Registration Dossier

Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Remarks:
Type of genotoxicity: sister chromatid exchange
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
no data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Only few information on the test conditions. Results are not detailed.

Data source

Reference
Reference Type:
publication
Title:
Toxicity of 2,2,2-trifluoroethanol in chinese hamsters and beagle dogs
Author:
Marshall TC, Hahn FF, Brooks AL and Hobbs CH
Year:
1981

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Chinese hamsters were treated by intraperitoneal route with the test item. Bone marrow cells were then prepared for differential staining of sister chromatids and evaluated for the frequency of sister chromatid exchange as decribed by Stedka and Wolff (Mutation research, 1976, 41:333-342).
GLP compliance:
no
Remarks:
study performed before GLP compliance
Type of assay:
sister chromatid exchange assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,2,2-trifluoroethanol
- Physical state: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: assumed to be stable during the test (sponsor responsibility)
- Storage condition of test material: no data
- Other: no data

Test animals

Species:
hamster, Chinese
Strain:
other: Laboratory-reared (LOV:(CHN))
Sex:
male
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: 5,20 or 30 mg/mL dilutions of the substance in water were prepared
- Amount of vehicle (if gavage or dermal): not applicable
- Type and concentration of dispersant aid (if powder): not applicable
- Lot/batch no. (if required): no data
- Purity:no data
Details on exposure:
no data
Duration of treatment / exposure:
the animals were treated for 4 consecutive days
Frequency of treatment:
each day for 4 days
Post exposure period:
Five hamsters from each dose group were sacrified 1 day after completion of the exposure regimen.
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Remarks:
for 4 consecutive days
Dose / conc.:
5 mg/kg bw/day (nominal)
Remarks:
for 4 consecutive days
Dose / conc.:
25 mg/kg bw/day (nominal)
Remarks:
for 4 consecutive days
Dose / conc.:
100 mg/kg bw/day (nominal)
Remarks:
for 4 consecutive days
No. of animals per sex per dose:
the doses were administered to 9 animals per dose level. 5 hamsters from each group were sacrified and bone marrow of 3 animals at each dose were prepared for the SCE assay.
Control animals:
yes, concurrent no treatment
Positive control(s):
cyclophosphamide
- Justification for choice of positive control(s): no data
- Route of administration: intraperitoneal injection
- Doses / concentrations: 30 mg/kg bw/day for 4 days

Examinations

Tissues and cell types examined:
Bone marrow cells from 3 animals at each dose were prepared. 50 cells per animal were counted for SCE.
Details of tissue and slide preparation:
No data
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
No additional information

Any other information on results incl. tables

No remark

Applicant's summary and conclusion

Conclusions:
Under the test conditions, 2,2,2-trifluoroethanol is not an in vivo mutagen or may have no direct affect on replicating chromosomes.
Executive summary:

In a mammalian cell cytogenetics assay (Sister Chromatid exchange assay), 9 male Chinese hamsters (LOV: (CHN)) were exposed to 2,2,2-trifluoroethanol (>99°%) diluted in water at concentrations of 0, 5, 25 and 100 mg/kg bw/day for 4 consecutive days by intraperitoneal injection.

One day after completion of the exposure regimen, bone marrow cells of 3 animals per dose were then prepared for differential staining of sister chromatids and evaluated for the frequency of sister chromatid exchange as decribed by Stedka and Wolff (1976).

Cyclophosphamide was used as positive control and induced the appropriate response.

There was no evidence of sister chromatid exchange induced over background with the test item.

Under the test conditions, 2,2,2-trifluoroethanol is not an in vivo mutagen or may have no direct effect on replicating chromosomes.