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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
The data source is authoritative. The results are sufficient to aim a conclusion for the health hazard assessment of the substance.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test was conducted in order to assess the skin absorption properties.
The study was conducted in two stages.
At the first stage the substance was applied in a single administration on the skin of the tails of white mice; contact time was 2 hours, after which the tails were washed with soap and water, and the animals were observed for 14 days.
Since the single exposure did not cause symptoms of intoxication and death of animals, a repeated applications of the substance for 12 days was included.
At this second stage the substance was applied to the section of rat skin sized 2 x 2 cm, and the application time was 4 hours. In order to prevent evaporation from the skin surface, the studied section of skin was sealed.
GLP compliance:
not specified
Test type:
other: subacute
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,2-trichloro-1,2-difluoroethane
EC Number:
940-543-9
Cas Number:
354-15-4
Molecular formula:
C2HCl3F2
IUPAC Name:
1,1,2-trichloro-1,2-difluoroethane
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): R122
- Molecular formula: CHCIF–ССI2F

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
4 hours/day x 12 days
Doses:
unchanged substance applied on 2x2 cmq of skin.
No. of animals per sex per dose:
no data
Control animals:
not specified

Results and discussion

Effect levels
Dose descriptor:
LD50
Remarks on result:
other: not determined

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
HCFC 122a does not posses potential toxicity following dermal exposure
Executive summary:

The objective of the reported study was to investigate the toxicity of HFCF 122a and HCFC 132 and to characterize their biological action in order to validate the approximate safe level of these compounds in the air of working area, ambient air, and water. In this study both a review of the available toxicological data on similar chemical compounds was made and toxicological tests on HFCF 122a and HCFC 132 were performed, including studies of skin absorption and acute toxicity by oral and inhalation routes.

Information on the acute toxicity of HCFC 122a by dermal exposure can be obtained from the study of skin absorption: under this test, in a first stage of the experiment, the toxicity of HCFC 122a was studied after application of the substances on the skin of the tails of the white mice; contact time was 2 hours after which the tails were washed with soap and water and the animals were observed for 14 days.

Since single exposure to the substances did not cause symptoms of intoxication and death of animals the experiments with repeated applications of HCFC 122a for 12 days were included. In this phase HCFC 122a was applied to the section of rat skin sized 2 x 2 cm, and the application time was 4 hours. In order to prevent evaporation of the substances from the skin surface, the studied section of skin was sealed.

The functional state of the experimental animals, used to determine if absorption occurred, was assessed based on some physiological parameters: orientation response and summation-threshold value (STV), the latter as index of adverse effect on the nervous system.

The method of summation of subthreshold pulses consists of recording of threshold stress causing the motor response. According to the authors it has a sufficiently high sensitivity for the detection of early changes in the condition of the nervous system.

These physiological parameters were chosen basing on the results of previous toxicological studies, which showed that the most evident signs of toxicity HCFC 122a and HCFC 132 are adverse effects on the nervous system.

Study showed that repeated application of HCFC 122a to the skin did not lead to changes in appearance and behaviour of animals and changes in functional parameters, indicating the absence of expressed skin-absorption properties. Basing on the results, it can be concluded that HCFC 122a does not posses potential toxicity following dermal exposure.