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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 - Guideline study.

Data source

Reference
Reference Type:
other: inquiry result from ECHA
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline No. 474, 1983
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-320-1
EC Name:
-
Cas Number:
690-39-1
Molecular formula:
C3H2F6
IUPAC Name:
1,1,1,3,3,3-hexafluoropropane

Test animals

Species:
other: mice, Crl:CD-1(ICR)BR

Administration / exposure

Route of administration:
inhalation: gas
Vehicle:
Not relevant.
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 10; Sacrifice time: 2 hours
Male: 5000 mg/kg; No. of animals: 10; Sacrifice time: 2 hours
Male: 20000 mg/kg; No. of animals: 10; Sacrifice time: 2 hours
Male: 50000 mg/kg; No. of animals: 10; Sacrifice time: 2 hours
Female: 0 mg/kg; No. of animals: 10; Sacrifice times: 2 hours
Female: 5000 mg/kg; No. of animals: 10; Sacrifice times: 2 hours
Female: 20000 mg/kg; No. of animals: 10; Sacrifice times: 2 hours
Female: 50000 mg/kg; No. of animals: 10; Sacrifice times: 2 hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
(Doses producing toxicity: Excluding diarrhea in one male in the 5000 and one male in the 20000 ppm group, no clinical signs of toxicity were observed at any concentration.)
Additional information on results:
Observations:
Weight losses were seen in the 0, 5000, 20000 and 50000 groups at each sacrifice time. However, statistically significant weight gain was observed in the positive control group.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative

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