Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404; BASF AG, 1987): not irritating
Eye irritation (OECD 405, BASF AG, 1987): irreversible effects on the eye

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:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

The skin irritation potential of the test substance was evaluated based on a test according to OECD guideline 404. The fur of three animals (2 males, 1 female) was clipped and the undiluted test substance was applicated using a test patch (2.5 x 2.5 cm) soaked with 0.5 ml of the undiluted test substance. The patch was applicated onto the upper third of the back or flank. After an exposure period of 4 hours the skin was washed with Lutrol and Lutrol/water (1:1) followed by a 72 hours observation period with readings after 30 min and 60 min after the removal of the test patches and 24 h, 48 h and 72 h after the beginning of application. Untreated skin sites of the same animal were used as negative control. The severity of substance induced edema and erythema was quantified for each time point using the following values: 0 = none, 1 = very slight, 2 = well-defined, 3 = moderate to severe, 4 = severe to very severe. The edema and erythema scores were calculated as mean of the single values of the time points 24 h, 48 h and 72 h and all three animals. The test substance did not cause any edema or erythema except in one male which developed a very slight erythema extending beyond the area of exposure after 4 hours which was fully reversible within 20 hours. The mean erythema and edema scores were 0.0 in each of 3/3 animals after 24/48 and 72 hours and the test substance was classified as not irritating to the skin.

Eye irritation:

The eye irritation potential of the test substance was evaluated in a test according to OECD guideline 405. A single application of 0.1 ml of the unchanged test substance was given into the conjunctival sac of the right eyelid of three rabbits (2 males, 1 female). The substance was not washed out. Eye effects were documented 1 h, 24 h, 48 h, 72 h, 8 days, 15 days and 21 days after the application. The untreated eyes of the animals were used as negative control. The severity of substance induced eye effects was quantified for each time point using the following values: opacity and swelling (0 = none, 1 = very slight, 2 = well defined, 3 = moderate to severe, 4 = severe to very severe), redness (0 = normal, 1 = slight, 2 = well-defined, 3 = severe) and iris (0 = normal, 1 = circum-corneal injection, 2 = iritis). The irritation scores were calculated as mean of the single values of the time points 24 h, 48 h and 72 h and all three animals: Cornea score = 0.2 (mean score 0 in 2/3 animals; 0.7 in 1/3 animals), conjunctivae score = 1.6 (mean score 2 in 1/3 animals; 1 in 1/3 animals; 1.7 in 1/3 animals), iris score = 0.0 (mean score 0 in each of 3/3 animals) and chemosis score = 0.4 (mean score 0 in 2/3 animals; 1.3 in 1/3 animals). Effects on cornea opacity was fully reversible within 72 hours in 1/3 animal, not reversible within 21 days in 1/3 animals (grade 2 at the end of the observation period) and one animal did not develop cornea effects. Redness was fully reversible within 72 hours in 1/3 animals, within 8 days in 1/3 animals and not reversible within 21 days in 1/3 animals. Swelling was fully reversible within 24 hours in 2/3 animals and not reversible within 21 days in 1/3 animals. One male animal showed contracted pupils starting 48 hours after application until day 21. Eight days after application of the test substance this animal also developed small retractions in the eyelid, loss of corneal tissue and suppuration. These effects persisted unchanged until day 21. Furthermore this animal showed marginal vascularization of the cornea on day 21 while the second male did not show any of these effects at any time point. The female developed loss of corneal tissue and contracted pupils only 48 hours after application of the test substance. These effects were fully reversible within 24 hours. Based on the irreversible effects in one animal, the test substance hold the risk of serious eye damage.


Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the skin irritation study, classification of skin irritation is not warranted according to EU directive 67/548/EEC and EU classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Based on the eye irritation study, the test substance poses the risk of serious damage to the eye (R41) according to EU directive 67/548/EEC and has to be classified as Eye irritant Cat. 1 according to EU classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.