OECD Template #53: Toxicity to birds (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.

 

 

 

SE06.03.05.0215

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.

 

SE06.03.05.0219

Reference

[Reference]

  1. HEAD BLOCK
  2. Block label
  3. g380
  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'

 

SE06.03.05.0220

Reference type

[Reference type]

  1. LIST-OPEN
  2. STRING/255
  3. g380
  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_BIRD_TOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE06.03.05.0221

Reference type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g380
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE06.03.05.0230

Author(s) (or transferred reference)

[Author]

  1. TEXT
  2. STRING/2000
  3. g380
  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_BIRD_TOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE06.03.05.0240

Year

[Year]

  1. YEAR
  2. NUMBER/4/###0
  3. g380
  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_BIRD_TOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE06.03.05.0250

Title

[Title]

  1. TEXT
  2. STRING/255
  3. g380
  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_BIRD_TOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE06.03.05.0260

Bibliographic source

[Bibliographic source]

  1. TEXT
  2. STRING/255
  3. g380
  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_BIRD_TOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE06.03.05.0270

Testing laboratory

[Testing laboratory]

  1. TEXT
  2. STRING/255
  3. g380
  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_BIRD_TOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE06.03.05.0280

Report no.

[Report no.]

  1. TEXT
  2. STRING/255
  3. g380
  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_BIRD_TOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE06.03.05.0290

Owner company

[Owner company]

  1. TEXT
  2. STRING/255
  3. g380
  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_BIRD_TOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE06.03.05.0300

Company study no.

[Company study no.]

  1. TEXT
  2. STRING/255
  3. g380
  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_BIRD_TOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE06.03.05.0310

Report date

[Report date]

  1. DATE
  2. DATE/255
  3. g380
  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_BIRD_TOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE06.03.05.0320

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_BIRD_TOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.03.05.0321

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_BIRD_TOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.03.05.0330

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_BIRD_TOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE06.03.05.0331

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_BIRD_TOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE06.03.05.0340

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_BIRD_TOX>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.03.05.0345

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.

 

SE06.03.05.0350

Test type

[Test type]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E135

Picklist Values:

acute oral toxicity || short-term dietary toxicity || avoidance (repellency) || reproduction toxicity || other:

Indicate test type.

Indicator specifying test type, e.g. acute oral toxicity.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:TESTTYPE_TERRTOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.03.05.0351

Test type

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:TESTTYPE_TERRTOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.03.05.0359

Test guideline

[Test guideline]

  1. HEAD BLOCK
  2. Block label
  3. g381
  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'

 

SE06.03.05.0360

Qualifier

[Qualifier]

  1. LIST-CLOSED
  2. STRING/255
  3. g381
  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_BIRD_TOX>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE06.03.05.0370

Guideline

[Guideline]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g381
  4. 1
  5. 1
  6. E27-1

Picklist Values:

OECD Guideline 205 (Avian Dietary Toxicity Test) || OECD Guideline 206 (Avian Reproduction Test) || OECD Guideline 223 (Avian Acute Oral Toxicity Test) || OECD Guideline Draft (Avian Reproduction Toxicity Test in Japanese Quail or Northern Bobwhite) || OECD Guideline Draft (Avian Repellency Test) || EPA OPP 71-1 (Avian Acute Oral Toxicity Test) || EPA OPP 71-2 (Avian Dietary Toxicity Test) || EPA OPP 71-4 (Avian Reproduction Test) || EPA OPPTS 850.2100 (Avian Acute Oral Toxicity Test) || EPA OPPTS 850.2200 (Avian Dietary Toxicity Test) || EPA OPPTS 850.2300 (Avian Reproduction Test) || EPA OTS 797.2050 (Avian Dietary Toxicity Test) || EPA OTS 797.2130 (Avian Reproduction Test) || EPA OTS 797.2150 (Avian Reproduction Test) || EPA OTS 797.2175 (Avian Acute Oral 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_BIRD_TOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE06.03.05.0371

Guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g381
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE06.03.05.0380

Deviations from guideline

[Deviations]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g381
  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_BIRD_TOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE06.03.05.0381

Deviations from guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g381
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE06.03.05.0390

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_BIRD_TOX>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE06.03.05.0400

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_BIRD_TOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.03.05.0401

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_BIRD_TOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.03.05.0405

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'

 

SE06.03.05.0410

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_BIRD_TOX>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.03.05.0419

Test material identity

[Test material identity]

  1. HEAD BLOCK
  2. Block label
  3. g382
  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'

 

SE06.03.05.0420

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g382
  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_BIRD_TOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE06.03.05.0421

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g382
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE06.03.05.0430

Identity

[Identity]

  1. TEXT
  2. STRING/2000
  3. g382
  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:EC_BIRD_TOX>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE06.03.05.0435

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE06.03.05.0436

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:EC_BIRD_TOX>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE06.03.05.0440

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:EC_BIRD_TOX>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.03.05.0450

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:EC_BIRD_TOX>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.03.05.0460

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 (under test conditions):

- Henry's law constant:

- log Pow:

- pKa:

- UV absorption:

- Stability of test material at room temperature:

OTHER PROPERTIES (if relevant for this endpoint)

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

Use freetext template and delete/add elements as appropriate.

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:PROPERTIES_TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.03.05.0470

Dose method

[Dose method]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E136

Picklist Values:

capsule || feed || gavage || drinking water || unspecified || other: || no data

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

Indicator how the chemical was administered to the test animals.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:DOSE_METHOD>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.03.05.0471

Dose method

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:DOSE_METHOD>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.03.05.0480

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 medium. If yes, specify in field 'Details on preparation and monitoring of diet'.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:ANALYT_MONIT>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.03.05.0490

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, e.g. to facilitate mixing with feed.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:VEHICLE_BIRDS>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.03.05.0500

Details on preparation and monitoring of diet

[Details on preparation and analysis of diet]

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

Freetext Templates:

DIET PREPARATION

- Description and nutrient analysis of basal diet provided in study report: yes / no

- Preparation of doses:

- Type and function of solvent/vehicle:

- Amount of vehicle:

HOMOGENEITY AND STABILITY OF TEST MATERIAL IN DIET

- How often was homogeneity and stability tested:

- When and at what dose levels were samples of treated food analyzed for stability and concentration during the study:

- Results of homogeneity analysis (range of values):

- Nominal concentration (mg/kg feed):

- Concentration analysed (mg/kg feed):

- % of nominal:

- Mixing procedure adequate and variance between nominal and actual dosage acceptable (yes/no):

Indicate details about diet preparation and homogeneity analysis of test material. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

In the case of OECD or similarly acknowledged guideline only items may be covered where deviations apply or where parameters are left open in the guideline, provided the respective regulatory programme allows so.

Further details on diet preparation and analysis.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:DIET_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.03.05.0505

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'

 

SE06.03.05.0510

Test organisms (species)

[Test organisms (species)]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E26-1

Picklist Values:

Alectoris rufa || Anas platyrhynchos || Colinus virginianus || Colomba livia || Coturnix coturnix japonica || Melopsittacus undulatus || Phasianus colchicus || Poephila guttata || other:

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

The test species or organism in an experimental study.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.03.05.0511

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:EC_BIRD_TOX>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.03.05.0520

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:

- Source:

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

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

- Sexes used:

- Cultural background:

- Disease free: yes / no

- Kept according to standard practices: yes / no

- Breeding population (e.g. reproductive history):

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

Details on test organisms.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:ORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.03.05.0525

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'

 

SE06.03.05.0530

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:LIMIT_TEST>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.03.05.0540

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EXP_DURATION>

<i5:set>

<i5:VALUEUNIT_VALUE>

<i5:VALUE>

SE06.03.05.0550

Unit

[Total exposure duration]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E30

Picklist Values:

h || d || wk || mo

Select from drop-down list.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EXP_DURATION>

<i5:set>

<i5:VALUEUNIT_VALUE>

<i5:UNIT>

SE06.03.05.0560

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EXP_DURATION>

<i5:set>

<i5:REM>

<i5:REM>

SE06.03.05.0570

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) during which 'clean' feed was administered.

Observation period after last exposure to the test chemical.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:POSTEXP_PERIOD>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.03.05.0580

No. of animals per dose

[No. of animals per sex per dose]

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

 

Indicate number of animals used per dose group. State if different numbers were used and reason why.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:NUMBER_ANIMALS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.03.05.0589

Control animals

[Control animals]

  1. HEAD BLOCK
  2. Block label
  3. g383
  4. 5
  5. 1
  6. [N/A]

 

Indicate whether and what type of concurrent control groups were used. If not available from picklist, select 'other' and specify. Copy field if more than one type of control was used.

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

 

SE06.03.05.0590

Control animals

[Control animals]

  1. LIST-OPEN
  2. STRING/255
  3. g383
  4. 1
  5. 1
  6. E137

Picklist Values:

yes || yes, concurrent no treatment || yes, concurrent vehicle || yes, plain diet || yes, plain drinking water || no || no data || other:

Indicate whether and what type of concurrent control groups were used. If not available from picklist, select 'other' and specify. Copy field if more than one type of control was used.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.03.05.0591

Control animals

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g383
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.03.05.0600

Nominal and measured doses / concentrations

[Nominal and measured doses / concentrations]

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

 

List nominal and, if available, measured dose levels or test concentrations (with unit). Indicate if nominal in diet, nominal in water, actual ingested, actual in diet, measured concentration in diet, etc. Provide range, median, mean, SD as applicable. As appropriate tabulate nominal vs. measured concentrations and refer to Table no..

Nominal dose levels or test concentrations (with unit) and results of measurements during test.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:NOM_MEAS_CONC>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.03.05.0610

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:

ACCLIMATION

- Acclimation period:

- Acclimation conditions (same as test or not):

- Feeding:

- Health (any disease or mortality observed):

- Fasting period before study:

FEED WITHHOLDING PERIOD BEFORE DOSING

- No. of days:

PEN SIZE AND CONSTRUCTION MATERIALS

- Description:

- Floor covering:

- Compliant to good husbandry practices: yes / no

- Suitable to avoid crowding stress: yes / no

- Caging: individual / group

NO. OF BIRDS PER REPLICATE

- For negative control:

- For vehicle control:

- For treated:

NO. OF REPLICATES PER GROUP

- For negative control:

- For vehicle control:

- For treated:

TEST CONDITIONS (range, mean, SD as applicable)

- Temperature:

- Brooder temperature:

- Room temperature:

- Relative humidity (%):

- Photoperiod:

- Ventilation:

- Shielding:

METHOD OF REPELLENCY TEST (if applicable)

- Type of test: choice test / no-choice test

- Remarks:

RANGE FINDING STUDY

- Test concentrations:

- Test conditions:

- 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:EC_BIRD_TOX>

<i5:TESTCONDIT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.03.05.0615

Examinations

[Examinations]

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

 

 

Subheading of section 'Examinations'

 

SE06.03.05.0620

Details on examinations and observations

[Details on examinations and observations]

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

Freetext Templates:

MORTALITY / CLINICAL SIGNS

- Time schedule for examinations:

- Remarks:

BODY WEIGHT

- Time schedule for examinations:

- Remarks:

FOOD CONSUMPTION (if feeding study)

- Time schedule for examinations:

- Remarks:

WATER CONSUMPTION (if drinking water study)

- Time schedule for examinations:

- Remarks:

PATHOLOGY

- Dose groups that were examined:

- Remarks:

ORGAN WEIGHTS

- Dose groups that were examined:

- Organs:

- Remarks:

REGURGITATION

- Test material was regurgitated: yes / no / not observed

OTHER:

Indicate the time schedule and further details for the examinations and observations performed (use separate freetext field for reproductive parameters, if applicable). Also indicate the dose groups that were examined if not all. When tabulating parameters examined, refer to respective table no.

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 examinations and observations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EXAM_OBSERV_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.03.05.0630

Details on reproductive parameters (if applicable)

[Details on reproductive parameters]

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

Freetext Templates:

The following parameters were examined per parental pen per week:

- Eggs laid

- Eggs cracked; eggs broken

- Egg abnormalities

- Eggs set

- Eggshell thickness or eggshell strength

- Eggs fertile

- Embryos viable

- Normal hatchlings

- Abnormal hatchlings

- Clinical signs of toxicity, abnormalities and mortality

- 14-day old surviving chicks

- Chick body weight at hatching and 14 days after hatching

OTHER:

For avian reproduction toxicity test, indicate the reproductive parameters examined.

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 reproductive parameters.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EXAM_REPRODUCTION_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.03.05.0640

Reference substance (positive control)

[Reference substance (positive control)]

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

Picklist Values:

yes || no || no data

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_BIRD_TOX>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.03.05.0641

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_BIRD_TOX>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.03.05.0650

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_BIRD_TOX>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.03.05.0655

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.

 

SE06.03.05.0659

Effect levels

[Effect levels]

  1. HEAD BLOCK
  2. Block label
  3. g384
  4. 20
  5. 1
  6. [N/A]

 

Report the LC50, LD50, NOEC or LOEC for all health (and reproductive) parameters depending on the study type. Copy this field block for entering more than one effect level if necessary.

Heading of field block 'Effect levels'

 

SE06.03.05.0660

Exposure duration

[Duration]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g384
  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_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:VALUEUNIT_EXP_DURATION_VALUE>

<i5:EXP_DURATION_VALUE>

SE06.03.05.0670

Unit

[Effect levels]

  1. LIST-CLOSED
  2. STRING/255
  3. g384
  4. 1
  5. 1
  6. E30

Picklist Values:

h || d || wk || mo

Select from drop-down list.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:VALUEUNIT_EXP_DURATION_VALUE>

<i5:EXP_DURATION_UNIT>

SE06.03.05.0680

Endpoint

[Endpoint]

  1. LIST-OPEN
  2. STRING/255
  3. g384
  4. 1
  5. 1
  6. E138

Picklist Values:

LC50 || LD50 || NOEC || NOEL || LOEC || LOEL || other:

Select from drop-down list.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT>

SE06.03.05.0681

Endpoint

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g384
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT_TXT>

SE06.03.05.0690

Effect level

[Effect level]

  1. LIST-CLOSED
  2. STRING/255
  3. g384
  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 level: Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE06.03.05.0700

Effect level

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g384
  4. 1
  5. 1
  6. [N/A]

 

 

Effect level: 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_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE06.03.05.0710

Effect level

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g384
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE06.03.05.0720

Effect level

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g384
  4. 1
  5. 1
  6. [N/A]

 

 

Effect level: 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_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE06.03.05.0730

Unit of effect level

[Effect levels]

  1. LIST-OPEN
  2. STRING/255
  3. g384
  4. 1
  5. 1
  6. E139

Picklist Values:

mg/kg bw || mg/kg bw/day (nominal) || mg/kg bw/day (actual dose received) || mg/kg bw/day || mg/kg diet || mg/L drinking water || other:

Select from drop-down list.

Unit of effect concentration or dose.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE06.03.05.0731

Unit of effect level

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g384
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT_TXT>

SE06.03.05.0740

Conc./dose based on

[Conc./dose based on]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g384
  4. 1
  5. 1
  6. E105

Picklist Values:

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

Indicate whether the dose/concentration is based on the test material (test mat.), 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.

Leave blank or select 'no data' if 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_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_EFF_CONC_TYPE>

<i5:EFF_CONC_TYPE>

SE06.03.05.0741

Conc./dose based on

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g384
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_EFF_CONC_TYPE>

<i5:EFF_CONC_TYPE_TXT>

SE06.03.05.0750

Basis for effect

[Basis for effect]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g384
  4. 1
  5. 1
  6. E28-2

Picklist Values:

behaviour || body weight || mean feed consumption || mean water consumption || mortality || organ weights || pathology || repellency || reproductive parameters || signs of toxicity || other: || no data

Select effect parameter such as mortality, which the effect concentration relates to. As appropriate include further details in the supplementary remarks field, e.g. 'related to number of eggs or young surviving'.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_BASIS_EFFECT>

<i5:BASIS_EFFECT>

SE06.03.05.0751

Basis for effect

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g384
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_BASIS_EFFECT>

<i5:BASIS_EFFECT_TXT>

SE06.03.05.0760

Remarks (e.g. 95% CL)

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

  1. TEXT
  2. STRING/255
  3. g384
  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_BIRD_TOX>

<i5:EFFLEVEL>

<i5:set>

<i5:REM>

<i5:REM>

SE06.03.05.0770

Repellency factors (if applicable)

[Repellency factors (if applicable)]

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

 

If repellency was investigated, describe the repellency results including all repellency factors (RF) given in the study report, i.e. either for each bird (choice test) or for per test group (no-choice test). As appropriate include or attach a table.

Description of repellency effects including all repellency factors (RF) given in the study report.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:REPELLENCY_RS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.03.05.0780

Mortality and sub-lethal effects

[Mortality and sub-lethal effects]

  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:

For details on cumulative mortality and sub-lethal effects see Table no. #.

MORTALITY

CLINICAL SIGNS

- Results:

- Remarks:

ABNORMAL BEHAVIOUR

- Results:

- Remarks:

BODY WEIGHT

- Results:

- Remarks:

FOOD CONSUMPTION (if feeding study)

- Results:

- Remarks:

WATER CONSUMPTION (if drinking water study)

- Results:

- Remarks:

PATHOLOGY

- Results:

- Remarks:

ORGAN WEIGHTS

- Results:

- Remarks:

HISTOPATHOLOGY

- Results:

- Remarks:

OTHER FINDINGS:

Briefly summarise relevant observations and any dose response relationship. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

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').

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

Mortality and sub-lethal effects

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:MORTALITY_SUBLETHAL_RS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.03.05.0790

Effects on reproduction (if applicable)

[Effects on reproduction]

  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:

- Number of eggs laid per hen and per day:

- Number of eggs set and the percentage eggs set related to eggs laid:

- Numbers of eggs cracked and the percentage eggs cracked related to eggs laid:

- Number of broken eggs:

- Eggshell thickness or eggshell strength measurements:

- Number of fertile eggs and the percentage fertility related to eggs set:

- Number of early viable embryos and the percentage viability related to fertile eggs:

- Number of late viable embryos and the percentage related to fertile eggs:

- Number of normal hatchlings as percentage of egg set:

- Number of normal hatchlings as percentage of fertile eggs:

- Number of normal hatchlings and the percentage related to total number of hatchlings:

- Number of 14-day old chicks per hen and per day:

- Number of 14-day old chicks as a percentage of (normal) hatchlings:

- Number of 14-day old chicks as a percentage of eggs set:

- Number of 14-day old chicks as a percentage of fertile eggs:

- Mean body weights of chicks on the day of hatching and after 14 days per pen, per test group:

- Description of abnormal behaviour of chicks, of severe birth defects and their general state of health, during the first 14 days after hatching, clinical signs of toxicity:

- Observations of hatchling mortality:

- Other:

For avian reproduction toxicity test, include data on reproduction during pre-treatment and treatment periods depending on the requirements of the test guideline used. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

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').

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

Details on reproductive parameters.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:REPRODUCTION_RS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.03.05.0800

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_BIRD_TOX>

<i5:RS_REF_SUBSTANCE>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.03.05.0810

Further details on results

[Further details on results]

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

 

Report any other relevant results. Compare the results for the test substance with that for the reference substance.

Additional information on results

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE06.03.05.0820

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.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BIRD_TOX>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE06.03.05.0830

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_BIRD_TOX>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.03.05.0835

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.

 

SE06.03.05.0840

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_BIRD_TOX>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.03.05.0849

Attached background material

[Attached background material]

  1. HEAD BLOCK
  2. Block label
  3. g385
  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'.

 

SE06.03.05.0850

Attached document

[Attached document]

  1. ATTACHMENT
  2. STRING/32768
  3. g385
  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_BIRD_TOX>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE06.03.05.0860

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g385
  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_BIRD_TOX>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE06.03.05.0869

Attached full study report

[Attached full study report]

  1. HEAD BLOCK
  2. Block label
  3. g386
  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

 

SE06.03.05.0870

Attached full study report

[Attached full study report]

  1. ATTACHMENT
  2. STRING/32768
  3. g386
  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_BIRD_TOX>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE06.03.05.0872

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_BIRD_TOX>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE06.03.05.0875

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.

 

SE06.03.05.0880

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_BIRD_TOX>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.03.05.0881

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_BIRD_TOX>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.03.05.0890

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_BIRD_TOX>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

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SE06.03.05.0900

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.

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SE06.03.05.0910

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.

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<i5:CROSSREF_OTHER_STUDY>

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<i5:TEXT_BELOW>

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