OECD Template #89: Efficacy data (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.

 

 

 

SE10.02.00.0215

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.

 

SE10.02.00.0220

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 relevant information on the test substance in fields on 'Test materials'.

PURPOSE OF THIS TEMPLATE:

This template can be used for summarising an efficacy study or, if appropriate and in line with relevant legislation guidance, several efficacy studies, conducted to support any proposed label claim.

Note that this template focuses primarily on biocides. If used for other than this purpose additional pieces of information may have to be added in several fields. Consult the programme-specific guidance on the details to be included in a study summary or whether several studies can be summarised in one record.

If this template is used to summarise several efficacy studies, the following should be taken into account:

- Attach summary table(s) in an appropriate rich text area, e.g. field 'Any other information on results incl. tables' and/or attach graphs in field 'Attached background material'.

- Tests summarised in overview table(s) should have some common objectives and conditions as far as possible. For instance, summarise all laboratory studies in one record that are intended to support a specific label claim, while combining all field studies in another record. Likewise you may use other criteria for splitting up into more than one record.

- If possible fill in distinct fields with information that relates to all studies summarised in a given record. For instance, enter fields 'Function addressed', 'Objective / label claim(s)' addressed'.

- Leave those fields or field blocks empty that are intended mainly for reporting an individual study, such as 'Reference', 'Test guideline', 'Principles of method if other than guideline', fields under heading 'Test materials'. Provide this type of information in the tables.

- It may be useful to indicate that there are studies for which data protection is claimed. If so you can indicate so in the corresponding field and include a note, in the supplementary remarks field, referring to the results table in which the respective study or studies is/are indicated as being data protected.

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:BACKGROUND_INFORMATION>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE10.02.00.0230

Objective / label claim(s) addressed

[Objective / label claim(s) addressed]

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

 

Briefly describe the objective of the efficacy data summarised in this record. This will normally be a (draft) label or statements concerning the label claim that is addressed or supported. As appropriate, include relevant label information such as function, mode of action, target / pest organism(s), stage of pest targeted, area of use, application methods and rates at which the product is to be applied.

If a label addresses multiple product types, functions, target organisms, materials or organisms to be protected, it may be sensible or required according to legislation-specific guidance to use separate records for each of them, as an alternative option to addressing all label claims by efficacy data in one record. One approach could be to create separate records for the label items taken line by line, or point by point (possibly in another order), and include the corresponding efficacy data intended to support this/these label claim(s). Make sure that every part of each claim and recommendation of the label has been covered.

Description of objective / label claim(s) addressed.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:OBJECTIVE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.02.00.0239

Source of information / type of study(ies)

[Source of information / type of study(ies)]

  1. HEAD BLOCK
  2. Block label
  3. g7
  4. 10
  5. 1
  6. [N/A]

 

Indicate whether the information entered originates from 'public domain evidence' (i.e. suitable information in published papers and books), 'summary of preliminary tests' (including early screening studies) or 'summary information' (e.g. overview of several tests) or addresses a 'laboratory study', 'simulated use test / small scale trials', 'field study / operational trials' or other ( to be specified). If the information was extrapolated from study(ies) with closely related formulations, select the corresponding indicator from the picklist.

This field is repeatable. As appropriate, copy the field e.g. for indicating 'summary information' and 'simulated test data'.

In the supplementary remarks field, you can add explanations as appropriate.

Note: In field 'Study result type', option 'experimental result' should also be selected if the efficacy data recorded is extrapolated information from experimental study(ies) with another target or related formulation.

Indicator specifying the type of study or information, e.g. 'laboratory study'.

 

SE10.02.00.0240

Source of information / type of study(ies)

[Source of information / type of study(ies)]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g7
  4. 1
  5. 1
  6. C112

Picklist Values:

public domain evidence || summary of preliminary tests || summary of several efficacy studies || laboratory study data || simulated use test / small scale trials data || field study / operational trials data || extrapolation from study(ies) with closely related formulation || extrapolation: other || other:

Indicate whether the information entered originates from 'public domain evidence' (i.e. suitable information in published papers and books), 'summary of preliminary tests' (including early screening studies) or 'summary information' (e.g. overview of several tests) or addresses a 'laboratory study', 'simulated use test / small scale trials', 'field study / operational trials' or other ( to be specified). If the information was extrapolated from study(ies) with closely related formulations, select the corresponding indicator from the picklist.

This field is repeatable. As appropriate, copy the field e.g. for indicating 'summary information' and 'simulated test data'.

In the supplementary remarks field, you can add explanations as appropriate.

Note: In field 'Study result type', option 'experimental result' should also be selected if the efficacy data recorded is extrapolated information from experimental study(ies) with another target or related formulation.

Indicator specifying the type of study or information, e.g. 'laboratory study'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:SOURCE_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE10.02.00.0241

Source of information / type of study(ies)

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g7
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:SOURCE_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE10.02.00.0249

Reference

[Reference]

  1. HEAD BLOCK
  2. Block label
  3. g8
  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'

 

SE10.02.00.0250

Reference type

[Reference type]

  1. LIST-OPEN
  2. STRING/255
  3. g8
  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:EF_EFFICACY_DATA>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE10.02.00.0251

Reference type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g8
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE10.02.00.0260

Author(s) (or transferred reference)

[Author]

  1. TEXT
  2. STRING/2000
  3. g8
  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:EF_EFFICACY_DATA>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE10.02.00.0270

Year

[Year]

  1. YEAR
  2. NUMBER/4/###0
  3. g8
  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:EF_EFFICACY_DATA>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE10.02.00.0280

Title

[Title]

  1. TEXT
  2. STRING/255
  3. g8
  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:EF_EFFICACY_DATA>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE10.02.00.0290

Bibliographic source

[Bibliographic source]

  1. TEXT
  2. STRING/255
  3. g8
  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:EF_EFFICACY_DATA>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE10.02.00.0300

Testing laboratory

[Testing laboratory]

  1. TEXT
  2. STRING/255
  3. g8
  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:EF_EFFICACY_DATA>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE10.02.00.0310

Report no.

[Report no.]

  1. TEXT
  2. STRING/255
  3. g8
  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:EF_EFFICACY_DATA>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE10.02.00.0320

Owner company

[Owner company]

  1. TEXT
  2. STRING/255
  3. g8
  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:EF_EFFICACY_DATA>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE10.02.00.0330

Company study no.

[Company study no.]

  1. TEXT
  2. STRING/255
  3. g8
  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:EF_EFFICACY_DATA>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE10.02.00.0340

Report date

[Report date]

  1. DATE
  2. DATE/255
  3. g8
  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:EF_EFFICACY_DATA>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE10.02.00.0350

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:EF_EFFICACY_DATA>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE10.02.00.0351

Data access

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE10.02.00.0360

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:EF_EFFICACY_DATA>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE10.02.00.0361

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:EF_EFFICACY_DATA>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE10.02.00.0370

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:EF_EFFICACY_DATA>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE10.02.00.0375

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.

 

SE10.02.00.0379

Test guideline

[Test guideline]

  1. HEAD BLOCK
  2. Block label
  3. g9
  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'

 

SE10.02.00.0380

Qualifier

[Qualifier]

  1. LIST-CLOSED
  2. STRING/255
  3. g9
  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:EF_EFFICACY_DATA>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE10.02.00.0390

Guideline

[Guideline]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g9
  4. 1
  5. 1
  6. C106

Picklist Values:

ASTM Method, other: || CEN Standard, other: || CEPE Method, other: || DIN Method, other: || EN Method, other: || EU Method, other: || OECD Guideline, other: || EPA Test Guidelines, other: || AOAC Method, other: || DGHM Method, other: || AATCC 174-1998 (Antimicrobial activity assessment of carpets qualitative antibacterial activity) || AATCC 174-1998 (Antimicrobial activity assessment of carpets quantitative antibacterial activity) || AATCC 174-1998 (Antimicrobial activity assessment of carpets quantitative antifungal activity) || AATCC 30-1998 (Antifungal activity, Assessment on textile materials: mildew and rot resistance of textile materials) || AATCC Technical Manual Method 24 (Test method for textiles to determine resistance to insects (e.g., moths, carpet beetles)) || AATCC Test Method 28 1991-01 || AFNOR B 51-295 (Wood-based panels - Method of test for determining the resistance against wood-destroying basidiomycetes) || AFNOR B50-105-3 (Durability of wood and wood-based products. Preservative treated solid wood - Part 3: Wood preservative performance and treatment certificate. Adaptation to metropolitan France) || AFNOR NF ISO 846 (Determination of the behaviour under the action of fungi and bacteria. Evaluation by visual examination or by measure of mass variations or physical characteristics) || AFNOR NF T 72-140 (Antiseptics and disinfectants - Keeping and testing bacterial strains used for the determination of bactericidal activity) || AFNOR NF T 72-320 (Method for aerosol space sprays against houseflies) || AFNOR NF T34-201 (Coating systems for wood surfaces-Lasures-Specifications) || AFNOR NF T72-083 (Products for Protecting Wood Surfaces - Method of Testing Resistance to Microorganisms) || AFNOR NF T72-171 (Water miscible antiseptics and disinfectants used in liquid form - Determination of bactericidal activity in the presence of specific interfering substances. (membrane filtration method)) || AFNOR NF T72-180 (Water miscible antiseptics and disinfectants used on liquid form - Determination of virucidal activity - Viruses of vertebrates) || AFNOR NF T72-181 (Water miscible antiseptics and disinfectants used on liquid form - Determination of virucidal activity with respect to bacteriophages) || AFNOR NF T72-190 (Water miscible contact disinfectants used in liquid form - Germ carrier method - Determination of the bactericidal, fungicidal and sporicidal activity) || AFNOR NF T72-231 (Water miscible antiseptics and disinfectants used on liquid form - Determination of sporicidal activity (membrane filtration method)) || AFNOR NF T72-281 (Disinfectants Methods of airborne disinfection of surfaces - Determination of bactericidal, fungicidal and sporicidal activity) || AFNOR NF T72-300 (Water miscible antiseptics and disinfectants used in liquid form - suspension test by dilution-neutralisation - determination of the efficacy under practical conditions) || AFNOR NF T72-301 (Water miscible antiseptics and disinfectants used in liquid form - suspension test by membrane filtration - determination of the efficacy under practical conditions) || AFNOR NF X 41-547 (Determination of fungicidal efficacy of products used for temporary protection of green sawn timber (laboratory method)) || AFNOR NF X 41-548 (Determination of the fungicidal efficacy of products used for temporary protection of fresh cut wood billets. (Laboratory method))......... || AFNOR NF X40-101 (Wood preservatives. Identification criteria)..............................

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:EF_EFFICACY_DATA>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE10.02.00.0391

Guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g9
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE10.02.00.0400

Deviations from guideline

[Deviations]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g9
  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:EF_EFFICACY_DATA>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE10.02.00.0401

Deviations from guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g9
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE10.02.00.0410

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:EF_EFFICACY_DATA>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.02.00.0420

Compliance with quality standards

[Compliance with quality standards]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z58

Picklist Values:

yes (GEP) || yes (official recognition) || yes (ISO 9000) || yes (as specified): || yes (not specified) || no || no data || not required

Indicate whether the efficacy data were generated according to GEP (Good Experimental Practice) or by an officially recognised organisation. If neither or is the case, enter 'no', 'no data' or 'not required' as applicable. Refer to programme-specific guidance as to the required adherence to official recognition, GEP or other quality assurance standards.

In the supplementary remarks field, you can add explanations as appropriate, e.g. provide a certificate number. If required, attach any (signed and dated) certificate or quality assurance statement in field 'Attached background material'.

Indication whether data were generated according to GEP (Good Experimental Practice) or by an officially recognised organisation.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:COMPLIANCE_QUALITY_STANDARDS>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE10.02.00.0421

Compliance with quality standards

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:COMPLIANCE_QUALITY_STANDARDS>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE10.02.00.0425

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'

 

SE10.02.00.0430

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:EF_EFFICACY_DATA>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE10.02.00.0439

Test material identity

[Test material identity]

  1. HEAD BLOCK
  2. Block label
  3. g10
  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'

 

SE10.02.00.0440

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g10
  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:EF_EFFICACY_DATA>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE10.02.00.0441

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g10
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE10.02.00.0450

Identity

[Identity]

  1. TEXT
  2. STRING/2000
  3. g10
  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:EF_EFFICACY_DATA>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE10.02.00.0455

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:EF_EFFICACY_DATA>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE10.02.00.0456

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:EF_EFFICACY_DATA>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE10.02.00.0460

Formulation type

[Formulation type]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. C115

Picklist Values:

liquid formulation: concentrate (water based) || solid formulation: salts || aerosol || paste || cartridge || foam || gaseous formulation: || gaseous formulation: coil || gaseous formulation: fume || gaseous formulation: gas || gaseous formulation: gas generating product || gaseous formulation: spray/electro-vaporiser || gaseous formulation: ULV-Fog || gas generating product || gel || impregnated sticker || lacquer || liquid formulation: || liquid formulation: concentrate || liquid formulation: concentrate (emulsion / micro-emulsion) || liquid formulation: concentrate (liquid based) || liquid formulation: concentrate (solvent based) || solid formulation: water dispersible granulate material || liquid formulation: liquid bait (ready-for-use) || liquid formulation: ready-for-use || liquid formulation: ready-for-use (creosote) || liquid formulation: ready-for-use (emulsion / micro-emulsion) || liquid formulation: ready-for-use (liquid bait) || liquid formulation: ready-for-use (solvent based) || liquid formulation: ready-for-use (suspension) || paste: concentrate || paste: ready-for-use || paste: ready-for-use (sachets and other) || plastic strip || rod / cartridge || solid formulation || solid formulation: block-bait || solid formulation: contact powder || solid formulation: granular bait || solid formulation: pellets || solid formulation: powder || solid formulation: powder (contact) || solid formulation: powder (dusting) || solid formulation: powder (wettable) || other: || no data

Indicate the type of formulation used in the study. If not listed, select 'other' and specify.

Any remarks can be entered in the supplementary remarks field, for instance any code for the formulation type if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. 'VIII.1 (EU BPD)'.

Indicator specifying the type of formulation, e.g. aerosol or gaseous formulation.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:FORMULATION_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE10.02.00.0461

Formulation type

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:FORMULATION_TYPE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE10.02.00.0470

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:EF_EFFICACY_DATA>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE10.02.00.0480

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:EF_EFFICACY_DATA>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE10.02.00.0490

Analytical monitoring

[Analytical monitoring]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z36

Picklist Values:

yes || no || no data || not required

Indicate whether the active substance was monitored during the test.

Indicator that instrumental analyses were applied to detect the precise amount of chemical exposed to the organisms.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:ANALYT_MONIT>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE10.02.00.0500

Details on sampling and analytical methods

[Details on sampling and analytical methods]

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

 

If the amount of test material exposed to the organisms was monitored, provide details on sampling and analytical methods used.

Details on sampling and analytical method used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:ANALYT_METHOD_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.02.00.0505

Pest / target organisms to be controlled

[Pest / target organisms to be controlled]

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

 

 

Subheading of section 'Pest / target organisms to be controlled'.

 

SE10.02.00.0509

Test / target organisms

[Test / target organisms]

  1. HEAD BLOCK
  2. Block label
  3. g11
  4. 40
  5. 1
  6. [N/A]

 

Specify the test / target organism(s) used in the study. Repeat this block of fields for specifying all organisms covered by this record. Due to the great number of possible test organisms this picklist is not exhaustive. If the species name is not listed, choose an appropriate superior term (e.g. 'Acaridae:') and specify by entering free text in the related field. If organism is not listed at all, choose 'other:' and enter the name or several names in a row in the related text field.

If this template is used to summarise several efficacy studies (e.g. by attaching summary tables as described in the instructions for field 'Background information'), this block of fields can be left empty. However, if the number of different species is reasonable, you should also specify them here in addition to the summary tables. This will allow searching.

Heading of field block 'Test / target organism(s) to be controlled'

 

SE10.02.00.0510

Scientific name of target organism

[Scientific name]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g11
  4. 1
  5. 1
  6. C109

Picklist Values:

Ixodidae: || Kalotermitidae || Larus argentatus || Larus carnus || Larus fuscus || Larus marinus || Larus ridibundus || Latridiidae: || Lecanora dispersa || Lepidoptera: || Lepismatidae: || Limnoria lignorum || Limnoria spp. || Linognathidae: || Liposcelidae: || Lunularia cruciata || Lyctus brunneus || Macronyssidae: || Mallophaga: || Marchantia polymorpha || Mesostigmata (Gamasida): || Metastigmata (Ixodida): || Microtidae: || Muridae: || Mus macedonius || Mus musculus || Mus musculus domesticus || Mus musculus musculus || Mus spretus || Muscidae: || Myrmicinae: || Nostoc commune || Oniscidae: || Ostomidae: || Passer domesticus || Pediculidae: || Penicillium purpurogenum || Phialophora spp. || Phoma violacea || Phthiraptera: || Phthiridae: || Pica pica || Pleurococcus spp. || Porcellionidae: || Prostigmata: || Pseudomonas aeruginosa || Pseudomonas spp. || Psocoptera: || Psoroptidae: || Psychodidae: || Psyllipsocidae: || Ptinidae: || Pulicidae: || Pyemotidae: || Pyraloidea: || Pyroglyphidae: || Rattus norvegicus || Rattus rattus || Reticulitermes sp. || Rhodotorula rubra || Rhynchostegiella tenella || Rodentia: || Saltatoria: || Sarcophagidae: || Sarcoptidae: || Sciurus carolinensis || Serpula lacrymans || Silvanidae: || Simuliidae: || Siphonaptera: || Sporbolomyces roseus || Stachybotrys atra || Stichococcus bacillaris || Streptopelia decaocto || Sturnus vulgaris || Tabanidae: || Tenebrionidae: || Teredo navalis || Teredo spp. || Tineidae: || Tortula muralis || Trogiidae: || Trombiculidae: || Ulocladium atrum || Xestobium rufovillosum || Zygentoma: || Acaridae: || Actinobacter spp. || Aerobacter spp. || Alternaria spp. || Amphora spp. || Anobiidae: || Anobium punctatum De Geer || Arachnida: Acari: || Argasidae: || Arthropoda: || Aspergillus versicolor || Astigmata: || Aureobasidium pullulans spp. || Bacillus spp. || Barbula cylindrica || Basidiomycetes: || Blattellidae: || Blattidae: || Blattodea: || Bostrichidae: || Branta bernicla || Branta canadensis || Buellia canescens || Calliphoridae: || Caloplaca spp. || Camptothecium sericenum || Candelariella spp. || Ceratocystis spp. || Ceratophyllidae: || Ceratopogonidae: || Cheyletiellidae: || Cimicidae: || Cladosporium caldosporioides || Coleoptera: || Columba livia || Columba palumbus || Corvus corone || Corvus frugilegus || Corvus monedula || Crustacea: || Culicidae: || Curculionidae: || Dermanyssidae: || Dermaptera: || Dermestidae: || Diptera: || Dolichoderinae: || Drosophilidae: || Enteromorpha spp. || Forficulidae: || Formicinae: || Fungi: || Garrulus glandarius || Gelechiidae: || Gloeocapsa alpicola || Glycyphagidae: || Grimmia pulvinata || Gryllidae: || Haematopinidae: || Hemiptera: Heteroptera: || Hesperophanes spp. || Hippoboscidae: || Hylotrupes bajulus L. || Hymenoptera: Formicidae: || Hymenoptera: Vespinae: || Insecta: || Isopoda: || Isoptera: || other: || no data

Select appropriate scientific name from picklist. If not listed, select 'other' and specify. If not given/known, select 'no data'. See also instructions on this block of fields.

Any remarks can be entered in the supplementary remarks field, for instance any code for target organism if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. 'I.1.1.1 (EU BPD)'.

Scientific name of the test organism.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_SCIENTIFIC_NAME>

<i5:SCIENTIFIC_NAME>

SE10.02.00.0511

Scientific name of target organism

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g11
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_SCIENTIFIC_NAME>

<i5:SCIENTIFIC_NAME_TXT>

SE10.02.00.0520

Common name of target organism

[Common name]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g11
  4. 1
  5. 1
  6. C110

Picklist Values:

Acarid mites || Aedes mosquitoes || common furniture beetle || algae || American Cockroach || Anopheles mosquitoes || ants || Arachnids: ticks and mites || astigmatid mites || Australian cockroach || autumn fly || bacon beetle || bacteria, aerobic Gram-negative || bacteria, aerobic Gram-positive || barklice || bed bug || beetles || biting lice || biting midges || black headed gull || blackflies || blattellid cockroaches || Blattid cockroaches || blow flies || blue stain fungi || blue-green algae || book louse || Brent goose || brown ear tick || brown rat || brown rot fungi || brown-banded cockroach || bugs || Canada goose || cat flea || cattle louse || cheese mite || chicken mite || chigger mites || cloth moth || common silverfish || cockroaches || collared dove || common cockroach || common earwig || common gull || common rough woodlouse || common shiny woodlouse || common wasp || confused flour beetle || corn moth || crickets || crickets and grasshoppers || crow || crustaceans || death-watch beetle || Dermanyssid mites || dog flea || dog louse || dry fruit moth || dry rot fungus || dry wood termites || earwigs || Eastern European house mouse || Eastern Mediterranean short-tailed mouse || European earwig || Feral pigeon || firebrat || fleas || flesh flies || flour moth || fodder mite || forficulid earwigs || four mite || fruit fly || fungi || fungi/yeasts || fur mites || gain itch mite || gain weevil || Gamasid mites || garden ant || German cockroach || German wasp || golden spider beetle || great black-backed gull || green algae || grey squirrel || gribble || hard ticks || herring gull || horn flies || house cricket || house dust mites || house fly || house longhorn beetle || house mites || house mosquitoe || house mouse || house rat || house sparrow || human body louse || human flea || human head louse || humpbacked spider beetle || huse itch mites || insects || isopods || jackdaw || jay || Lataste's mouse || Lepismatid silverfishes || lesser black-backed gull || lesser grain borer || lesser house fly || lesser mealworm || lesser rice weevil || lichens || liverworts || lizard mites || long-cheeked Norvegian wasp || long-cheeked Saxon wasp || long-cheeked tree wasp || longhorned wood borer || louse flies || Macronyssid mites || magpie || mange mite || mange mites || marines borers (genus claimed) || median wasp || Mesostigmatid mites || micro-organisms || microtids || mill moth || mosquitoes || mosses || mould fungi || mould mite || murids || mussels || Northern fowl mite || oriental rat flea || other arthropods || other murids: || Pharaoh ant || pig louse || pigeon tick || plaster beetle || poultry mite || poultry red mite || powder post beetles || Prostigmatid mites || pubic louse || rabbit ear mite || red wasp || reptile mites || rodents || roof rat || rook || rusty grain beetle || sandflies || sapstain fungi || sawtoothed grain beetle || scabies mites || sheep scab mite || sheep tick || shipworm || silverfishes || skin moth || snake mite || soft rot fungi || soft ticks || spider beetle || stable flies || starling || straw itch mites || subterranean termites || Sucking lice: pediculid lice || tapestry moth || Tapinoma ant || termites || ticks || tree termites || Trombiculid mites || tropical bedbug || tropical rat mite || wasps || weat or cadelle beetle || Western European house mouse || white rot fungi || white shouldered moth || wood boring beetles || wood destroying insects || wood destroying marine organisms... || wood pigeo...

Select appropriate common name from picklist. If not listed, select 'other' and specify. If not given/known, select 'no data'. See also instructions on this block of fields.

Any remarks can be entered in the supplementary remarks field.

Common name of the test organism.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_COMMON_NAME>

<i5:COMMON_NAME>

SE10.02.00.0521

Common name of target organism

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g11
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_COMMON_NAME>

<i5:COMMON_NAME_TXT>

SE10.02.00.0530

Developmental stage of target organism

[Developm. stage]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g11
  4. 1
  5. 1
  6. C116

Picklist Values:

hyphae || pupae || adults || eggs || spores and spore producing structures || juveniles || larvae || nymphs || other: || no data

Indicate the developmental stage of the target organism. If not listed, select 'other' and specify. If not given/known, select 'no data'. If not applicable, leave field empty.

Any remarks can be entered in the supplementary remarks field, for instance any code for the developmental stage if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. 'I.1.1.1 (EU BPD)'.

Developmental stage of target organism.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_DEVELSTAGE>

<i5:DEVELSTAGE>

SE10.02.00.0531

Developmental stage of target organism

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g11
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:TARGETORGANISM>

<i5:set>

<i5:PHRASEOTHER_DEVELSTAGE>

<i5:DEVELSTAGE_TXT>

SE10.02.00.0540

Details on test/target organisms

[Details on test/target organisms]

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

Freetext Templates:

- Strain:

- Source:

- Wild type: [yes/no]

- Any selection pressure (sensitivity, resistance):

- Pre-conditioning / rearing conditions:

- Weight at study initiation:

- Age (of the stadium) at study initiation: [mixed age population / ....]

- Numbers used in the test:

- Sex of those used in the test (where appropriate):

- Other (specify): - Nature:

- Origin:

- Collection / storage of samples:

- Preparation of inoculum for exposure:

- Pretreatment:

- Initial biomass / density / numbers in test system:

- Other (specify):

Provide further details on test organisms, particularly on rearing conditions, numbers and sexes used (where appropriate) and any other relevant information. Because of the wide range of efficacy trials identification of all relevant items is not practical. Hence, the optional freetext templates provided are not exhaustive. If you use one of them, delete/add elements and edit text set in [...] as appropriate. Specific studies may require other or additional information to be included. 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. EU BPD (TNsG)) thereof.

If this record summarises several studies with different organisms, it may be appropriate to include the most relevant details in the summary table(s).

Details on test/target organisms.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:TARGETORGANISM_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE10.02.00.0545

Products (materials), organisms or objects to be protected / under study

[Products (materials), organisms or objects to be protected / under study]

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

 

 

Subheading of section 'Products (materials), organisms or objects to be protected / under study'.

 

SE10.02.00.0550

Organisms (to be protected) or treated materials

[Organisms (to be protected) or treated materials]

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

 

If applicable, describe and specify the organism(s) or materials(s) / object(s) to be protected as addressed by these efficacy data, e.g. human, pets, farm animals, fur- and wool-bearing animals, drinking water, hard surface material, porous surface.

Note: If studies were conducted on human beings (e.g. testing insect repellents for human skin), it should be indicated whether and what kind of consent was received from the persons studied.

Description of organisms (to be protected) or treated materials.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:OBJECTS_PROTECTED>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE10.02.00.0555

Study design

[Study design]

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

 

 

Subheading of section 'Study design'

 

SE10.02.00.0560

Exposure duration

[Duration]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. A02-1

Picklist Values:

> || >= || ca.

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

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

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

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

Exposure duration or range: Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE10.02.00.0570

Exposure duration

[no label]

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

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE10.02.00.0580

Exposure duration

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

Exposure duration or range: Upper qualifier field providing a list with following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE10.02.00.0590

Exposure duration

[no label]

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

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE10.02.00.0600

Unit

[Total exposure duration (contact time)]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. C113

Picklist Values:

s || min || h || d || wk || mo || yr

Select from drop-down list.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EXP_DURATION>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE10.02.00.0610

Remarks

[Remarks]

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

 

Enter any remarks related to the total exposure duration.

Remarks on exposure duration.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EXP_DURATION>

<i5:set>

<i5:REM>

<i5:REM>

SE10.02.00.0620

Mode of efficacy assessment

[Mode of efficacy assessment]

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

Freetext Templates:

- Effects investigated:

- Method for recording / scoring effects:

- Intervals of examination:

- Post monitoring of test organisms:

Describe the parameter(s) measured for assessing efficacy and the intervals of measurements, together with the scoring or assessment system used. Where appropriate, describe the duration of post monitoring of test organisms.

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. EU BPD) thereof.

Parameter(s) measured for determining the effectiveness and the intervals of examinations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY_ASSESSMENT_PARAMETER>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE10.02.00.0630

Method of application

[Method of application]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. C118

Picklist Values:

open || spraying || bait application || closed system || closed system: pressure process || closed system: vacuum impregnation || foam application || fogging || fumigation || fumigation || health protection || in bait boxes || material protection || mixing with glue and mortar || stored product protection / food protection || open system || open system: brush treatment || open system: deluging || open system: diffusion || open system: dip treatment || open system: foam application || open system: immersion || open system: injection || open system: spray treatment || open system: wrapping || painting || pouring || other: || no data

Indicate the method of application. If not listed, select 'other' and specify.

Any remarks can be entered in the supplementary remarks field, for instance any code for the method of application if required so according to programme-specific guidance. If so, indicate the type of coding system in parentheses, e.g. 'VII.1 (EU BPD)'.

Indicator specifying the method of application used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:APPLICATION_METHOD>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE10.02.00.0631

Method of application

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:APPLICATION_METHOD>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE10.02.00.0640

Details on study design

[Details on study design]

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

Freetext Templates:

FURTHER DETAILS ON APPLICATION

- Application/dosage and dilution rates (incl. dose justification):

- Adjuvant/vehicle/carrier:

- Presence of interfering substances:

- Other (specify)

MONITORING OF TEST SUBSTANCE

- Monitoring of active substance concentration:

- Method of analysis:

TEST CHAMBER / DEVICE

- Type and design of test chamber / device:

- Other (specify)

SURFACE TYPES

- Type: [porous, non-porous, soft furnishes]

TEST CONDITIONS

- Temperature:

- Rel. humidity:

- Aeration:

- Light cycles during test:

- pH:

- Water hardness:

- Soil type:

- Nutrient supply conditions:

- Any additions or alterations to the test environment during the study:

- Other (specify)

INITIAL DENSITY/NUMBERS OF TARGET ORGANISMS

- Initial density / numbers in test system:

- Frequency or level of infestation / infection:

REPLICATES

- Number of replicates:

CONTROLS

- Untreated controls:

- Positive controls (reference substance):

OTHER (specify):

APPLICATION

- Type/method of application:

- Code of application type (if any):

- Application/dosage and dilution rates (incl. dose justification):

- Adjuvant/vehicle/carrier:

- Other (specify)

EXPERIMENTAL DESIGN

-

GEOGRAPHICAL LOCATION

-

TEST CONDITIONS / METEOROLOGICAL INFORMATION

-

INITIAL DENSITY/NUMBERS OF TARGET ORGANISMS

- Initial density / numbers in test system:

- Frequency or level of infestation / infection:

REPLICATES

- Number of replicates:

CONTROLS

- Untreated controls:

- Positive controls (reference substance):

OTHER (specify):

Provide further details on the study design. Because of the wide range of efficacy trials, identification of all relevant items is not practical. Hence, the optional freetext templates provided are not exhaustive. If you use one of them, delete/add elements and edit items as appropriate. Specific studies may require other or additional information to be included. 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. EU BPD) thereof.

If this record summarises several studies, it may be appropriate to include the most relevant details in the summary table(s).

Details on study design.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:STUDY_DESIGN_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE10.02.00.0650

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:EF_EFFICACY_DATA>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE10.02.00.0655

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.

 

SE10.02.00.0659

Efficacy / performance assessment

[Efficacy / performance assessment]

  1. HEAD BLOCK
  2. Block label
  3. g12
  4. 20
  5. 1
  6. [N/A]

 

If possible, indicate the percentage of efficacy in terms of control, reduction, damage of target organisms or reduction of disease caused by pest organisms. Copy this field block for entering more than one efficacy level (e.g. based on other exposure duration, dose or endpoint) if necessary.

Note: It may be appropriate to record, in this block of fields, only the mean level of effect or control. If the effect level relates to several test runs (i.e. test conditions), give ranges.

Heading of field block 'Efficacy / performance assessment'

 

SE10.02.00.0660

Efficacy parameter

[Efficacy parameter]

  1. LIST-OPEN
  2. STRING/255
  3. g12
  4. 1
  5. 1
  6. C114

Picklist Values:

% inhibition/stasis || % pest control rating || % reduction in infestation || % kill/cidal activity || other: || not specified

Indicate the efficacy / performance parameter (e.g. % kill/cidal activity) to which the index entered in the next field refers to.

Indication of efficacy parameter, e.g. '% inhibition/stasis'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PHRASEOTHER_PARAMETER>

<i5:PARAMETER>

SE10.02.00.0661

Efficacy parameter

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g12
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PHRASEOTHER_PARAMETER>

<i5:PARAMETER_TXT>

SE10.02.00.0670

Efficacy (in %)

[Efficacy (in %)]

  1. LIST-CLOSED
  2. STRING/255
  3. g12
  4. 1
  5. 1
  6. A02-1

Picklist Values:

> || >= || ca.

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

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

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

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

Percentage of efficacy: Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PRECISION_PERCENTAGE_LOQUALIFIER>

<i5:PERCENTAGE_LOQUALIFIER>

SE10.02.00.0680

Efficacy (in %)

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g12
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PRECISION_PERCENTAGE_LOQUALIFIER>

<i5:PERCENTAGE_LOVALUE>

SE10.02.00.0690

Efficacy (in %)

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g12
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

Percentage of efficacy: Upper qualifier field providing a list with following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PRECISION_PERCENTAGE_LOQUALIFIER>

<i5:PERCENTAGE_UPQUALIFIER>

SE10.02.00.0700

Efficacy (in %)

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g12
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PRECISION_PERCENTAGE_LOQUALIFIER>

<i5:PERCENTAGE_UPVALUE>

SE10.02.00.0710

Time to produce effect

[Time to produce effect]

  1. LIST-CLOSED
  2. STRING/255
  3. g12
  4. 1
  5. 1
  6. A02-1

Picklist Values:

> || >= || ca.

Select from drop-down list.

Time to produce effect: Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PRECISION_TIME_LOQUALIFIER>

<i5:TIME_LOQUALIFIER>

SE10.02.00.0720

Time to produce effect

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g12
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PRECISION_TIME_LOQUALIFIER>

<i5:TIME_LOVALUE>

SE10.02.00.0730

Time to produce effect

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g12
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

Time to produce effect: Upper qualifier field providing a list with following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PRECISION_TIME_LOQUALIFIER>

<i5:TIME_UPQUALIFIER>

SE10.02.00.0740

Time to produce effect

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g12
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PRECISION_TIME_LOQUALIFIER>

<i5:TIME_UPVALUE>

SE10.02.00.0750

Unit

[Efficacy / performance assessment]

  1. LIST-CLOSED
  2. STRING/255
  3. g12
  4. 1
  5. 1
  6. C113

Picklist Values:

s || min || h || d || wk || mo || yr

If possible, indicate the percentage of efficacy in terms of control, reduction, damage of target organisms or reduction of disease caused by pest organisms. Copy this field block for entering more than one efficacy level (e.g. based on other exposure duration, dose or endpoint) if necessary.

Note: It may be appropriate to record, in this block of fields, only the mean level of effect or control. If the effect level relates to several test runs (i.e. test conditions), give ranges.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PRECISION_TIME_LOQUALIFIER>

<i5:TIME_UNIT>

SE10.02.00.0760

Treatment

[Treatment]

  1. TEXT
  2. STRING/255
  3. g12
  4. 1
  5. 1
  6. [N/A]

 

If efficacy results are recorded for different treatment conditions (by repeating this block of fields), briefly indicate the type of treatment/application the results refer to. Specify dose, application rate, duration, etc.

Description of treatment/application the results refer to.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:TREATMENT>

<i5:TREATMENT>

SE10.02.00.0770

Interfering substances

[Interfering substances]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g12
  4. 1
  5. 1
  6. Z08

Picklist Values:

yes || no || no data || not applicable

Indicate if interfering substances were present. If 'yes' is selected, briefly specify in the supplementary remarks field.

Indication if interfering substances were present.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PHRASEOTHER_INTERFERING_SUBSTANCE>

<i5:INTERFERING_SUBSTANCE>

SE10.02.00.0771

Interfering substances

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g12
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:PHRASEOTHER_INTERFERING_SUBSTANCE>

<i5:INTERFERING_SUBSTANCE_TXT>

SE10.02.00.0780

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g12
  4. 1
  5. 1
  6. [N/A]

 

Enter any remarks related to the efficacy / performance assessment recorded in this block of fields.

Remarks on efficacy / performance assessment

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:EFFICACY>

<i5:set>

<i5:REM>

<i5:REM>

SE10.02.00.0789

Efficacy / performance assessment

[Minimum effective dose]

  1. HEAD BLOCK
  2. Block label
  3. g13
  4. 20
  5. 1
  6. [N/A]

 

If determined, provide the minimum effective dose, i.e. the dose or concentration considered the minimum necessary to achieve sufficient efficacy against the target organism(s) studied under the treatment conditions indicated. Copy this field block for recording values based on different treatment conditions if necessary.

Heading of field block 'Efficacy / performance assessment'

 

SE10.02.00.0790

Minimum effective dose

[Min. effective dose]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g13
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value of minimum effective dose.

Numeric value of minimum effective dose.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:VALUEUNIT_VALUE>

<i5:VALUE>

SE10.02.00.0800

Unit of minimum effective dose

[Minimum effective dose]

  1. LIST-OPEN
  2. STRING/255
  3. g13
  4. 1
  5. 1
  6. C117

Picklist Values:

% (m/m) || % (v/w) || % (v/v) || % (w/w) || % (w/v) || g/cm³ || kg/m³ || g/ha || kg/ha || mL/ha || µg per animal || ng/L || µg/L || mg/L || g/L || µmol/L || mmol/L || mol/L || mg/cm² || mg/kg bw || mg/kg diet || ng/kg sediment dw || µg/kg sediment dw || mg/kg sediment dw || mg/kg soil d.w. || g/kg soil d.w. || ppb || ppm || other:

Select from drop-down list.

Unit of minimum effective dose.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:VALUEUNIT_VALUE>

<i5:UNIT>

SE10.02.00.0801

Unit of minimum effective dose

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g13
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:VALUEUNIT_VALUE>

<i5:UNIT_TXT>

SE10.02.00.0810

Time to produce effect

[Time to produce effect]

  1. LIST-CLOSED
  2. STRING/255
  3. g13
  4. 1
  5. 1
  6. A02-1

Picklist Values:

> || >= || ca.

Select from drop-down list.

Time to produce effect: Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:PRECISION_TIME_LOQUALIFIER>

<i5:TIME_LOQUALIFIER>

SE10.02.00.0820

Time to produce effect

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g13
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:PRECISION_TIME_LOQUALIFIER>

<i5:TIME_LOVALUE>

SE10.02.00.0830

Time to produce effect

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g13
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

Time to produce effect: Upper qualifier field providing a list with following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:PRECISION_TIME_LOQUALIFIER>

<i5:TIME_UPQUALIFIER>

SE10.02.00.0840

Time to produce effect

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g13
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:PRECISION_TIME_LOQUALIFIER>

<i5:TIME_UPVALUE>

SE10.02.00.0850

Unit

[Minimum effective dose]

  1. LIST-CLOSED
  2. STRING/255
  3. g13
  4. 1
  5. 1
  6. C113

Picklist Values:

s || min || h || d || wk || mo || yr

If determined, provide the minimum effective dose, i.e. the dose or concentration considered the minimum necessary to achieve sufficient efficacy against the target organism(s) studied under the treatment conditions indicated. Copy this field block for recording values based on different treatment conditions if necessary.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:PRECISION_TIME_LOQUALIFIER>

<i5:TIME_UNIT>

SE10.02.00.0860

Treatment

[Treatment]

  1. TEXT
  2. STRING/255
  3. g13
  4. 1
  5. 1
  6. [N/A]

 

If efficacy results are recorded for different treatment conditions (by repeating this block of fields), briefly indicate the type of treatment/application the results refer to. Specify dose, application rate, duration, etc.

Description of treatment/application the results refer to.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:TREATMENT>

<i5:TREATMENT>

SE10.02.00.0870

Interfering substances

[Interfering substances]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g13
  4. 1
  5. 1
  6. Z08

Picklist Values:

yes || no || no data || not applicable

Indicate if interfering substances were present. If 'yes' is selected, briefly specify in the supplementary remarks field.

Indication if interfering substances were present.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:PHRASEOTHER_INTERFERING_SUBSTANCE>

<i5:INTERFERING_SUBSTANCE>

SE10.02.00.0871

Interfering substances

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g13
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:PHRASEOTHER_INTERFERING_SUBSTANCE>

<i5:INTERFERING_SUBSTANCE_TXT>

SE10.02.00.0880

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g13
  4. 1
  5. 1
  6. [N/A]

 

Enter any remarks related to the minimum effective dose recorded in this block of fields.

Remarks on minimum effective dose.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:MIN_EFF_DOSE>

<i5:set>

<i5:REM>

<i5:REM>

SE10.02.00.0890

Details on results

[Details on results]

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

Freetext Templates:

RESULTS

- Effects observed:

- Dose/concentration dependence of effects:

- Begin and duration of effectiveness:

- Observed effects in post-monitoring phase:

- Reinvasion/reinfestation:

- Existence of threshold concentration:

- Other:

REPORTED STATISTICS:

REFERENCE SUBSTANCE

- Results with reference substance:

- Results with reference substance valid?

Summarise any relevant results. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report, upload predefined table(s) in the rich text field 'Any other information on results incl. tables' or attach graphs in field 'Attached background material'.

Note: Observed limitations on efficacy in terms of resistance, undesirable or unintended side effects, or other limitations should be described in the corresponding fields below.

Additional information on results

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE10.02.00.0895

Observed limitations on efficacy

[Observed limitations on efficacy]

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

 

 

Subheading of section 'Observed limitations on efficacy'

 

SE10.02.00.0900

Indication of resistance

[Indication of resistance]

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

Picklist Values:

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

Indicate whether any development of resistance was observed or not. In below field 'Details on development of resistance', give details or provide any further explanation, e.g. stating that effects were observed, but considered negligible.

Select 'not examined' or 'no data' as applicable.

Indicator if resistance was observed or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:RESISTANCE_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE10.02.00.0910

Details on development of resistance

[Details on development of resistance]

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

 

Provide details on the development of resistance as observed in the efficacy study(ies), including any evidence of cross-resistance.

Details on development of resistance.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:RESISTANCE_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.02.00.0920

Undesirable or unintended side effects

[Undesirable or unintended side effects]

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

Picklist Values:

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

Indicate whether any undesirable or unintended side effects were observed or not. In below field 'Details on undesirable or unintended side effects', give details or provide any further explanation, e.g. stating that effects were observed, but considered negligible.

Select 'not examined' or 'no data' as applicable.

Indicator if undesirable or unintended side effects were observed or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:SIDEEFFECTS_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE10.02.00.0930

Details on undesirable or unintended side effects

[Details on undesirable or unintended side effects]

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

 

Provide details on undesirable or unintended side effects as observed in the efficacy study(ies).

Where appropriate or required by the relevant legislation, insert subheadings, e.g.:

- Adverse effects on health of host animals

- Adverse effects on site of application (e.g. discoloration, corrosion, etc.)

- Adverse effects on beneficial and other non-target organisms

- Adverse effects on objects to be protected:

Details on undesirable or unintended side effects.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:SIDEEFFECTS_DETAILS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.02.00.0940

Other limitations observed

[Other limitations observed]

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

 

Where there is evidence of other possible limitations as derived from the study results, describe the relevant factors that can possibly reduce the efficacy, e.g. certain climatic or edaphic conditions.

Other limitations observed.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:OTHER_LIMITATIONS>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE10.02.00.0950

Relevance of study results

[Relevance of study results]

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

Freetext Templates:

RELEVANCE OF LABORATORY TESTING

- Reasons for laboratory testing:

- Intended actual scale of biocide application:

- Relevance compared to field conditions:

- Application method:

- Test organism:

- Observed effect:

RELEVANCE OF STUDY FOR READ-ACROSS

...

For laboratory studies, provide arguments for performing such studies instead of a field test. If a study was conducted in a reduced scale, the dimension should be given as compared to the actual scale of the product (e.g. 'Test was reduced to a scale of 1:100').

If the study or studies summarised in this record were conducted with another formulation type or application method, provide a justification for this read-across through either the provision of a reasoned case based on data or through bridging arguments.

Use freetext template and delete/add elements as appropriate.

Relevance of study results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EF_EFFICACY_DATA>

<i5:RELEVANCE_RESULTS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE10.02.00.0960

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:EF_EFFICACY_DATA>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE10.02.00.0965

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.

 

SE10.02.00.0970

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:EF_EFFICACY_DATA>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE10.02.00.0979

Attached background material

[Attached background material]

  1. HEAD BLOCK
  2. Block label
  3. g14
  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'.

 

SE10.02.00.0980

Attached document

[Attached document]

  1. ATTACHMENT
  2. STRING/32768
  3. g14
  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.