Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- sodium 2,4,5-trichlorobenzenesulphonate

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: none available
- Available non-GLP studies: none available
- Historical human/control data: none available
- (Q)SAR: Registrant is considering options for valid (Q)SAR models
- In vitro methods: substance was positive (+) in vitro for chrom. abb.
- Weight of evidence: none available
- Grouping and read-across: none available
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: 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 Column 2 adaptations that can be applied.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- An OECD 474 / EC B.12 Micronucleous test in rats is proposed.

Data source

Materials and methods

Test guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2,4,5-trichlorobenzenesulphonate
EC Number:
258-548-3
EC Name:
Sodium 2,4,5-trichlorobenzenesulphonate
Cas Number:
53423-65-7
Molecular formula:
C6H2Cl3O3S.Na
IUPAC Name:
sodium 2,4,5-trichlorobenzene-1-sulfonate
Test material form:
solid: particulate/powder

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion