OECD Template #77: Immunotoxicity (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.

 

 

 

SE07.09.02.0215

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.

 

SE07.09.02.0219

Reference

[Reference]

  1. HEAD BLOCK
  2. Block label
  3. g609
  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'

 

SE07.09.02.0220

Reference type

[Reference type]

  1. LIST-OPEN
  2. STRING/255
  3. g609
  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_IMMUNOTOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE07.09.02.0221

Reference type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g609
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE07.09.02.0230

Author(s) (or transferred reference)

[Author]

  1. TEXT
  2. STRING/2000
  3. g609
  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_IMMUNOTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE07.09.02.0240

Year

[Year]

  1. YEAR
  2. NUMBER/4/###0
  3. g609
  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_IMMUNOTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE07.09.02.0250

Title

[Title]

  1. TEXT
  2. STRING/255
  3. g609
  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_IMMUNOTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE07.09.02.0260

Bibliographic source

[Bibliographic source]

  1. TEXT
  2. STRING/255
  3. g609
  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_IMMUNOTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE07.09.02.0270

Testing laboratory

[Testing laboratory]

  1. TEXT
  2. STRING/255
  3. g609
  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_IMMUNOTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE07.09.02.0280

Report no.

[Report no.]

  1. TEXT
  2. STRING/255
  3. g609
  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_IMMUNOTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE07.09.02.0290

Owner company

[Owner company]

  1. TEXT
  2. STRING/255
  3. g609
  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_IMMUNOTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE07.09.02.0300

Company study no.

[Company study no.]

  1. TEXT
  2. STRING/255
  3. g609
  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_IMMUNOTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE07.09.02.0310

Report date

[Report date]

  1. DATE
  2. DATE/255
  3. g609
  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_IMMUNOTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE07.09.02.0320

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_IMMUNOTOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.09.02.0321

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_IMMUNOTOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.02.0330

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_IMMUNOTOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.09.02.0331

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_IMMUNOTOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.09.02.0340

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_IMMUNOTOX>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.09.02.0345

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.

 

SE07.09.02.0350

Test type

[Test type]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T135

Picklist Values:

acute || subacute || subchronic || chronic || developmental || other:

Select appropriate test type.

Indicator showing whether the study was an acute, subacute, subchronic or chronic or other.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:TESTTYPE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.09.02.0351

Test type

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:TESTTYPE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.02.0360

Limit test

[Limit test]

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

Picklist Values:

yes || no

Indicate if the experiment was a limit test.

An indicator that the experiment was a limit test.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:LIMIT_TEST>

<i5:set>

<i5:LIST_RIGHT_SEL>

<i5:LIST_RIGHT_SEL>

SE07.09.02.0369

Test guideline

[Test guideline]

  1. HEAD BLOCK
  2. Block label
  3. g610
  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'

 

SE07.09.02.0370

Qualifier

[Qualifier]

  1. LIST-CLOSED
  2. STRING/255
  3. g610
  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_IMMUNOTOX>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE07.09.02.0380

Guideline

[Guideline]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g610
  4. 1
  5. 1
  6. T139

Picklist Values:

EPA OPP 85-7 (Immunotoxicity) || EPA OPPTS 870.7800 || EPA OPPTS 880.3550

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_IMMUNOTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE07.09.02.0381

Guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g610
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE07.09.02.0390

Deviations from guideline

[Deviations]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g610
  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_IMMUNOTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE07.09.02.0391

Deviations from guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g610
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE07.09.02.0400

Principles of method if other than guideline

[Principles of method if other than guideline]

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

 

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

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.09.02.0410

GLP compliance

[GLP compliance]

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

Picklist Values:

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

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

Indication whether a GLP certificate or compliance statement is available.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.02.0411

GLP compliance

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.02.0415

Test materials

[Test materials]

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

 

 

Subheading of section 'Test materials'

 

SE07.09.02.0420

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_IMMUNOTOX>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE07.09.02.0429

Test material identity

[Test material identity]

  1. HEAD BLOCK
  2. Block label
  3. g611
  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'

 

SE07.09.02.0430

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g611
  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_IMMUNOTOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE07.09.02.0431

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g611
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE07.09.02.0440

Identity

[Identity]

  1. TEXT
  2. STRING/2000
  3. g611
  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_IMMUNOTOX>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE07.09.02.0445

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_IMMUNOTOX>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE07.09.02.0446

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_IMMUNOTOX>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE07.09.02.0450

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_IMMUNOTOX>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0460

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_IMMUNOTOX>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0465

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'

 

SE07.09.02.0470

Species

[Species]

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

Picklist Values:

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

Select name of species. If not available from picklist, select 'other' and specify.

Organism/cell culture used in the experiment.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.09.02.0471

Species

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.02.0480

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_IMMUNOTOX>

<i5:STRAIN>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.09.02.0481

Strain

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:STRAIN>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.02.0490

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_IMMUNOTOX>

<i5:SEX>

<i5:set>

<i5:LIST_BELOW_POP>

<i5:LIST_BELOW_POP>

SE07.09.02.0500

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:

- 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:

- Housing: describe housing conditions. Indicate whether individual metabolism cages were used.

- 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_IMMUNOTOX>

<i5:ORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0505

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'

 

SE07.09.02.0510

Route of administration

[Route of administration]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. T25

Picklist Values:

oral: gavage || oral: capsule || oral: feed || oral: drinking water || oral: unspecified || inhalation: aerosol || inhalation: dust || inhalation: gas || inhalation: vapour || inhalation || dermal || implantation || infusion || intramuscular || intraperitoneal || intratracheal || intravenous || subcutaneous || other:

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

Indicator how the chemical was administered to the test animals.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:ROUTE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.09.02.0511

Route of administration

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:ROUTE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.02.0520

Vehicle

[Vehicle]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. TD390

Picklist Values:

unchanged (no vehicle) || acetone || air || arachis oil || beeswax || carbowaxe || castor oil || cetosteryl alcohol || cetyl alcohol || clean air || 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 || oxygen || 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_IMMUNOTOX>

<i5:VEHICLE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE07.09.02.0521

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_IMMUNOTOX>

<i5:VEHICLE_TOX>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE07.09.02.0530

Details on exposure

[Details on exposure]

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

Freetext Templates:

PREPARATION OF DOSING SOLUTIONS:

DIET PREPARATION

- Rate of preparation of diet (frequency):

- Mixing appropriate amounts with (Type of food):

- Storage temperature of food:

VEHICLE

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

- Concentration in vehicle:

- Amount of vehicle (if gavage):

- Lot/batch no. (if required):

- Purity:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Exposure apparatus:

- Method of holding animals in test chamber:

- Source and rate of air:

- Method of conditioning air:

- System of generating particulates/aerosols:

- Temperature, humidity, pressure in air chamber:

- Air flow rate:

- Air change rate:

- Method of particle size determination:

- Treatment of exhaust air:

TEST ATMOSPHERE

- Brief description of analytical method used:

- Samples taken from breathing zone: yes/no

VEHICLE (if applicable)

- Justification for use and choice of vehicle:

- Composition of vehicle:

- Type and concentration of dispersant aid (if powder):

- Concentration of test material in vehicle:

- Lot/batch no. of vehicle (if required):

- Purity of vehicle:

TEST SITE

- Area of exposure:

- % coverage:

- Type of wrap if used:

- Time intervals for shavings or clipplings:

REMOVAL OF TEST SUBSTANCE

- Washing (if done):

- Time after start of exposure:

TEST MATERIAL

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

- Concentration (if solution):

- Constant volume or concentration used: yes/no

- For solids, paste formed: yes/no

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:

USE OF RESTRAINERS FOR PREVENTING INGESTION: yes/no

Select freetext template for the respective route of administration 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 exposure.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EXP_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0540

Analytical verification of doses or concentrations

[Analytical verification of doses or concentrations]

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

Picklist Values:

yes || no || no data

Indicate whether the doses or concentrations were analytically verified.

Indicator whether doses or concentrations were analytically verified.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:ANALYT_VERIF_DOSE_CONC>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE07.09.02.0550

Details on analytical verification of doses or concentrations

[Details on analytical verification of doses or concentrations]

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

 

For robust study summaries or as requested by the regulatory programme, include a short description on the method of analysis in the supplementary remarks field. If any problems occurred in any of these procedures, then they should be reported in more detail. If this could have affected the veracity or conclusions of the study, discuss this in field 'Rationale for reliability incl. deficiencies'.

Further route-dependent information to be included:

- For oral studies: State whether the analytical data indicated that the variance between nominal and actual dosage (if diet is route of administration) or concentrations (for drinking water study) was acceptable.

If diet is the route of administration, briefly record when and at what dose levels the dosage analyses were made and include the results (range of values) of (i) Homogeneity analysis, (ii) Stability analysis and (iii) Concentration analysis. It may be appropriate to include a cross-reference to another study in which stability analysis was performed and reported. If so, a justification should also be included briefly explaining the rationale of referring to another study.

- For inhalation studies: State whether the analytical data indicated that the variance between nominal and actual concentrations was acceptable.

- For dermal studies: State whether the analytical data indicated that the variance between nominal and actual concentrations of the test substance in the vehicle was acceptable.

Details on analytical verification of doses or concentrations

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:ANALYT_VERIF_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.09.02.0560

Duration of treatment / exposure

[Duration of treatment / exposure]

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

 

Indicate duration in days, weeks or months, e.g. '28 days' or '18 months'.

Exposure duration including unit.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EXP_PERIOD>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.09.02.0570

Frequency of treatment

[Frequency of treatment]

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

 

Indicate the frequency of the administration of doses to the test animals (e.g., 'daily, 7 days each week'). Use of non-standard dosing regime (e.g. a five-day per week regime) should be justified.

Description of the administration of doses to the test animals (e.g., n doses per day, n days per week).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:FREQUENCY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.09.02.0579

Doses / concentrations

[Doses / concentrations]

  1. HEAD BLOCK
  2. Block label
  3. g612
  4. 5
  5. 1
  6. [N/A]

 

Indicate the dose or concentration levels applied and the basis of quantity used. Copy this block of fields if the dose/concentration levels were determined on more than one basis of quantity as appropriate.

Heading of field block 'Doses / concentrations'.

 

SE07.09.02.0580

Doses / concentrations

[Doses / concentrations]

  1. TEXT
  2. STRING/255
  3. g612
  4. 1
  5. 1
  6. [N/A]

 

Indicate the doses or concentrations including unit applied to the test animals, e.g. '0, 112, 220, 523 mg/kg bw/day (m/f)' or '0, 112, 220, 523 mg/kg bw/day (m); 0, 87, 198, 477 mg/kg bw/day (f)'. You may enter explanatory text.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:DOSES>

<i5:set>

<i5:CONCENTRATIONS>

<i5:CONCENTRATIONS>

SE07.09.02.0590

Basis

[Basis]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g612
  4. 1
  5. 1
  6. T128

Picklist Values:

nominal in diet || nominal in water || actual ingested || nominal conc. || analytical conc. || other: || no data

Indicate whether doses/concentrations are based on nominal or actually ingested or analytically measured values. In the supplementary remarks field provide further details as appropriate.

Indicator showing whether the doses/concentrations given are based on nominal or actually ingested values or nominal or analytical concentrations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:DOSES>

<i5:set>

<i5:PHRASEOTHER_BASIS>

<i5:BASIS>

SE07.09.02.0591

Basis

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g612
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:DOSES>

<i5:set>

<i5:PHRASEOTHER_BASIS>

<i5:BASIS_TXT>

SE07.09.02.0600

No. of animals per dose group

[No. of animals per sex per dose]

  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.

Enter value or specify according to dose if different number of animals per dose, e.g. '10 in each dose group of main study; 10 f and 5 m in interim sacrifice group'. Also specify number of animals in recovery group if applicable.

For robust study summaries or as requested by the regulatory programme, also include 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.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:NUMBER_ANIMALS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE07.09.02.0609

Control animals

[Control animals]

  1. HEAD BLOCK
  2. Block label
  3. g613
  4. 5
  5. 1
  6. [N/A]

 

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

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

 

SE07.09.02.0610

Control animals

[Control animals]

  1. LIST-OPEN
  2. STRING/255
  3. g613
  4. 1
  5. 1
  6. T27

Picklist Values:

yes || yes, concurrent no treatment || yes, concurrent vehicle || yes, plain diet || yes, sham-exposed || yes, historical || no || no data || other:

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE07.09.02.0611

Control animals

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g613
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE07.09.02.0620

Further details on study design

[Further details on study design]

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

Freetext Templates:

- Dose selection rationale:

- Rationale for selecting satellite groups:

- Post-exposure recovery period in satellite groups:

- Rationale for animal assignment (if not random):

- Other:

Include any details on the study design including a brief description of the rationale for dose selection, animal assignment and selection of satellite groups including the duration of the post-exposure recovery period. As appropriate state study type(s) and briefly describe the results from range-finding or other studies used as basis for dose selection. More comprehensive details may be attached.

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

Further details on study design.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:STUDY_DESIGN_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0625

Examinations

[Examinations]

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

 

 

Subheading of section 'Examinations'

 

SE07.09.02.0630

Observations and clinical examinations

[Observations and clinical examinations performed and frequency]

  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:

CAGE SIDE OBSERVATIONS: Yes / No / No data

- Time schedule:

- Cage side observations checked in table [No.?] were included.

DETAILED CLINICAL OBSERVATIONS: Yes / No / No data

- Time schedule:

BODY WEIGHT: Yes / No / No data

- Time schedule for examinations:

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):

- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data

- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data

- Time schedule for examinations:

OPHTHALMOSCOPIC EXAMINATION: Yes / No / No data

- Time schedule for examinations:

- Dose groups that were examined:

HAEMATOLOGY: Yes / No / No data

- Time schedule for collection of blood:

- Anaesthetic used for blood collection: Yes (identity) / No / No data

- Animals fasted: Yes / No / No data

- How many animals:

- Parameters checked in table [No.?] were examined.

CLINICAL CHEMISTRY: Yes / No / No data

- Time schedule for collection of blood:

- Animals fasted: Yes / No / No data

- How many animals:

- Parameters checked in table [No.?] were examined.

URINALYSIS: Yes / No / No data

- Time schedule for collection of urine:

- Metabolism cages used for collection of urine: Yes / No / No data

- Animals fasted: Yes / No / No data

- Parameters checked in table [No.?] were examined.

OTHER:

Indicate if and which examinations were performed and the time schedule for those examinations. Also indicate the dose groups that were examined if not all. As appropriate include detailed 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').

If other observations (e.g. haematology) are reported in another study summary (e.g. repeated dose toxicity), include a note in field 'Cross-reference to same study' and refer to that summary.

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 clinical examinations performed and frequency.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:CLIN_EXAM_PERFORMED>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0640

Sacrifice and pathology

[Sacrifice and pathology]

  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:

GROSS PATHOLOGY: Yes (see table) / No / No data

HISTOPATHOLOGY: Yes (see table) / No / No data

Indicate if and which examinations were performed. Also indicate the dose groups that were examined if not all. Note if not all collected tissues were examined. As appropriate include detailed 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').

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 sacrifice and pathology.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:PATHOLOGY>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0650

Cell viabilities

[Cell viabilities]

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

Freetext Templates:

SPLEEN: Yes / No / No data

- Method:

- Dose groups:

- No. of animals:

THYMUS: Yes / No / No data

- Method:

- Dose groups:

- No. of animals:

BONE MARROW: Yes / No / No data

- Method:

- Dose groups:

- No. of animals:

Indicate if and which examinations were performed and give details on the method and test protocol, the dose groups and number of animals examined.

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

Details on cell viabilities examinations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EXAM_CELL_VIABILITIES>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0660

Humoral immunity examinations

[Humoral immunity examinations]

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

Freetext Templates:

ANTIBODY PLAQUE FORMING CELLS (PFC) ASSAY: Yes / No / No data

- Method:

- Dose groups:

- No. of animals:

ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA): Yes / No / No data

- Method:

- Dose groups:

- No. of animals:

OTHER ASSAYS [SPECIFY IF APPLICABLE]

- Method:

- Dose groups:

- No. of animals:

Indicate if and which examinations were performed and give details on the method and test protocol, the dose groups and number of animals examined. Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Example of brief description of protocol: 'Spleen IgM antibody response to a T-dependent antigen, sheep erythrocytes (sRBC) - Day 4 response: Animals were exposed to the test substance or positive control for 28 days, then injected intravenously to sheep erythrocytes on day 25. On day 29 (peak day of IgM response), the animals were sacrificed, spleens were removed and weighed, then spleen cells were prepared on day 30. The primary response to sheep erythrocytes was measured using a modified hemolytic plaque assay (Jerne, N.K., et al., Plaque forming cells: Methodology and Theory. Transpl. Rev. 18:130-191, 1974). Cell counts were performed and the number of cells/spleen, AFC/spleen and AFC/106 spleen cells were determined.'

Example of brief description of protocol for Enzyme-Linked Immunosorbent Assay (ELISA): 'The effects of test substance on antibody response to antigen were determined by an ELISA using methods described by Temple et al. (1995). Test animals were dosed with test material for ... days. Animals were exposed to sheep erythrocytes on day...IgM titers in serum were determined ... days after immunization. '

Details on specific biochemical examinations of humoral immunity examinations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EXAM_HUMORAL_IMMUNITY>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0670

Specific cell-mediated immunity

[Specific cell-mediated immunity]

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

Freetext Templates:

ONE-WAY MIXED LYMPHOCYTE CULTURE (MLC) ASSAY: Yes / No / No data

- Method:

- Dose groups:

- No. of animals:

DELAYED-TYPE HYPERSENSITIVITY (DTH) REACTION: Yes / No / No data

- Method:

- Dose groups:

- No. of animals:

CYTOTOXIC T-LYMPHOCYTE (CTL) ASSAY: Yes / No / No data

- Method:

- Dose groups:

- No. of animals:

OTHER ASSAYS [SPECIFY IF APPLICABLE]

- Method:

- Dose groups:

- No. of animals:

Indicate if and which examinations were performed and give details on the method and test protocol, the dose groups and number of animals examined. Use freetext template and delete/add elements as appropriate. Enter any details that could be relevant for evaluating this study summary or that are requested by the respective regulatory programme. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Describe cell harvest and culture and proliferation measurement ((3H) thymidine) incorporation, etc.

Details on examinations of specific cell-mediated immunity.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EXAM_SPECIF_CELLMEDIATED_IMM>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0680

Non-specific cell-mediated immunity

[Non-specific cell-mediated immunity]

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

Freetext Templates:

NATURAL KILLER (NK) CELL ACTIVITY: Yes / No / No data

- Method:

- Dose groups:

- No. of animals:

MACROPHAGE NUMBER AND FUNCTION: Yes / No / No data

- Method:

- Dose groups:

- No. of animals:

OTHER ASSAYS [SPECIFY IF APPLICABLE]:

- Method:

- Dose groups:

- No. of animals:

Indicate if and which examinations were performed and give details on the method and test protocol, the dose groups and number of animals examined.

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

Example of brief description of protocol: 'Following ... days of exposure to test material or positive control, the effects of test substance on spontaneous cytotoxic activity were determined by incubating splenocytes from treated and control animals with 51Cr-labeled YAC-1 lymphoma cells (target cell). Following a 4-hour incubation period, the amount of radiolabel released from target cells was determined (measure of NK cytolysis).'

Details on examinations of non-specific cell-mediated immunity.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EXAM_NONSPECIF_CELLMEDIATED_IMM>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0690

Other functional activity assays

[Other functional activity assays]

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

Freetext Templates:

SPLEEN CELL PROLIFERATION ASSAY (ANTI-CD3 MEDIATED T CELL PROLIFERATION)

- Method:

- Dose groups:

- No. of animals:

ENUMERATION TOTAL B CELLS, TOTAL T CELLS AND T CELL SUBPOPULATIONS

- Method:

- Dose groups:

- No. of animals:

OTHER ASSAYS [SPECIFY IF APPLICABLE]:

- Method:

- Dose groups:

- No. of animals:

Indicate if and which examinations were performed and give details on the method and test protocol, the dose groups and number of animals examined.

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

Example of brief description of protocol: 'On day 30, a single cell suspension was prepared from each spleen and incubated in flat bottom microtiter plates (RPMI media supplemented with 10% fetal bovine serum and 5x10-5 2-mercaptoethanol). The spleen cells were cultured in either non-treated or anti-CD3-treated wells (100 µL of 1 µg/mL anti-CD3) and incubated at 4°C overnight. Prior to harvest on day 3, the cells were pulsed with 3H-thymidine for 18-24 hours.'

Example of brief description of protocol for enumeration total B cells, total T cells and T cell subpopulations: 'Following ... days of dosing, single cell preparations from each spleen were seeded at 1x106 cells/well into a 96-well microtiter plate. Phenotypic analysis of total B cell, T cell, and T cell subpopulations were conducted using monoclonal antibody conjugates to fluorescein isothiocyanate (FITC) or phycoerythrin (PE). The specific monoclonal antibodies used were: OX19 conjugated to PE to enumerate total T-cells (CD5+), OX38 conjugated to FITC to enumerate CD4+ cells (T helper cells) and OX8 conjugated to FITC to enumerate CD8+ cells (T suppressor/cytotoxic cells). For both the CD4+ and CD8+ cells, a double label with OX19 was used. OX33 conjugated to FITC was used to enumerate CD45+ (B lymphocytes). Following the initial staining with antibody and washing with staining buffer, the DNA specific fluorescent stain propidium iodide (PI) was added to each well as a viability stain. Following a 5 minute incubation with PI, the cells were washed once with staining buffer and then enumerated on a Coulter Epics XL-MCL Flow Cytometer. At least 5,000 cells were counted for each sample.'

Details on other functional activity assays.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EXAM_OTHER_FUNCTIONAL_ASSAYS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE07.09.02.0700

Other examinations

[Other examinations]

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

 

Describe any other examinations.

Description of other examinations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OTHER_EXAM>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE07.09.02.0710

Positive control

[Positive control]

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

 

Briefly describe the positive control data cited, and its acceptability for use with the current study. Criteria for acceptability include the positive demonstration of sensitivity of the test methods to detect changes in the measured parameters.

Indication if a positive control was used and if appropriate indication of purity, Lot/batch No.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:POS_CONTROL>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE07.09.02.0720

Statistics

[Statistics]

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

 

List parameters that were analysed and the statistical methods used; include a statement that the Reviewer considers the analyses used to be appropriate. If inappropriate, provide alternative/rationale.

Indication of parameters analyzed and statistical tests performed.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE07.09.02.0730

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_IMMUNOTOX>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE07.09.02.0735

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.

 

SE07.09.02.0739

Effect levels

[Effect levels]

  1. HEAD BLOCK
  2. Block label
  3. g614
  4. 20
  5. 1
  6. [N/A]

 

Record effect levels, based on different endpoints and/or separated for males and females. Copy this block of fields as appropriate.

Heading of field block 'Other effect levels'.

 

SE07.09.02.0740

Endpoint

[Endpoint]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g614
  4. 1
  5. 1
  6. T166

Picklist Values:

no NOAEC identified || no NOAEL identified || NOAEC || NOAEL || NOEC || NOEL || LOAEC || LOAEL || LOEC || LOEL || BMD05 || BMDL05 || BMDL10 || BMD: || BMC05 || BMCL05 || BMCL10 || BMC: || dose level: || conc. level: || other:

Select type of endpoint, normally NOAEC or LOAEC. If adverse effects were observed at the highest dose tested, select 'no NOAEC identified'. If a benchmark dose / concentration was calculated, select appropriate BMC indicator (e.g. 'BMC05' or 'BMC:' and specify in the related text field). If the critical effects at a specific dose or concentration level are reported only, select 'dose. level:' or 'conc. level:' and specify.

Type of endpoint (e.g. NOAEL) to which the data entered in this field block relate.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT>

SE07.09.02.0741

Endpoint

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g614
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT_TXT>

SE07.09.02.0750

Sex

[Sex]

  1. LIST-CLOSED
  2. STRING/255
  3. g614
  4. 1
  5. 1
  6. T24

Picklist Values:

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

Select from drop-down list.

Indication of the sex of the animals the effect level refers to in field block 'Effect levels'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:SEX>

<i5:SEX>

SE07.09.02.0760

Effect level

[Effect level]

  1. LIST-CLOSED
  2. STRING/255
  3. g614
  4. 1
  5. 1
  6. A02-1

Picklist Values:

> || >= || ca.

Enter a numeric value or a range of numeric values according to following conventions:

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

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

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE07.09.02.0770

Effect level

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g614
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE07.09.02.0780

Effect level

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g614
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE07.09.02.0790

Effect level

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g614
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE07.09.02.0800

Unit of dose

[Effect levels]

  1. LIST-OPEN
  2. STRING/255
  3. g614
  4. 1
  5. 1
  6. T28-4

Picklist Values:

mg/kg bw/day (nominal) || mg/kg bw/day (actual dose received) || mg/kg bw/day || mg/kg diet || mg/L drinking water || mg/kg bw (total dose) || mg/L air || mg/L air (nominal) || mg/L air (analytical) || mg/m³ air || mg/m³ air (nominal) || mg/m³ air (analytical) || ppm || ppm (nominal) || ppm (analytical) || other:

Select unit of dose or concentration as appropriate.

Unit of effect level.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE07.09.02.0801

Unit of dose

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g614
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT_TXT>

SE07.09.02.0802

Effect concentration type

[Based on]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g614
  4. 1
  5. 1
  6. E105

Picklist Values:

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

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

Leave blank or select 'no data' if type is not known.

Heading of field block 'Other effect levels'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_EFF_CONC_TYPE>

<i5:EFF_CONC_TYPE>

SE07.09.02.0803

Effect concentration type

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g614
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:PHRASEOTHER_EFF_CONC_TYPE>

<i5:EFF_CONC_TYPE_TXT>

SE07.09.02.0810

Basis for effect level / Remarks

[Basis for effect level / Remarks]

  1. TEXT-TEMPL
  2. STRING/32768
  3. g614
  4. 1
  5. 1
  6. [N/A]

Freetext Templates:

overall effects

no data; cell viability (spleen, thymus, bone marrow); humoral immunity (PFC assay; ELISA); cell-mediated immunity (MLC assay; DTH reaction; NK cell activity; macrophage no. and function); other functional activity assays (T cell proliferation; enumeration total B cells, T cells and T cell subpopulations); other:

Indicate the parameter(s) used to establish the given effect level. If necessary, give further details, e.g. 'cell viability (spleen); humoral immunity (ELISA)'. Delete any elements in the predefined freetext that do not apply.

This subfield can also be used to enter any other explanations, e.g. for indicating that the effect level provided was derived by the notifier or for indicating 'NOAEL = highest dose tested' if applicable.

Effect parameter or parameters, which the results given relate to, and/or any remarks.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:EFFLEVEL>

<i5:set>

<i5:BASIS>

<i5:BASIS>

SE07.09.02.0815

Observations

[Results of examinations]

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

 

 

Subheading of section 'Observations'

 

SE07.09.02.0820

Clinical signs and mortality

[Clinical signs and mortality]

  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 treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if 'yes') or provide any further explanation (if 'no effects'), e.g. stating that effects were observed, but considered negligible. Select 'not examined' or 'no data' as applicable.

Indication whether mortality or clinical signs were observed or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_CLIN_SIGNS>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.02.0821

Clinical signs and mortality

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_CLIN_SIGNS>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.02.0830

Body weight and weight gain

[Body weight and weight gain]

  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 treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if 'yes') or provide any further explanation (if 'no effects'), e.g. stating that effects were observed, but considered negligible. Select 'not examined' or 'no data' as applicable.

Indication whether effects were observed on body weight and weight gain or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_BODYWEIGHT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.02.0831

Body weight and weight gain

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_BODYWEIGHT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.02.0840

Food consumption and compound intake (if feeding study)

[Food consumption and compound intake (if feeding study)]

  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 treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if 'yes') or provide any further explanation (if 'no effects'), e.g. stating that effects were observed, but considered negligible. Select 'not examined' or 'no data' as applicable.

Indication whether effects were observed on food consumption or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_FOOD_CONSUM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.02.0841

Food consumption and compound intake (if feeding study)

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_FOOD_CONSUM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.02.0850

Food efficiency

[Food efficiency]

  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 treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if 'yes') or provide any further explanation (if 'no effects'), e.g. stating that effects were observed, but considered negligible. Select 'not examined' or 'no data' as applicable.

Indication whether effects were observed on food efficiency or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_FOOD_EFFICIENCY>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.02.0851

Food efficiency

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_FOOD_EFFICIENCY>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.02.0860

Water consumption and compound intake (if drinking water study)

[Water consumption and compound intake (if drinking water study)]

  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 treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if 'yes') or provide any further explanation (if 'no effects'), e.g. stating that effects were observed, but considered negligible. Select 'not examined' or 'no data' as applicable.

Indication whether effects were observed on water consumption or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_WATER_CONSUM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.02.0861

Water consumption and compound intake (if drinking water study)

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_WATER_CONSUM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.02.0870

Ophthalmoscopic examination

[Ophthalmoscopic examination]

  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 treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if 'yes') or provide any further explanation (if 'no effects'), e.g. stating that effects were observed, but considered negligible. Select 'not examined' or 'no data' as applicable.

Indication whether effects were observed on ophthalmoscopic examination or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_OPHTHALM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.02.0871

Ophthalmoscopic examination

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_OPHTHALM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.02.0880

Haematology

[Haematology]

  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 treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if 'yes') or provide any further explanation (if 'no effects'), e.g. stating that effects were observed, but considered negligible. Select 'not examined' or 'no data' as applicable.

Indication whether effects were observed on haematology or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_HAEMATOL>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.02.0881

Haematology

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_HAEMATOL>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE07.09.02.0890

Clinical chemistry

[Clinical chemistry]

  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 treatment-related effects were observed. In the supplementary remarks field related to this list field, describe the effects by dose (if 'yes') or provide any further explanation (if 'no effects'), e.g. stating that effects were observed, but considered negligible. Select 'not examined' or 'no data' as applicable.

Indication whether effects were observed on clinical chemistry or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_IMMUNOTOX>

<i5:OBSERV_CLIN_CHEM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE07.09.02.0891

Clinical chemistry

[no label]

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