OECD Template #47: Toxicity to microorganisms (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.

 

 

 

SE06.01.07.0215

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.

 

SE06.01.07.0219

Reference

[Reference]

  1. HEAD BLOCK
  2. Block label
  3. g337
  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'

 

SE06.01.07.0220

Reference type

[Reference type]

  1. LIST-OPEN
  2. STRING/255
  3. g337
  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:EC_BACTOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE06.01.07.0221

Reference type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g337
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE06.01.07.0230

Author(s) (or transferred reference)

[Author]

  1. TEXT
  2. STRING/2000
  3. g337
  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:EC_BACTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE06.01.07.0240

Year

[Year]

  1. YEAR
  2. NUMBER/4/###0
  3. g337
  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:EC_BACTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE06.01.07.0250

Title

[Title]

  1. TEXT
  2. STRING/255
  3. g337
  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:EC_BACTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE06.01.07.0260

Bibliographic source

[Bibliographic source]

  1. TEXT
  2. STRING/255
  3. g337
  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:EC_BACTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE06.01.07.0270

Testing laboratory

[Testing laboratory]

  1. TEXT
  2. STRING/255
  3. g337
  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:EC_BACTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE06.01.07.0280

Report no.

[Report no.]

  1. TEXT
  2. STRING/255
  3. g337
  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:EC_BACTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE06.01.07.0290

Owner company

[Owner company]

  1. TEXT
  2. STRING/255
  3. g337
  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:EC_BACTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE06.01.07.0300

Company study no.

[Company study no.]

  1. TEXT
  2. STRING/255
  3. g337
  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:EC_BACTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE06.01.07.0310

Report date

[Report date]

  1. DATE
  2. DATE/255
  3. g337
  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:EC_BACTOX>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE06.01.07.0320

Data access

[Data access]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z03

Picklist Values:

data submitter is data owner || data submitter has Letter of Access || data no longer protected || data published || not applicable || other:

Select appropriate indication for data access. Enter 'Not applicable' if the summary consists of information that is commonly accessible such as guidance on safe use.

Indication for data access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE06.01.07.0321

Data access

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE06.01.07.0330

Data protection claimed

[Data protection claimed]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z30

Picklist Values:

yes || yes, but willing to share || yes, but not willing to share

Indicate as appropriate. Note: 'yes' should be selected only if 'Data submitter is data owner' or 'Data submitter has Letter of Access'. Options 'yes, but willing to share' or 'yes, but not willing to share' may be relevant for specific regulatory programmes where the submitter is requested to indicate whether he is willing to share studies (e.g. with vertebrates).

In the supplementary remarks field, include an explanation as appropriate, i.e. justification for denial of sharing the corresponding study or refer to a document attached that provides justification (e.g. 'for justification see attached document X')

Indication if data protection is claimed by the submitter who has to be data owner or have letter of access.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE06.01.07.0331

Data protection claimed

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE06.01.07.0340

Cross-reference to same study

[Cross-reference to same study]

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

 

A cross-reference can be included to indicate that the same study is recorded in another record. Indicate the respective chapter and record ID and enter relevant explanatory text. This may be useful if specific endpoints of a given study are described in another chapter (e.g. results on reproduction toxicity in case of a combined repeated dose / reproduction toxicity study) or if more than one experiment is described by the same study report, but included in separate records.

Check with the relevant guidance document whether all the methodology details must be repeated or whether a cross-reference to the same study in another chapter may suffice.

Note that any such cross-reference may become useless if a record is either printed or exchanged on its own.

Indication that the same study is described in another study summary / chapter of the data set.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE06.01.07.0345

MATERIALS AND METHODS

[Materials and methods]

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

 

 

Main heading under which generic 'Materials and methods' fields are subsumed.

 

SE06.01.07.0349

Test guideline

[Test guideline]

  1. HEAD BLOCK
  2. Block label
  3. g338
  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'

 

SE06.01.07.0350

Qualifier

[Qualifier]

  1. LIST-CLOSED
  2. STRING/255
  3. g338
  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:EC_BACTOX>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE06.01.07.0360

Guideline

[Guideline]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g338
  4. 1
  5. 1
  6. E12-1

Picklist Values:

OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test) || OECD Guideline 224 (Determination of the Inhibition of the Activity of Anaerobic Bacteria) || EU Method C.11 (Biodegradation: Activated Sludge Respiration Inhibition Test) || EPA OPPTS 850.6800 (Modified Activated Sludge, Respiration Inhibition Test for Sapringly Soluble Chemicals) || EPA OTS 795.1700 (Modified Activated Sludge, Respiration Inhibition Test for Sapringly Soluble Chemicals) || DIN 38412, part 8 (Pseudomonas Zellvermehrungshemm-Test) || ETAD Fermentation Tube Method || ISO 8192 (Test for Inhibition of Oxygen Consumption by Activated Sludge) || ISO DIS 9509 (Method for Assessing the Inhibition of Nitrification of Activated Sludge Microorganisms by Chemicals and Waste Waters) || 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:EC_BACTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE06.01.07.0361

Guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g338
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE06.01.07.0370

Deviations from guideline

[Deviations]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g338
  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:EC_BACTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE06.01.07.0371

Deviations from guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g338
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE06.01.07.0380

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:EC_BACTOX>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE06.01.07.0390

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:EC_BACTOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.01.07.0391

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:EC_BACTOX>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.01.07.0395

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'

 

SE06.01.07.0400

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:EC_BACTOX>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE06.01.07.0409

Test material identity

[Test material identity]

  1. HEAD BLOCK
  2. Block label
  3. g339
  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'

 

SE06.01.07.0410

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g339
  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:EC_BACTOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE06.01.07.0411

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g339
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE06.01.07.0420

Identity

[Identity]

  1. TEXT
  2. STRING/2000
  3. g339
  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:EC_BACTOX>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE06.01.07.0425

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:EC_BACTOX>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE06.01.07.0426

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:EC_BACTOX>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE06.01.07.0430

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.

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SE06.01.07.0440

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.

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SE06.01.07.0450

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:

- Boiling point:

- Vapour pressure:

- Water solubility (under test conditions):

- Henry's law constant:

- log Pow:

- pKa:

- Stability in water:

- Stability in light:

- pH dependance on stability:

OTHER PROPERTIES (if relevant for this endpoint)

- Results of test for ready biodegradability:

- Other:

ONLY if another substance, i.e. analogue or surrogate (e.g. degradation/transformation product) was used as test material, enter any relevant details on the properties of this substance that may possibly affect the test performance, particularly physico-chemical 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 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.

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SE06.01.07.0460

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 test substance was monitored in the test solutions.

For robust study summaries or as requested by the regulatory programme, provide further details on sampling and analytical methods in the corresponding freetext fields.

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

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SE06.01.07.0470

Details on sampling

[Details on sampling]

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

Freetext Templates:

- Concentrations:

- Sampling method:

- Sample storage conditions before analysis:

If the amount of test material exposed to the organisms was monitored, enter details on sampling. Use freetext template as appropriate and delete/add elements as appropriate.

Details on sampling.

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SE06.01.07.0480

Details on analytical methods

[Details on analytical methods]

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

Freetext Templates:

DETAILS ON PRETREATMENT

- Centrifugation:

- Filtration:

- Digestion (acid used, method: e.g. micro-oven):

- Extraction (solvent used, method: e.g. liquid-liquid, SPE):

- Clean up method: e.g. chemical used for chemistry method (Cu, Hg, ...) or phase and solvent used for SPE method:

- Derivatisation method if used:

- Concentration (method):

IDENTIFICATION AND QUANTIFICATION OF TEST SUBSTANCE/PRODUCT

- Separation method (e.g. HPLC, GC):

- Conditions (column, mobile phase, etc.):

- Detection method (e.g. ECD, UV, MS, ICP-AES, ICP-MS):

- Detection limits (LOD, LOQ) (indicate method of determination/calculation):

- Reproducibility in % (indicate method of evaluation; should be given for stated concentration levels):

- Linearity range:

- Internal or external calibration:

- Extraction recovery (indicate if results are corrected or not for recoveries):

- Method of confirmation of identity of measured compound:

If the amount of test material exposed to the organisms was monitored, enter any details on the analytical methods used. Use freetext template and delete/add elements as appropriate.

Details on the analytical method used.

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SE06.01.07.0490

Vehicle

[Vehicle]

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

Picklist Values:

yes || no || no data

Indicate whether vehicle was used to emulsify or mix the experimental test material to enhance its solubility. If yes, specify in field 'Details on test solution'.

Indicator that a chemical was used to emulsify or mix the experimental test material to enhance its solubility.

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SE06.01.07.0500

Details on test solutions

[Details on test solutions]

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

Freetext Templates:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

- Method:

- Eluate:

- Differential loading:

- Controls:

- Chemical name of vehicle (organic solvent, emulsifier or dispersant):

- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)):

- Evidence of undissolved material (e.g. precipitate, surface film, etc):

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

Details on preparation and application of test solution.

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SE06.01.07.0505

Test organisms

[Test organisms]

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

 

 

Subheading of section 'Test organisms'

 

SE06.01.07.0510

Test organisms (species)

[Test organisms (species)]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E11

Picklist Values:

activated sludge || activated sludge of a predominantly domestic sewage || activated sludge of a predominantly industrial sewage || activated sludge of a predominantly industrial sewage, de-adapted || activated sludge, domestic || activated sludge, industrial || sewage, domestic || sewage, industrial || aerobic microorganisms || anaerobic bacteria from a domestic water treatment plant || anaerobic bacteria || anaerobic microorganisms || anaerobic sludge || Achromobacter sp. || Acrostalagmus sp. || Aerobacter sp. || Aeromonas hydrophila || Aeromonas sp. || Agrobacterium sp. || Alcaligenes sp. || Anacystis aeruginosa || Anacystis sp. || Arthrobacter sp. || Arthrobacter terregnes || Aspergillus niger || Aspergillus sp. || Aureobasidium sp. || Azobacter sp. || Azospirillum brasilense || Azospirillum sp. || Azotobacter sp. || Bacillus cirroflagellosus || Bacillus sp. || Bacillus stearothermophilus || Bacillus subtilis || Bacillus thuringiensis || Brevibacterium sp. || Candida albicans || Candida boidinii || Candida sp. || Candida utilis || Caulobacter sp. || Chilomonas paramaecium || Chilomonas sp. || Citrobacter sp. || Claviceps sp. || Clitocybe nebularis || Clonostachys sp. || Clostridium sordellii || Clostridium sp. || Colpidium campylum || Colpidium sp. || Corynebacterium sp. || Cylindrocardon sp. || Endomycopsis fibuligera || Endomycopsis sp. || Enterobacteria sp. || Entosiphon sp. || Entosiphon sulcatum || Escherichia coli || Escherichia sp. || Euglena sp. || Euplotes sp. || Flavobacterium sp. || Fusarium lini || Fusarium sp. || Geotrichum sp. || Hansenula glucozyma || Hansenula sp. || Helminthosporium sp. || Klebsiella sp. || Lactobacillus sp. || Lepista nuda || Lepista sp. || Lycoperdum mammaeforme || Lycoperdum piriforme || Lycoperdum sp. || Macrolepiota procera || Macrplepiota sp. || Micrococcus sp. || Microcystis aeruginosa || Microcystis sp. || Microspora canis || Microspora sp. || Mucor sp. || Mycobacter sp. || Mycoplana sp. || Myrothecium sp. || Nitrobacter sp. || Nitrosomonas sp. || Nocardia resticta || Nocardia sp. || Olomerella sp. || Paecilomyces sp. || Paramaecium caudatum || Paramaecium sp. || Pavlova sp. || Penicilium sp. || Periconia prolifica || Periconia sp. || Phialophora cinerescens || Phialophora sp. || Phormidium sp. || Photobacterium phosphoreum || Photobacterium sp. || Proteus mirabilis || Proteus sp. || Proteus vulgaris || Pseudomonas aeruginosa || Pseudomonas alcalignes || Pseudomonas fluorescens || Pseudomonas putida || Pseudomonas sp. || Pseudomonas testosteroni || Rhizobium sp. || Saccharomyces cerevisiae || Saccharomyces sp. || Salmonella sp. || Salmonella typhimurium || Sarcina sp. || Sclerotinia sp. || Scopulariopsis sp. || Serratia sp. || Sporocytophaga sp. || Staphylococcus aureus || Staphylococcus sp. || Stemphylium sp. || Stemphylium vesicarium || Streptococcus faecalis || Streptococcus lactus || Streptococcus sp. || Streptomyces antibiotio || Streptomyces griseus || Streptomyces sp. || Tetrahymena pyriformis || Tetrahymena sp. || Thiobacillus sp. || Torulopsis sp. || Trichoderma mentagrophythes || Trichoderma sp. || Uronema parduzci || Uronema sp. || Verticillium sp. || Vibrio fisheri || Vibrio sp. || Vorticella sp. || Xanthomonas sp. || Xylaria sp. || other:

Select species or type of activated sludge used as inoculum. If not available, select 'other' and specify.

The test species or organism in an experimental study.

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SE06.01.07.0511

Test organisms (species)

[no label]

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

 

 

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SE06.01.07.0520

Details on inoculum

[Details on inoculum]

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

Freetext Templates:

- Laboratory culture:

- Method of cultivation:

- Preparation of inoculum for exposure:

- Pretreatment:

- Initial biomass concentration:

Give details on inoculum as appropriate.

Details on inoculum as appropriate.

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SE06.01.07.0525

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'

 

SE06.01.07.0530

Test type

[Test type]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E01

Picklist Values:

static || semi-static || flow-through || other: || no data

Select appropriate test type.

Indicator showing whether medium was supplied in a static, semi-static or flow-through way.

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SE06.01.07.0531

Test type

[no label]

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

 

 

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SE06.01.07.0540

Water media type

[Water media type]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E102

Picklist Values:

freshwater || saltwater || brackish water || no data

Indicate whether organisms were tested in fresh-/salt- or brackish/estuarine water.

Indicator specifying whether organisms were tested in fresh-/salt- or brackish/estuarine water.

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SE06.01.07.0550

Limit test

[Limit test]

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

Picklist Values:

yes || no

Indicate if the experiment was a limit test.

An indicator that the experiment was a limit test.

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SE06.01.07.0560

Duration

[Total exposure duration]

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

 

Enter numeric value.

Numeric value of exposure duration.

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SE06.01.07.0570

Unit

[Total exposure duration]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E18

Picklist Values:

min || d || h

Select from drop-down list.

Unit of exposure duration

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SE06.01.07.0580

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.

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SE06.01.07.0590

Post exposure observation period

[Post exposure observation period]

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

 

Indicate the post-observation period (with unit) if appropriate.

Observation period after last exposure to the test chemical.

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SE06.01.07.0595

Test conditions

[Test conditions]

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

 

 

Subheading of section 'Test conditions'

 

SE06.01.07.0600

Hardness

[Hardness]

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

 

For freshwater tests, indicate water hardness as mg/L calcium carbonate equivalent values measured in the treatment and control solutions during test. Include range, mean, standard deviation and unit. Alternatively refer to table (e.g. 'see table no. 2') if the test conditions are presented in tabular form in the rich text editor field.

The concentration of calcium and magnesium ions in water, measured as mg/L calcium carbonate equivalent.

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SE06.01.07.0610

Test temperature

[Test temperature]

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

 

Indicate test temperature values measured in the treatment and control solutions during test. Include range, mean, standard deviation and unit. As appropriate state the location (e.g. water bath, test chambers) and type of measurement (e.g. continuous monitoring). Alternatively refer to table (e.g. 'see table no. 2') if the test conditions are presented in tabular form in the rich text editor field.

The temperature used in the experimental determination of the test value.

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SE06.01.07.0620

pH

[pH]

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

 

Indicate pH values measured in the treatment and control solutions during test. Include range, mean, standard deviation and unit. Alternatively refer to table (e.g. 'see table no. 2') if the test conditions are presented in tabular form in the rich text editor field.

The pH value applicable to the measured test value or mean or range.

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SE06.01.07.0630

Dissolved oxygen

[Dissolved oxygen]

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

 

Indicate dissolved oxygen values measured in the treatment and control solutions during test. Include range, mean, standard deviation and unit. Alternatively refer to table (e.g. 'see table no. 2' ) if the test conditions are presented in tabular form in the rich text editor field.

The amount of soluble oxygen in water including mean or range.

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SE06.01.07.0640

Salinity

[Salinity]

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

 

For marine studies, indicate salinity values measured in the treatment and control solutions during test. Include range, mean, standard deviation and unit. Alternatively refer to table (e.g. 'see table no. 2') if the test conditions are presented in tabular form in the rich text editor field.

The salinity used in the experimental determination of the test value.

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SE06.01.07.0650

Nominal and measured concentrations

[Nominal and measured concentrations]

  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.

List nominal and, if available, measured test concentrations (with unit). As appropriate tabulate nominal vs. measured concentrations in the rich text field 'Any other information on results incl. tables'. Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the Remarks text (e.g. '... see Table 1').

Use alternative predefined tables if data for both the technical end product and the active ingredient are to be recorded.

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

Nominal and, if available, measured test concentrations (with unit) and/or reference to table.

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SE06.01.07.0660

Details on test conditions

[Details on test conditions]

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

Freetext Templates:

TEST SYSTEM

- Test vessel:

- Type (delete if not applicable): open / closed

- Material, size, headspace, fill volume:

- Aeration:

- Type of flow-through (e.g. peristaltic or proportional diluter):

- Renewal rate of test solution (frequency/flow rate):

- No. of organisms per vessel:

- No. of vessels per concentration (replicates):

- No. of vessels per control (replicates):

- No. of vessels per vehicle control (replicates):

- Biomass loading rate:

TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water:

- Total organic carbon:

- Particulate matter:

- Metals:

- Pesticides:

- Chlorine:

- Alkalinity:

- Ca/mg ratio:

- Conductivity:

- Culture medium different from test medium:

- Intervals of water quality measurement:

OTHER TEST CONDITIONS

- Adjustment of pH:

- Photoperiod:

- Light intensity:

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS

- Spacing factor for test concentrations:

- Justification for using less concentrations than requested by guideline:

- Range finding study

- Test concentrations:

- Results used to determine the conditions for the definitive study:

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

Further details on test conditions.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:TESTCONDIT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.07.0670

Reference substance (positive control)

[Reference substance (positive control)]

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

Picklist Values:

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

Indicate if a positive control was tested, i.e. a reference substance with known toxicity. If yes, include the identity of the substance(s) and the concentrations in the supplementary remarks field.

Indicator specifying whether reference substance(s) was/were tested and identity and concentrations in supplementary remarks field.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.01.07.0671

Reference substance (positive control)

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:REFERENCE_SUBSTANCE>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.01.07.0680

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:EC_BACTOX>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.01.07.0685

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.

 

SE06.01.07.0689

Effect concentrations

[Effect concentrations]

  1. HEAD BLOCK
  2. Block label
  3. g340
  4. 20
  5. 1
  6. [N/A]

 

Report the EC50 or other effect levels. Copy this field block for entering more than one effect level if necessary.

Heading of field block 'Effect concentrations'

 

SE06.01.07.0690

Exposure duration

[Duration]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g340
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Numeric value of exposure duration to which the effect concentration refers.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:VALUEUNIT_EXP_DURATION_VALUE>

<i5:EXP_DURATION_VALUE>

SE06.01.07.0700

Unit

[Effect concentrations]

  1. LIST-CLOSED
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. E18

Picklist Values:

min || d || h

Select from drop-down list.

Unit of exposure duration

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:VALUEUNIT_EXP_DURATION_VALUE>

<i5:EXP_DURATION_UNIT>

SE06.01.07.0710

Endpoint

[Endpoint]

  1. LIST-OPEN
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. E107

Picklist Values:

EC0 || EC10 || EC50 || EC100 || IC0 || IC10 || IC50 || IC100 || NOEC || LOEC || other:

Select from drop-down list.

Endpoint type, e.g. LC50, to which the effect concentration refers.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT>

SE06.01.07.0711

Endpoint

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_ENDPOINT>

<i5:ENDPOINT_TXT>

SE06.01.07.0720

Effect concentration

[Effect conc.]

  1. LIST-CLOSED
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. A02-1

Picklist Values:

> || >= || ca.

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

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

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

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE06.01.07.0730

Effect concentration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g340
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE06.01.07.0740

Effect concentration

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE06.01.07.0750

Effect concentration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g340
  4. 1
  5. 1
  6. [N/A]

 

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE06.01.07.0760

Unit of effect concentrations

[Effect concentrations]

  1. LIST-OPEN
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. E05

Picklist Values:

ng/L || µg/L || mg/L || g/L || µmol/L || mmol/L || mol/L || other:

Select from drop-down list.

Unit of effect concentrations

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE06.01.07.0761

Unit of effect concentrations

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT_TXT>

SE06.01.07.0770

Basis for concentration

[Nominal/Measured]

  1. LIST-CLOSED
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. E35

Picklist Values:

nominal || meas. (initial) || meas. (geom. mean) || meas. (arithm. mean) || meas. (TWA) || meas. (not specified) || acid equivalent || estimated || no data

Indicate whether the effect concentration is based on nominal, measured (initial / geometric mean / arithmetic mean), measured (time weighted average = TWA), measured (not specified), acid equivalent or estimated. Select 'no data' if not known.

Indication of whether the effect concentration is based on (mean/initial) measured, nominal or estimated concentrations.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:BASIS_CONC>

<i5:BASIS_CONC>

SE06.01.07.0780

Effect concentration type

[Conc. based on]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. E105

Picklist Values:

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

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

Select 'no data' if effect concentration type is not known.

Indication of whether the concentration is based on the test material, active ingredient, free metal etc.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_EFF_CONC_TYPE>

<i5:EFF_CONC_TYPE>

SE06.01.07.0781

Effect concentration type

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_EFF_CONC_TYPE>

<i5:EFF_CONC_TYPE_TXT>

SE06.01.07.0790

Basis for effect

[Basis for effect]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. E108

Picklist Values:

growth inhibition || nitrification rate || respiration rate || other: || no data

Select effect parameter such as respiratory rate or growth inhibition, which the effect concentration relates to. As appropriate include further details in the supplementary remarks field.

Effect parameter such as mortality or behaviour, which the effect concentration relates to.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_BASIS_EFFECT>

<i5:BASIS_EFFECT>

SE06.01.07.0791

Basis for effect

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:PHRASEOTHER_BASIS_EFFECT>

<i5:BASIS_EFFECT_TXT>

SE06.01.07.0800

Remarks (e.g. 95% CL)

[Remarks (e.g. 95% CL)]

  1. TEXT
  2. STRING/255
  3. g340
  4. 1
  5. 1
  6. [N/A]

 

For robust study summaries or as requested by the regulatory programme, provide the 95% confidence limits and/or any relevant short remarks.

Remarks on effect concentration.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:EFFCONC>

<i5:set>

<i5:REM>

<i5:REM>

SE06.01.07.0810

Details on results

[Details on 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:

- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values:

- Effect concentrations exceeding solubility of substance in test medium:

Briefly summarise relevant observations and any dose response relationship. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

Include table(s) with raw data in the rich text field 'Any other information on results incl. tables'. Upload predefined table(s) if any or adapt table(s) from study report. Use table numbers in the sequence in which you refer to them in the text (e.g. '... see Table 1').

As appropriate also attach a figure with growth curves in field 'Attached background material'.

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

Details on results

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:RESULTS_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.07.0820

Results with reference substance (positive control)

[Results with reference substance (positive control)]

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

Freetext Templates:

- Results with reference substance valid?

- Relevant effect levels:

- Other:

If reference substance(s) was/were tested, indicate whether the results with it/them are valid and provide relevant effect levels and other relevant information.

Use freetext template and delete/add elements as appropriate.

Indication whether the results with the reference substance(s) are valid.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:RS_REF_SUBSTANCE>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE06.01.07.0830

Reported statistics and error estimates

[Reported statistics and error estimates]

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

 

Indicate the parameters analysed, the statistical method used and the statistical test performed. If probit analysis was used, indicate the intercept and probit slope. As appropriate state any relevant error estimates associated with the determination of concentration-response relationship.

Indication of statistical data and error estimates associated with the determination of the concentration-response relationship.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:STATISTICS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE06.01.07.0840

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:EC_BACTOX>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.01.07.0845

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.

 

SE06.01.07.0850

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:EC_BACTOX>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE06.01.07.0859

Attached background material

[Attached background material]

  1. HEAD BLOCK
  2. Block label
  3. g341
  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'.

 

SE06.01.07.0860

Attached document

[Attached document]

  1. ATTACHMENT
  2. STRING/32768
  3. g341
  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:EC_BACTOX>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE06.01.07.0870

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g341
  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:EC_BACTOX>

<i5:AD>

<i5:set>

<i5:REM>

<i5:REM>

SE06.01.07.0879

Attached full study report

[Attached full study report]

  1. HEAD BLOCK
  2. Block label
  3. g342
  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

 

SE06.01.07.0880

Attached full study report

[Attached full study report]

  1. ATTACHMENT
  2. STRING/32768
  3. g342
  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:EC_BACTOX>

<i5:AD_STUDYREPORT>

<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE06.01.07.0882

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:EC_BACTOX>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE06.01.07.0885

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.

 

SE06.01.07.0890

Validity criteria fulfilled

[Validity criteria fulfilled]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. F102

Picklist Values:

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

Indicate whether validity criteria given by test guideline have been fulfilled or not. Use supplementary remarks field for indicating the criteria and entering remarks. Clearly indicate if the criteria used are not consistent with those given by the test guideline. If so, give justification in field 'Rationale for reliability incl. deficiencies' as to why this study summary is considered reliable.

Indication of validity criteria and whether they have been fulfilled or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE06.01.07.0891

Validity criteria fulfilled

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:EC_BACTOX>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE06.01.07.0900

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:EC_BACTOX>

<i5:APPL_CL>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE06.01.07.0910

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.

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SE06.01.07.0920

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.

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