Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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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

Constituent 1
Chemical structure
Reference substance name:
Polysulfides, di-tert-Bu
EC Number:
273-103-3
EC Name:
Polysulfides, di-tert-Bu
Cas Number:
68937-96-2
Molecular formula:
not applicable
IUPAC Name:
di tertiobutyl, polysulfure S3-S5 rich

Test animals

Species:
rabbit

Results and discussion

Applicant's summary and conclusion