OECD Template #80: Epidemiological data (Version 3-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.

 

 

 

SE07.10.02.0215

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.

 

SE07.10.02.0219

Reference

[Reference]

  1. HEAD BLOCK
  2. Block label
  3. g416
  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'

 

SE07.10.02.0220

Reference type

[Reference type]

  1. LIST-OPEN
  2. STRING/255
  3. g416
  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:TO_EPIDEMIOLOGICAL>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE07.10.02.0221

Reference type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g416
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE07.10.02.0230

Author(s) (or transferred reference)

[Author]

  1. TEXT
  2. STRING/2000
  3. g416
  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:TO_EPIDEMIOLOGICAL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE07.10.02.0240

Year

[Year]

  1. YEAR
  2. NUMBER/4/###0
  3. g416
  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:TO_EPIDEMIOLOGICAL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE07.10.02.0250

Title

[Title]

  1. TEXT
  2. STRING/255
  3. g416
  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:TO_EPIDEMIOLOGICAL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE07.10.02.0260

Bibliographic source

[Bibliographic source]

  1. TEXT
  2. STRING/255
  3. g416
  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:TO_EPIDEMIOLOGICAL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE07.10.02.0270

Testing laboratory

[Testing laboratory]

  1. TEXT
  2. STRING/255
  3. g416
  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:TO_EPIDEMIOLOGICAL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE07.10.02.0280

Report no.

[Report no.]

  1. TEXT
  2. STRING/255
  3. g416
  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:TO_EPIDEMIOLOGICAL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE07.10.02.0290

Owner company

[Owner company]

  1. TEXT
  2. STRING/255
  3. g416
  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:TO_EPIDEMIOLOGICAL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE07.10.02.0300

Company study no.

[Company study no.]

  1. TEXT
  2. STRING/255
  3. g416
  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:TO_EPIDEMIOLOGICAL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE07.10.02.0310

Report date

[Report date]

  1. DATE
  2. DATE/255
  3. g416
  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:TO_EPIDEMIOLOGICAL>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE07.10.02.0320

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:TO_EPIDEMIOLOGICAL>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.10.02.0321

Data access

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.10.02.0330

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:TO_EPIDEMIOLOGICAL>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.10.02.0331

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:TO_EPIDEMIOLOGICAL>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.10.02.0340

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:TO_EPIDEMIOLOGICAL>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.10.02.0345

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.

 

SE07.10.02.0350

Study type

[Study type]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z12

Picklist Values:

cohort study (prospective) || cohort study (retrospective) || case control study (prospective) || case control study (retrospective) || cross sectional study || longitudinal study || ecological study || other:

Select appropriate study type.

Indicator specifying study type, e.g. cohort study (prospective).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:STUDY_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.10.02.0351

Study type

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:STUDY_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.10.02.0359

Endpoint addressed

[Endpoint addressed]

  1. HEAD BLOCK
  2. Block label
  3. g417
  4. 10
  5. 1
  6. [N/A]

 

If the study recorded gives useful information on one or several of the classic endpoints, select the endpoint(s) addressed from the picklist. Copy this field as appropriate.

NOTE: The list of endpoints provided is a generic list. Some endpoints may not be applicable for the type of study summarised in this record.

Indicator specifying whether the record gives useful information on a classic endpoint.

 

SE07.10.02.0369

Test guideline

[Test guideline]

  1. HEAD BLOCK
  2. Block label
  3. g418
  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'

 

SE07.10.02.0370

Qualifier

[Qualifier]

  1. LIST-CLOSED
  2. STRING/255
  3. g418
  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:TO_EPIDEMIOLOGICAL>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE07.10.02.0380

Guideline

[Guideline]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g418
  4. 1
  5. 1
  6. Z60

Picklist Values:

other guideline:

Select the applicable test guideline, e.g. 'OECD Guideline xxx'. If the test guideline used is not listed, choose 'other guideline:' and specify the test guideline in the related text field.

In this text field, you can also enter any remarks as applicable, particularly:

- To include any other title of the test guideline draft used, a subtitle, another version or update number and the year of update (For instance, different titles and/or numbers may exist for a given EU test guideline.);

- To indicate if a the study was performed prior to the adoption of the test guideline specified;

- To indicate if the methodology used was based on an extension of the test guideline specified.

The name of the guideline followed in performing the study or to which the method used can be compared. Also indication if no guideline was used, available or required. In supplementary remarks field indication of guideline version, or title if deviating from the picklist value, or of additional test guidelines cited.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE07.10.02.0381

Guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g418
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE07.10.02.0390

Deviations from guideline

[Deviations]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g418
  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:TO_EPIDEMIOLOGICAL>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE07.10.02.0391

Deviations from guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g418
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE07.10.02.0400

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:TO_EPIDEMIOLOGICAL>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.10.02.0410

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:TO_EPIDEMIOLOGICAL>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.10.02.0411

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:TO_EPIDEMIOLOGICAL>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.10.02.0415

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'

 

SE07.10.02.0420

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:TO_EPIDEMIOLOGICAL>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE07.10.02.0429

Test material identity

[Test material identity]

  1. HEAD BLOCK
  2. Block label
  3. g419
  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'

 

SE07.10.02.0430

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g419
  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:TO_EPIDEMIOLOGICAL>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE07.10.02.0431

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g419
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE07.10.02.0440

Identity

[Identity]

  1. TEXT
  2. STRING/2000
  3. g419
  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:TO_EPIDEMIOLOGICAL>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE07.10.02.0445

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:TO_EPIDEMIOLOGICAL>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE07.10.02.0446

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:TO_EPIDEMIOLOGICAL>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE07.10.02.0450

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:TO_EPIDEMIOLOGICAL>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.10.02.0460

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:TO_EPIDEMIOLOGICAL>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.10.02.0465

Method

[Method]

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

 

 

Subheading of section 'Method'

 

SE07.10.02.0469

Type of population

[Type of population]

  1. HEAD BLOCK
  2. Block label
  3. g420
  4. 2
  5. 2
  6. [N/A]

 

Indicate whether subjects of the general population or from an occupational environment were investigated. If both were included in the same study, duplicate this field and indicate both types. If two independent studies are reported by the same report, use two separate records.

Indicator specifying whether subjects of the general population or from an occupational environment were investigated.

 

SE07.10.02.0470

Type of population

[Type of population]

  1. LIST-OPEN
  2. STRING/255
  3. g420
  4. 1
  5. 2
  6. Z24

Picklist Values:

general || occupational || other: || no data

Indicate whether subjects of the general population or from an occupational environment were investigated. If both were included in the same study, duplicate this field and indicate both types. If two independent studies are reported by the same report, use two separate records.

Indicator specifying whether subjects of the general population or from an occupational environment were investigated.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:POPULATION_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.10.02.0471

Type of population

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g420
  4. 1
  5. 2
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:POPULATION_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.10.02.0480

Ethical approval

[Ethical approval]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 2
  6. Z13

Picklist Values:

confirmed and informed consent free of coercion received || confirmed, but no further information available || no || not applicable || no data || other:

For ethical reasons indicate whether and what kind of consent was received from the persons studied. Include details in the supplementary remarks field. If 'not applicable' or 'no' is selected, give reasoning as appropriate.

Indicator specifying whether and what kind of consent was received from the persons studied.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:ETHICAL_APPROVAL>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.10.02.0481

Ethical approval

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:ETHICAL_APPROVAL>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.10.02.0490

Details on study design

[Details on study design]

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

Freetext Templates:

HYPOTHESIS TESTED (if cohort or case control study):

METHOD OF DATA COLLECTION

- Type: Interview / Questionnaire / Record review / Work history / Clinical tests / other:

- Details:

STUDY PERIOD:

SETTING:

STUDY POPULATION

- Total population (Total no. of persons in cohort from which the subjects were drawn):

- Selection criteria:

- Total number of subjects participating in study:

- Sex/age/race:

- Smoker/nonsmoker:

- Total number of subjects at end of study:

- Matching criteria:

- Other:

COMPARISON POPULATION

- Type: State registry / Regional registry / National registry / Control or reference group / Other comparison group:

- Details:

HEALTH EFFECTS STUDIED

- Disease(s):

- ICD No.:

- Year of ICD revision:

- Diagnostic procedure:

- Other health effects:

OTHER DESCRIPTIVE INFORMATION ABOUT STUDY:

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

Explanations:

- HYPOTHESIS TESTED: If study type is cohort or case control study, state the hypothesis(es) tested in this study.

- STUDY PERIOD: Give dates during which the data were collected (from ... to ...)

- SETTING: Indicate the setting where this study took place, e.g., occupational, residential, hospital-based, clinical practice, environmental (e.g., fence line of waste sites, air monitoring); its geographic location(s); and any other pertinent information.

- STUDY POPULATION: Include details on the study population using the predefined items and inserting additional ones if required. Alternatively include or a attach a table and refer to respective Table no.

- COMPARISON POPULATION: Indicate one of the predefined types; delete those being not applicable. Provide details, e.g., note the parameters that were 'matched' (i.e., smoking, age, sex, etc.).

- HEALTH EFFECTS STUDIED: Describe as appropriate. Note whether the diagnosis of the effects was made blind to exposure status. Alternatively include or a attach a table and refer to respective Table no.

Details on study design.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:STUDY_DESIGN_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.10.02.0500

Exposure assessment

[Exposure assessment]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z14

Picklist Values:

estimated || measured || no data

Indicate whether the exposure was measured or estimated.

For robust study summaries or as requested by the regulatory programme, provide further details in the following freetext field.

Indicator specifying whether the exposure was estimated or measured.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:EXPOSURE_ASSESSMENT>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE07.10.02.0510

Details on exposure

[Details on exposure]

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

Freetext Templates:

TYPE OF EXPOSURE:

TYPE OF EXPOSURE MEASUREMENT: Area air sampling / Personal sampling / Exposure pads / Biomonitoring (urine) / Biomonitoring blood / other:

EXPOSURE LEVELS:

EXPOSURE PERIOD:

POSTEXPOSURE PERIOD:

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES:

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

Explanations:

- TYPE OF EXPOSURE: Characterise type of exposure including information on manufacturing / processing / use as applicable. If available, describe special exposure situations / workplaces.

- TYPE OF EXPOSURE MEASUREMENT: Indicate relevant predefined type(s); delete those being not applicable.

- EXPOSURE LEVELS: Give exposure level(s) reported (with units) or insert/attach table, for several exposure conditions and levels.

- EXPOSURE PERIOD: Describe when subjects were exposed and duration of exposure, i.e., hours, hours per day, days, days per week, weeks, months, years, person years, other.

- POSTEXPOSURE PERIOD: State period of time elapsed between last exposure/first examination or time study was conducted.

- DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: If several exposure groups (e.g. different concentrations or durations) are analysed, identify the exposure groups or categories, number of subjects within each group, sex, other categorical descriptions, etc.

Details on exposure

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:EXPOSURE_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.10.02.0520

Statistical methods

[Statistical methods]

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

 

Describe all statistical methods used and the data to which they were applied (include sample size and power calculations, if available).

Statistical methods

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE07.10.02.0530

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:TO_EPIDEMIOLOGICAL>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.10.02.0535

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.

 

SE07.10.02.0540

Results

[Results]

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

REMARKS:

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

Freetext Templates:

EXPOSURE

- Number of measurements:

- Average concentrations:

- Arithmetic mean:

- Geometric mean:

- Median:

- 95-Percentile:

- Standard deviation:

- Date(s) of measurement(s):

- Other:

FINDINGS

INCIDENCE / CASES

- Incidence/ Number of cases for each disease / parameter under consideration:

- Other:

STATISTICAL RESULTS

- SMR (Standard mortality ratio):

- RR (Relative risk):

- OR (Odds ratio):

- Other:

OTHER OBSERVATIONS:

Provide exposure data as available. Give numbers of cases for each effect/disease/parameter under consideration, include measures of disease frequency (SMRs, ORs, PMRs, RR, prevalence, incidence, adjusted and/or crude rates), correlations, distributions etc., statistical data (significance, confidence intervals). If appropriate present the data in tabular form. Upload predefined table in the rich text field 'Any other information on results incl. tables' 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').

Description of results including exposure data, case reports (if applicable) and statistical results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:RESULTS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.10.02.0550

Confounding factors

[Confounding factors]

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

 

Indicate any (possible) confounding factor(s), e.g. multi chemical exposure or smoking, and discuss their influence on the observed causal association.

Discussion of confounding factors.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:CONFOUNDING_FACTORS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.10.02.0560

Strengths and weaknesses

[Strengths and weaknesses]

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

 

Explain findings and discuss any other factors, i.e. bias, validity issues, reliability issues (including the adequacy of the exposure estimation or measurements), representativeness concerns, unique nature of study, influence of past exposures, latency, turnover rates in occupation studies.

Discussion of strengths and weaknesses.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:STRENGTHS_WEAKNESSES>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.10.02.0570

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:TO_EPIDEMIOLOGICAL>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.10.02.0575

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.

 

SE07.10.02.0580

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:TO_EPIDEMIOLOGICAL>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.10.02.0589

Attached background material

[Attached background material]

  1. HEAD BLOCK
  2. Block label
  3. g421
  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'.

 

SE07.10.02.0590

Attached document

[Attached document]

  1. ATTACHMENT
  2. STRING/32768
  3. g421
  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:TO_EPIDEMIOLOGICAL>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE07.10.02.0600

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g421
  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:TO_EPIDEMIOLOGICAL>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE07.10.02.0609

Attached full study report

[Attached full study report]

  1. HEAD BLOCK
  2. Block label
  3. g422
  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

 

SE07.10.02.0610

Attached full study report

[Attached full study report]

  1. ATTACHMENT
  2. STRING/32768
  3. g422
  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:TO_EPIDEMIOLOGICAL>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE07.10.02.0612

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:TO_EPIDEMIOLOGICAL>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE07.10.02.0615

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.

 

SE07.10.02.0620

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:TO_EPIDEMIOLOGICAL>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.10.02.0630

Executive summary

[Executive summary]

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

 

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

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.10.02.0640

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:TO_EPIDEMIOLOGICAL>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.10.02.0650

Endpoint addressed

[Endpoint addressed]

  1. LIST-OPEN
  2. STRING/255
  3. g417
  4. 1
  5. 1
  6. T167

Picklist Values:

not applicable || basic toxicokinetics || dermal absorption || acute toxicity: oral || acute toxicity: inhalation || acute toxicity: dermal || skin irritation / corrosion || eye irritation || respiratory irritation || skin sensitisation || respiratory sensitisation || repeated dose toxicity: oral || repeated dose toxicity: inhalation || repeated dose toxicity: dermal || genetic toxicity || carcinogenicity || toxicity to reproduction / fertility || developmental toxicity / teratogenicity || neurotoxicity || immunotoxicity || other:

If the study recorded gives useful information on one or several of the classic endpoints, select the endpoint(s) addressed from the picklist. Copy this field as appropriate.

NOTE: The list of endpoints provided is a generic list. Some endpoints may not be applicable for the type of study summarised in this record.

Indicator specifying whether the record gives useful information on a classic endpoint.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:ENDPOINT_ADDRESSED>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.10.02.0660

Endpoint addressed

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g417
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_EPIDEMIOLOGICAL>

<i5:ENDPOINT_ADDRESSED>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>