Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
There are no GLP, non-GLP studies nor any historical human data for the registered substance available. Application of grouping, read-across and (Q)SAR is difficult due to the complex composition of the material (UVCB). Furthermore, the registrant is not aware of any In vitro method which can fulfil data requirements for this endpoint. There are no studies which can be used in combination to fullfil data requirements using weight of evidence approach. Substance-tailored exposure driven testing is not applicable for the registered substance and relevant uses.
According to Annex VIII, the OECD 414 prenatal toxicity study is required for compounds with an average tonnage band of >=100 t. Hence, we propose an oral OECD 414 study with rats.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

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

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion