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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Adequacy of study:
other information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EC Directive 92/69/EEC, Method B12 OECD Guideline No. 474 (revised draft 1996)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: Mice, Swiss CD-1

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
1% aqueous carboxymethyl cellulose
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: 175 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 175 mg/kg; No. of animals: 9; Sacrifice time: 48 hours
Male: 87.5 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 87.5 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 43.75 mg/kg; No. of animals: 5; Sacrifice time: 24 hours
Male: 43.75 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 0 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 175 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 175 mg/kg; No. of animals: 8; Sacrifice times: 48 hours
Female: 87.5 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 87.5 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 43.75 mg/kg; No. of animals: 5; Sacrifice times: 24 hours
Female: 43.75 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Additional information on results:
Doses producing toxicity:
175 mg/kg bw: Within 3 hours after dosing one male and two
females died. All remaining males were lethargic, showed
ataxia and had a rough coat. All remaining females were
lethargic and showed ataxia.

87.5 mg/kg bw: All males had a rough coat. Females showed no
abnormalities.

43.75 mg/kg bw: No treatment-related findings.

Observations:
Within 48 hours after dosing, all male and female animals in
the treated groups showed no abnormalities.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative