Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
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 performed on guinea pig.
The induction phase was a single intradermal injection of substance solutions into ears.
After 11 days, the substance was applied on the shaved skin sections sized 2 x 2 cm to check for hypersensitivity. The reaction was recorded immediately after the substance application and after 24 and 48 hours.
GLP compliance:
not specified
Type of study:
intracutaneous test

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

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction exposure: dilutions 1:250 and 1:500
Challenge exposure: unchanged

Challengeopen allclose all
Route:
other: epicutaneous, coverage not reported.
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Induction exposure: dilutions 1:250 and 1:500
Challenge exposure: unchanged

No. of animals per dose:
no data

Results and discussion

Any other information on results incl. tables

At the challenge, 1-2 hours after the application of the substances, no visible changes were observed.

After 24 hours, exposure to HFCF 122a caused low-grade hyperemia with dilution ratio 1:250.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Since essential data on the method and results are not reported, the test cannot be interpreted and the results cannot be considered adequate to aim a definite conclusion on the sensitizing properties of the substance.
Executive summary:

The objective of the research was to study 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, includingstudies of skin-absorption, eye irritating and skin sensitizing properties.

The sensitizing properties of the substances were studied on guinea pigs through the method of O.G. Alekseeva and A.I. Petkevich (1972). Substance solutions were injected intradermally into the outer surface of guinea pig ears with dilution ratio 1:250 and 1:500.

After 11 days, spot tests with the substances were performed on the shaved skin sections sized 2 x 2 cm to check for hypersensitivity. The reaction was recorded immediately after the substance application and after 24 and 48 hours.

The study showed that after 1-2 hours after the application of the substances, no visible changes were observed. However, after 24 hours, exposure to HFCF 122a caused low-grade hyperemia with dilution ratio 1:250.

According to the authors, the study suggests that HFCF 122a has mild allergic action. However, the test was not conducted according to the current recognized guidelines and essential data on method and results are not reported. For this reasoning the results cannot be interpreted and they cannot be considered adequate to aim a definitive conclusion on the sensitizing potential of the substance.