Registration Dossier

Administrative data

Description of key information

Skin irritation
Three standard rabbit skin irritation studies, two with 24-hour occlusive exposures to abraded and intact skin with the undiluted test material, and one with a 4-hour occlusive exposure to intact skin with the undiluted test material, revealed different results (Jones 1983; Nelson et al. 1977; Heenehan 1977). In one of the 24-hour studies, the test material was classified as mildly irritating (Heenehan 1977), whereas in the other 24-hour study the test material was classified as non irritating (Nelson et al. 1977). Different laboratories performed these studies, but the same volume of the test material was used in each study, along with the same species/strain of animal, and application area for the test material. Therefore, one study cannot be readily dismissed over the other. The 4-hour study results were classified as non irritating (Jones 1983). Based on the foregoing information, it was concluded that the test material was slightly irritating.
Eye irritation
Two standard eye irritation studies were performed in rabbits using the undiluted test material (Heenehan 1977; Nelson et al. 1977). Irritation was noted in both studies. Heenehan (1977) utilized six animals, and Nelson et al. (1977) used nine animals. Of the 15 animals evaluated from both studies, one animal exhibited a response that persisted for up to 21 days. This finding was, however, considered spurious in light of the total number of animals evaluated.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

The available irritation/corrosion studies indicate that the test material is slightly irritating to the skin and irritating to the eyes.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

The major criterion for classification as a Category 2 Irritant under GHS is the mean value of the scores for either erythema/eschar greater than or equal to 2.3, or oedema in at least two of three animals tested. Two of the three studies did not identify signs of skin irritation. In the one study that identified positive findings of skin irritation, the highest mean value for erythema/eschar formation at any time point was 2.0. Further, the oedema scores were either '1' (barely perceptible) or '0' (no oedema) at all time points. Therefore, the test substance does not meet the criteria for classification under GHS. See: Regulation (EC) No 1272/2008; See Official Journal of the European Union, (2008) Vol. L353, pp. 1-1355, at p. 88.

Two eye irritation studies reported positive findings. In one study, all of the effects were reversible. In the second study, corneal opacity was observed in one animal up to 21 days post treatment. This finding was, however, considered spurious because only one animal out of the fifteen used from both studies exibited such a response. Therefore, these data support the GHS classification criteria for substances that may cause Reversible effects on the eye (Category 2). See: Regulation (EC) No 1272/2008; See Official Journal of the European Union, (2008) Vol. L353, pp. 1-1355, at p. 93.