OECD Template #87: Analytical methods (Version 2-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.

 

 

 

SE08.00.00.0215

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.

 

SE08.00.00.0220

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 analytical methods for determining a given substance in various matrices. Depending on the requirements of the relevant legislation, methods for the following matrices may have to be recorded: soil, sediment, suspended particulates, air, water (including drinking water), animal and human body fluids and tissues, plants, plant products, food and feedingstuffs, formulated product, other.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:BACKGROUND_INFORMATION>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE08.00.00.0229

Reference

[Reference]

  1. HEAD BLOCK
  2. Block label
  3. g625
  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'

 

SE08.00.00.0230

Reference type

[Reference type]

  1. LIST-OPEN
  2. STRING/255
  3. g625
  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:DI_ANALYTICAL_METHOD>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE08.00.00.0231

Reference type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g625
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE08.00.00.0240

Author(s) (or transferred reference)

[Author]

  1. TEXT
  2. STRING/2000
  3. g625
  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:DI_ANALYTICAL_METHOD>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE08.00.00.0250

Year

[Year]

  1. YEAR
  2. NUMBER/4/###0
  3. g625
  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:DI_ANALYTICAL_METHOD>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE08.00.00.0260

Title

[Title]

  1. TEXT
  2. STRING/255
  3. g625
  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:DI_ANALYTICAL_METHOD>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE08.00.00.0270

Bibliographic source

[Bibliographic source]

  1. TEXT
  2. STRING/255
  3. g625
  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:DI_ANALYTICAL_METHOD>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE08.00.00.0280

Testing laboratory

[Testing laboratory]

  1. TEXT
  2. STRING/255
  3. g625
  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:DI_ANALYTICAL_METHOD>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE08.00.00.0290

Report no.

[Report no.]

  1. TEXT
  2. STRING/255
  3. g625
  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:DI_ANALYTICAL_METHOD>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE08.00.00.0300

Owner company

[Owner company]

  1. TEXT
  2. STRING/255
  3. g625
  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:DI_ANALYTICAL_METHOD>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE08.00.00.0310

Company study no.

[Company study no.]

  1. TEXT
  2. STRING/255
  3. g625
  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:DI_ANALYTICAL_METHOD>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE08.00.00.0320

Report date

[Report date]

  1. DATE
  2. DATE/255
  3. g625
  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:DI_ANALYTICAL_METHOD>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE08.00.00.0330

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:DI_ANALYTICAL_METHOD>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE08.00.00.0331

Data access

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE08.00.00.0340

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:DI_ANALYTICAL_METHOD>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE08.00.00.0341

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:DI_ANALYTICAL_METHOD>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE08.00.00.0350

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:DI_ANALYTICAL_METHOD>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE08.00.00.0355

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.

 

SE08.00.00.0359

Matrix / medium

[Matrix / medium]

  1. HEAD BLOCK
  2. Block label
  3. g626
  4. 10
  5. 1
  6. [N/A]

 

Indicate the medium for which the analytical method is described. In the supplementary remarks field, you can add explanations as appropriate.

Note: The picklist is not descriptive as to whether analytical methods have to be submitted for each of the matrices provided in the picklist. Consult with the programme-specific guidance (e.g. EU BPD, OECD HPVC, Pesticides NAFTA or EU REACH) as to what matrices need to be addressed. If the methods for several matrices can be summarised in one record, you can copy this field for indicating the respective matrices.

Indicator specifying the medium for which the analytical method is described.

 

SE08.00.00.0360

Matrix / medium

[Matrix / medium]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g626
  4. 1
  5. 1
  6. C54

Picklist Values:

soil || air || animal and human body fluids and tissues || plants, plant products, food and feedingstuffs || formulated product || suspended particulates || sediment || water || other:

Indicate the medium for which the analytical method is described. In the supplementary remarks field, you can add explanations as appropriate.

Note: The picklist is not descriptive as to whether analytical methods have to be submitted for each of the matrices provided in the picklist. Consult with the programme-specific guidance (e.g. EU BPD, OECD HPVC, Pesticides NAFTA or EU REACH) as to what matrices need to be addressed. If the methods for several matrices can be summarised in one record, you can copy this field for indicating the respective matrices.

Indicator specifying the medium for which the analytical method is described.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:MEDIUM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE08.00.00.0361

Matrix / medium

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g626
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:MEDIUM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE08.00.00.0369

Test guideline

[Test guideline]

  1. HEAD BLOCK
  2. Block label
  3. g627
  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'

 

SE08.00.00.0370

Qualifier

[Qualifier]

  1. LIST-CLOSED
  2. STRING/255
  3. g627
  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:DI_ANALYTICAL_METHOD>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE08.00.00.0380

Guideline

[Guideline]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g627
  4. 1
  5. 1
  6. C102

Picklist Values:

ASTM Method, other: || EPA Method 502.2 || EPA Method 504.1 || EPA Method 505 || EPA Method 506 || EPA Method 507 || EPA Method 508 || EPA Method 508.1 || EPA Method 508A || EPA Method 515.1 || EPA Method 515.2 || EPA Method 524.2 || EPA Method 525.1 || EPA Method 525.2 || EPA Method 531.1 || EPA Method 547 || EPA Method 548 || EPA Method 548.1 || EPA Method 549.1 || EPA Method 550 || EPA Method 550.1 || EPA Method 551 || EPA Method 551.1 || EPA Method 552 || EPA Method 552.1 || EPA Method 552.2 || EPA Method 553 || EPA Method 554 || EPA Method 555 || EPA Method 601 || EPA Method 602 || EPA Method 603 || EPA Method 604 || EPA Method 605 || EPA Method 606 || EPA Method 607 || EPA Method 608 || EPA Method 609 || EPA Method 610 || EPA Method 611 || EPA Method 612 || EPA Method 613 || EPA Method 624 || EPA Method 625 || EPA Method 1311 || EPA Method 1312 || EPA Method 1614 || EPA Method 8000B || EPA Method 8011 || EPA Method 8015B || EPA Method 8021B || EPA Method 8031 || EPA Method 8032A || EPA Method 8033 || EPA Method 8041 || EPA Method 8061A || EPA Method 8070A || EPA Method 8081A || EPA Method 8082 || EPA Method 8091 || EPA Method 8100 || EPA Method 8111 || EPA Method 8121 || EPA Method 8131 || EPA Method 8141A || EPA Method 8151A || EPA Method 8260B || EPA Method 8270C || EPA Method 8275A || EPA Method 8280A || EPA Method 8290 || EPA Method 8310 || EPA Method 8315A || EPA Method 8316 || EPA Method 8318 || EPA Method 8321A || EPA Method 8325 || EPA Method 8330 || EPA Method 8331 || EPA Method 8332 || EPA Method 8410 || EPA Method 8430 || EPA Method 8440 || EPA Method, other: || other guideline:

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

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

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

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

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

The name of the guideline followed in performing the study or to which the method used can be compared. Also indication if no guideline was used, available or required. In supplementary remarks field indication of guideline version, or title if deviating from the picklist value, or of additional test guidelines cited.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE08.00.00.0381

Guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g627
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE08.00.00.0390

Deviations from guideline

[Deviations]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g627
  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:DI_ANALYTICAL_METHOD>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE08.00.00.0391

Deviations from guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g627
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE08.00.00.0400

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:DI_ANALYTICAL_METHOD>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE08.00.00.0410

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:DI_ANALYTICAL_METHOD>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE08.00.00.0411

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:DI_ANALYTICAL_METHOD>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE08.00.00.0415

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'

 

SE08.00.00.0420

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:DI_ANALYTICAL_METHOD>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE08.00.00.0429

Test material identity

[Test material identity]

  1. HEAD BLOCK
  2. Block label
  3. g628
  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'

 

SE08.00.00.0430

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g628
  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:DI_ANALYTICAL_METHOD>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE08.00.00.0431

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g628
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE08.00.00.0440

Identity

[Identity]

  1. TEXT
  2. STRING/2000
  3. g628
  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:DI_ANALYTICAL_METHOD>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE08.00.00.0445

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:DI_ANALYTICAL_METHOD>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE08.00.00.0446

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:DI_ANALYTICAL_METHOD>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE08.00.00.0450

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:DI_ANALYTICAL_METHOD>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE08.00.00.0460

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:DI_ANALYTICAL_METHOD>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE08.00.00.0470

Details on properties of test surrogate or analogue material

[Details on properties of test surrogate or analogue material]

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

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, particularly physico-chemical properties. Relevant if an analogue or surrogate was used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:PROPERTIES_TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE08.00.00.0475

Principles of analytical methods

[Principles of analytical methods]

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

 

 

Subheading of section 'Principles of analytical methods'.

 

SE08.00.00.0479

Instrument / detector for data collection

[Instrument / detector]

  1. HEAD BLOCK
  2. Block label
  3. g629
  4. 10
  5. 1
  6. [N/A]

 

Indicate the instrument / detector used for the quantitative analysis of the parent compound / transformation products including the type of detector, e.g. 'HPLC-UV'. Copy this field if more than one method needs to be specified. Give any further details in field 'Details on analytical data collection method'.

Note: If a residue analytical method is recorded, the instrument/detector used for the so-called data collection or data-gathering method should be specified here. Data collection method is the analytical method used to collect quantitative residue data by analysing the analyte(s) in the matrices. This method can be identical with or differ from the so-called enforcement method which has to be recorded under the heading 'Enforcement method (if applicable)'. Enforcement method is a validated analytical method which can be applied by the regulatory agency for enforcing the proposed tolerance, i.e. maximum residue limits (MRL) for pesticides.

Indicator specifying which instrument / detector was used for data collection, e.g. 'HPLC-MS-MS'.

 

SE08.00.00.0480

Instrument / detector for data collection

[Instrument / detector]

  1. LIST-OPEN
  2. STRING/255
  3. g629
  4. 1
  5. 1
  6. C104

Picklist Values:

GC-FID || ICP-MS || GC-MS || HPLC-DAD || HPLC-MS-MS || HPLC-UV || IR || LSC || NMR || GC-AFID || GC-ECD || GC-MS-MS || GC-PND || HPLC-MS || LC-MS || LC-MS-MS || AAS || other:

Indicate the instrument / detector used for the quantitative analysis of the parent compound / transformation products including the type of detector, e.g. 'HPLC-UV'. Copy this field if more than one method needs to be specified. Give any further details in field 'Details on analytical data collection method'.

Note: If a residue analytical method is recorded, the instrument/detector used for the so-called data collection or data-gathering method should be specified here. Data collection method is the analytical method used to collect quantitative residue data by analysing the analyte(s) in the matrices. This method can be identical with or differ from the so-called enforcement method which has to be recorded under the heading 'Enforcement method (if applicable)'. Enforcement method is a validated analytical method which can be applied by the regulatory agency for enforcing the proposed tolerance, i.e. maximum residue limits (MRL) for pesticides.

Indicator specifying which instrument / detector was used for data collection, e.g. 'HPLC-MS-MS'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:DATACOLLECT_DETECTOR>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL>

<i5:LIST_SEL>

SE08.00.00.0481

Instrument / detector

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g629
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:DATACOLLECT_DETECTOR>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL>

<i5:LIST_SEL_TXT>

SE08.00.00.0490

Details on analytical method

[Details on analytical method]

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

Freetext Templates:

COMPOUND (ANALYTE): ...

- Method ID:

- Extraction solvent/technique:

- Cleanup strategies:

- Derivatisation (if any):

- Instrument/detector (if further details):

- Standardisation method:

- Stability of standard solution:

- Retention times:

- Other

CHROMATOGRAMS: see Fig. attached

INTERFERING SUBSTANCE(S):

STABILITY OF PARENT AND TRANSFORMATION PRODUCTS AT VARIOUS STAGES OF ANALYSIS:

PROBLEMS / PRECAUTIONS

- Special problems encountered:

- Precautions to be taken during

- analysis of samples:

- handling of samples:

- storage of samples:

TOTAL TIME FOR COMPLETION:

Briefly describe further details on the principles of the method used to detect the analytes (to be specified, e.g. 'parent compound', 'parent and transformation products' or 'transformation product: .....') in matrices. Use freetext template and delete/add elements as appropriate. For example, add specific parameters in the case of inorganic chemicals. As an option you may include an excerpt from the study report.

Note: If a residue analytical method is recorded, the details for the so-called data collection or data-gathering method should be specified here. As to the terms 'data collection method' and 'enforcement method' see help text for field 'Instrument / detector'.

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 analytical method

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:DATACOLLECT_METHOD_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE08.00.00.0495

Enforcement method

[Enforcement method (if applicable)]

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

 

 

Subheading of section 'Enforcement method'.

 

SE08.00.00.0499

Instrument / detector for enforcement

[Instrument / detector for enforcement method]

  1. HEAD BLOCK
  2. Block label
  3. g630
  4. 10
  5. 1
  6. [N/A]

 

If no enforcement method is proposed or required, ignore this field. An enforcement method is a validated analytical method which can be applied by the regulatory agency for enforcing the proposed tolerance, i.e. maximum residue limits (MRL) for pesticides. If such a method is proposed indicate the instrument / detector used in the enforcement method.

Copy this field if more than one method needs to be specified.

Give any further details in field 'Details on data enforcement method'.

Indicator specifying which instrument / detector was used for enforcement, e.g. 'HPLC-MS-MS'.

 

SE08.00.00.0500

Instrument / detector for enforcement

[Instrument / detector for enforcement method]

  1. LIST-OPEN
  2. STRING/255
  3. g630
  4. 1
  5. 1
  6. C104

Picklist Values:

GC-FID || ICP-MS || GC-MS || HPLC-DAD || HPLC-MS-MS || HPLC-UV || IR || LSC || NMR || GC-AFID || GC-ECD || GC-MS-MS || GC-PND || HPLC-MS || LC-MS || LC-MS-MS || AAS || other:

If no enforcement method is proposed or required, ignore this field. An enforcement method is a validated analytical method which can be applied by the regulatory agency for enforcing the proposed tolerance, i.e. maximum residue limits (MRL) for pesticides. If such a method is proposed indicate the instrument / detector used in the enforcement method.

Copy this field if more than one method needs to be specified.

Give any further details in field 'Details on data enforcement method'.

Indicator specifying which instrument / detector was used for enforcement, e.g. 'HPLC-MS-MS'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:ENFORCEMENT_DETECTOR>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL>

<i5:LIST_SEL>

SE08.00.00.0501

Instrument / detector for enforcement method

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g630
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:ENFORCEMENT_DETECTOR>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL>

<i5:LIST_SEL_TXT>

SE08.00.00.0510

Details on enforcement method

[Details on enforcement method]

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

Freetext Templates:

COMPOUND (ANALYTE): ...

- Method ID:

- Extraction solvent/technique:

- Cleanup strategies:

- Derivatisation (if any):

- Instrument/detector (if further details):

- Standardisation method:

- Stability of standard solution:

- Retention times:

- Other:

CHROMATOGRAMS: see Fig. attached

INTERFERING SUBSTANCE(S):

STABILITY OF PARENT AND TRANSFORMATION PRODUCTS AT VARIOUS STAGES OF ANALYSIS:

PROBLEMS / PRECAUTIONS

- Special problems encountered:

- Precautions to be taken during

- analysis of samples:

- handling of samples:

- storage of samples:

TOTAL TIME FOR COMPLETION:

'Briefly describe further details on the principles of the method used to detect the analytes (to be specified, e.g. ''parent compound'', ''parent and transformation products'' or ''transformation product: .....'') in matrices. Use freetext template and delete/add elements as appropriate. For example, add specific parameters in the case of inorganic chemicals. As an option you may include an excerpt from the study report.

Note: If a residue analytical method is recorded, the details for the so-called data collection or data-gathering method should be specified here. As to the terms ''data collection method'' and ''enforcement method'' see help text for field ''Instrument / detector''.

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 enforcement method

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:ENFORCEMENT_METHOD_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE08.00.00.0515

Confirmatory method (if applicable)

[Confirmatory method (if applicable)]

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

 

 

Subheading of section 'Confirmatory method'.

 

SE08.00.00.0519

Instrument / detector for confirmatory method

[Instrument / detector for confirmatory method]

  1. HEAD BLOCK
  2. Block label
  3. g631
  4. 10
  5. 1
  6. [N/A]

 

'If not applicable, ignore this field. If a confirmatory method was used (i.e. applying techniques to demonstrate specificity in case the original method is not highly specific), indicate the instrument / detector used. Note: Not all picklist items may be relevant for a confirmatory technique.

Copy this field if more than one method needs to be specified.

Give any further details in field ''Details on data confirmatory method''.'

Indicator specifying which instrument / detector was used in the confirmatory method, e.g. 'HPLC-MS-MS'.

 

SE08.00.00.0520

Instrument / detector for confirmatory method

[Instrument / detector for confirmatory method]

  1. LIST-OPEN
  2. STRING/255
  3. g631
  4. 1
  5. 1
  6. C104

Picklist Values:

GC-FID || ICP-MS || GC-MS || HPLC-DAD || HPLC-MS-MS || HPLC-UV || IR || LSC || NMR || GC-AFID || GC-ECD || GC-MS-MS || GC-PND || HPLC-MS || LC-MS || LC-MS-MS || AAS || other:

'If not applicable, ignore this field. If a confirmatory method was used (i.e. applying techniques to demonstrate specificity in case the original method is not highly specific), indicate the instrument / detector used. Note: Not all picklist items may be relevant for a confirmatory technique.

Copy this field if more than one method needs to be specified.

Give any further details in field ''Details on data confirmatory method''.'

Indicator specifying which instrument / detector was used in the confirmatory method, e.g. 'HPLC-MS-MS'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:CONFIRMATORY_DETECTOR>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL>

<i5:LIST_SEL>

SE08.00.00.0521

Instrument / detector for confirmatory method

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g631
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:CONFIRMATORY_DETECTOR>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL>

<i5:LIST_SEL_TXT>

SE08.00.00.0530

Details on confirmatory method

[Details on confirmatory method]

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

 

Briefly describe further details on the principles of the confirmatory method if any.

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 confirmatory method

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:CONFIRMATORY_METHOD_DETAILS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE08.00.00.0540

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:DI_ANALYTICAL_METHOD>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE08.00.00.0545

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.

 

SE08.00.00.0546

Recovery results and characteristics of analytical method

[Recovery results and characteristics of analytical method]

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

 

 

Subheading of section 'Results using data collection method'.

 

SE08.00.00.0550

Recovery results

[Recovery results]

  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:

COMPOUND (ANALYTE): ...

- Recovery rates at each spiking level: ...% at ... mg/kg; ...% at ... mg/kg; etc.

- Mean recovery (%): ... from ... recovery studies

- RSD (mean rel. stand. dev. %): ... from ... recovery studies

- Repeatability of method:

COMPOUND (ANALYTE): ...

[as above]

Indicate the compound (analyte) addressed (e.g. 'parent compound', 'parent and transformation products' or 'transformation product: .....'). Report the recovery rates at each level (e.g. at spiking level 1, spiking level 2 etc.) at the limit of quantification and give the mean % recovery and the relative standard deviation in % including the number of recovery studies. Include a brief evaluation of the repeatability of the method (e.g. 'These values demonstrate that the method has satisfactory repeatability.')

Use freetext template and delete/add elements as appropriate, or include a table (particularly for comprehensive data) in 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 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 rates at different levels (e.g. at spiking level 1, spiking level 2 etc.) at the limit of quantification.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:DATACOLLECT_RECOVERY_RATES>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE08.00.00.0560

Characteristics of analytical method

[Characteristics of analytical method]

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

Freetext Templates:

COMPOUND (ANALYTE): ...

- Equipment ID:

- Limit of quantitation (LOQ):

- Limit of detection (LOD):

- Accuracy / precision: [range of percent recoveries ' coefficient of variation (specify range) indicating acceptable/unacceptable accuracy/precision in the range of spiking levels ( x).]

- Reliability of method: [An independent laboratory method validation [ILV], method No. AAA , was conducted to verify the reliability of method No. AAA for the determination of (pesticide) residues in [matrices]. The values obtained are indicative that method No. is reliable].

- Linearity: [The method/detector response was linear (coefficient of determination, r2= 0.xxx) within the range of xxx - yyy ppm.]

- Specificity: [The control chromatograms generally have no peaks above the chromatographic background and the spiked sample chromatograms contain only the analyte peak of interest. Peaks were well defined and symmetrical. There appeared to be no carryover to the following chromatograms].

COMPOUND (ANALYTE): ...

[as above]

For each compound (analyte) addressed (to be specified, e.g. 'parent compound', 'parent and transformation products' or 'transformation product: .....'), report both the limit of quantitation (LOQ) and limit of detection (LOD), and the criteria used to determine the LOD or LOQ, i.e., the lowest fortification/spiking level or S/N ratio.

Use freetext template, delete/add elements and edit text set in [...] as appropriate, or include a table (particularly for comprehensive data) in 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 text (e.g. '... see Table 1'). If a residue analytical method is recorded, the details for the so-called data collection or data-gathering method should be specified here. As to the terms 'data collection method' and 'enforcement method' see help text for field 'Instrument / detector'.

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

Characteristics of analytical method

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:DATACOLLECT_CHARACTERISTICS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE08.00.00.0565

Results using enforcement method

[Results using enforcement method (if applicable)]

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

 

 

Subheading of section 'Results using enforcement method'.

 

SE08.00.00.0570

Recovery results (enforcement method)

[Recovery results (enforcement method)]

  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:

COMPOUND (ANALYTE): ...

- Recovery rates at each spiking level: ...% at ... mg/kg; ...% at ... mg/kg; etc.

- Mean recovery (%): ... from ... recovery studies

- RSD (mean rel. stand. dev. %): ... from ... recovery studies

- Repeatability of method:

COMPOUND (ANALYTE): ...

[as above]

If not applicable, ignore this field. If an enforcement method is proposed which is different from the analytical method described as general analytical method (or 'data-gathering method' in residue analysis), indicate the compound (analyte) addressed (e.g. 'parent compound', 'parent and transformation products' or 'transformation product: .....'). Report the recovery rates at each level (e.g. at spiking level 1, spiking level 2 etc.) at the limit of quantification and give the mean % recovery and the relative standard deviation in % including the number of recovery studies. Include a brief evaluation of the repeatability of the method (e.g. 'These values demonstrate that the method has satisfactory repeatability.')

Use freetext template and delete/add elements as appropriate, or include a table (particularly for comprehensive data) in 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 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 rates at different levels (e.g. at spiking level 1, spiking level 2 etc.) at the limit of quantification.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:ENFORCEMENT_RECOVERY_RATES>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE08.00.00.0580

Characteristics for enforcement method

[Characteristics for enforcement method]

  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:

COMPOUND (ANALYTE): ...

- Equipment ID:

- Limit of quantitation (LOQ):

- Limit of detection (LOD):

- Accuracy / precision: [range of percent recoveries ' coefficient of variation (specify range) indicating acceptable/unacceptable accuracy/precision in the range of spiking levels ( x).]

- Reliability of method: [An independent laboratory method validation [ILV], method No. AAA , was conducted to verify the reliability of method No. AAA for the determination of (pesticide) residues in [matrices]. The values obtained are indicative that method No. is reliable].

- Linearity: [The method/detector response was linear (coefficient of determination, r2= 0.xxx) within the range of xxx - yyy ppm.]

- Specificity: [The control chromatograms generally have no peaks above the chromatographic background and the spiked sample chromatograms contain only the analyte peak of interest. Peaks were well defined and symmetrical. There appeared to be no carryover to the following chromatograms].

COMPOUND (ANALYTE): ...

[as above]

If not applicable, ignore this field. If an enforcement method is proposed which is different from the analytical method described as general analytical method (or 'data-gathering method' in residue analysis), report both the limit of quantitation (LOQ) and limit of detection (LOD), and the criteria used to determine the LOD or LOQ, i.e., the lowest fortification/spiking level or S/N ratio for each compound (analyte) addressed (to be specified, e.g. 'parent compound', 'parent and transformation products' or 'transformation product: .....').

Use freetext template, delete/add elements and edit text set in [...] as appropriate, or include a table (particularly for comprehensive data) in 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 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.

Characteristics for enforcement method

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:ENFORCEMENT_CHARACTERISTICS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE08.00.00.0585

Independent laboratory validation (if applicable)

[Independent laboratory validation (if applicable)]

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

 

 

Subheading of section 'Independent laboratory validation'.

 

SE08.00.00.0590

Independent laboratory validation

[Independent laboratory validation]

  1. TEXTAREA
  2. STRING/2000
  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.

If not applicable, ignore this field. If applicable (as for enforcement methods), discuss the independent laboratory validation (ILV) in terms of whether or not it was conducted according to guideline specifications. Discuss any method modifications that may impact the analyses of the residues (e.g., altered LOQ) that are suggested by the independent laboratory. Alternatively, include a table (particularly for comprehensive data) in 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 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.

Discussion of the independent laboratory validation (ILV) in terms of whether or not it was conducted according to guideline specifications.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:IL_VALIDATION>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE08.00.00.0600

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:DI_ANALYTICAL_METHOD>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE08.00.00.0605

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.

 

SE08.00.00.0610

Remarks on results including tables and figures

[Remarks on results including tables and figures]

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

 

In this field, you can enter any overall remarks or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

Note: One rich text editor field each is provided for the MATERIALS AND METHODS and RESULTS section. In addition the fields 'Overall remarks' and 'Executive summary' allow rich text entry.

Rich text editor field for creating formatted text and tables or inserting and editing any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:DI_ANALYTICAL_METHOD>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE08.00.00.0619

Attached background material

[Attached background material]

  1. HEAD BLOCK
  2. Block label
  3. g632
  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'.

 

SE08.00.00.0620

Attached document

[Attached document]

  1. ATTACHMENT
  2. STRING/32768
  3. g632
  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:DI_ANALYTICAL_METHOD>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE08.00.00.0630

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g632
  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:DI_ANALYTICAL_METHOD>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE08.00.00.0639

Attached full study report

[Attached full study report]

  1. HEAD BLOCK
  2. Block label
  3. g633
  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

 

SE08.00.00.0640

Attached full study report

[Attached full study report]

  1. ATTACHMENT
  2. STRING/32768
  3. g633
  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:DI_ANALYTICAL_METHOD>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE08.00.00.0642

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:DI_ANALYTICAL_METHOD>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE08.00.00.0645

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.

 

SE08.00.00.0650

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:DI_ANALYTICAL_METHOD>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE08.00.00.0660

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:DI_ANALYTICAL_METHOD>

<i5:APPL_EXEC_SUM>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE08.00.00.0670

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:DI_ANALYTICAL_METHOD>

<i5:CROSSREF_OTHER_STUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>