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: Dimethylhydantoin, reaction products with ethylene oxide

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies : There is no available GLP developmental toxicity studies
- Available non-GLP studies : There is no available non-GLP developmental toxicity studies
- Historical human data : There is no relevent human data
- (Q)SAR : This is generally considered to be not sufficiently robust to address developmental toxicity
- In vitro methods : These are generally considered to be not sufficiently robust for developmental toxicity
- Weight of evidence : There is insufficient data to build a weight of evidence approach
- Grouping and read-across : There are no close structural analogues which have reliable developmental toxicity data
- Substance-tailored exposure driven testing: Not applicable
- Approaches in addition to above: Not applicable
- Other reasons: Not applicable

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 suitable adaption possibilities available

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed
Developmental toxicity study in the rat to be conducted to OECD 414 and to GLP

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 material form:
other: pale yellow solid block
Details on test material:
- Name of test material (as cited in study report): Dantocol DHE
- Physical state: pale yellow solid block
- Lot/batch No.: M5469330
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion