OECD Template #25: Hydrolysis (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.

 

 

 

SE05.01.02.0215

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.

 

SE05.01.02.0219

Reference

[Reference]

  1. HEAD BLOCK
  2. Block label
  3. g169
  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'

 

SE05.01.02.0220

Reference type

[Reference type]

  1. LIST-OPEN
  2. STRING/255
  3. g169
  4. 1
  5. 1
  6. Z31

Picklist Values:

study report || other company data || publication || review article or handbook || secondary source || grey literature || other:

Indicate the type of reference, e.g. 'Study report' or 'Publication'. Select 'Other company data' to characterise any unpublished information from a company other than a study report. Select 'Grey literature' for any other unpublished information or 'other:' and specify.

Indicator specifying the type of reference, e.g. 'Study report' or 'Publication'.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE>

SE05.01.02.0221

Reference type

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g169
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REFERENCE>

<i5:set>

<i5:PHRASEOTHER_REFERENCE_TYPE>

<i5:REFERENCE_TYPE_TXT>

SE05.01.02.0230

Author(s) (or transferred reference)

[Author]

  1. TEXT
  2. STRING/2000
  3. g169
  4. 1
  5. 1
  6. [N/A]

 

For ease of sorting and searchability use following convention: Surname, Initial (Example 1: White D, Ruehl KJ, Borman SA & Little J. Example 2: Hartley M & Murray W (avoid unnecessary full-stops, commas)). If no individuals are cited as authors, enter name of company or organisation or 'Anon.' as appropriate.

Note that the complete bibliographic reference may appear in this field after migration of unstructured data from existing databases.

Name(s) of author(s) of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_AUTHOR>

<i5:REFERENCE_AUTHOR>

SE05.01.02.0240

Year

[Year]

  1. YEAR
  2. NUMBER/4/###0
  3. g169
  4. 1
  5. 1
  6. [N/A]

 

Enter year of study report or publication. For a study report this field should be completed to include it in any searches, regardless of whether the complete date is given in field 'Report date'.

Year of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_YEAR>

<i5:REFERENCE_YEAR>

SE05.01.02.0250

Title

[Title]

  1. TEXT
  2. STRING/255
  3. g169
  4. 1
  5. 1
  6. [N/A]

 

Include the title of the report. For publications, include the title of the article of a journal or article/chapter of a book (e.g. handbook).

Title of a study report or title of published article of journal or book (e.g. handbook).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TITLE>

<i5:REFERENCE_TITLE>

SE05.01.02.0260

Bibliographic source

[Bibliographic source]

  1. TEXT
  2. STRING/255
  3. g169
  4. 1
  5. 1
  6. [N/A]

 

Not relevant for any study report. For publications or any other literature source (grey literature) specify the following type of information: (i) Title of scientific journal or book (e.g. if handbook); (ii) Volume of journal; (iii) Editor, publisher, place of publication for books or articles in books; (iv) Pagination.

Example 1 (journal): J. Agric. Food Chem. 38: 215-227

Example 2 (handbook): In: Lyman WJ (ed.) Handbook of chemical property estimation methods. Environmental behavior of organic compounds. McGraw-Hill Book Company 15.1-15.34, New York.

Bibliographic source of the study report or publication.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_SOURCE>

<i5:REFERENCE_SOURCE>

SE05.01.02.0270

Testing laboratory

[Testing laboratory]

  1. TEXT
  2. STRING/255
  3. g169
  4. 1
  5. 1
  6. [N/A]

 

Either manually enter the name of the testing laboratory or select it from the picklist. In either case, editing is possible.

Name of the testing laboratory.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_TESTLAB>

<i5:REFERENCE_TESTLAB>

SE05.01.02.0280

Report no.

[Report no.]

  1. TEXT
  2. STRING/255
  3. g169
  4. 1
  5. 1
  6. [N/A]

 

Specify the report number allocated by the testing laboratory. Note that any company-specific study number should be included in the respective field.

Report number allocated by the testing laboratory.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_NO>

<i5:REFERENCE_REPORT_NO>

SE05.01.02.0290

Owner company

[Owner company]

  1. TEXT
  2. STRING/255
  3. g169
  4. 1
  5. 1
  6. [N/A]

 

Either manually enter the identity of the company who owns the data or select it from the picklist. In either case, editing is possible.

Identity of the sponsor company who owns the study report.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_ID>

<i5:REFERENCE_COMPANY_ID>

SE05.01.02.0300

Company study no.

[Company study no.]

  1. TEXT
  2. STRING/255
  3. g169
  4. 1
  5. 1
  6. [N/A]

 

Specify any company study no. if there is such a number and if it is different from the report no. of the testing laboratory. Otherwise leave field empty.

Company-specific study number.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_COMPANY_STUDY_NO>

<i5:REFERENCE_COMPANY_STUDY_NO>

SE05.01.02.0310

Report date

[Report date]

  1. DATE
  2. DATE/255
  3. g169
  4. 1
  5. 1
  6. [N/A]

 

Specify the complete date of the study report, e.g. '2005-05-12' for 12 May 2005. Note that subfield 'Year' should be completed in any case for sorting and searching purposes.

Complete date of the study report.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REFERENCE>

<i5:set>

<i5:REFERENCE_REPORT_DATE>

<i5:REFERENCE_REPORT_DATE>

SE05.01.02.0320

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:TO_HYDROLYSIS>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP>

SE05.01.02.0321

Data access

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:DATA_ACCESS>

<i5:set>

<i5:PHRASEOTHER_LIST_POP>

<i5:LIST_POP_TXT>

SE05.01.02.0330

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:TO_HYDROLYSIS>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX>

SE05.01.02.0331

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:TO_HYDROLYSIS>

<i5:DATA_PROT_CLAIM>

<i5:set>

<i5:PHRASEOTHER_LIST_POP_FIX>

<i5:LIST_POP_FIX_TXT>

SE05.01.02.0340

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:TO_HYDROLYSIS>

<i5:CROSSREF_SAMESTUDY>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.01.02.0345

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.

 

SE05.01.02.0349

Test guideline

[Test guideline]

  1. HEAD BLOCK
  2. Block label
  3. g170
  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'

 

SE05.01.02.0350

Qualifier

[Qualifier]

  1. LIST-CLOSED
  2. STRING/255
  3. g170
  4. 1
  5. 1
  6. Z06

Picklist Values:

according to || equivalent or similar to || no guideline followed || no guideline available || no guideline required

Select appropriate qualifier, i.e.

- 'according to' (if a given test guideline was followed);

- 'equivalent or similar to' (if no test guideline was explicitly followed, but the methodology is equivalent or similar to a specific guideline);

- 'no guideline followed' (if none of above qualifiers apply. If so, fill in field 'Principles of method if other than guideline');

- 'no guideline available' (if so, fill in field 'Principles of method if other than guideline').

- 'no guideline required' (if so, fill in field 'Principles of method if other than guideline').

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:GUIDELINE>

<i5:set>

<i5:QUALIFIER>

<i5:QUALIFIER>

SE05.01.02.0360

Guideline

[Guideline]

  1. LIST-OPEN-SUP
  2. STRING/255
  3. g170
  4. 1
  5. 1
  6. F09

Picklist Values:

OECD Guideline 111 (Hydrolysis as a Function of pH) || EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH) || EPA Guideline Subdivision N 161-1 (Hydrolysis) || EPA OPPTS 835.2110 (Hydrolysis as a Function of pH) || EPA OPPTS 835.2120 (Hydrolysis of Parent and Degradates as a Function of pH at 25°C) || EPA OPPTS 835.2130 (Hydrolysis as a Function of pH and Temperature) || EPA OTS 796.3500 (Hydrolysis as a Function of pH at 25°C) || EPA OTS 796.3510 (Hydrolysis as a Function of pH and Temperature) || 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:TO_HYDROLYSIS>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE>

SE05.01.02.0361

Guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g170
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_GUIDELINE>

<i5:GUIDELINE_TXT>

SE05.01.02.0370

Deviations from guideline

[Deviations]

  1. LIST-CLOSED-SUP
  2. STRING/255
  3. g170
  4. 1
  5. 1
  6. Z08

Picklist Values:

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

For robust study summaries or as requested by the regulatory programme, indicate if there are any deviations from the test guideline specified. If 'yes' is selected, only briefly state relevant deviations in the supplementary remarks field (e.g. 'other species used'); details should be described in the respective fields of the section MATERIALS AND METHODS.

Indication that a study contains deviations from the standard test protocol.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION>

SE05.01.02.0371

Deviations from guideline

[no label]

  1. SUP-TEXT
  2. STRING/255
  3. g170
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:GUIDELINE>

<i5:set>

<i5:PHRASEOTHER_DEVIATION>

<i5:DEVIATION_TXT>

SE05.01.02.0380

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.

Description of the test protocol or estimated method used in the study, if other than a guideline, and justification for using this method if appropriate.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:METHOD_NOGUIDELINE>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE05.01.02.0390

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:TO_HYDROLYSIS>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE05.01.02.0391

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:TO_HYDROLYSIS>

<i5:GLP_COMPLIANCE_STATEMENT>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE05.01.02.0395

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'

 

SE05.01.02.0400

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:TO_HYDROLYSIS>

<i5:TESTMAT_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.01.02.0409

Test material identity

[Test material identity]

  1. HEAD BLOCK
  2. Block label
  3. g171
  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'

 

SE05.01.02.0410

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g171
  4. 1
  5. 1
  6. Z39

Picklist Values:

CAS name || CAS number || Common name || EC name || EC number || IUPAC name || TSCA name || other:

Select an appropriate identifier from drop-down list, e.g. 'CAS number'. Use 'Other:' and specify, if identity according to a standard identifier is not known or if an additional chemical name or number is provided.

Indicator specifying the type of chemical identifier, e.g. CAS name.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE05.01.02.0411

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g171
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TESTMAT>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE05.01.02.0420

Identity

[Identity]

  1. TEXT
  2. STRING/2000
  3. g171
  4. 1
  5. 1
  6. [N/A]

 

Select the corresponding substance identity from drop-down list or enter manually if the identity is not available from the list or if no list is provided for the type of identifier selected.

Identity of the chemical substance used in the study or referred to in the record.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TESTMAT>

<i5:set>

<i5:ID>

<i5:ID>

SE05.01.02.0425

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:TO_HYDROLYSIS>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM>

SE05.01.02.0426

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:TO_HYDROLYSIS>

<i5:TESTMAT_FORM>

<i5:set>

<i5:PHRASEOTHER_TESTMAT_FORM>

<i5:TESTMAT_FORM_TXT>

SE05.01.02.0430

Radiolabelling

[Radiolabelling]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. F14

Picklist Values:

no || yes || no data

Indicate if labelled or non-labelled test material was used. Details on labelled material to be described in field 'Details on test material'.

Indication whether labelled or non-labelled test material was used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:RADIO_LABEL>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.01.02.0440

Details on test material

[Details on test material]

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

Freetext Templates:

- Name of test material (as cited in study report):

- Molecular formula (if other than submission substance):

- Molecular weight (if other than submission substance):

- Smiles notation (if other than submission substance):

- InChl (if other than submission substance):

- Structural formula attached as image file (if other than submission substance): see Fig.

- Substance type:

- Physical state:

- Analytical purity:

- Impurities (identity and concentrations):

- Composition of test material, percentage of components:

- Isomers composition:

- Purity test date:

- Lot/batch No.:

- Expiration date of the lot/batch:

- Radiochemical purity (if radiolabelling):

- Specific activity (if radiolabelling):

- Locations of the label (if radiolabelling):

- Expiration date of radiochemical substance (if radiolabelling):

- Stability under test conditions:

- Storage condition of test material:

- Other:

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

Note that any information that can be claimed confidential should be included in the subsequent field 'Confidential details on test material'.

Explanations:

- Name of test material (as cited in study report): only if different from any other identifiers provided in the preceding fields.

- Molecular formula (if other than submission substance): specify

- Molecular weight (if other than submission substance): specify

- Smiles notation (if other than submission substance): provide if available

- InChl (if other than submission substance): provide if available

- Structural formula attached as image file (if other than submission substance): see Fig.: only if different from submission substance. Indicate Fig. no. if a file is attached in field 'Attached document', e.g. state 'see Fig. 1'.

- Substance type: indicate whether pure active substance, technical product, formulation or other.

- Physical state: indicate 'gas', 'solid' or 'liquid' only if different from submission substance or if substance can occur in different physical states.

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if applicable

- Isomers composition: specify if applicable

- Purity test date: provide if available

- Lot/batch No.: provide if available

- Expiration date of the lot/batch: provide if available

- Radiochemical purity (if radiolabelling): specify if applicable

- Specific activity (if radiolabelling): specify if applicable

- Locations of the label (if radiolabelling): specify if applicable

- Expiration date of radiochemical substance (if radiolabelling): specify if applicable

- Storage condition of test substance: specify if applicable

- Stability under test conditions: indicate if available

Details on description and specification of the actual test material.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.01.02.0450

Confidential details on test material

[Confidential details on test material]

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

Freetext Templates:

- Analytical purity:

- Impurities (identity and concentrations):

- Composition of test material, percentage of components:

- Purity test date:

- Lot/batch No.:

- Expiration date of the lot/batch:

- Isomers composition:

- Other:

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

Explanations:

- Analytical purity: specify in %

- Impurities (identity and concentrations): specify

- Composition of the test material, percentage of components: specify if applicable

- Purity test date: provide if available

- Lot/batch No.: : provide if available

- Expiration date of the lot/batch: : provide if available

- Isomers composition: specify if applicable

Confidential details on the actual test material.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TESTMAT_CONFIDENTIAL_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.01.02.0460

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

- Vapour pressure:

- Water solubility:

- log Pow:

- pKa:

- Base or acid catalysis of test material:

- UV absorption:

- Stability of test material at room temperature:

OTHER PROPERTIES (if relevant for this endpoint)

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 'Test performance'. 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.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:PROPERTIES_TESTMAT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.01.02.0465

Study design

[Study design]

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

 

 

Subheading of section 'Study design'

 

SE05.01.02.0470

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 throughout the experiment.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:ANALYT_MONIT>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.01.02.0480

Details on sampling

[Details on sampling]

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

Freetext Templates:

- Sampling intervals for the parent/transformation products:

- Sampling method:

- Sampling methods for the volatile compounds, if any:

- Sampling intervals/times for pH measurements:

- Sampling intervals/times for sterility check:

- Sample storage conditions before analysis:

- Other observation, if any (e.g.: precipitation, color change etc.):

Enter details on sampling regime and method. Use freetext template as appropriate.

Details on sampling.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:SAMPLING_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.01.02.0490

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):

- Total 14C measurement:

- 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 PARENT COMPOUND

- 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:

IDENTIFICATION AND QUANTIFICATION OF TRANSFORMATION PRODUCTS

If the amount of test material in the test solutions was monitored, enter any details on the analytical methods used. Use freetext template and delete/add elements as appropriate. Copy any subheading(s) under IDENTIFICATION AND QUANTIFICATION OF PARENT COMPOUND to include the respective information for transformation products.

Details on the analytical method used.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:ANALYT_METHOD_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.01.02.0500

Buffers

[Buffers]

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

Freetext Templates:

- pH:

- Type and final molarity of buffer:

- Composition of buffer:

Give details on the buffer(s) used for each nominal pH tested; copy any subheading(s) as appropriate for indicating buffers at different pH values. Use freetext template and delete/add elements as appropriate.

Details on the buffer(s) used for each nominal pH tested.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:BUFFERS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.01.02.0510

Estimation method (if used)

[Estimation method (if used)]

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

 

If an estimation method was used, describe relevant details and input parameters and/or indicate the computer programme used.

Details on parameters used to estimate hydrolysis.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:ESTIMATION_METHOD>

<i5:set>

<i5:TEXTAREA_BELOW>

<i5:TEXTAREA_BELOW>

SE05.01.02.0520

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

- Type, material and volume of test flasks, other equipment used:

- Sterilisation method:

- Lighting:

- Measures taken to avoid photolytic effects:

- Measures to exclude oxygen:

- Details on test procedure for unstable compounds:

- Details of traps for volatile, if any

- If no traps were used, is the test system closed/open

- Is there any indication of the test material adsorbing to the walls of the test apparatus?

TEST MEDIUM

- Volume used/treatment

- Kind and purity of water:

- Preparation of test medium:

- Renewal of test solution:

- Identity and concentration of co-solvent:

OTHER TEST CONDITIONS

- Adjustment of pH:

- Dissolved oxygen:

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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TESTCONDIT_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.01.02.0529

Duration of test at given conditions

[Duration of test]

  1. HEAD BLOCK
  2. Block label
  3. g172
  4. 10
  5. 1
  6. [N/A]

 

Indicate the test duration, pH and temperature condition and initial test substance concentration at which test was conducted. Copy this block of fields for different test conditions as appropriate.

Heading of field block 'Duration of test'.

 

SE05.01.02.0530

Duration

[Duration of test]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g172
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Numeric value of duration of test.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:DURATION>

<i5:set>

<i5:VALUEUNIT_VALUE>

<i5:VALUE>

SE05.01.02.0540

Unit

[Duration of test]

  1. LIST-CLOSED
  2. STRING/255
  3. g172
  4. 1
  5. 1
  6. F05

Picklist Values:

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

Select from drop-down list.

Unit of test duration.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:DURATION>

<i5:set>

<i5:VALUEUNIT_VALUE>

<i5:UNIT>

SE05.01.02.0550

pH

[pH]

  1. TEXT
  2. STRING/255
  3. g172
  4. 1
  5. 1
  6. [N/A]

 

Enter the pH value during the test..

pH values to which the duration given applies.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:DURATION>

<i5:set>

<i5:PH>

<i5:PH>

SE05.01.02.0560

Temperature

[Temp.]

  1. TEXT
  2. STRING/255
  3. g172
  4. 1
  5. 1
  6. [N/A]

 

Enter the temperature with unit (normally °C) during the test.

Temperature with unit (normally °C) to which the duration given applies.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:DURATION>

<i5:set>

<i5:TEMP>

<i5:TEMP>

SE05.01.02.0570

Initial measured concentration

[Initial conc. measured]

  1. LIST-CLOSED
  2. STRING/255
  3. g172
  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').

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:DURATION>

<i5:set>

<i5:PRECISION_INITIAL_CONC_LOQUALIFIER>

<i5:INITIAL_CONC_LOQUALIFIER>

SE05.01.02.0580

Initial measured concentration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g172
  4. 1
  5. 1
  6. [N/A]

 

 

Initial test substance 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:TO_HYDROLYSIS>

<i5:DURATION>

<i5:set>

<i5:PRECISION_INITIAL_CONC_LOQUALIFIER>

<i5:INITIAL_CONC_LOVALUE>

SE05.01.02.0590

Initial measured concentration

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g172
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:DURATION>

<i5:set>

<i5:PRECISION_INITIAL_CONC_LOQUALIFIER>

<i5:INITIAL_CONC_UPQUALIFIER>

SE05.01.02.0600

Initial measured concentration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g172
  4. 1
  5. 1
  6. [N/A]

 

 

Initial test substance 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:TO_HYDROLYSIS>

<i5:DURATION>

<i5:set>

<i5:PRECISION_INITIAL_CONC_LOQUALIFIER>

<i5:INITIAL_CONC_UPVALUE>

SE05.01.02.0610

Unit

[Duration of test]

  1. LIST-OPEN
  2. STRING/255
  3. g172
  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 test substance concentration.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:DURATION>

<i5:set>

<i5:PRECISION_INITIAL_CONC_LOQUALIFIER>

<i5:INITIAL_CONC_UNIT>

SE05.01.02.0611

Unit

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g172
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:DURATION>

<i5:set>

<i5:PRECISION_INITIAL_CONC_LOQUALIFIER>

<i5:INITIAL_CONC_UNIT_TXT>

SE05.01.02.0620

Number of replicates

[Number of replicates]

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

 

Indicate the number of replicates tested. If different at the different test runs, specify for each pH and temperature.

Number of replicates tested for each pH and temperature.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:NUMBER_REPLICATES>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.01.02.0630

Positive controls

[Positive controls]

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

Picklist Values:

yes || no || no data

Indicate if a positive control (test with a substance with known hydrolysis) was performed. If yes, report the identity of the substance in the supplementary remarks field.

Indication if a positive control was performed.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:POS_CONTROLS>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE05.01.02.0631

Positive controls

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:POS_CONTROLS>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE05.01.02.0640

Negative controls

[Negative controls]

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

Picklist Values:

yes || no || no data

Indicate if a negative control (test with a stable substance) was performed. If yes, report the identity of the substance in the supplementary remarks field.

Indication if a negative control was performed.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:NEG_CONTROLS>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE05.01.02.0641

Negative controls

[no label]

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

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:NEG_CONTROLS>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE05.01.02.0650

Statistical methods

[Statistical methods]

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

 

Enter details on statistical methods used to interpret the results.

Statistical methods used to interpret the results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:STATISTICAL_METHODS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE05.01.02.0660

Any other information on materials and methods incl. tables

[Any other information on materials and methods incl. tables]

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

 

In this field, you can enter any information on materials and methods, for which no distinct field is available, or transfer free text from other databases. You can also open a rich text editor and create formatted text and tables or insert and edit any excerpt from a word processing or spreadsheet document, provided it was converted to the HTML format.

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

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REM_ME_TC>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.01.02.0665

RESULTS AND DISCUSSION

[Results and discussion]

  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.

 

SE05.01.02.0670

Preliminary study

[Preliminary study]

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

 

Describe results from preliminary study performed, if any (e.g., adsorption of test material to the walls of the test container).

Results from preliminary study performed, if any

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:PRELIM_STUDY_RS>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE05.01.02.0680

Test performance - Remarks

[Test performance - Remarks]

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

 

Report on any unusual observations during test, deviations from test procedure or any other information affecting results.

Description of any unusual observations during test, deviations from test procedure or any other information affecting results.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TEST_PERFORM_REM>

<i5:set>

<i5:TEXT_INT>

<i5:TEXT_INT>

SE05.01.02.0690

Transformation products

[Transformation products]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. E34

Picklist Values:

no || not measured || yes || no data

Indicate whether transformation products occurred. If yes, provide the identified transformation products in following block of fields. Any further details can be entered in field 'Any other information on results incl. tables'.

Indicator that transformation products occurred or not.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TRANSF_PRODUCTS_INDICATOR>

<i5:set>

<i5:LIST_BELOW_SEL>

<i5:LIST_BELOW_SEL>

SE05.01.02.0699

Identity of transformation products

[Identity of degradation products]

  1. HEAD BLOCK
  2. Block label
  3. g173
  4. 20
  5. 1
  6. [N/A]

 

Indicate the identity of the transformation products using an appropriate identifier, e.g. CAS number, CAS name, IUPAC name. Copy this block of fields for each relevant substance.

Any further details on transformation products can be provided in field 'Any other information on materials and methods incl. tables'.

Heading of field block 'Identity of degradation / transformation products'.

 

SE05.01.02.0700

No.

[No.]

  1. LIST-CLOSED
  2. STRING/255
  3. g173
  4. 1
  5. 1
  6. F137

Picklist Values:

#1 || #2 || #3 || #4 || #5 || #6 || #7 || #8 || #9 || #10 || #11 || #12 || #13 || #14 || #15 || #16 || #17 || #18 || #19 || #20

For easier distinction select a consecutive number for each transformation product from drop-down list if more than one transformation product is entered. If the same substance is identified by more than one identifiers (e.g. by CAS name and Common name), make sure that the same number is allocated to these entries.

Indication of a consecutive number 1-n used to distinguish the degradation / transformation products.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TRANSF_PRODUCTS_ID>

<i5:set>

<i5:NO>

<i5:NO>

SE05.01.02.0710

Identifier

[Identifier]

  1. LIST-OPEN
  2. STRING/255
  3. g173
  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:' if identity according to a standard identifier is not known. Specify if another identifier is provided (e.g. 'Other: xxx').

Indicator specifying the type of chemical identifier, e.g. CAS name.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TRANSF_PRODUCTS_ID>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER>

SE05.01.02.0711

Identifier

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g173
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TRANSF_PRODUCTS_ID>

<i5:set>

<i5:PHRASEOTHER_IDENTIFIER>

<i5:IDENTIFIER_TXT>

SE05.01.02.0720

Identity

[Identity]

  1. TEXT
  2. STRING/255
  3. g173
  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.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TRANSF_PRODUCTS_ID>

<i5:set>

<i5:ID>

<i5:ID>

SE05.01.02.0730

Details on hydrolysis and appearance of transformation product(s)

[Details on hydrolysis and appearance of transformation product(s)]

  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:

- Formation and decline of each transformation product during test:

- Pathways for transformation:

- Other:

Indicate the hydrolysis of the test material and appearance of transformation products, expressed as percentage of the parent substance or applied radioactivity. Use freetext template and delete/add items as appropriate.

Particularly with comprehensive data include a table 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').

If useful attach a figure in field 'Attached background material'.

Hydrolysis and appearance of transformation product(s)

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HYDROLYSIS_DETAILS>

<i5:set>

<i5:FREETEXT_BELOW>

<i5:FREETEXT_BELOW>

SE05.01.02.0739

Total recovery of test substance (in %)

[Total recovery of test substance (in %)]

  1. HEAD BLOCK
  2. Block label
  3. g174
  4. 10
  5. 1
  6. [N/A]

 

For each pH and temperature condition, indicate the total recovery in % of initial concentration (with standard deviation) or range if reported so. Copy this block of fields as necessary.

Heading of field block 'Total recovery of test substance (in %)'.

 

SE05.01.02.0740

Total recovery (in %)

[%Recovery]

  1. LIST-CLOSED
  2. STRING/255
  3. g174
  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').

Total recovery or range in % of initial concentration: Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.01.02.0750

Total recovery (in %)

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g174
  4. 1
  5. 1
  6. [N/A]

 

 

Total recovery or range in % of initial 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:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.01.02.0760

Total recovery (in %)

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g174
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

Total recovery or range in % of initial concentration: Upper qualifier field providing a list with following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.01.02.0770

Total recovery (in %)

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g174
  4. 1
  5. 1
  6. [N/A]

 

 

Total recovery or range in % of initial 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:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.01.02.0780

St. dev.

[St. dev.]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g174
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Standard deviation of total recovery.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:ST_DEV>

<i5:ST_DEV>

SE05.01.02.0790

pH

[pH]

  1. NUM
  2. NUMBER/5/#0.##
  3. g174
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Nominal pH value of test run.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:PH>

<i5:PH>

SE05.01.02.0800

Temperature

[Temp.]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g174
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Temperature with unit (normally °C) .

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:VALUEUNIT_TEMP_VALUE>

<i5:TEMP_VALUE>

SE05.01.02.0810

Unit

[Total recovery of test substance (in %)]

  1. LIST-CLOSED
  2. STRING/255
  3. g174
  4. 1
  5. 1
  6. A102

Picklist Values:

°C || K || °F

Select from drop-down list.

Unit of temperature.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:VALUEUNIT_TEMP_VALUE>

<i5:TEMP_UNIT>

SE05.01.02.0820

Duration

[Duration]

  1. LIST-CLOSED
  2. STRING/255
  3. g174
  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').

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:PRECISION_DURATION_LOQUALIFIER>

<i5:DURATION_LOQUALIFIER>

SE05.01.02.0830

Duration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g174
  4. 1
  5. 1
  6. [N/A]

 

 

Test duration: 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:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:PRECISION_DURATION_LOQUALIFIER>

<i5:DURATION_LOVALUE>

SE05.01.02.0840

Duration

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g174
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:PRECISION_DURATION_LOQUALIFIER>

<i5:DURATION_UPQUALIFIER>

SE05.01.02.0850

Duration

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g174
  4. 1
  5. 1
  6. [N/A]

 

 

Test duration: 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:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:PRECISION_DURATION_LOQUALIFIER>

<i5:DURATION_UPVALUE>

SE05.01.02.0860

Unit

[Total recovery of test substance (in %)]

  1. LIST-CLOSED
  2. STRING/255
  3. g174
  4. 1
  5. 1
  6. F05

Picklist Values:

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

Select from drop-down list.

Unit of test duration.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:TOTALRECOVERY>

<i5:set>

<i5:PRECISION_DURATION_LOQUALIFIER>

<i5:DURATION_UNIT>

SE05.01.02.0869

Dissipation half-life of parent compound

[Dissipation half-life of parent compound]

  1. HEAD BLOCK
  2. Block label
  3. g175
  4. 10
  5. 1
  6. [N/A]

 

Indicate the half-lives measured at different pH values and temperature as well as the extrapolated results for 25 degrees Celsius where applicable. Copy this block of fields for each test condition as appropriate.

For robust study summaries or as requested by the regulatory programme, fill in also subfields 'Regression equation and r²' and 'DT90' (with unit) if available.

Heading of field block 'Dissipation half-life of parent compound'

 

SE05.01.02.0870

pH

[pH]

  1. NUM
  2. NUMBER/5/#0.##
  3. g175
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Nominal pH value of test run.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PH>

<i5:PH>

SE05.01.02.0880

Temperature

[Temp.]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g175
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Temperature with unit (normally °C) .

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:VALUEUNIT_TEMP_VALUE>

<i5:TEMP_VALUE>

SE05.01.02.0890

Unit

[Dissipation half-life of parent compound]

  1. LIST-CLOSED
  2. STRING/255
  3. g175
  4. 1
  5. 1
  6. A102

Picklist Values:

°C || K || °F

Select from drop-down list.

Unit of temperature.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:VALUEUNIT_TEMP_VALUE>

<i5:TEMP_UNIT>

SE05.01.02.0891

Hydrolysis rate constant

[Hydrolysis rate constant]

  1. LIST-CLOSED
  2. STRING/255
  3. g175
  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').

Heading of field block 'Dissipation half-life of parent compound'

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PRECISION_HYDROLYSISRATE_LOQUALIFIER>

<i5:HYDROLYSISRATE_LOQUALIFIER>

SE05.01.02.0900

Hydrolysis rate constant

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g175
  4. 1
  5. 1
  6. [N/A]

 

 

Heading of field block 'Dissipation half-life of parent compound'

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PRECISION_HYDROLYSISRATE_LOQUALIFIER>

<i5:HYDROLYSISRATE_LOVALUE>

SE05.01.02.0901

Hydrolysis rate constant

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g175
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

Heading of field block 'Dissipation half-life of parent compound'

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PRECISION_HYDROLYSISRATE_LOQUALIFIER>

<i5:HYDROLYSISRATE_UPQUALIFIER>

SE05.01.02.0902

Hydrolysis rate constant

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g175
  4. 1
  5. 1
  6. [N/A]

 

 

Heading of field block 'Dissipation half-life of parent compound'

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PRECISION_HYDROLYSISRATE_LOQUALIFIER>

<i5:HYDROLYSISRATE_UPVALUE>

SE05.01.02.0910

Unit

[Dissipation half-life of parent compound]

  1. LIST-CLOSED
  2. STRING/255
  3. g175
  4. 1
  5. 1
  6. F140

Picklist Values:

s-1 || min-1 || h-1 || d-1 || a-1

Select from drop-down list.

Unit of hydrolysis rate constant.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PRECISION_HYDROLYSISRATE_LOQUALIFIER>

<i5:HYDROLYSISRATE_UNIT>

SE05.01.02.0920

Half-life

[Half-life]

  1. LIST-CLOSED
  2. STRING/255
  3. g175
  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').

Half life / DT50: Lower qualifier field providing a list with following operators: >, >=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOQUALIFIER>

SE05.01.02.0930

Half-life

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g175
  4. 1
  5. 1
  6. [N/A]

 

 

Half life / DT50: 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:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:LOVALUE>

SE05.01.02.0940

Half-life

[no label]

  1. LIST-CLOSED
  2. STRING/255
  3. g175
  4. 1
  5. 1
  6. A02-2

Picklist Values:

< || <= || ca.

 

Half life / DT50: Upper qualifier field providing a list with following operators: <, <=, and ca.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPQUALIFIER>

SE05.01.02.0950

Half-life

[no label]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g175
  4. 1
  5. 1
  6. [N/A]

 

 

Half life / DT50: 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:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UPVALUE>

SE05.01.02.0960

Unit

[Dissipation half-life of parent compound]

  1. LIST-CLOSED
  2. STRING/255
  3. g175
  4. 1
  5. 1
  6. F05

Picklist Values:

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

Select from drop-down list.

Unit of time.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PRECISION_LOQUALIFIER>

<i5:UNIT>

SE05.01.02.0970

St. dev.

[St. dev.]

  1. NUM
  2. NUMBER/20/########0.#########
  3. g175
  4. 1
  5. 1
  6. [N/A]

 

Enter numeric value.

Standard deviation of half-life / DT50.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:STDEV>

<i5:STDEV>

SE05.01.02.0980

Type of half-life

[Type]

  1. LIST-OPEN
  2. STRING/255
  3. g175
  4. 1
  5. 1
  6. F136

Picklist Values:

(pseudo-)first order (= DT50) || second order || zero order || other: || no data

Select from drop-down list.

Indicator specifying type of half-life.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PHRASEOTHER_TYPE>

<i5:TYPE>

SE05.01.02.0981

Type of half-life

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. g175
  4. 1
  5. 1
  6. [N/A]

 

 

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:PHRASEOTHER_TYPE>

<i5:TYPE_TXT>

SE05.01.02.0990

Remarks (e.g. regression equation, r², DT90)

[Remarks (e.g. regression equation, r², DT90)]

  1. TEXT
  2. STRING/255
  3. g175
  4. 1
  5. 1
  6. [N/A]

 

For robust study summaries or as requested by the regulatory programme, provide the regression equation, r² , DT90 (with unit) and/or any relevant remarks.

Remarks (e.g. regression equation, r², DT90).

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:HALFLIFE>

<i5:set>

<i5:REM>

<i5:REM>

SE05.01.02.1000

Other kinetic parameters

[Other kinetic parameters]

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

 

Describe any other kinetic parameters, if relevant.

Any other kinetic parameters, if relevant.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:OTHER_KINETICS>

<i5:set>

<i5:TEXT_BELOW>

<i5:TEXT_BELOW>

SE05.01.02.1010

Details on results

[Details on results]

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

Freetext Templates:

TEST CONDITIONS

- pH, sterility, temperature, and other experimental conditions maintained throughout the study: Yes/No

- Anomalies or problems encountered (if yes):

MAJOR TRANSFORMATION PRODUCTS

At pH5:

- Range of maximum concentrations in % of the applied amount and day(s) of incubation when observed:

- Range of maximum concentrations in % of the applied amount at end of study period:

on the - the and -th day of incubation, respectively. At the end of the study period, the corresponding concentrations were - and -- % of the applied amount, respectively.

At pH7:

- Range of maximum concentrations in % of the applied amount and day(s) of incubation when observed:

- Range of maximum concentrations in % of the applied amount at end of study period:

on the - the and -th day of incubation, respectively. At the end of the study period, the corresponding concentrations were - and -- % of the applied amount, respectively.

At pH9:

- Range of maximum concentrations in % of the applied amount and day(s) of incubation when observed:

- Range of maximum concentrations in % of the applied amount at end of study period:

on the - the and -th day of incubation, respectively. At the end of the study period, the corresponding concentrations were - and -- % of the applied amount, respectively.

MINOR TRANSFORMATION PRODUCTS

Maximum concentrations in % of the applied amount

- at pH5:

- at pH7:

- at pH9:

MINERALISATION (distinguish between dark and irradiated samples)

- % of applied radioactivity present as CO2 at end of study:

INDICATION OF UNSTABLE TRANSFORMATION PRODUCTS:

VOLATILIZATION (at end of study)

- Evolved CO2 in % of the applied: .. at pH 5, .. at pH 7, .. at pH 9

- Total volatile organics in % of the applied: .. at pH 5, .. at pH 7, .. at pH 9

UNIDENTIFIED RADIOACTIVITY (at end of study)

- at pH5:

- at pH7:

- at pH9:

PATHWAYS OF HYDROLYSIS

- Description of pathways:

- Figures of chemical structures attached: Yes/No

SUPPLEMENTARY EXPERIMENT (if any): RESULTS:

Indicate any further relevant details of test results. Use freetext template and delete/add elements as appropriate. As an option you may include an excerpt from the study report.

TEST CONDITIONS: If the test conditions were not maintained, describe any anomalies or problems encountered.

MAJOR / MINOR TRANSFORMATION PRODUCTS: Indicate concentration ranges of the transformation products specified in the defined field 'Identity of transformation products' or specify if no major transformation products were detected. Tabulate comprehensive data and refer to respective table no. (use predefined table if any) or other appropriate table. Distinguish between dark and irradiated samples; compare the transformation products formed in the dark and irradiated samples, and identify and quantify the products that are formed by phototransformation only.

As appropriate attach Figure showing the pathway of phototransformation of the test substance.

SUPPLEMENTARY EXPERIMENT: Briefly describe the results of the supplementary experiment, if any.

Details on results

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SE05.01.02.1020

Any other information on results incl. tables

[Any other information on results incl. tables]

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

 

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

Note: Both the 'Materials and methods' section and 'Results' section. In addition the fields 'Overall remarks' and 'Executive summary' allow rich text entry.

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

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:REM_RS>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.01.02.1025

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.

 

SE05.01.02.1030

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:TO_HYDROLYSIS>

<i5:REM_ANYOTHER>

<i5:set>

<i5:RICHTEXT_BELOW>

<i5:RICHTEXT_BELOW>

SE05.01.02.1039

Attached background material

[Attached background material]

  1. HEAD BLOCK
  2. Block label
  3. g176
  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'.

 

SE05.01.02.1040

Attached document

[Attached document]

  1. ATTACHMENT
  2. STRING/32768
  3. g176
  4. 1
  5. 1
  6. [N/A]

 

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

File name of document uploaded, i.e. attached. No restriction as to file type.

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:AD>

<i5:set>

<i5:DOC>

<i5:DOC>

SE05.01.02.1050

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g176
  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.

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<i5:scientificPart>

<i5:TO_HYDROLYSIS>

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SE05.01.02.1059

Attached full study report

[Attached full study report]

  1. HEAD BLOCK
  2. Block label
  3. g177
  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

 

SE05.01.02.1060

Attached full study report

[Attached full study report]

  1. ATTACHMENT
  2. STRING/32768
  3. g177
  4. 1
  5. 1
  6. [N/A]

 

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

Attached full study report

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

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<i5:set>

<i5:ATTACHMENT_BELOW>

<i5:ATTACHMENT_BELOW>

SE05.01.02.1062

Illustration (picture/graph)

[Illustration (picture/graph)]

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

 

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

Illustration (picture/graph)

<i5:EndpointStudyRecord>

<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:PG_ILLUSTRATION>

<i5:set>

<i5:PIC_BELOW>

<i5:PIC_BELOW>

SE05.01.02.1065

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.

 

SE05.01.02.1070

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.

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<i5:scientificPart>

<i5:TO_HYDROLYSIS>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX>

SE05.01.02.1071

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:TO_HYDROLYSIS>

<i5:VALIDITY_CRIT_SUBM>

<i5:set>

<i5:PHRASEOTHER_LIST_SEL_FIX>

<i5:LIST_SEL_FIX_TXT>

SE05.01.02.1080

Conclusions

[Conclusions]

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