OECD Template #85-6: Expected exposure and proposed acceptable residues

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'.

Table 85-6.1. 

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.
   

SE09.04.00.0215

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.

 

SE09.04.00.0220

Background information

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

Use this field to include any background information, if required, or any relevant introductory remarks on the study summary. Leave field empty if not applicable. Do not include information for which specific fields are provided. For instance, include any background information on the test substance in fields on 'Test materials'.

PURPOSE OF THIS TEMPLATE:

This template can be used for summarising information on expected exposure and/or proposed acceptable residues if required so by the relevant legislation. For instance, estimation of the exposure potential or actual exposure of the active substance to humans or animals through food and feedingstuffs and other means, proposed acceptable residues and the justification of their acceptability (e.g. EU BPD Ann. IIIA, XI.1.4; XI.1.7).

Description of any relevant background information or any relevant introductory remarks on the study summary.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_ACCEPTABLE>

<i5:BACKGROUND_INFORMATION>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE09.04.00.0229

Reference

[Reference]
  1. HEAD BLOCK
  2. Block label
  3. g673
  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'

 

SE09.04.00.0230

Reference type

[Reference type]
  1. LIST-OPEN
  2. STRING/255
  3. g673
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE09.04.00.0231

Reference type

[no label]
  1. OTHERTEXT
  2. STRING/255
  3. g673
  4. 1
  5. 1
  6. [N/A]
  

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_ACCEPTABLE>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE09.04.00.0240

Author(s) (or transferred reference)

[Author]
  1. TEXT
  2. STRING/2000
  3. g673
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE09.04.00.0250

Year

[Year]
  1. YEAR
  2. NUMBER/4/###0
  3. g673
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE09.04.00.0260

Title

[Title]
  1. TEXT
  2. STRING/255
  3. g673
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE09.04.00.0270

Bibliographic source

[Bibliographic source]
  1. TEXT
  2. STRING/255
  3. g673
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE09.04.00.0280

Testing laboratory

[Testing laboratory]
  1. TEXT
  2. STRING/255
  3. g673
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE09.04.00.0290

Report no.

[Report no.]
  1. TEXT
  2. STRING/255
  3. g673
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE09.04.00.0300

Owner company

[Owner company]
  1. TEXT
  2. STRING/255
  3. g673
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE09.04.00.0310

Company study no.

[Company study no.]
  1. TEXT
  2. STRING/255
  3. g673
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE09.04.00.0320

Report date

[Report date]
  1. DATE
  2. DATE/255
  3. g673
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE09.04.00.0330

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE09.04.00.0331

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE09.04.00.0340

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE09.04.00.0341

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE09.04.00.0350

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE09.04.00.0355

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.

 

SE09.04.00.0360

Product type

[Product type]
  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. C111

Picklist Values:

EU BPD Product type 1: Human hygiene biocidal products || EU BPD Product type 2: Private area and health area disinfectants || EU BPD Product type 3: Veterinary hygiene biocidal products || EU BPD Product type 4: Food and feed area disinfectants || EU BPD Product type 5: Drinking water disinfectants || EU BPD Product type 6: In-can preservatives || EU BPD Product type 7: Film preservatives || EU BPD Product type 8: Wood preservatives || EU BPD Product type 9: Preservatives for fibres, leather, rubber and polymerised material || EU BPD Product type 10: Masonry preservatives || EU BPD Product type 11: Preservatives for liquid-cooling and processing systems || EU BPD Product type 12: Slimicides || EU BPD Product type 13: Metalworking fluid preservatives || EU BPD Product type 14: Rodenticides || EU BPD Product type 15: Avicides || EU BPD Product type 16: Molluscicides || EU BPD Product type 17: Piscicides || EU BPD Product type 18: Insecticides, acaricides and products to control other arthropods || EU BPD Product type 19: Repellents and attractants || EU BPD Product type 20: Preservatives for food and feedstock || EU BPD Product type 21: Antifouling products || EU BPD Product type 22: Embalming and taxidermist fluids || EU BPD Product type 23: Products for the control of other vertebrates || other:

Indicate the product type addressed by the information entered in this record. Leave field empty if not applicable.

Indicator specifying the product type(s) addressed by the information entered in this study summary.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_ACCEPTABLE>

<i5:PRODUCT_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL>

<i5:LIST_SEL>

SE09.04.00.0361

Product type

[no label]
  1. OTHERTEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]
  

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_ACCEPTABLE>

<i5:PRODUCT_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL>

<i5:LIST_SEL_TXT>

SE09.04.00.0369

Test guideline

[Test guideline]
  1. HEAD BLOCK
  2. Block label
  3. g674
  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'

 

SE09.04.00.0370

Qualifier

[Qualifier]
  1. LIST-CLOSED
  2. STRING/255
  3. g674
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE09.04.00.0380

Guideline

[Guideline]
  1. LIST-OPEN-SUP
  2. STRING/255
  3. g674
  4. 1
  5. 1
  6. Z45

Picklist Values:

other guideline:

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

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

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

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

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

The name of the guideline followed in performing the study or to which the method used can be compared. Also indication if no guideline was used, availaible 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_FOOD_RESIDUES_ACCEPTABLE>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE09.04.00.0381

Guideline

[no label]
  1. SUP-TEXT
  2. STRING/255
  3. g674
  4. 1
  5. 1
  6. [N/A]
  

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_ACCEPTABLE>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE09.04.00.0390

Deviations from guideline

[Deviations]
  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g674
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE09.04.00.0391

Deviations from guideline

[no label]
  1. SUP-TEXT
  2. STRING/255
  3. g674
  4. 1
  5. 1
  6. [N/A]
  

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_ACCEPTABLE>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE09.04.00.0400

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE09.04.00.0410

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE09.04.00.0411

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE09.04.00.0415

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'

 

SE09.04.00.0420

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE09.04.00.0429

Test material identity

[Test material identity]
  1. HEAD BLOCK
  2. Block label
  3. g675
  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'

 

SE09.04.00.0430

Identifier

[Identifier]
  1. LIST-OPEN
  2. STRING/255
  3. g675
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE09.04.00.0431

Identifier

[no label]
  1. OTHERTEXT
  2. STRING/255
  3. g675
  4. 1
  5. 1
  6. [N/A]
  

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_ACCEPTABLE>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE09.04.00.0440

Identity

[Identity]
  1. TEXT
  2. STRING/2000
  3. g675
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE09.04.00.0450

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE09.04.00.0460

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE09.04.00.0465

Study design

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

Subheading of section 'Study design'

 

SE09.04.00.0470

Details on study design

[Further details on study design]
  1. TEXTAREA
  2. STRING/32768
  3. [N/A]
  4. 1
  5. 2
  6. [N/A]
 

Describe the study design, i.e. methodology used to estimate the potential of exposure or determine actual exposure of the active substance to humans or animals through food and feedingstuffs and other means.

If proposed acceptable residues are recorded, describe the relevant input parameters and how these values were derived.

Consult any the programme-specific guidance (e.g. EU BPD TNsG).

Details on study design.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_ACCEPTABLE>

<i5:STUDY_DESIGN_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE09.04.00.0480

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE09.04.00.0485

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.

 

SE09.04.00.0490

Details on results

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

Briefly summarise all relevant results, i.e. estimated potential or actual exposure of the active substance to humans or animals through food and feedingstuffs and other means, and/or proposed acceptable residues, including the justification of their acceptability.

As appropriate include table(s) with raw data in the rich text field 'Any other information on results incl. tables'.

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. EU BPD TNsG).

Details on results

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_ACCEPTABLE>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE09.04.00.0500

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE09.04.00.0505

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.

 

SE09.04.00.0510

Overall remarks

[Overall remarks]
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE09.04.00.0519

Attached background material

[Attached background material]
  1. HEAD BLOCK
  2. Block label
  3. g676
  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'.

 

SE09.04.00.0520

Attached document

[Attached document]
  1. ATTACHMENT
  2. STRING/32768
  3. g676
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE09.04.00.0530

Remarks

[Remarks]
  1. TEXT
  2. STRING/255
  3. g676
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE09.04.00.0539

Attached full study report

[Attached full study report]
  1. HEAD BLOCK
  2. Block label
  3. g677
  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

 

SE09.04.00.0540

Attached full study report

[Attached full study report]
  1. ATTACHMENT
  2. STRING/32768
  3. g677
  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_FOOD_RESIDUES_ACCEPTABLE>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE09.04.00.0542

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE09.04.00.0545

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.

 

SE09.04.00.0550

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE09.04.00.0560

Executive summary

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

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

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_ACCEPTABLE>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE09.04.00.0570

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_FOOD_RESIDUES_ACCEPTABLE>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>