Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
The test will be conducted after a final decision on the requirement to carry out the proposed test has been taken and a deadline to submit the information required has been set by the Agency.
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: allyl(cyclohexyloxy)acetate (CAS 68901-15-5)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: No adequate and reliable GLP studies addressing developmental toxicity are available with the registered substance itself or similar substances defined according to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006.
- Available non-GLP studies: none for developmental toxicity endpoint
- Historical human data: not available
- (Q)SAR: Q(SAR) methods are not applicable to assess the full scope of developmental toxicity.
- In vitro methods: No validated in vitro methods to assess developmental toxicity are available so far.
- Weight of evidence: There is no information (QSAR, in vitro data, developmental toxicity or fertility data) available which is suitable to assess developmental toxicity in a weight of evidence approach.
- Grouping and read-across: No read-across data is available for the developmental toxicity endpoint.

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:
- There are no Column 2 adaptations for developmental toxicity.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: a Prenatal Developmental Toxicity study in rodents (OECD 414) by oral route will be conducted with the source substance allyl(cyclohexyloxy)acetate (CAS 68901-15-5)

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Version / remarks:
adopted Jan 2001
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion