Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The data source is the competent authority, it is considered reliable. Although the test method is not in agreement with current official guidelines and study details are not fully reported, 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:
Two drops of the substance were introducted into the conjunctival sac of the rabbits. Changes were registered after 1, 24 and 72 hours, and 7 days. The degree of damage to the mucous membranes of the eyes caused by these compounds was assessed qualitatively based on changes in the cornea, iris and conjunctiva.
No information on washing are reported. No information on the number of animals and the negative control.
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 / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
single administration
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
not reported

Results and discussion

In vivo

Results
Time point:
other: 1 hour
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: palpebral fissure completely closed, diffuse corneal opacity developed, conjunctival hyperemia and inflammatory edema of the eyelids was observed.
Other effects:
Immediately after the application of refrigerants, the animals displayed sharp excitement.
After 1 hour, the palpebral fissure completely closed, diffuse corneal opacity developed, conjunctival hyperemia and inflammatory edema of the eyelids was observed.
After 24 and 72 hours, the severity of the described processes decreased, and a week later the changes almost disappeared.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
Under the reported study, HCFC 122a exhibited irritating effect on the mucous membranes of the eyes.
Executive summary:

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

To identify the substance action on conjunctiva, the test solutions of HCFC 122a and HCFC 132

were introduced into the conjunctival sac of rabbit eyes; besides, local action of the substances was studied by Draize method.

Two drops of the substances were introducted into the conjunctival sac of the rabbits. Changes were registered after 1, 24 and 72 hours, and 7 days. The degree of damage to the mucous membranes of the eyes caused by these compounds was assessed qualitatively based on changes in the cornea, iris and conjunctiva.

Studies showed that immediately after the application of refrigerants, the animals displayed sharp excitement. After 1 hour, the palpebral fissure completely closed, diffuse corneal opacity developed, conjunctival hyperemia and inflammatory edema of the eyelids was observed. After 24 and 72 hours, the severity of the described processes decreased, and a week later the changes almost disappeared; HFCF 122a caused more severe irritation than HCFC 132.

The study authors established that the test compounds exhibit slight irritating effect on the mucous membranes of the eyes, wherein these properties are more pronounced in HFCF 122a.