Registration Dossier

Administrative data

Description of key information

Skin: not irritating (RCC, 2002)
Eye: not irritating (RCC, 2002)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

The primary skin irritation potential of the test substance was investigated by topical semiocclusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits (RCC, 2002). The duration of treatment was four hours. The study was conducted according to OECD 404 guideline and GLP. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. The test item caused no staining and no corrosive effects were noted on the treated skin of any animal at any of the measuring intervals. Thus, the test item did not induce significant or irreversible damage to the skin.

Eye irritation:

The primary eye irritation potential of the test substance was investigated by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits (RCC, 2002). Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14 and 17 days after test item application. The study was conducted according to OECD 405 guideline and GLP. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary eye irritation score was calculated by totaling the mean cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary eye irritation score was 0.89 (max. 13). The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.67, 1.00 and 1.00 for reddening and 0.00, 0.00 and 0.00 for chemosis, respectively. The instillation of the test substance into the eye resulted in mild, eariy-onset and transient ocular changes, such as chemosis and reddening of the conjunctivae and sclerae. These effects were reversible and were no longer evident 17 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

Justification for classification or non-classification

No signs of skin irritation were observed, signs of eye irritation were only slight. Therefore no classification and labeling according to DSD-DPD and CLP is required.