REMARKS:

SE09.02.01.0215

Data source

SE09.02.01.0220

Background information

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'.

Description of any relevant background information, if required according to specific guidance of the relevant legislation, or any relevant introductory remarks on the study summary.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE09.02.01.0229

Reference

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.

SE09.02.01.0230

Reference type

Picklist Values:

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 Select 'Other company data' to characterise any unpublished information from a company other than a study report. Select 'Grey literature' for any other unpublished information or 'other:' and specify.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'.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE09.02.01.0231

Reference type

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE09.02.01.0240

Author(s) (or transferred reference)

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE09.02.01.0250

Year

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE09.02.01.0260

Title

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_LIVESTOCK>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE09.02.01.0270

Bibliographic source

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE09.02.01.0280

Testing laboratory

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 .

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE09.02.01.0290

Report no.

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE09.02.01.0300

Owner company

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_LIVESTOCK>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE09.02.01.0310

Company study no.

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE09.02.01.0320

Report date

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE09.02.01.0330

Data access

Picklist Values:

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE09.02.01.0331

Data access

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE09.02.01.0340

Data protection claimed

Picklist Values:

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')

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE09.02.01.0341

Data protection claimed

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE09.02.01.0350

Cross-reference to same study

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE09.02.01.0355

Materials and methods

SE09.02.01.0360

Product type

Picklist Values:

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

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:PRODUCT_TYPE>

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<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE09.02.01.0361

Product type

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:PRODUCT_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE09.02.01.0370

Type of study

Picklist Values:

Indicate the type of study in terms of exposure source. Select either 'livestock feeding', 'direct animal treatment', 'livestock feeding and direct animal treatment', 'animal premise treatment' or 'other:' (specify). In the supplementary remarks field, you can add explanations as appropriate.

Indicator specifying the type of study in terms of exposure source.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:STUDYTYPE>

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<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE09.02.01.0371

Type of study

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:STUDYTYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE09.02.01.0379

Test guideline

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) or for indicating e.g. 'no guideline available/required' and 'equivalent or similar to' a specific test guideline.

Heading of field block 'Guideline'

SE09.02.01.0380

Qualifier

Picklist Values:

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/required' (if applicable; 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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE09.02.01.0390

Guideline

Picklist Values:

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.

An indicator signifying how strict the guideline given in the subsequent field 'Guideline' was followed or whether no guideline was used or available/required.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE09.02.01.0391

Guideline

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE09.02.01.0400

Draft / update

Picklist Values:

If available, indicate the year the guideline was published / drafted or updated and if necessary, update number. Provide any (sub)title if different from the title given in subfield 'Guideline'. For instance, different titles and/or numbers may exist for a given EU test guideline.

An indication of the update (year / title) to a given guideline if applicable. Intention of this field is to avoid frequent update of the picklist for the field 'Guideline'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:GUIDELINE>

<i5:set>

<i5:DRAFT>

<i5:DRAFT>

SE09.02.01.0410

Deviations from guideline

Picklist Values:

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE09.02.01.0411

Deviations from guideline

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<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE09.02.01.0420

Principles of method if other than guideline

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE09.02.01.0430

GLP compliance

Picklist Values:

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_LIVESTOCK>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE09.02.01.0431

GLP compliance

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<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE09.02.01.0435

Test materials

SE09.02.01.0440

Test material equivalent to submission substance identity

Picklist Values:

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE09.02.01.0449

Test material identity

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'

SE09.02.01.0450

Identifier

Picklist Values:

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:TESTMAT>

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<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE09.02.01.0451

Identifier

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE09.02.01.0460

Identity

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.

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<i5:scientificPart>

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<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE09.02.01.0470

Details on test material

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.

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<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE09.02.01.0480

Confidential details on test material

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.

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<i5:scientificPart>

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<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE09.02.01.0490

Details on properties of test surrogate or analogue material

Freetext Templates:

PHYSICO-CHEMICAL PROPERTIES

- Melting point/range:

- pH:

- Density:

- Water solubility (at ... °C):

- Solvent solubility (mg/L at ... °C):

- Vapour pressure (at ... °C):

- Dissociation constant (pKa):

- Octanol/water partition coefficient log Kow:

- UV/visible absorption spectrum:

OTHER PROPERTIES (if relevant)

-

ONLY if the study summary is a read-across to another substance, i.e. analogue or surrogate (e.g. degradation / transformation product), enter any relevant details on the physico-chemical or other relevant properties. Use freetext template and delete/add elements as appropriate.

Note that the physico-chemical properties of the substance for which the submission is made should be recorded in the corresponding chapters (templates) and therefore need not be repeated here. Nevertheless, the possible influence of any physico-chemical properties should be indicated / discussed in appropriate fields, particularly in fields 'Details on test conditions' and 'Details on results'. This holds also true if any property of the substance is different in the test medium as compared to the data recorded in the section on physico-chemical properties, e.g. lower water solubility.

Details on properties of test material, particuarly physico-chemical properties. Relevant if an analogue or surrogate was used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:PROPERTIES_TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE09.02.01.0495

Test animals

Subheading of section 'Test animals'

SE09.02.01.0499

Species

Select name of species. If not available from picklist, select 'other' and specify. You may copy this field for indicating additional species, if the studies are summarised in one record. However, it may be sensible or required according to legislation-specific guidance to use separate records for each animal species studied. You can include a cross-reference, in field 'Same study also described in chapter:', to the record where the methodology is described in detail.

Organism/cell culture used in the experiment.

SE09.02.01.0500

Species

Picklist Values:

Select name of species. If not available from picklist, select 'other' and specify. You may copy this field for indicating additional species, if the studies are summarised in one record. However, it may be sensible or required according to legislation-specific guidance to use separate records for each animal species studied. You can include a cross-reference, in field 'Same study also described in chapter:', to the record where the methodology is described in detail.

Organism/cell culture used in the experiment.

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<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE09.02.01.0501

Species

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:ORGANISM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE09.02.01.0510

Details on housing conditions and test animals

Freetext Templates:

TEST ANIMALS

- Breed:

- Age at study initiation:

- Weight at study initiation (kg):

- Stage of development:

- Health status:

- Condition of animals:

- Mode of identification:

HOUSING / HOLDING AREA

- Size of enclosures:

- Individual vs. group housing:

- Food and water containers:

- Temperature:

- Lighting:

- Waste handling:

Include details on housing conditions and test animals. Use freetext template and delete/add elements as appropriate, or upload predefined table(s), if any, in rich text field 'Any other information on materials and methods incl. tables' or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. '... see Table 1').

The following information should be addressed:

HOUSING / HOLDING AREA: Describe the test facilities, i.e. animal housing including size of enclosures, individual vs. group housing, food and water containers, temperature, lighting, and waste handling.

TEST ANIMALS: Include information on breed, age, weight, stage of development, health status and condition of test animals.

Details on housing conditions and test animals

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:ORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE09.02.01.0520

Details on dietary regime

Freetext Templates:

- Composition of diet:

- Feed consumption:

- Water:

- Acclimation period:

Include details on dietary regime. Use freetext template and delete/add elements as appropriate, upload predefined table(s), if any, in rich text field 'Any other information on materials and methods incl. tables' or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. '... see Table 1').

The following information should be addressed:

- Composition of diet: Describe the diet of animals during acclimation and the dosing period regarding: (1) Types of feed (e.g., corn grain, layers mash, alfalfa pellets) and liquids; (2) Quantities provided (i.e., specific amounts or ad libitum).

- Feed consumption: Report the feed consumption (dry weight for ruminants) on an individual or treatment group basis throughout the study.

- Water: Report water consumption

- Acclimation period: specify

Details on dietary regime.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:DIET_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE09.02.01.0525

Administration / exposure

Subheading of section 'Administration / exposure'.

SE09.02.01.0529

Treatment type (route of exposure)

Select the treatment type used which determines the primary route of exposure in the study. If not available from picklist, select 'other' and specify. If, in specific situations, direct application of a product to livestock was studied in addition to exposure through feeding of treated crops, copy this field and indicate both treatment types.

Indicator showing which route of exposure is used in the study.

SE09.02.01.0530

Treatment type (route of exposure)

Picklist Values:

Select the treatment type used which determines the primary route of exposure in the study. If not available from picklist, select 'other' and specify. If, in specific situations, direct application of a product to livestock was studied in addition to exposure through feeding of treated crops, copy this field and indicate both treatment types.

Indicator showing which route of exposure is used in the study.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:ROUTE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE09.02.01.0531

Treatment type (route of exposure)

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:ROUTE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE09.02.01.0540

Duration and frequency of dosing

Indicate the total length of the dosing period (e.g. 20 days) including withdrawal periods where applicable, and the frequency of application / dosing if the test material is not incorporated into the total diet or feed.

Note: Reporting of the dates of the initial and final doses/applications may also be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Exposure duration and frequency of dosing.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:EXP_PERIOD_FREQU>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE09.02.01.0550

Doses / concentrations

Depending on the route of exposure, indicate the dose rates or application rates as mg/kg diet, mg/animal/day, mg/kg bw/day or other.

If diet is the route of administration, report the level of the test material in the total diet in parts per million (mg/kg feed) (dry weight basis for ruminants).

If direct treatment, indicate the nominal concentration and maximum concentration of treatment (mg/kg bw or mg/kg bw/day). If animal premises treatment, indicate the concentration of test material per area or other. If inhalation exposure, indicate nominal and, if measured, analytical concentrations of test material in air.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:DOSES>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE09.02.01.0560

Details on dosing

Freetext Templates:

PREPARATION OF DOSE

- Method of preparation:

- Date of dose preparation and storage conditions prior to its administration:

RATIONALE FOR SELECTION OF DOSE LEVELS

- Level of intake expected:

- Exaggerated levels:

ANALYSIS OF SPIKED FEED

- Method used to analyse spiked feeds:

- Results of such analyses:

DOSING REGIME: see Table [#?]

Include further details on the preparation of dose and the dosing regime. If diet is the route of administration, use freetext template (delete/add elements as appropriate) or formulate otherwise or upload predefined table(s), if any, in rich text field 'Any other information on materials and methods incl. tables' or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. '... see Table 1').

The following information should be addressed:

PREPARATION OF DOSE:

Describe the method of preparation of the dose (mixing with feed or concentrate ration, gelatin capsule, bolus, etc.). Indicate the date of dose preparation and storage conditions prior to its administration.

RATIONALE FOR SELECTION OF DOSE LEVELS: Briefly describe, i.e. Level of intake expected, Exaggerated levels. Provide justification for other than the recommended dosing scheme.

ANALYSIS OF SPIKED FEED: Describe the method used to analyse spiked feeds and the results of such analyses. If the methodology is described in chapter 'Analytical methods', you can include a cross-reference to that record in field 'Cross-reference to other study'.

DOSING REGIME: Using an appropriate predefined table indicate the dosing regime used.

Note: Specific tables may be required. Consult the programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) thereof.

Details on dosing.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:DOSING_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE09.02.01.0570

No. of animals per dose group

Report the number of animals per dose group, e.g. per feeding level.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:NUMBER_ANIMALS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE09.02.01.0579

Control animals

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.

SE09.02.01.0580

Control animals

Picklist Values:

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_FOOD_RESIDUES_LIVESTOCK>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE09.02.01.0581

Control animals

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:CONTROL_GROUP>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE09.02.01.0590

Further details on study design

Include any further relevant details on the study design.

Further details on study design.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:STUDY_DESIGN_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE09.02.01.0600

Details on sampling and analytical method

Freetext Templates:

IN-LIFE SAMPLING

- Milk / eggs collected:

- Amount of milk and number of eggs produced during normal production:

- Urine, faeces, cage wash collected:

POST-SLAUGTHER SAMPLING

- Mode of sacrifice:

- Interval from last dose or treatment to sacrifice:

- Tissue harvested and their weights:

- Specification of and combining of samples from different animals:

SAMPLE HANDLING AND PREPARATION

- Sample preparation prior to storage:

- Containers:

- Storage temperature:

- Length of storage:

- Mode of shipping, if applicable:

ANALYTICAL METHODOLOGY

- Detailed description of method for each chemical species measured:

- Experimental design of validation studies:

- Analytical responses of standards: Copies of calibration curves attached

- Sample calculations of residue levels and percent recoveries: Copies attached

Include details on the sampling, handling and preparation of samples and the analytical methodology applied. Use freetext template and delete/add elements as appropriate, or upload predefined table(s), if any, in rich text field 'Any other information on materials and methods incl. tables' or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. '... see Table 1').

The following information should be addressed:

IN-LIFE SAMPLING

- Milk / eggs collected: Explain the collection of milk and eggs with any deviations from normal practice explained. Note compositing or pooling of samples; no pooling of milk from animals within a dosage group.

- Amount of milk and number of eggs produced during normal production: Provide data as indicated.

- Urine, faeces, cage wash collected: For feed-through pesticides, include data on urine, feces and cage wash.

POST-SLAUGTHER SAMPLING

- Mode of sacrifice: Describe

- Interval from last dose or treatment to sacrifice: Describe the time interval in hours or days between time of sacrifice and administration of last dose or application of final treatment. Give an explanation of intervals longer than 24 hours and consideration of their effect on residues.

- Tissue harvested and their weights: Indicate the tissues taken after sacrifice, their type (e.g., thigh muscle, omental fat, etc.), and their weights.

- Specification of and combining of samples from different animals: Indicate if pooling was done (usually acceptable for poultry, but not ruminants).

SAMPLE HANDLING AND PREPARATION: Describe the handling of tissues, eggs and milk between sample collection and storage addressing at least following items:

- Sample preparation prior to storage: e.g., chopping

- Containers

- Storage temperature

- Length of storage: Include dates of collection, shipping, analysis, etc.

- Mode of shipping, if applicable:

ANALYTICAL METHODOLOGY

- Description of instrumentation, equipment and reagents used for determining total radioactivity in each sample: Give a detailed description of the analytical method employed to measure residues and listing of which chemical species were measured (parent pesticide, metabolites). If the methodology is described in chapter 'Analytical methods', you can include a cross-reference to that record in field 'Cross-reference to other study'.

- Extraction schemes: state 'see graphic attached' if a figure is attached in field 'Attached background material'.

- Description of extraction and fractionation of radioactivity in each matrix

- Chromatographic and spectroscopic behaviour of radioactive residues in extracts of animal matrices, parent, metabolites, and reference standards

RADIOCHEMICAL EXTRACTION EFFICIENCY

- Quantitative information on the recovery of the radioactive residue: Report quantitative information on the recovery of the radioactive residue via the extraction methods used, especially as related to (probable) enforcement analytical methods if reported in this report. As appropriate, upload predefined table(s), if any, in rich text field 'Any other information on results incl. tables' or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the 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.

Details on sampling and analytical method.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:ANALYT_METHOD_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE09.02.01.0610

Any other information on materials and methods incl. tables

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_LIVESTOCK>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE09.02.01.0615

Results and discussion

SE09.02.01.0620

Storage stability

Provide storage stability data showing the behavior of residues as a function of time in tissues, milk, and eggs. Where samples were not analysed within 30 days, provide evidence showing that the storage did not affect the results of the study.

As appropriate, upload predefined table(s), if any, in rich text field 'Any other information on results incl. tables' or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the 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.

Storage stability data showing the behavior of residues as a function of time in tissues, milk, and eggs.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:STABILITY_RESULTS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE09.02.01.0630

Distribution of residues

Report quantitative information on the recovery of the radioactive residue from the animal tissues, milk, and eggs via the extraction methods used, especially as related to (probable) enforcement analytical methods.

As appropriate, upload predefined table(s), if any, in rich text field 'Any other information on results incl. tables' or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the 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.

Quantitative information on the recovery of the radioactive residue from the animal tissues, milk, and eggs via the extraction methods used, especially as related to (probable) enforcement analytical methods.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:RESIDUES_RS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE09.02.01.0640

Recoveries

Provide recovery percentages (all values, not just averages or ranges) for the test substance and/or its metabolites for tissues, milk, and eggs fortified with these compounds.

As appropriate, upload predefined table(s), if any, in rich text field 'Any other information on results incl. tables' or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the 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.

Recovery percentages for the test substance and/or its metabolites for tissues, milk, and eggs fortified with these compounds.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:RECOVERIES_RS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE09.02.01.0650

Any other information on results incl. tables

In this field, you can enter any other information on results, 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_LIVESTOCK>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE09.02.01.0655

OVERALL REMARKS, ATTACHMENTS

Main heading under which 'Overall remarks, attachments' fields are subsumed.

SE09.02.01.0660

Overall remarks

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_LIVESTOCK>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE09.02.01.0669

Attached background material

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'.

SE09.02.01.0670

Attached document

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_LIVESTOCK>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE09.02.01.0680

Remarks

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_LIVESTOCK>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE09.02.01.0689

Attached full study report

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

SE09.02.01.0690

Attached full study report

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_LIVESTOCK>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE09.02.01.0700

Illustration (picture/graph)

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_LIVESTOCK>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE09.02.01.0705

Applicant's summary and conclusion

SE09.02.01.0710

Conclusions

Enter any conclusions if applicable.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE09.02.01.0720

Executive summary

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE09.02.01.0730

Cross-reference to other study

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_FOOD_RESIDUES_LIVESTOCK>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>