Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- 1,2 Propanediamine (CAS 78-90-0)

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 data available for teratogenicity
- Available non-GLP studies: no data available for teratogenicity
- Historical human data: none available for this endpoint
- (Q)SAR: not reliable for this endpoint
- In vitro methods: none available
- Weight of evidence: no studies available
- Grouping and read-across: no data available for similar substances

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:
The substance is neither genotoxic, nor are there indications based on the available data that it adversely affects reproduction. Based on physical chemical properties, the expected tissue damage at port of entry due to the corrosive properties, resorption has to be assumed.

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

Applicant's summary and conclusion