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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Irritant potency of the principal aliphatic chloride solvents on the skin and ocular mucous membranes of rabbits
Author:
Duprat P, Delsant L and Gradiski D
Year:
1976
Bibliographic source:
Eur J Toxicol. 3; 171-177

Materials and methods

Principles of method if other than guideline:
eye irritation study
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 ml undiluted tetrachloroethylene

Results and discussion

In vivo

Results
Irritation parameter:
other:
Remarks on result:
other: A mild catarrhal conjunctivitis was observed. The total score for eye irritation was only 4 on a scale of 0‑110. This result does not trigger classification for eye irritation.
Irritant / corrosive response data:
A mild catarrhal conjunctivitis was observed. The total score for eye irritation was only 4 on a scale of 0‑110. This result does not trigger classification for eye irritation.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In the poorly reported data (assigned reliability “4”) on eye irritation potential of rabbits by Duprat et al. (1976), 0.1 ml of undiluted tetrachloroethylene was applied giving rise to a mild catarrhal conjunctivitis in rabbits. The total score for eye irritation was only 4 on a scale of 0‑110 but the scoring system is not detailed. The conclusion was made that this result does not trigger classification for eye irritation. However, in a study in human volunteers (Stewart et al., 1970), slight and transient eye irritation which developed within the first two hours of exposure and subsided before the end of the 7-hour exposure has been reported at about 100 ppm (690 mg/m3). In addition, according to the study with human volunteers performed by Rowe VK et al., 1952, the vapour concentration of tetrachloroethylene which will cause minimal irritation of the eyes in the unacclimated individual lies between 100 and 200 ppm, but 280 ppm causes a burning sensation in the eyes. Higher concentrations are provoking even more serious eye irritation effects. Therefore, a proposal was made by the evaluating MSCA to classify tetrachloroethylene as eye irritant category 2 based on GSH criteria.
Executive summary:

In the poorly reported study (assigned reliability “4”) on the eye irritation potential of tetrachloroethylene in rabbits by Duprat et al. (1976), 0.1 ml of undiluted tetrachloroethylene was applied giving rise to a mild catarrhal conjunctivitis in rabbits. The total score for eye irritation was only 4 on a scale of 0‑110 but the scoring system is not detailed. The conclusion was made that this result does not trigger classification for eye irritation.