Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
The test will be conducted after a decision on the requirement to carry out the proposed test has been taken according to the procedure laid down in Regulation (EC) 1907/2006 and a deadline to submit the information required has been set by the Agency.
Justification for type of information:
PROPOSAL ON VERTEBRATE ANIMALSNON-CONFIDENTIAL NAME OF SUBSTANCE:- Name of the substance on which testing is proposed to be carried out: 2-isocyanatoethyl methacrylateCONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION- Available GLP studies: none- Available non-GLP studies: none- Historical human data: not available- (Q)SAR: not applicable- In vitro methods: not applicable- Weight of evidence: no studies regarding developmental toxicity are available- Grouping and read-across: no reliable read across data are availableCONSIDERATIONS 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:There are no data available on the developmental toxicity/teratogenicity of 2-isocyanatoethyl methacrylate.In order to fulfil the standard information requirements, a GLP-compliant pre-natal developmenta toxicity study in rats via the oral route following OECD guideline 414 is proposed according to Annex IX, Column 1, Section 8.7.2.TESTING

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion