Registration Dossier

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Type of information:
experimental study planned
Study period:
to be planned
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 : Soybean oil, epoxidized, Me ester, reaction products with propylene glycol

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies : 2 in vitro studies on the target substance (OECD TG 471, negative and OECD TG 487, positive), 1 in vitro read-across study (OECD TG 476, negative)
- Available non-GLP studies : none
- Historical human data": none
- (Q)SAR: not sufficiently reliable for the prediction of repeated dose toxicity
- In vitro methods: performed, and the study result provide sufficient base for further in vivo examination
- Weight of evidence: no data are available
- Grouping and read-across: A read-across is not sufficiently reliable for the prediction of this in vivo effect
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable

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:
The provision of a n in vivo study is a standard REACH requirement.Appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII. It is not possible to meet this data requirement through any non-testing methods or any Column 2 or Annex XI adaptations

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: For Soybean oil, epoxidized, Me ester, reaction products with propylene glycol it is proposed by the registrant to perform an OECD TG 489 assay as a follow up study. This β€œIn vivo alkaline single-cell gel electrophoresis assay for DNA strand breaks (Comet assay)” can provide conclusive information on both the clastogenicity as well as possible gene mutations of the test substance.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
Version / remarks:
current
Deviations:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Results and discussion

Applicant's summary and conclusion