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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: the standard operating procedure SOP "GEN-018"-I n -v i v o Assay f o r S i s t e r Chromatid Exchange Induction i n Lymphocytes of Rabbit, June, 1980.
Deviations:
no
GLP compliance:
no
Type of assay:
sister chromatid exchange assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the substance as cited in the report: CTFE (Chloro trifluoroethylene)
Storage Conditions Room Temperature
Espiration Date February, 1983
Analysis Purity - 99%
Stability: stable @ room temperature

Test animals

Species:
other: rabbits and rats
Strain:
other: strain of the rabbits: New Zealand White; strain of rats: Fisher 344
Sex:
male/female
Details on test animals and environmental conditions:
1.Species: Rat
Strain: Fischer 344
Supplier: Charles River Breeding Laboratories Kingston, N.Y.
Reason for Species Choice: Standard Laboratory Test Systems
Age on Test: Not defined
Weight Range: 125-175 gm
Number : 20 males
2. Species: Rabbit
Strain: New Zealand White
Supplier Summit View Farm Belvidere, N J
Reason for Species,Choice: Good model for studies involving lymphocyte c u l t u r e
Age on Test: Not defined
Weight range: approximately 2.0 Kg
Number 14 males

Husbandry:
Lights : 12 hours on, 12 hours off
During Exposure Period:
Housing :
Food :
Water :
During Exposure Period:
Housing :Individual in wire mesh cages
Food : none
Water: none
During the non-Exposure period
Housing: Individual in suspended stainless steel wlre mesh bottom cages
Food: Purina Rodent Laboratory Chow 5001 ad libitum.
Water: Tap water with automatic watering system - ad libitum
Quarantine period: Minimum 14 days ( inhalation SOP INH-051)

Administration / exposure

Route of administration:
inhalation: vapour
Vehicle:
none
Details on exposure:
The test item is administrated in the breathing air of the animals since there is a potential for human exposure by this route.
the exposure concentrations will be generated by metering known amounts of the undiluted test material into the chamber air intake.
The glass and stainless seel chambers are operated at an air flow rate that provides 99% equilibration time to or less than 10% of the total exposure time.
Duration of treatment / exposure:
5 days/week in the first week, 4 days in the second week.
Frequency of treatment:
6 hours/day
Post exposure period:
1 week
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
10 ppm
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
30 ppm
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
100 ppm
Basis:
nominal conc.
No. of animals per sex per dose:
three groups of 4 rats each and 3 rabbits each is exposed to a vapour of CTFE.
Control animals:
yes
Positive control(s):
A non inhalation positive control group was considered

Examinations

Tissues and cell types examined:
not applicable
Details of tissue and slide preparation:
not applicable, SCE frequency were monitored before, during and after exposure period after collection of animal's blood.
Evaluation criteria:
In case of test item with unknown and perhaps weak or no SCE inducting potential as CTFE the complete set of data from all animals is considered.
The data are plotted on a linear regression analysis.
Statistics:
Despite the absence of positive statistical findings using Student's t-test, the X^2-analysis was carried out.
It was again clear from these analysis that CTFE did not induce SCRs in peripheral lynphocytes of either rats or rabbits, and so no further statistical tests were performed.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Peripheral lymphocyte SCE frequencies were monitored before, during and after the exposure period. CTFE failed to induce significant increases in
SCE frequency at any dose level, and there was no suggestion of a dose response.
The test compound was therefore concluded to be negative in this assay.
Executive summary:

Test animals (rats and rabbits) were exposed to CTFE via inhalation for 6 hours a day, 5 days during week one and 4 days during week two; and their peripheral lymphocyte SCE frequencies were monitored before, during and after the exposure period. Exposure to CTFE failed to induce significant increases in SCE frequency at any dose level, and there was no suggestion of a dose response. This test compound is therefore concluded to be negative in this assay.