Registration Dossier

Administrative data

Endpoint:
fish, juvenile growth test
Type of information:
experimental study planned
Study period:
the study will be performed upon ECHA's decision on the testing proposal
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Condensation products of triethanolamine with addition products of fatty acids, C18 (unsaturated) alkyl with maleic anhydride

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
No other studies - either GLP or non-GLP - are available on the substance. Moreover, no historical human data is available. Since Addition reaction products of conjugated sunflower-oil fatty acids and tall-oil fatty acids with maleic anhydride is a highly complex UVCB substance with both unknown as well as variable constituents, no other alternative method, e.g. (Q)SAR, In vitro methods, Weight of evidence, Grouping and read-across, is available to fulfil this information requirement.

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
Since Addition reaction products of conjugated sunflower-oil fatty acids and tall-oil fatty acids with maleic anhydride is a highly complex UVCB substance with both unknown as well as variable constituents, no other alternative method or adaptation possibility is available to fulfil this information requirement.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 215 (Fish, Juvenile Growth Test)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Applicant's summary and conclusion