Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
An O.E.C.D. test guideline 414 Prenatal Developmental Toxicity Study will be conducted in the rat by the oral gavage route of exposure following approval of this Test Plan study by the ECHA. A second study in the rabbit may also be necessary.
Justification for type of information:
- Available GLP studies: None available
- Available non-GLP studies: None available
- Grouping and read-across: No suitable substitute
- Historical human data: None available
- (Q)SAR: Not applicable
- In vitro methods: None suitable to cover endpoint.
- Weight of evidence: None avaiable
- Substance-tailored exposure driven testing [if applicable]: Intermediate use substance

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

Test animals

Species:
rat

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion