Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Remarks:
Prenatal developmental Toxicity Study in rats by oral administration according to OECD guideline 414
Type of information:
experimental study planned
Study period:
To be determined by ECHA
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
A Prenatal Developmental Toxicity study for the first species is conducted as a standard information requirement as laid down in Annex IX, Section 8.7.2. of the REACH Regulation. The endpoint "Developmental toxicity/teratogenicity" will again evaluated if the complete data set of the OECD TG 414 (first species in rat) is present.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Diisononyl 1,4-cyclohexanedicarboxylate (DINCD)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: A 28-day oral Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test is available, which was conducted according to OECD TG 422, and in compliance with GLP.
- Available non-GLP studies: none available for toxicity to reproduction endpoint
- Historical human data: no data
- (Q)SAR: no data
- In vitro methods: no validated alternative in vitro methods are available
- Weight of evidence: insufficient data existing
- Grouping and read-across: no read-across data available


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 repeated dose 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 according to OECD TG 414 will be conducted with Diisononyl 1,4-cyclohexanedicarboxylate (DINCD).

Data source

Materials and methods

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

Test material

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

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion