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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Compliance

Data source

Reference
Reference Type:
other: body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
A mixture of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate; thiophenoxyphenylsulfonium hexafluoroantimonate
EC Number:
403-500-0
EC Name:
A mixture of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate; thiophenoxyphenylsulfonium hexafluoroantimonate
IUPAC Name:
403-500-0
Constituent 2
Reference substance name:
reaction mass of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate and thiophenoxyphenylsulfonium hexafluoroantimonate
IUPAC Name:
reaction mass of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate and thiophenoxyphenylsulfonium hexafluoroantimonate

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
- Vehicle(s)/solvent(s) used: corn oil
No. of animals per sex per dose:
Male: 0 mg/kg; No of animals: 5; Sacrifice time: 24 hours
Male: 0 mg/kg; No of animals: 5; Sacrifice time: 48 hours
Male: 0 mg/kg; No of animals: 5; Sacrifice time: 72 hours
Male: 1000 mg/kg; No of animals: 5; Sacrifice time: 24 hours
Male: 1000 mg/kg; No of animals: 5; Sacrifice time: 48 hours
Male: 1000 mg/kg; No of animals: 5; Sacrifice time: 72 hours
Female: 0 mg/kg; No of animals: 5; Sacrifice time: 24 hours
Female: 0 mg/kg; No of animals: 5; Sacrifice time: 48 hours
Female: 0 mg/kg; No of animals: 5; Sacrifice time: 72 hours
Female: 1000 mg/kg; No of animals: 6; Sacrifice time: 24 hours
Female: 1000 mg/kg; No of animals: 7; Sacrifice time: 48 hours
Female: 1000 mg/kg; No of animals: 5; Sacrifice time: 72 hours

Results and discussion

Additional information on results:
Doses producing toxicity:
In a preliminary experiment 100% of the animals died at 5000 mg/kg, while 83% died at 2000 mg/kg and 17% at 1500 mg/kg.

At the 1000 mg/kg dose level one animal (17%) showed pilo-erection and at 500 mg/kg no effects were found. In the final experiment at 1000 mg/kg no animals died.

Ratio polychromatic/normochromatic: at 1000 mg/kg bw: not significantly different from the negative controls.

Observations:
The mean number of micronuclei per group and the mean ratio of polychromatic to normochromatic erythro's were calculated. The test groups showed no increase in the frequncy of micronuclei. In negative control animals, the incidence of micronuclei was found to be in the range of historical data. In positive control animals, a decrease in the ratio polychr./normochr. erythro's and a statistically significant increase in the number of micronuclei.

It is concluded that this test is valid and that the substance can be considered as not mutageinc under the experimental conditions of the micronucleus test.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Not mutagenic in the micronucleus test.
Executive summary:

Limited data provided by ECHA. Not possible to make further conclusions.