Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
developmental toxicity
Type of information:
experimental study planned (based on read-across)
Justification for type of information:
Refer to the section 13 of the IUCLID dataset for details on the read across justification. The planned pre-natal developmental toxicity study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Version / remarks:
According to ECHA/PR/09/13, an OECD 414 study has been proposed with the read-across substance (CAS 68187-30-4) to ECHA. Additionally, the anticipated metabolites coco fatty acids and glutamic acid are physiological components and are also consumed daily via conventional foods.
Species:
rabbit

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 414

Results and discussion

Applicant's summary and conclusion