OECD Template #59: Dermal absorption (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.

 

 

 

SE07.01.02.0215

DATA SOURCE

[Data source]

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

 

 

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

 

SE07.01.02.0219

Reference

[Reference]

  1. HEAD BLOCK
  2. Block label
  3. g460
  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'

 

SE07.01.02.0220

Reference type

[Reference type]

  1. LIST-OPEN
  2. STRING/255
  3. g460
  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_DERMAL_ABSORPTION>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE07.01.02.0221

Reference type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g460
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE07.01.02.0230

Author(s) (or transferred reference)

[Author]

  1. TEXT
  2. STRING/2000
  3. g460
  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_DERMAL_ABSORPTION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE07.01.02.0240

Year

[Year]

  1. YEAR
  2. NUMBER/4/###0
  3. g460
  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_DERMAL_ABSORPTION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE07.01.02.0250

Title

[Title]

  1. TEXT
  2. STRING/255
  3. g460
  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_DERMAL_ABSORPTION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE07.01.02.0260

Bibliographic source

[Bibliographic source]

  1. TEXT
  2. STRING/255
  3. g460
  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_DERMAL_ABSORPTION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE07.01.02.0270

Testing laboratory

[Testing laboratory]

  1. TEXT
  2. STRING/255
  3. g460
  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_DERMAL_ABSORPTION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE07.01.02.0280

Report no.

[Report no.]

  1. TEXT
  2. STRING/255
  3. g460
  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_DERMAL_ABSORPTION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE07.01.02.0290

Owner company

[Owner company]

  1. TEXT
  2. STRING/255
  3. g460
  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_DERMAL_ABSORPTION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE07.01.02.0300

Company study no.

[Company study no.]

  1. TEXT
  2. STRING/255
  3. g460
  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_DERMAL_ABSORPTION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE07.01.02.0310

Report date

[Report date]

  1. DATE
  2. DATE/255
  3. g460
  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_DERMAL_ABSORPTION>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE07.01.02.0320

Data access

[Data access]

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

Picklist Values:

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

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

Indication for data access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.02.0321

Data access

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.02.0330

Data protection claimed

[Data protection claimed]

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

Picklist Values:

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

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

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.01.02.0331

Data protection claimed

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.01.02.0340

Cross-reference to same study

[Cross-reference to same study]

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

 

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

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

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.01.02.0345

MATERIALS AND METHODS

[Materials and methods]

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

 

 

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

 

SE07.01.02.0350

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 'Details on in vitro test system (if applicable)'. 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_DERMAL_ABSORPTION>

<i5:TYPE_INVIVO_INVITRO>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.02.0351

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_DERMAL_ABSORPTION>

<i5:TYPE_INVIVO_INVITRO>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.02.0359

Test guideline

[Test guideline]

  1. HEAD BLOCK
  2. Block label
  3. g461
  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'

 

SE07.01.02.0360

Qualifier

[Qualifier]

  1. LIST-CLOSED
  2. STRING/255
  3. g461
  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_DERMAL_ABSORPTION>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE07.01.02.0370

Guideline

[Guideline]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g461
  4. 1
  5. 1
  6. T132

Picklist Values:

OECD Guideline 427 (Skin Absorption: In Vivo Method) || OECD Guideline 428 (Skin Absorption: In Vitro Method) || EPA OPP 85-3 (Dermal Penetration) || EPA OPPTS 870.7600 (Dermal Penetration) || EPA OPPTS 870.8245 (Dermal Pharmacokinetics of DGBE and DGBA) || EPA OPPTS 870.8300 (Dermal Absorption for Compounds that are Volatile and Metabolised to Carbon Monoxide) || EPA OPPTS 870.8320 (Oral/dermal pharmacokinetics) || EPA OPPTS 870.8380 (Inhalation and Dermal Pharmacokinetics of Commercial Hexane) || EPA OTS 795.2250 (Dermal Pharmacokinetics of DGBE and DGBA) || EPA OTS 795.2260 (Dermal Absorption for Compounds that are Volatile and Metabolised to Carbon Monoxide) || EPA OTS 795.2280 (Oral/Dermal Pharmacokinetics) || EPA OTS 795.2320 (Inhalation and Dermal Pharmacokinetics of Commercial Hexane) || 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_DERMAL_ABSORPTION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE07.01.02.0371

Guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g461
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE07.01.02.0380

Deviations from guideline

[Deviations]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g461
  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_DERMAL_ABSORPTION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE07.01.02.0381

Deviations from guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g461
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE07.01.02.0390

Principles of method if other than guideline

[Principles of method if other than guideline]

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

 

If no guideline was followed, include a description of the principles of the test protocol or estimated method used in the study. Details should be entered in appropriate distinct fields of section MATERIALS AND METHODS if available. Also provide a justification for using this method if appropriate.

If an estimation method was used (to be indicated in field 'Study result type') state the equation(s) and/or computer software or other methods applied to calculate the value(s).

Description of the test protocol or estimated method used in the study, if other than a guideline, and justification for using this method if appropriate.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.01.02.0400

GLP compliance

[GLP compliance]

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

Picklist Values:

yes (incl. certificate) || yes || no || no data

Indicate whether the study was conducted following Good Laboratory Practice or not. Select 'yes (incl. certificate)' if a GLP certificate of a test facility is available. Select 'yes' if a GLP compliance statement is available, but no information on a GLP certificate. You can give an explanation in the supplementary remarks field, e.g. for explaining why GLP was not complied with or for specifying which (national) GLP was followed.

Indication whether a GLP certificate or compliance statement is available.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.01.02.0401

GLP compliance

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.01.02.0405

Test materials

[Test materials]

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

 

 

Subheading of section 'Test materials'

 

SE07.01.02.0410

Radiolabelling

[Radiolabelling]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T151

Picklist Values:

yes || no || other: || no data

Indicate if labelled or non-labelled test material was used. Details on labelled material to be described in field 'Details on test material'. In the supplementary remarks field, any further explanations can be provided, e.g. for indicating that both labelled and unlabelled substances were used.

Indication whether labelled or non-labelled test material was used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:RADIO_LABEL>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.01.02.0411

Radiolabelling

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:RADIO_LABEL>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.01.02.0420

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_DERMAL_ABSORPTION>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE07.01.02.0429

Test material identity

[Test material identity]

  1. HEAD BLOCK
  2. Block label
  3. g462
  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 enterd 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'

 

SE07.01.02.0430

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g462
  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_DERMAL_ABSORPTION>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE07.01.02.0431

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g462
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE07.01.02.0440

Identity

[Identity]

  1. TEXT
  2. STRING/2000
  3. g462
  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_DERMAL_ABSORPTION>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE07.01.02.0445

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_DERMAL_ABSORPTION>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE07.01.02.0446

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_DERMAL_ABSORPTION>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE07.01.02.0450

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_DERMAL_ABSORPTION>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.02.0460

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_DERMAL_ABSORPTION>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.02.0465

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'

 

SE07.01.02.0470

Species

[Species]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T02-10

Picklist Values:

cat || human || cattle || dog || gerbil || guinea pig || hamster || hamster, Armenian || hamster, Chinese || hamster, Syrian || hen || miniature swine || monkey || mouse || pig || primate || rabbit || rat || sheep || other:

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

Note: If human skin was used in an in vitro test, comment on ethical approval in field 'Details on in vitro test system'.

Organism/cell culture used in the experiment.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.02.0471

Species

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.02.0480

Strain

[Strain]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T23-123456

Picklist Values:

Sencar || Zucker || Beagle || Abyssinian || Dunkin-Hartley || Hartley || Peruvian || Pirbright-Hartley || Shorthair || Macaca fascicularis || Marmoset || Mulatta arctoides || AKR || B6C3F1 || Balb/c || C3H || C57BL || CAF1 || CB6F1 || CBA || CD-1 || CF-1 || DBA || DBF1 || FVB || ICL-ICR || ICR || NMRI || Nude Balb/cAnN || Nude CD-1 || Tif:MAGf || 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 || Vienna White || Brown Norway || Crj: CD(SD) || Fischer 344 || Fischer 344/DuCrj || Lewis || Long-Evans || Osborne-Mendel || Sherman || Sprague-Dawley || Wistar || Wistar Kyoto (WKY) || 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_DERMAL_ABSORPTION>

<i5:STRAIN>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.02.0481

Strain

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:STRAIN>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.02.0490

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_DERMAL_ABSORPTION>

<i5:SEX>

<i5:set>

<i5:LIST_BELOW_POP>

<i5:LIST_BELOW_POP>

SE07.01.02.0500

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:

- Fasting period before study:

- Housing:

- Individual metabolism cages: yes/no

- 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_DERMAL_ABSORPTION>

<i5:ORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.02.0505

Administration / exposure

[Administration / exposure]

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

 

 

Subheading of section 'Administration / exposure'

 

SE07.01.02.0510

Type of coverage

[Type of coverage]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T50

Picklist Values:

occlusive || semiocclusive || open || other: || no data

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

Indicator whether the test material was covered on the site applied to.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:TYPE_COVERAGE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.01.02.0511

Type of coverage

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:TYPE_COVERAGE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.01.02.0520

Vehicle

[Vehicle]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T48

Picklist Values:

unchanged (no vehicle) || acetone || arachis oil || beeswax || carbowaxe || castor oil || cetosteryl alcohol || cetyl alcohol || CMC (carboxymethyl cellulose) || coconut oil || corn oil || cotton seed oil || DMSO || ethanol || glycerol ester || glycolester || 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. If not available from picklist, select 'other' and specify. Further information can be given in the supplementary remarks field.

Note that some of the vehicles provided in this list are used for specific routes of administration only.

Identity of the vehicle used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:VEHICLE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.01.02.0521

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_DERMAL_ABSORPTION>

<i5:VEHICLE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.01.02.0530

Duration of exposure

[Duration of exposure]

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

 

Indicate the time interval between application and removal of test preparation by skin washing, e.g. '6 hours'. Describe when termination occurred. Explain if some groups were terminated at wash and some were washed, then terminated later.

Exposure duration including unit, i.e. time interval between application and removal of test preparation by skin washing.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:EXP_PERIOD>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.01.02.0540

Doses

[Doses]

  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:

- Nominal doses:

- Actual doses:

- Actual doses calculated as follows:

- Dose volume:

- Rationale for dose selection:

As appropriate enter text or use freetext template and delete/add elements. Indicate the nominal and, if available, the actual doses including unit applied to the test animals (e.g. '0.0X, 0.X, and X.0 µg ai/X cm² skin over all duration periods'). Also state the dose volume (e.g. in ml/cm²) and provide the rationale for dose selection (explain, e.g., anticipated dermal deposition in the field). Modify any unit in the freetext template as appropriate.

For i.v. dosing, specify whether the same animal is used for intravenous and dermal dosing.

In case of a robust study summary or as requested by the regulatory programme, also provide a detailed table on the animal assignment 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.

Dose(s) or concentration(s) tested/administered including unit.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:DOSES_CONCENTRATIONS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.02.0550

No. of animals per group

[No. of animals per group]

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

 

Indicate number of animals per group of one sex, i.e. each test preparation and each scheduled termination time. If numbers differ, specify, e.g. '4 in all groups but one; 3 in 2 mg/cm² group scheduled for termination at 48 hours'

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:NUMBER_ANIMALS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.01.02.0560

Control animals

[Control animals]

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

Picklist Values:

yes || no

Indicate whether control groups were used and specify or comment in supplementary remarks field as appropriate.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.01.02.0561

Control animals

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.01.02.0570

Details on study design

[Details on study design]

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

Freetext Templates:

DOSE PREPARATION

- Method for preparation of dose suspensions:

- Method of storage:

APPLICATION OF DOSE:

VEHICLE

- Justification for use and choice of vehicle (if other than water):

- Amount(s) applied (volume or weight with unit):

- Concentration (if solution):

- Lot/batch no. (if required):

- Purity:

TEST SITE

- Preparation of test site:

- Area of exposure:

- % coverage:

- Type of cover / wrap if used:

- Time intervals for shavings or clipplings:

SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: yes: (describe)/no

REMOVAL OF TEST SUBSTANCE

- Removal of protecting device:

- Washing procedures and type of cleansing agent:

- Time after start of exposure:

SAMPLE COLLECTION

- Collection of blood:

- Collection of urine and faeces:

- Collection of expired air:

- Terminal procedure:

- Analysis of organs:

SAMPLE PREPARATION

- Storage procedure:

- Preparation details:

ANALYSIS

- Method type(s) for identification (e.g. GC-FID, GC-MS, HPLC-DAD, HPLC-MS-MS, HPLC-UV, Liquid scintillation counting, NMR, TLC)

- Liquid scintillation counting results (cpm) converted to dpm as follows:

- Validation of analytical procedure:

- Limits of detection and quantification:

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.

Explanations:

DOSE PREPARATION: e.g., combining appropriate amounts of the radioactive and non-radioactive formulation, and water and thoroughly mixing.

APPLICATION OF DOSE: provide details on how the dose was applied (e.g., X µL was applied and spread evenly across the surface of the skin site using (e.g., a glass rod). The glass rod used to apply the dose was (e.g. rinsed with X ml of methanol, wiped with a gauze pad and the rinse and wipe collected for analysis).).

TEST SITE:

- Preparation of test site: e.g. shaved (or discuss); shaved area washed with XXXX. Abrasion?

- Area of exposure: expressed in cm²

- % coverage / - Type of cover / wrap if used: provide data on the percentage and type of coverage (e.g., The dosing enclosure was covered by (e.g., a nonocclusive filter paper cover attached using rubber cement)).

SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: indicate if restrainers (spacers) were used and what type (e.g. Elizabethan collar placed on each animal's neck).

REMOVAL OF TEST SUBSTANCE: Describe timing, removal of apparatus, washing procedures, other approaches used (e.g., tape stripping), etc.

SAMPLE COLLECTION: Describe sample collection during the exposure period and until termination of study (e.g. urine, faeces, blood, expired air), procedures for termination, analysis of organs (e.g., Skin from application site; blood; residual urine; residual carcass; cover, cage wahings and other potentially contaminated equipment)

Details on study design

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:STUDY_DESIGN_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.02.0580

Details on in vitro test system (if applicable)

[Details on in vitro test system (if applicable)]

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

Freetext Templates:

SKIN PREPARATION

- Source of skin:

- Ethical approval if human skin:

- Type of skin:

- Preparative technique:

- Thickness of skin (in mm):

- Membrane integrity check:

- Storage conditions:

- Justification of species, anatomical site and preparative technique:

PRINCIPLES OF ASSAY

- Diffusion cell:

- Receptor fluid:

- Solubility of test substance in receptor fluid:

- Static system:

- Flow-through system:

- Test temperature:

- Humidity:

- Occlusion:

- Reference substance(s):

- Other:

In the case of in vitro testing give details on the skin preparation. Include source of skin (State what type of skin was used, i.e. viable or non-viable skin, epidermal membranes or split / full thickness skin). Give details on how skin was prepared and any treatment(s) (heat separation, chemical or enzymatic separation). Include data on any check for membrane integrity.

Briefly describe the principles of the assay. Note: Enter information on duration, application, sampling and analysis in the respective fields.

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

Details on the study design of an in vitro test (if applicable).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:INVITRO_STUDYDESIGN_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.02.0590

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_DERMAL_ABSORPTION>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.01.02.0595

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.

 

SE07.01.02.0600

Signs and symptoms of toxicity

[Signs and symptoms of toxicity]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 2
  6. T102

Picklist Values:

yes || no effects || not examined || no data

Indicate whether signs and symptoms of toxicity were observed or not. If yes, describe the effects at the different doses in the supplementary remarks field. In addition or as an alternative option, include a table and refer to the respective table no.

Indication whether signs and symptoms of toxicity were observed or not and option to specify the effects or refer to a results table.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:SIGNS_SYMPTOMS_TOXICITY>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.01.02.0601

Signs and symptoms of toxicity

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:SIGNS_SYMPTOMS_TOXICITY>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.01.02.0610

Dermal irritation

[Dermal irritation]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 2
  6. T102

Picklist Values:

yes || no effects || not examined || no data

Indicate whether any dermal irritation were observed or not. If yes, describe the effects and at what doses in the supplementary remarks field.

Indication whether dermal irritation was observed or not and option to specify the effects.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:DERMAL_IRRITATION>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.01.02.0611

Dermal irritation

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:DERMAL_IRRITATION>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.01.02.0620

Absorption in different matrices

[Absorption in different matrices]

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

REMARKS:

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

Freetext Templates:

- Non-occlusive cover + enclosure rinse:

- Skin wash:

- Skin test site:

- Skin, untreated site:

- Blood:

- Carcass:

- Urine:

- Cage wash + cage wipe:

- Faeces:

- Expired air (if applicable):

- Serial non-detects in excreta at termination:

- Receptor fluid, receptor chamber, donor chamber (in vitro test system):

- Skin preparation (in vitro test system):

- Stratum corneum (in vitro test system): (i.e tape strips)

Include the dose recovery in the various matrices, i.e. amount of compound in each sample ( % of dose applied). The dose recovery should include skin wash, cover and enclosure (if applicable), carbon filter (if applicable), tape stripping (if applicable), urine, cage wash and wipe , faeces, expired air, carcass and skin application site. Use freetext template delete/add elements as appropriate.

For very comprehensive data refer to summary tables for each dose level (e.g. predefined table). 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.

Absorption data, i.e. description of the dose recovery in the various matrices or reference to summary tables for each dose.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:ABSORPTION_MATRICES>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.02.0630

Total recovery

[Total recovery]

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

Freetext Templates:

- Total recovery:

- Recovery of applied dose acceptable:

- Results adjusted for incomplete recovery of the applied dose:

- Limit of detection (LOD):

- Quantification of values below LOD or LOQ:

Include the total recovery and information on its validity. Use freetext template delete/add elements as appropriate.

- Total recovery: e.g., Total amounts of radioactivity in samples were reported as a percentage of the total dose (or discuss).

- Limit of detection (LOD): e.g., Limits of detection were established as follows: range µg/g sample for the low dose group, range µg/g sample for the medium dose group and range µg/g sample for the high dose group. [or note if this data not reported]

- Quantification of values below LOD or LOQ: describe how values below LOD or LOQ were quantified (i.e. values < LOD = 1/2 LOD or 0)

Description of the total recovery and information on its validity.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:TOTAL_RECOVERY>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.01.02.0639

Percutaneous absorption rate

[Percutaneous absorption rate]

  1. HEAD BLOCK
  2. Block label
  3. g463
  4. 10
  5. 1
  6. [N/A]

 

Include the most appropriate mean dermal absorption value. Copy this block of fields for different dose groups as appropriate.

Heading of field block 'Percutaneous absorption rate'.

 

SE07.01.02.0640

Time point

[Time point]

  1. TEXT
  2. STRING/255
  3. g463
  4. 1
  5. 1
  6. [N/A]

 

Include hours after application when the residues were determined, e.g. '120 h'.

Time point after application.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:ABSORPTION>

<i5:set>

<i5:TIMEPOINT>

<i5:TIMEPOINT>

SE07.01.02.0650

Dose group

[Dose]

  1. TEXT
  2. STRING/255
  3. g463
  4. 1
  5. 1
  6. [N/A]

 

Indicate the group for which the absorption value is provided, e.g. '2 g/cm² skin'. As appropriate several groups may be included, for example if absorption was less than a certain percentage in all groups.

Description of dose group(s) for which the value is given.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:ABSORPTION>

<i5:set>

<i5:DOSE>

<i5:DOSE>

SE07.01.02.0660

Absorption rate (%)

[Absorption (%)]

  1. LIST-CLOSED
  2. STRING/255
  3. g463
  4. 1
  5. 1
  6. A02-1

Picklist Values:

> || >= || ca.

Include the respective value or range of values if given e.g. for several groups. Include qualifiers as appropriate. Enter a numeric value or a range of numeric values according to following conventions:

(i) In the first numeric field, enter a single value (Qualifier subfield left blank) or a value if preceded by '>', '>=' or 'ca.' (e.g. '20', 'ca. 20', '>20').

(ii) In the second numeric field, enter a single value if preceded by '<' or '<='.

(iii) Use both numeric fields and, as required, the lower and upper qualifier field to enter a range of numeric values (e.g. '2 - 8' or '>2 <8').

Mean percutaneous absorption rate in % of applied dose or range: Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:ABSORPTION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE07.01.02.0670

Absorption rate (%)

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g463
  4. 1
  5. 1
  6. [N/A]

 

 

Mean percutaneous absorption rate in % of applied dose or range: Lower numeric field for entering a numeric value preceded either by no operator, '>', '>=' or 'ca.' (e.g. '20', '>20', '>=20', '20')

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:ABSORPTION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE07.01.02.0680

Absorption rate (%)

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g463
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

Mean percutaneous absorption rate in % of applied dose or range: Upper qualifier field providing a list with following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:ABSORPTION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE07.01.02.0690

Absorption rate (%)

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g463
  4. 1
  5. 1
  6. [N/A]

 

 

Mean percutaneous absorption rate in % of applied dose or range: Upper numeric field for entering a numeric value only if either a lower value is already entered to specify a numeric range or if the numeric value is preceded by either operator '<' or '<='.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:ABSORPTION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE07.01.02.0700

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g463
  4. 1
  5. 1
  6. [N/A]

 

Remarks: For any comments as appropriate.

Remarks on percutaneous absorptian rate.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:ABSORPTION>

<i5:set>

<i5:REM>

<i5:REM>

SE07.01.02.0710

Conversion factor human vs. animal skin

[Conversion factor human vs. animal skin]

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

 

If a conversion factor was derived to account for the difference in permeability between human and animal skin, provide this factor including details on the calculation basis, e.g. based on differences in absorption rates or in flux as applicable.

Conversion factor human vs. animal skin

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_DERMAL_ABSORPTION>

<i5:CONVERSION_FACTOR>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.01.02.0720

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_DERMAL_ABSORPTION>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.01.02.0725

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.

 

SE07.01.02.0730

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_DERMAL_ABSORPTION>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.01.02.0739

Attached background material

[Attached background material]

  1. HEAD BLOCK
  2. Block label
  3. g464
  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'.

 

SE07.01.02.0740

Attached document

[Attached document]

  1. ATTACHMENT
  2. STRING/32768
  3. g464
  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_DERMAL_ABSORPTION>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE07.01.02.0750

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g464
  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_DERMAL_ABSORPTION>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE07.01.02.0759

Attached full study report

[Attached full study report]

  1. HEAD BLOCK
  2. Block label
  3. g465
  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

 

SE07.01.02.0760

Attached full study report

[Attached full study report]

  1. ATTACHMENT
  2. STRING/32768
  3. g465
  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_DERMAL_ABSORPTION>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE07.01.02.0762

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_DERMAL_ABSORPTION>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE07.01.02.0765

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.

 

SE07.01.02.0770

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_DERMAL_ABSORPTION>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.01.02.0780

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_DERMAL_ABSORPTION>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.01.02.0790

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_DERMAL_ABSORPTION>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>