OECD Template #66-1: Skin sensitisation (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.

 

 

 

SE07.04.01.0215

DATA SOURCE

[Data source]

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

 

 

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

 

SE07.04.01.0219

Reference

[Reference]

  1. HEAD BLOCK
  2. Block label
  3. g507
  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'

 

SE07.04.01.0220

Reference type

[Reference type]

  1. LIST-OPEN
  2. STRING/255
  3. g507
  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_SENSITIZATION>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE07.04.01.0221

Reference type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g507
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE07.04.01.0230

Author(s) (or transferred reference)

[Author]

  1. TEXT
  2. STRING/2000
  3. g507
  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_SENSITIZATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE07.04.01.0240

Year

[Year]

  1. YEAR
  2. NUMBER/4/###0
  3. g507
  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_SENSITIZATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE07.04.01.0250

Title

[Title]

  1. TEXT
  2. STRING/255
  3. g507
  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_SENSITIZATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE07.04.01.0260

Bibliographic source

[Bibliographic source]

  1. TEXT
  2. STRING/255
  3. g507
  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_SENSITIZATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE07.04.01.0270

Testing laboratory

[Testing laboratory]

  1. TEXT
  2. STRING/255
  3. g507
  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_SENSITIZATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE07.04.01.0280

Report no.

[Report no.]

  1. TEXT
  2. STRING/255
  3. g507
  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_SENSITIZATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE07.04.01.0290

Owner company

[Owner company]

  1. TEXT
  2. STRING/255
  3. g507
  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_SENSITIZATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE07.04.01.0300

Company study no.

[Company study no.]

  1. TEXT
  2. STRING/255
  3. g507
  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_SENSITIZATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE07.04.01.0310

Report date

[Report date]

  1. DATE
  2. DATE/255
  3. g507
  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_SENSITIZATION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE07.04.01.0320

Data access

[Data access]

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

Picklist Values:

data submitter is data owner || data submitter has Letter of Access || data no longer protected || data published || not applicable || other:

Select appropriate indication for data access. Enter 'Not applicable' if the summary consists of information that is commonly accessible such as guidance on safe use.

Indication for data access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.04.01.0321

Data access

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.04.01.0330

Data protection claimed

[Data protection claimed]

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

Picklist Values:

yes || yes, but willing to share || yes, but not willing to share

Indicate as appropriate. Note: 'yes' should be selected only if 'Data submitter is data owner' or 'Data submitter has Letter of Access'. Options 'yes, but willing to share' or 'yes, but not willing to share' may be relevant for specific regulatory programmes where the submitter is requested to indicate whether he is willing to share studies (e.g. with vertebrates).

In the supplementary remarks field, include an explanation as appropriate, i.e. justification for denial of sharing the corresponding study or refer to a document attached that provides justification (e.g. 'for justification see attached document X')

Indication if data protection is claimed by the submitter who has to be data owner or have letter of access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.04.01.0331

Data protection claimed

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.04.01.0340

Cross-reference to same study

[Cross-reference to same study]

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

 

A cross-reference can be included to indicate that the same study is recorded in another record. Indicate the respective chapter and record ID and enter relevant explanatory text. This may be useful if specific endpoints of a given study are described in another chapter (e.g. results on reproduction toxicity in case of a combined repeated dose / reproduction toxicity study) or if more than one experiment is described by the same study report, but included in separate records.

Check with the relevant guidance document whether all the methodology details must be repeated or whether a cross-reference to the same study in another chapter may suffice.

Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.

Indication that the same study is described in another study summary / chapter of the data set.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.04.01.0345

MATERIALS AND METHODS

[Materials and methods]

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

 

 

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

 

SE07.04.01.0350

Type of method

[Type of method]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. C08

Picklist Values:

in vivo || in vitro || other: || no data

Indicate if study was in vivo or in vitro test. If in vitro test, describe study design in field 'Any other information on materials and methods incl. tables' and the results in field 'Any other information on results incl. tables'. If a specific template for in vitro assays is provided include the data in that template instead.

Indicator specifying whether study was in vivo or in vitro test.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:TYPE_INVIVO_INVITRO>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.04.01.0351

Type of method

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:TYPE_INVIVO_INVITRO>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.04.01.0360

Type of study

[Type of study]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T18

Picklist Values:

Buehler test || Draize test || Freund's complete adjuvant test || Guinea pig maximisation test || Intracutaneus test || Maurer optimisation test || Mouse ear swelling test || Mouse local lymphnode assay (LLNA) || Open epicutaneous test || Patch-Test || Skin painting test || Split adjuvant test || no data || other:

Select type of study e.g. 'Draize Test' as appropriate.

Select type of study e.g. 'Draize Test' or 'in vitro assay' as appropriate.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:STUDYTYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.04.01.0361

Type of study

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:STUDYTYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.04.01.0369

Test guideline

[Test guideline]

  1. HEAD BLOCK
  2. Block label
  3. g508
  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'

 

SE07.04.01.0370

Qualifier

[Qualifier]

  1. LIST-CLOSED
  2. STRING/255
  3. g508
  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_SENSITIZATION>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE07.04.01.0380

Guideline

[Guideline]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g508
  4. 1
  5. 1
  6. T20

Picklist Values:

OECD Guideline 406 (Skin Sensitisation) || OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) || EU Method B.6 (Skin Sensitisation) || EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay) || EPA OPP 81-6 (Skin Sensitisation) || EPA OPPTS 870.2600 (Skin Sensitisation) || EPA OTS 798.4100 (Skin Sensitisation) || OECD Guideline 442A (Skin Sensitization) || OECD Guideline 442B (Skin Sensitization) || 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_SENSITIZATION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE07.04.01.0381

Guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g508
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE07.04.01.0390

Deviations from guideline

[Deviations]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g508
  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_SENSITIZATION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE07.04.01.0391

Deviations from guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g508
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE07.04.01.0400

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_SENSITIZATION>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.04.01.0410

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_SENSITIZATION>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.04.01.0411

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_SENSITIZATION>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.04.01.0415

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'

 

SE07.04.01.0420

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_SENSITIZATION>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE07.04.01.0429

Test material identity

[Test material identity]

  1. HEAD BLOCK
  2. Block label
  3. g509
  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'

 

SE07.04.01.0430

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g509
  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_SENSITIZATION>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE07.04.01.0431

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g509
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE07.04.01.0440

Identity

[Identity]

  1. TEXT
  2. STRING/2000
  3. g509
  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_SENSITIZATION>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE07.04.01.0445

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_SENSITIZATION>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE07.04.01.0446

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_SENSITIZATION>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE07.04.01.0450

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_SENSITIZATION>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.04.01.0460

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_SENSITIZATION>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.04.01.0465

Test animals

[Test animals]

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

 

 

Subheading of section 'Test animals'

 

SE07.04.01.0470

Species

[Species]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T02-6

Picklist Values:

guinea pig || mouse || rabbit || human || other:

Select as appropriate. For in vitro tests, indicate the species used as source of the test system. If not available from picklist, select 'other' and specify.

NOTE: Although species 'human' is provided in the picklist for specifying the source of in vitro test systems as applicable, human data should be reported in an appropriate subsection of section 'Exposure related observations', particularly subsection 'Sensitisation data'.

It can be useful to document, in section 'Skin sensitisation', that human data are provided by creating a record and referring to the human data in field 'Cross-reference to same study'. This could be relevant if lack of animal experiments is defended by the availability of data on experience with human exposure.

Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) as to whether human data should be referenced in the appropriate endpoint summary record.

Organism/cell culture used in the experiment.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.04.01.0471

Species

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.04.01.0480

Strain

[Strain]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T23-234

Picklist Values:

ICR || Vienna White || Abyssinian || Dunkin-Hartley || Hartley || Peruvian || Pirbright-Hartley || Shorthair || AKR || B6C3F1 || Balb/c || C3H || C57BL || CAF1 || CB6F1 || CBA || CD-1 || CF-1 || DBA || DBF1 || FVB || ICL-ICR || Tif:MAGf || NMRI || Nude Balb/cAnN || Nude CD-1 || Sencar || SIV 50 || SKH/HR1 || Strain A || Swiss || Swiss Webster || Angora || Belgian Hare || Californian || Chinchilla || Dutch || Flemish Giant || Himalayan || New Zealand Black || New Zealand Red || New Zealand White || Polish || San Juan || other: || no data

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

The strain of the animal tested.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:STRAIN>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.04.01.0481

Strain

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:STRAIN>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.04.01.0490

Sex

[Sex]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T24

Picklist Values:

female || male || male/female || no data

Select as appropriate.

Sex of the tested animals.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:SEX>

<i5:set>

<i5:LIST_BELOW_POP>

<i5:LIST_BELOW_POP>

SE07.04.01.0500

Details on test animals and environmental conditions

[Details on test animals and environmental conditions]

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

Freetext Templates:

TEST ANIMALS

- Source:

- Age at study initiation:

- Weight at study initiation:

- Housing:

- Diet (e.g. ad libitum):

- Water (e.g. ad libitum):

- Acclimation period:

ENVIRONMENTAL CONDITIONS

- Temperature (°C):

- Humidity (%):

- Air changes (per hr):

- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

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:

- Diet: Describe type of diet (e.g. conventional laboratory diet / caloric restriction) and whether it was provided ad libitum.

- Water: Describe type (e.g. drinking water) and whether it was provided ad libitum.

- IN-LIFE DATES: If required, specify the in-life dates (i.e. the phase of a study following treatment in which the test system is alive/growing).

Details on test organisms and environmental conditions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:ORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.04.01.0505

Test system

[Test system]

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

 

 

Subheading of section 'Test system'

 

SE07.04.01.0506

Traditional sensitisation test

[Traditional sensitisation test]

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

 

 

Subheading of section 'Traditional sensitisation test'

 

SE07.04.01.0510

Route of induction exposure

[Route of induction exposure]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T54

Picklist Values:

epicutaneous, open || epicutaneous, occlusive || epicutaneous, semiocclusive || intradermal || intradermal and epicutaneous || other:

Indicate the route of induction exposure.

Route of induction exposure

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:ROUTE_INDUCTION>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.04.01.0511

Route of induction exposure

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:ROUTE_INDUCTION>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.04.01.0520

Route of challenge exposure

[Route of challenge exposure]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T54

Picklist Values:

epicutaneous, open || epicutaneous, occlusive || epicutaneous, semiocclusive || intradermal || intradermal and epicutaneous || other:

Indicate the route of challenge exposure

Route of challenge exposure

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:ROUTE_CHALLENGE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.04.01.0521

Route of challenge exposure

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:ROUTE_CHALLENGE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.04.01.0530

Vehicle / solvent

[Vehicle]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T52-1

Picklist Values:

unchanged (no vehicle) || arachis oil || beeswax || carbowaxe || castor oil || CMC (carboxymethyl cellulose) || coconut oil || corn oil || cotton seed oil || DMSO || hydrogenated vegetable oil || lecithin || macrogel ester || maize oil || olive oil || paraffin oil || peanut oil || petrolatum || physiol. saline || poloxamer || polyethylene glycol || propylene glycol || silicone oil || sorbitan derivative || soya oil || theobroma oil || vegetable oil || water || other: || no data

Select 'unchanged (no vehicle)' if none was used or select vehicle used if any. Further information can be given in the supplementary remarks field.

Indication of vehicle / solvent.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:VEHICLE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.04.01.0531

Vehicle

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:VEHICLE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.04.01.0540

Concentration

[Concentration]

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

 

For each exposure phase (i.e. induction/challenge) provide the doses / concentrations of the test substance applied including unit (i.e. undiluted, %, % active substance, FCA, mg, g).

Concentration(s) used in the test solution.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:DOSES_CONCENTRATIONS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.04.01.0550

No. of animals per dose

[No. of animals per dose]

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

 

Provide number of animals per dose or range if different numbers were used, e.g. '10 (controls), 10-20 (in test groups)'.

Number of animals.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:NUMBER_ANIMALS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.04.01.0560

Details on study design (Traditional tests)

[Details on study design (Traditional tests)]

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

Freetext Templates:

RANGE FINDING TESTS:

MAIN STUDY

A. INDUCTION EXPOSURE

- No. of exposures:

- Exposure period:

- Test groups:

- Control group:

- Site:

- Frequency of applications:

- Duration:

- Concentrations:

B. CHALLENGE EXPOSURE

- No. of exposures:

- Day(s) of challenge:

- Exposure period:

- Test groups:

- Control group:

- Site:

- Concentrations:

- Evaluation (hr after challenge):

OTHER:

For traditional sensitisation tests, describe any range finding tests (pilot study) and for the main study the induction and challenge procedures including the type of information given in the freetext template. 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.

Example for Freund's Complete Adjuvant (FCA) test (partly adopted from OECD 406):

A. INDUCTION EXPOSURE

- No. of exposures: 5

- Exposure period: -

- Test groups: TS in FCA

- Control group: FCA only

- Site: R flank

- Frequency of applications: every 2nd day

- Duration: 0-8 d

- Concentrations: same throughout

B. CHALLENGE EXPOSURE

- No. of exposures: 2

- Day(s) of challenge: 22 & 35

- Exposure period: -

- Test groups: TS

- Control group: TS

- Site: L flank

- Concentrations: 4 different

- Evaluation (hr after challenge): 24, 48, 72

Further details on study design.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:STUDYDESIGN_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.04.01.0570

Challenge controls

[Challenge controls]

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

 

Discuss the use of a challenge (i.e. naive) control group: number and sex of animals, dose for challenge application.

Indication whether a challenge (i.e. naive) control group was used, including number and sex of animals, dose for challenge application.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:CHALLENGE_CONTROLS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.04.01.0580

Positive control substance(s)

[Positive control substance(s)]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 2
  6. T158

Picklist Values:

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

Indicate if positive control substance(s) was/were used. If yes, describe the positive control(s) in supplementary field as appropriate.

Positive control substance used and if appropriate additional remarks in supplementary field.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:POS_CONTROL>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.04.01.0581

Positive control substance(s)

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:POS_CONTROL>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.04.01.0585

LLNA

[LLNA]

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

 

 

Subheading of section 'LLNA'

 

SE07.04.01.0590

Vehicle / solvent

[Vehicle]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T52-2

Picklist Values:

unchanged (no vehicle) || acetone/olive oil (4:1 v/v) || dimethyl sulphoxide || dimethylformamide || methyl ethyl ketone || propylene glycol || other: || no data

Select 'unchanged (no vehicle)' if none was used or select vehicle used if any. If the vehicle used is not from the list a rationale must be provided in the supplementary remarks field.

Indication of vehicle / solvent.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:VEHICLE_LLNA>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.04.01.0591

Vehicle

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:VEHICLE_LLNA>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.04.01.0600

Concentration

[Concentration]

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

 

Describe dose selection, i.e. at least 3 consecutive concentrations (100%, 50%, 25% 10%, 5%, 2.5%, 1%, 0.5% etc.) of the test substance.

Concentration(s) used in the test solution.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:LLNA_DOSES_CONCENTRATIONS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.04.01.0610

No. of animals per dose

[No. of animals per dose]

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

 

Provide number of animals per dose or range if different numbers were used, e.g. '4 per group (pooled lymph nodes)' or '5 per group (individual animals used)'.

Number of animals.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:LLNA_NUMBER_ANIMALS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.04.01.0620

Details on study design (LLNA)

[Details on study design (LLNA)]

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

Freetext Templates:

RANGE FINDING TESTS:

- Compound solubility:

- Irritation:

- Lymph node proliferation response:

MAIN STUDY

ANIMAL ASSIGNMENT AND TREATMENT

- Name of test method:

- Criteria used to consider a positive response:

TREATMENT PREPARATION AND ADMINISTRATION:

For LLNA, describe details on materials and methods as indicated in the freetext template. 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 radio isotope: to be included in field 'Details on test material'

- RANGE FINDING TESTS: Briefly describe compound solubility, irritation and lymph node proliferation response if significant.

MAIN STUDY

- ANIMAL ASSIGNMENT AND TREATMENT: Indicate name of test method used. Comment on criteria used to consider a positive response.

- TREATMENT PREPARATION AND ADMINISTRATION: Describe dose preparation and administration. (e.g. 25 µl of compound x was applied to the entire dorsal surface of each ear of each mouse. The application was repeated on days 2 and 3). On day 6 an injection of 250 µl phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (3H-TdR) or 250 µl PBS containing 2 µCi of 125 I-iododeoxy-uridine (125IU) and 10-5 M fluorodeoxy-uridine was made into the tail vein of each experimental mouse. Five hours later, the draining Auricular lymph node of each ear was excised into PBS. A single cell suspension of lymph node cells was prepared from each mouse. (describe method of cell suspension). Cells were precipitated with 5% trichloroacetic acid at 4 °C for 18 hours.

Details on materials and methods for LLNA study.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:LLNA_STUDYDESIGN_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.04.01.0629

Positive control substance(s)

[Positive control substance(s)]

  1. HEAD BLOCK
  2. Block label
  3. g510
  4. 5
  5. 2
  6. [N/A]

 

Indicate the positive control substance(s) used and give additional remarks in supplementary field as appropriate. Copy this field if more than one substance was used.

Positive control substance used and if appropriate additional remarks in supplementary field.

 

SE07.04.01.0630

Positive control substance(s)

[Positive control substance(s)]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g510
  4. 1
  5. 2
  6. T109

Picklist Values:

hexyl cinnamic aldehyde (CAS No 101-86-0) || mercaptobenzothiazole (CAS No 149-30-4) || other: || no data

Indicate the positive control substance(s) used and give additional remarks in supplementary field as appropriate. Copy this field if more than one substance was used.

Positive control substance used and if appropriate additional remarks in supplementary field.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:LLNA_POS_CONTROL>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.04.01.0631

Positive control substance(s)

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g510
  4. 1
  5. 2
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:LLNA_POS_CONTROL>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.04.01.0640

Statistics

[Statistics]

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

 

Provide the statistical procedures employed (e.g., linear regression analysis to assess dose-response trends; Dunnett's test to make pairwise comparisons).

Indication of parameters analyzed and statistical tests performed.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE07.04.01.0650

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:TO_SENSITIZATION>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.04.01.0655

RESULTS AND DISCUSSION

[Results and discussion]

  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.

 

SE07.04.01.0660

Positive control results

[Positive control results]

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

 

Discuss the positive control results and demonstrate that the laboratory has the capability to identify positive dermal sensitizers.

Discussion of positive control results and indication that laboratory has capability to identify positive dermal sensitizers.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:POS_CONTROL_RESULTS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE07.04.01.0665

Traditional sensitisation test

[Traditional sensitisation test]

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

 

 

Subheading of section 'Traditional sensitisation test'

 

SE07.04.01.0669

Results of test

[Results of test (except LLNA)]

  1. HEAD BLOCK
  2. Block label
  3. g511
  4. 20
  5. 1
  6. [N/A]

 

Record the results of traditional tests at the different readings for each test or control group used. Copy this block of fields as appropriate.

Present the scores from the challenge responses in a table.

Heading of field block 'Results of test (except LLNA)'.

 

SE07.04.01.0670

Reading

[Reading]

  1. LIST-OPEN
  2. STRING/255
  3. g511
  4. 1
  5. 1
  6. T110

Picklist Values:

1st reading || 2nd reading || rechallenge || other:

Select from drop-down list.

Indication of 1st / 2nd reading or rechallenge.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:RESULTS>

<i5:set>

<i5:PHRASEOTHER_READING>

<i5:READING>

SE07.04.01.0671

Reading

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g511
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:RESULTS>

<i5:set>

<i5:PHRASEOTHER_READING>

<i5:READING_TXT>

SE07.04.01.0680

Hours after challenge

[Hours after challenge]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g511
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Numeric value of hours after challenge.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:RESULTS>

<i5:set>

<i5:TIMEPOINT>

<i5:TIMEPOINT>

SE07.04.01.0690

Group

[Group]

  1. LIST-OPEN
  2. STRING/255
  3. g511
  4. 1
  5. 1
  6. T111

Picklist Values:

negative control || test group || positive control || other:

Select from drop-down list.

Indication whether test group, negative or positive control group is referred to.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:RESULTS>

<i5:set>

<i5:PHRASEOTHER_GROUP>

<i5:GROUP>

SE07.04.01.0691

Group

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g511
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:RESULTS>

<i5:set>

<i5:PHRASEOTHER_GROUP>

<i5:GROUP_TXT>

SE07.04.01.0700

Dose level

[Dose level]

  1. TEXT
  2. STRING/255
  3. g511
  4. 1
  5. 1
  6. [N/A]

 

If more than one concentration was tested at challenge, specify the concentration(s) the reading refers to, e.g. '0.15 g of a 10% aqueous solution'. Several dose levels can be given if the results reported in this block of fields is the same for all challenge groups, e.g. '0.15 or 0.3 g of a 10% aqueous solution'.

Concentration(s) including unit the reading refers to.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:RESULTS>

<i5:set>

<i5:DOSE>

<i5:DOSE>

SE07.04.01.0710

Number of animals with positive reactions

[No. with + reactions]

  1. NUM
  2. NUMBER/2/#0
  3. g511
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Number of animals with positive reactions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:RESULTS>

<i5:set>

<i5:NUMBER_POSITIVE>

<i5:NUMBER_POSITIVE>

SE07.04.01.0720

Total number of animals in group

[Total no. in group]

  1. NUM
  2. NUMBER/2/#0
  3. g511
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Total number of animals in group.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:RESULTS>

<i5:set>

<i5:NUMBER_TOTAL>

<i5:NUMBER_TOTAL>

SE07.04.01.0730

Clinical observations

[Clinical observations]

  1. TEXT
  2. STRING/255
  3. g511
  4. 1
  5. 1
  6. [N/A]

 

Briefly describe relevant clinical observations.

Brief description of clinical observations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:RESULTS>

<i5:set>

<i5:CLINICAL_OBSERV>

<i5:CLINICAL_OBSERV>

SE07.04.01.0735

LLNA

[LLNA]

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

 

 

Subheading of section 'LLNA'

 

SE07.04.01.0740

Disintegrations per minute (DPM)

[Disintegrations per minute (DPM)]

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

REMARKS:

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

Briefly describe the results of DPM measurements. Comment on dose-response trends and comparisons with the vehicle control group. Give statistical comparisons of group mean DPMs compared to control. Indicate whether results are from the individual animals or pooled. As appropriate include table(s) in the rich text field 'Any other information on results incl. tables'. Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks 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.

Disintegrations per minute (DPM)

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:LLNA_DPM>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE07.04.01.0750

Stimulation index

[Stimulation index]

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

REMARKS:

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

Briefly describe the calculated SI and EC3. Calculation of µg/cm2 dose applied. As appropriate include table(s) in the rich text field 'Any other information on results incl. tables'. Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks 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.

Stimulation index

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:LLNA_SI>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE07.04.01.0760

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_SENSITIZATION>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.04.01.0765

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.

 

SE07.04.01.0770

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_SENSITIZATION>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.04.01.0779

Attached background material

[Attached background material]

  1. HEAD BLOCK
  2. Block label
  3. g512
  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'.

 

SE07.04.01.0780

Attached document

[Attached document]

  1. ATTACHMENT
  2. STRING/32768
  3. g512
  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_SENSITIZATION>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE07.04.01.0790

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g512
  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_SENSITIZATION>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE07.04.01.0799

Attached full study report

[Attached full study report]

  1. HEAD BLOCK
  2. Block label
  3. g513
  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

 

SE07.04.01.0800

Attached full study report

[Attached full study report]

  1. ATTACHMENT
  2. STRING/32768
  3. g513
  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_SENSITIZATION>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE07.04.01.0802

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_SENSITIZATION>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE07.04.01.0805

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.

 

SE07.04.01.0810

Interpretation of results

[Interpretation of results]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T21

Picklist Values:

ambiguous || not sensitising || sensitising || other: || no data

Indicate overall interpretation of test results as given in the study report or as concluded by the submitter. Use supplementary remarks field for indicating if conclusions originally reported were changed by submitter.

Note that a classification in the strict sense is normally not based on an individual study, but includes a weight of evidence evaluation of all relevant data. However, if a single study is used for a classification, you can indicate this In the supplementary remarks field.

Interpretation of test results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:INTERPRET_RS_SUBMITTER>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.04.01.0811

Interpretation of results

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:INTERPRET_RS_SUBMITTER>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.04.01.0813

Criteria used for interpretation of results

[Criteria used for interpretation of results]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T108

Picklist Values:

Canada pesticides || Canada workplace || EU || Japan || OECD GHS || US EPA pesticides || US CPSC / US OSHA || US CPSC / US FDA || expert judgment || other: || not specified

If the conclusions were based on hazard classification criteria, indicate the respective organisation. If no criteria are indicated in the report, enter 'expert judgment', 'no data' or 'other: <describe>' as appropriate.

Criteria used for interpretation of results

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:CRITERIA_SUBMITTER>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.04.01.0814

Criteria used for interpretation of results

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:CRITERIA_SUBMITTER>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.04.01.0820

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_SENSITIZATION>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.04.01.0830

Executive summary

[Executive summary]

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

REMARKS:

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

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

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_SENSITIZATION>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.04.01.0840

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_SENSITIZATION>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>