:EC_CHRONFISHTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE06.01.02.0250

Title

[Title]

  1. TEXT
  2. STRING/255
  3. g307
  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:EC_CHRONFISHTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE06.01.02.0260

Bibliographic source

[Bibliographic source]

  1. TEXT
  2. STRING/255
  3. g307
  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:EC_CHRONFISHTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE06.01.02.0270

Testing laboratory

[Testing laboratory]

  1. TEXT
  2. STRING/255
  3. g307
  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:EC_CHRONFISHTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE06.01.02.0280

Report no.

[Report no.]

  1. TEXT
  2. STRING/255
  3. g307
  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:EC_CHRONFISHTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE06.01.02.0290

Owner company

[Owner company]

  1. TEXT
  2. STRING/255
  3. g307
  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:EC_CHRONFISHTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE06.01.02.0300

Company study no.

[Company study no.]

  1. TEXT
  2. STRING/255
  3. g307
  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:EC_CHRONFISHTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE06.01.02.0310

Report date

[Report date]

  1. DATE
  2. DATE/255
  3. g307
  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:EC_CHRONFISHTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE06.01.02.0320

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:EC_CHRONFISHTOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.01.02.0321

Data access

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.01.02.0330

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:EC_CHRONFISHTOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE06.01.02.0331

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:EC_CHRONFISHTOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE06.01.02.0340

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:EC_CHRONFISHTOX>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.02.0345

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.

 

SE06.01.02.0350

Life stage / endpoint studied

[Life stage / endpoint studied]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E146

Picklist Values:

adult fish: (sub)lethal effects || juvenile fish: growth || embryo and sac-fry stage: (sub)lethal effects || early-life stage: reproduction, (sub)lethal effects || life cycle: reproduction, (sub)lethal effects || other:

Select the appropriate life stage / endpoint studied (e.g. 'early-life stage: reproduction, toxicity').

Select 'adult fish: toxicity' for long-term toxicity tests performed according to the modified OECD 204 or similar. Note that the regulatory programme may request to record the Prolonged Toxicity Test (14-day Study) conducted according to OECD Guideline 204 using the template 'Short-term toxicity to fish'.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:LIFE_STAGE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.01.02.0351

Life stage / endpoint studied

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:LIFE_STAGE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.01.02.0359

Test guideline

[Test guideline]

  1. HEAD BLOCK
  2. Block label
  3. g308
  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'

 

SE06.01.02.0360

Qualifier

[Qualifier]

  1. LIST-CLOSED
  2. STRING/255
  3. g308
  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:EC_CHRONFISHTOX>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE06.01.02.0370

Guideline

[Guideline]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g308
  4. 1
  5. 1
  6. E03-2

Picklist Values:

OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study) || OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test) || OECD Guideline 212 (Fish, Short-term Toxicity Test on Embryo and Sac-Fry Stages) || OECD Guideline 215 (Fish, Juvenile Growth Test) || EU Method C.14 (Fish Juvenile Growth Test) || EU Method C.15 (Fish, Short-term Toxicity Test on Embryo and Sac-fry Stages) || EPA OPP 72-4 (Fish Early Life-Stage and Aquatic Invertebrate Life-Cycle Studies) || EPA OPP 72-5 (Fish Life Cycle Toxicity) || EPA OPPTS 850.1400 (Fish Early-life Stage Toxicity Test) || EPA OPPTS 850.1500 (Fish Life Cycle Toxicity) || EPA OTS 797.1000 (Fish Early-life Stage Toxicity Test) || 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:EC_CHRONFISHTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE06.01.02.0371

Guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g308
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE06.01.02.0380

Deviations from guideline

[Deviations]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g308
  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:EC_CHRONFISHTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE06.01.02.0381

Deviations from guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g308
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE06.01.02.0390

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:EC_CHRONFISHTOX>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE06.01.02.0400

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:EC_CHRONFISHTOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.01.02.0401

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:EC_CHRONFISHTOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.01.02.0405

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'

 

SE06.01.02.0410

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:EC_CHRONFISHTOX>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.01.02.0419

Test material identity

[Test material identity]

  1. HEAD BLOCK
  2. Block label
  3. g309
  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'

 

SE06.01.02.0420

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g309
  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:EC_CHRONFISHTOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE06.01.02.0421

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g309
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE06.01.02.0430

Identity

[Identity]

  1. TEXT
  2. STRING/2000
  3. g309
  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.

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SE06.01.02.0435

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.

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<i5:scientificPart>

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<i5:TESTMAT_FORM>

SE06.01.02.0436

Test material form

[no label]

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

 

 

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<i5:TESTMAT_FORM>

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<i5:TESTMAT_FORM_TXT>

SE06.01.02.0440

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.

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SE06.01.02.0450

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.

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<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

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<i5:FREETEXT_BELOW>

SE06.01.02.0460

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

- Melting point:

- Boiling point:

- Vapour pressure:

- Water solubility (under test conditions):

- Henry's law constant:

- log Pow:

- pKa:

- Stability in water:

- Stability in light:

- pH dependence on stability:

OTHER PROPERTIES (if relevant for this endpoint)

- Results of test for ready biodegradability:

- 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.

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<i5:PROPERTIES_TESTMAT_DETAILS>

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SE06.01.02.0470

Analytical monitoring

[Analytical monitoring]

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

Picklist Values:

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

Indicate whether test substance was monitored in the test solutions.

For robust study summaries or as requested by the regulatory programme, provide further details on sampling and analytical methods in the corresponding freetext fields.

Indicator that instrumental analyses were applied to detect the precise amount of chemical exposed to the organisms.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:ANALYT_MONIT>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.01.02.0480

Details on sampling

[Details on sampling]

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

Freetext Templates:

- Concentrations:

- Sampling method:

- Sample storage conditions before analysis:

If the amount of test material exposed to the organisms was monitored, enter details on sampling. Use freetext template as appropriate and delete/add elements as appropriate.

Details on sampling.

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<i5:scientificPart>

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SE06.01.02.0490

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):

- 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:

If the amount of test material exposed to the organisms was monitored, enter any details on the analytical methods used. Use freetext template and delete/add elements as appropriate.

Details on the analytical method used.

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SE06.01.02.0500

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 solution'.

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

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<i5:scientificPart>

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<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.01.02.0510

Details on test solutions

[Details on test solutions]

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

Freetext Templates:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

- Method:

- Eluate:

- Differential loading:

- Controls:

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

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

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

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 preparation and application of test solution.

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SE06.01.02.0515

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'

 

SE06.01.02.0520

Test organisms (species)

[Test organisms (species)]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E02

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 appropriate value from picklist. If not available, select 'other' and type name of organism (species).

CAVEAT: The following species have been renamed:

- Brachydanio rerio

- Salmo gairdneri

If one of these names is reported, select the appropriate picklist value which indicates both the new name plus, in parentheses, the name as reported, i.e.

- Danio rerio (reported as Brachydanio rerio)

- Oncorhynchus mykiss (reported as Salmo gairdneri)

(Note: The outdated names are kept in the picklist for data migration reasons.)

The test species or organism in an experimental study.

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SE06.01.02.0521

Test organisms (species)

[no label]

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

 

 

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<i5:ORGANISM>

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SE06.01.02.0530

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):

- Method of breeding:

- 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):

QUARANTINE (wild caught)

- Duration:

- Health/mortality: TEST ORGANISM

- Common name:

- Strain:

- Source:

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

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

- Method of breeding:

FEEDING DURING TEST

- Food type:

- Amount:

- Frequency:

TEST ORGANISM

- Common name:

- Strain:

- Source:

METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS

- Numbers of parental fish (i.e. of females used to provide required number of eggs):

- Method of collection of fertilised eggs:

- Subsequent handling of eggs: TEST ORGANISM

- Common name:

- Strain:

- Source:

METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS

- Numbers of parental fish (i.e. of females used to provide required number of eggs):

- Method of collection of fertilised eggs:

- Subsequent handling of eggs:

POST-HATCH FEEDING

- Start date:

- Type/source of feed:

- Amount given:

- Frequency of feeding:

TEST ORGANISM

- Common name:

- Strain:

- Source:

- Pre-exposure reproductive performance

METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS

- Numbers of parental fish (i.e. of females used to provide required number of eggs):

- Method of collection of fertilised eggs:

- Subsequent handling of eggs:

POST-HATCH FEEDING

- Start date:

- Type/source of feed:

- Amount given:

- Frequency of feeding:

Select freetext template for the respective type of study 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.

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SE06.01.02.0535

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'

 

SE06.01.02.0540

Test type

[Test type]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E01

Picklist Values:

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

Select appropriate test type.

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

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SE06.01.02.0541

Test type

[no label]

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

 

 

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SE06.01.02.0550

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.

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SE06.01.02.0560

Limit test

[Limit test]

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

Picklist Values:

yes || no

Indicate if the experiment was a limit test.

An indicator that the experiment was a limit test.

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SE06.01.02.0570

Duration

[Total exposure duration]

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

 

Enter numeric value.

Numeric value of exposure duration.

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SE06.01.02.0580

Unit

[Total exposure duration]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E15

Picklist Values:

min || h || d || wk || mo

Select from drop-down list.

Unit of exposure duration

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SE06.01.02.0590

Remarks

[Remarks]

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

 

Enter any remarks related to the total exposure duration.

Remarks on exposure duration.

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<i5:EXP_DURATION>

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SE06.01.02.0600

Post exposure observation period

[Post exposure observation period]

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

 

Indicate the post-observation period (with unit) if appropriate.

Observation period after last exposure to the test chemical.

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<i5:TEXT_BELOW>

SE06.01.02.0605

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'

 

SE06.01.02.0610

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 in the treatment and control solutions 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:EC_CHRONFISHTOX>

<i5:HARDNESS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.02.0620

Test temperature

[Test temperature]

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

 

Indicate test temperature values measured in the treatment and control solutions 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:EC_CHRONFISHTOX>

<i5:TEST_TEMP>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.02.0630

pH

[pH]

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

 

Indicate pH values measured in the treatment and control solutions 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 test value or mean or range.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:PH>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.02.0640

Dissolved oxygen

[Dissolved oxygen]

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

 

Indicate dissolved oxygen values measured in the treatment and control solutions 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:EC_CHRONFISHTOX>

<i5:DISS_OXYGEN>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.02.0650

Salinity

[Salinity]

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

 

For marine studies, indicate salinity values measured in the treatment and control solutions 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:EC_CHRONFISHTOX>

<i5:SALINITY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.02.0660

Nominal and measured concentrations

[Nominal and measured concentrations]

  1. TEXTAREA
  2. STRING/2000
  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.

List nominal and, if available, measured test concentrations (with unit). As appropriate tabulate nominal vs. measured concentrations in the rich text field 'Any other information on results incl. tables'. Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. '... see Table 1').

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

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:EC_CHRONFISHTOX>

<i5:NOM_MEAS_CONC>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.02.0670

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 (replicates):

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

- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water:

- Total organic carbon:

- Particulate matter:

- Metals:

- Pesticides:

- Chlorine:

- Alkalinity:

- Ca/mg ratio:

- Conductivity:

- Culture medium different from test medium:

- Intervals of water quality measurement:

OTHER TEST CONDITIONS

- Adjustment of pH:

- Photoperiod:

- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS

- Spacing factor for test concentrations:

- Justification for using less concentrations than requested by guideline:

- Range finding study

- Test concentrations:

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

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 (replicates):

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

- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water:

- Total organic carbon:

- Particulate matter:

- Metals:

- Pesticides:

- Chlorine:

- Alkalinity:

- Ca/mg ratio:

- Conductivity:

- Salinity:

- Culture medium different from test medium:

- Intervals of water quality measurement:

OTHER TEST CONDITIONS

- Adjustment of pH:

- Photoperiod:

- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

VEHICLE CONTROL PERFORMED: yes/no

RANGE-FINDING STUDY

- Test concentrations:

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

TEST SYSTEM

- Embryo cups (if used, type/material, size, fill volume):

- 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 fertilized eggs/embryos per vessel:

- No. of vessels per concentration (replicates):

- No. of vessels per control (replicates):

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

- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water:

- Total organic carbon:

- Particulate matter:

- Metals:

- Pesticides:

- Chlorine:

- Alkalinity:

- Ca/mg ratio:

- Conductivity:

- Salinity:

- Culture medium different from test medium:

- Intervals of water quality measurement:

OTHER TEST CONDITIONS

- Adjustment of pH:

- Photoperiod:

- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

VEHICLE CONTROL PERFORMED: yes/no

RANGE-FINDING STUDY

- Test concentrations:

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

......

Select freetext template for the respective type of study 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:EC_CHRONFISHTOX>

<i5:TESTCONDIT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.02.0680

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 toxicity. 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:EC_CHRONFISHTOX>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.01.02.0681

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:EC_CHRONFISHTOX>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.01.02.0690

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:EC_CHRONFISHTOX>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.01.02.0695

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.

 

SE06.01.02.0699

Effect concentrations

[Effect concentrations]

  1. HEAD BLOCK
  2. Block label
  3. g310
  4. 20
  5. 1
  6. [N/A]

 

Report the EC50, NOEC, LOEC or other effect levels with 95% conf. limits if appropriate. Copy this field block for entering more than one effect level if necessary.

Heading of field block 'Effect concentrations'

 

SE06.01.02.0700

Exposure duration

[Duration]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g310
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Numeric value of exposure duration to which the effect concentration refers.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:VALUEUNIT_EXP_DURATION_VALUE>

<i5:EXP_DURATION_VALUE>

SE06.01.02.0710

Unit

[Effect concentrations]

  1. LIST-CLOSED
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. E15

Picklist Values:

min || h || d || wk || mo

Select from drop-down list.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:VALUEUNIT_EXP_DURATION_VALUE>

<i5:EXP_DURATION_UNIT>

SE06.01.02.0720

Endpoint

[Endpoint]

  1. LIST-OPEN
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. E115b

Picklist Values:

NOEC || LOEC || NOELR || LOELR || EC10 || EC50 || EL10 || EL50 || IC10 || IC50 || LC10 || LC50 || LL10 || LL50 || other:

Select from drop-down list. Note: When the results are expressed in terms of the loading rate of water accommodated fraction (WAF) causing a particular effect, use respective endpoints, i.e. 'ELx' (Effect loading rate giving x% effect) or 'NOELR' / 'LOELR' (No observed / lowest observed effect loading rate).

Endpoint type, e.g. LC50, to which the effect concentration refers.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT>

SE06.01.02.0721

Endpoint

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT_TXT>

SE06.01.02.0730

Effect concentration

[Effect conc.]

  1. LIST-CLOSED
  2. STRING/255
  3. g310
  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').

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_CONC_LOQUALIFIER>

<i5:CONC_LOQUALIFIER>

SE06.01.02.0740

Effect concentration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g310
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_CONC_LOQUALIFIER>

<i5:CONC_LOVALUE>

SE06.01.02.0750

Effect concentration

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_CONC_LOQUALIFIER>

<i5:CONC_UPQUALIFIER>

SE06.01.02.0760

Effect concentration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g310
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_CONC_LOQUALIFIER>

<i5:CONC_UPVALUE>

SE06.01.02.0770

Unit of effect concentrations

[Effect concentrations]

  1. LIST-OPEN
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. E05

Picklist Values:

ng/L || µg/L || mg/L || g/L || µmol/L || mmol/L || mol/L || other:

Select from drop-down list.

Unit of effect concentrations

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_CONC_LOQUALIFIER>

<i5:CONC_UNIT>

SE06.01.02.0771

Unit of effect concentrations

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_CONC_LOQUALIFIER>

<i5:CONC_UNIT_TXT>

SE06.01.02.0780

Basis for concentration

[Nominal/Measured]

  1. LIST-CLOSED
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. E35

Picklist Values:

nominal || meas. (initial) || meas. (geom. mean) || meas. (arithm. mean) || meas. (TWA) || meas. (not specified) || acid equivalent || estimated || no data

Indicate whether the effect concentration is based on nominal, measured (initial / geometric mean / arithmetic mean), measured (time weighted average = TWA), measured (not specified), acid equivalent or estimated. Select 'no data' if not known.

Indication of whether the effect concentration is based on (mean/initial) measured, nominal or estimated concentrations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:BASIS_CONC>

<i5:BASIS_CONC>

SE06.01.02.0790

Effect concentration type

[Conc. based on]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. E105

Picklist Values:

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

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

Select 'no data' if effect concentration type is not known.

Indication of whether the concentration is based on the test material, active ingredient, free metal etc.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_EFF_CONC_TYPE>

<i5:EFF_CONC_TYPE>

SE06.01.02.0791

Effect concentration type

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_EFF_CONC_TYPE>

<i5:EFF_CONC_TYPE_TXT>

SE06.01.02.0800

Basis for effect

[Basis for effect]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. E14

Picklist Values:

mortality || adult mortality || growth rate || length || weight || behaviour || adult behaviour || morphology || time to swim up || number of spawns || number of eggs/spawn || time to hatch || number hatched || fertility || larval development || reproduction || secondary sexual characteristics || gonadal histology || other: || no data

Select effect parameter such as 'mortality' or 'adult mortality' (if life cycle study), which the effect concentration relates to. As appropriate include further details in the supplementary remarks field, e.g. organism stage for effect, dry or wet weight, total length or standard fork length, time for start until end of hatching, etc.

Effect parameter such as mortality or behaviour, which the effect concentration relates to.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_BASIS_EFFECT>

<i5:BASIS_EFFECT>

SE06.01.02.0801

Basis for effect

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_BASIS_EFFECT>

<i5:BASIS_EFFECT_TXT>

SE06.01.02.0810

Remarks (e.g. 95% CL)

[Remarks (e.g. 95% CL)]

  1. TEXT
  2. STRING/255
  3. g310
  4. 1
  5. 1
  6. [N/A]

 

For robust study summaries or as requested by the regulatory programme, provide the 95% confidence limits and/or any relevant short remarks.

Remarks on effect concentration.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:EFFCONC>

<i5:set>

<i5:REM>

<i5:REM>

SE06.01.02.0820

Details on results

[Details on results]

  1. TEXT-TEMPL
  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.

Freetext Templates:

- Mortality/survival at embryo and larval stages:

- Overall mortality/survival:

- Days to hatch and numbers hatched:

- Data for length and weight of surviving fish:

- Type of and number with morphological abnormalities:

- Type of and number with behavioural abnormalities:

- Other biological observations:

- Effect concentrations exceeding solubility of substance in test medium:

- Incidents in the course of the test which might have influenced the results:- Mortality/survival at embryo, larval, juvenile, and adult stages:

- Days to hatch or time to release of young:

- Numbers hatched, Numbers of offspring produced, or Number of offspring per live female per day:

- Number of fish in swim-up stage at one or more time periods (e.g., day x1, x2):

- Observations on body length and weight of young and/or exposed parents at one or more time periods:

- Number of healthy fish at end of test:

- Type of and number with morphological abnormalities:

- Type of and number with behavioural abnormalities:

- Type and number of developmental effects:

- Type and magnitude of hormonal changes:

- Other biological observations:

- Effect concentrations exceeding solubility of substance in test medium:

- Incidents in the course of the test which might have influenced the results:- Mortality/survival at embryo, larval, juvenile, and adult stages:

- Days to hatch or time to release of young:

- Numbers hatched, Numbers of offspring produced, or Number of offspring per live female per day:

- Number of fish in swim-up stage at one or more time periods (e.g., day x1, x2):

- Observations on body length and weight of young and/or exposed parents at one or more time periods:

- Number of healthy fish at end of test:

- Type of and number with morphological abnormalities:

- Type of and number with behavioural abnormalities:

- Type and number of developmental/reproductive effects:

- Detailed data on spawning, egg numbers, fertility, and fecundity:

- Type and magnitude of hormonal changes:

- Other biological observations:

- Effect concentrations exceeding solubility of substance in test medium:

- Incidents in the course of the test which might have influenced the results:- Observed effects at each concentration for each observation time: see Table [#?]

- Concentrations that produce lethal or other effects: [describe and attach graph showing effects with respect

to time]

- Cumulative mortality at each concentration and for each recommended observation time if possible:

- Mortality in the controls:

- Behavioural observation of the fish:

- Effect concentrations exceeding solubility of substance in test medium:

- Incidents in the course of the test which might have influenced the results:- Fish weights (individual and mean values) on day 0, 14 (if measured) and 28: see Table [#?]

- Tank-average or pseudo-specific growth rates for periods 0-28 or 0-14 and 0-28 (if possible):

- Type of and number with morphological abnormalities:

- Type of and number with behavioural abnormalities:

- Other biological observations:

- Effect concentrations exceeding solubility of substance in test medium:

- Incidents in the course of the test which might have influenced the results:

Select freetext template for the respective type of study 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.

Particularly with comprehensive data, include table(s) with raw data 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'). Narrative accompanying such tabular data can then be rather short and should not repeat what is presented in the table(s). The same holds true if any figure is attached in field 'Attached background material'.

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

Details on results

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.02.0830

Results with reference substance (positive control)

[Results with reference substance (positive control)]

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

Freetext Templates:

- Results with reference substance valid?

- Relevant effect levels:

- Other:

If reference substance(s) was/were tested, indicate whether the results with it/them are valid and provide relevant effect levels and other relevant information.

Use freetext template and delete/add elements as appropriate.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:RS_REF_SUBSTANCE>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.02.0840

Reported statistics and error estimates

[Reported statistics and error estimates]

  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. If probit analysis was used, indicate the intercept and probit slope. As appropriate state any relevant error estimates associated with the determination of concentration-response relationship.

Indication of statistical data and error estimates associated with the determination of the concentration-response relationship.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE06.01.02.0850

Any other information on results incl. tables

[Any other information on results incl. tables]

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

 

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:EC_CHRONFISHTOX>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.01.02.0855

OVERALL REMARKS, ATTACHMENTS

[Overall remarks, attachments]

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

 

 

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

 

SE06.01.02.0860

Remarks on results including tables and figures

[Remarks on results including tables and figures]

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

 

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:EC_CHRONFISHTOX>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.01.02.0869

Attached background material

[Attached background material]

  1. HEAD BLOCK
  2. Block label
  3. g311
  4. 10
  5. 1
  6. [N/A]

 

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'.

 

SE06.01.02.0870

Attached document

[Attached document]

  1. ATTACHMENT
  2. STRING/32768
  3. g311
  4. 1
  5. 1
  6. [N/A]

 

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:EC_CHRONFISHTOX>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE06.01.02.0880

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g311
  4. 1
  5. 1
  6. [N/A]

 

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:EC_CHRONFISHTOX>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE06.01.02.0889

Attached full study report

[Attached full study report]

  1. HEAD BLOCK
  2. Block label
  3. g312
  4. 10
  5. 1
  6. [N/A]

 

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

 

SE06.01.02.0890

Attached full study report

[Attached full study report]

  1. ATTACHMENT
  2. STRING/32768
  3. g312
  4. 1
  5. 1
  6. [N/A]

 

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:EC_CHRONFISHTOX>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE06.01.02.0892

Illustration (picture/graph)

[Illustration (picture/graph)]

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

 

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:EC_CHRONFISHTOX>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE06.01.02.0895

APPLICANT'S SUMMARY AND CONCLUSION

[Applicant's summary and conclusion]

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

 

 

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

 

SE06.01.02.0900

Validity criteria fulfilled

[Validity criteria fulfilled]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. F102

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:EC_CHRONFISHTOX>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.01.02.0901

Validity criteria fulfilled

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.01.02.0910

Conclusions

[Conclusions]

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

 

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:EC_CHRONFISHTOX>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE06.01.02.0920

Executive summary

[Executive summary]

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

REMARKS:

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

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

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_CHRONFISHTOX>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.01.02.0930

Cross-reference to other study

[Cross-reference to other study]

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

 

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:EC_CHRONFISHTOX>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>