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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: 2000/32/EG, B.12 (Mikrokerntest)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test animals

Species:
other: mus, Swiss Ico:OF1 (IOPS Caw)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
distilled water
No. of animals per sex per dose:
Male: 50 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 100 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: 200 mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Male: mg/kg; No. of animals: 5; Sacrifice time: 48 hours
Female: 37.5 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 75 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: 150 mg/kg; No. of animals: 5; Sacrifice times: 48 hours
Female: mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
Doses producing toxicity: Highest tested dose corresponds to maximum tolerated dose two administrations of each dose with an interval of 24 h.
Additional information on results:
Observations:
No toxic signs; no lethal effects; no cytotoxicity (PCE/NCE)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positive

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