Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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