Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
The data source is the competent authority, it is considered reliable. Although the test method was not specifically conducted for the assessment of the skin irritating potential, 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

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 sigle 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 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:
other: mouse and rat
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
1 stage: 2h single exposure
2 stage: 4h/day exposure for 12 days
Observation period:
1 stage: 14 days
2 stage: no data
Number of animals:
no data

Results and discussion

In vivo

Results
Irritation parameter:
other: general assessment
Remarks on result:
other: Repeated application of HCFC 122a to the skin (4h/day for 12 days) caused dryness of the skin followed by development of redness and cracks.
Other effects:
At the end of the experiment, repeated application of refrigerants to the skin (4h/day for 12 days) caused dryness of the skin followed by development of redness and cracks.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Possible irritant effect after repeated application. Criteria used for interpretation of results: EU
Conclusions:
Repeated application of HCFC 122a to the skin (4h/day for 12 days) caused dryness of the skin followed by development of redness and cracks. The effects did not meet criteria for classification as a skin irritant but warrant a supplemental hazard statement (EUH066 - Repeated exposure may cause skin dryness or cracking).
Executive summary:

The objective of the research was to study the toxicity of HCFC 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, eye irritating and sensitizing properties.

Information on the potential skin irritating properties of HCFC 122a can be obtained from the study of skin absorption.

The study of skin- absorption properties of the substances was conducted in two stages. At the first stage of the experiment, the toxicity of HCFC 122a and HCFC 132 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.

Single exposure to the substances did not cause symptoms of intoxication and death of animals. Therefore, experiments with repeated applications of HCFC 122a and HCFC 132 for 4 hours/day for 12 days were included.

At the second stage of the experiment, the ability of the substances to penetrate the skin was investigated. The substances were applied to the section of rat skin sized 2 x 2 cm. 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 was assessed based on some physiological parameters.

Study showed that repeated application of the two substances 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. However, repeated application of both the susbtances to the skin at the end of the experiment caused dryness of the skin followed by development of redness and cracks.