Registration Dossier
Registration Dossier
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EC number: 224-226-6 | CAS number: 4253-90-1
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Study period:
- After approval by ECHA
- 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: di-tert-butyl, polysulfides
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: There are no developmental toxicity studies available for di-tert-butyl, polysulfides.
- Available non-GLP studies: There are no non-GLP studies available.
- Historical human data: No data available.
- (Q)SAR: No data available.
- In vitro methods: There are no in vitro test methods available for developmental toxicity.
- Weight of evidence: Insufficient data available.
- Grouping and read-across: There are two prenatal developmental toxicity studies for 2-methyl-propane-2-thiol in rats and mice available. A developmental toxicity study in the rabbit has been proposed for the substance polysulfides, di-tert-dodecyl (CAS number: 68425-15-0; EC number: 270-335-7). Read across of the proposed study has been considered. The differences in molecular weight, physicochemical properties and structural differences in the length and complexity the hydrocarbon part of the two substances indicate that read across is not sufficiently justified.
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 of Annexes VI to X for developmental toxicity testing.
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 will be conducted with the registered substance di-tert-butyl, polysulfides in a second species (rabbits), according to OECD Test Guideline 414 and in compliance with GLP, after approval by ECHA.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- Reference substance name:
- Di-tert-butyl trisulphide
- EC Number:
- 224-226-6
- EC Name:
- Di-tert-butyl trisulphide
- Cas Number:
- 4253-90-1
- Molecular formula:
- C8H18S3
- IUPAC Name:
- di-tert-butyltrisulfane
Constituent 1
Test animals
- Species:
- rabbit
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.
