Registration Dossier
Registration Dossier
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EC number: 701-388-0 | CAS number: -
Developmental toxicity / teratogenicity
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
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- Reference substance name:
- 1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione
- EC Number:
- 701-388-0
- Cas Number:
- 26850-24-8
- IUPAC Name:
- 1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione
- 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
Constituent 1
Test animals
- Species:
- rat
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
