Registration Dossier

Administrative data

Description of key information

Skin irritation (INBIFO, 1979): irritating
Eye irritation (INBIFO, 1979): serious eye damage

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

Skin irritation:

The skin irritation potential of the test substance (ca. 0.5 ml) was tested in a Draize-Test on the shaved and intact skin for 24 hours under occlusive conditions in six rabbits (INBIFO, 1979). The skin reactions were scored comparable to the scoring system reported in OECD 404 guideline after 24 and 72 hours. The skin was examined for a total of 7 days. The mean erythema score (24/72 hours) was 1.92, the mean edema score (24/72 hours) was 2.59. The individual mean erythema scores in the animals were: 1 in 1/6 animals, 2 in 4/6 animals, 2.5 in 1/6 animals. The individual mean edema scores in the animals were: 2 in 4/6 animals, 3.5 in 1/6 animals, 4 in 1/6 animals. Based on these results, the test substance was irritating to the skin.

When the test substance (ca. 0.5 ml) was tested on the shaved and intact skin for 5 minutes (open conditions) and 2 hours (occlusive conditions) in two rabbits (BASF, 1981), no signs of skin irritation (neither erythema nor edema) were reported 24, 48 and 72 hours post exposure as well as 8 days post exposure. The results show, that the results observed after 24 hours of occlusive exposure might be overpredictive but nevertheless a skin irritation potential has to be assumed as no data is available for a 4 hour exposure periode.

Eye irritation

The eye irriation potential of the test substance (ca. 0.1 ml) was tested in a Draize-Test in six rabbits (INBIFO, 1979). The occular reactions were scored comparable to the scoring system reported in OECD 405 guideline after 24, 48 and 72 hours. The eyes were examined for a total of 7 days, one eye per animal was treated, the other eye served as control. The mean cornea score (24/48/72 hours) was 1.17, the mean iris score (24/48/72 hours) was 0.83, the mean conjunctivae score (24/48/72 hours) was 1.73 and the mean chemosis score (24/48/72 hours) was 2.67. The individual mean cornea scores in the animals were: 0.33 in 2/6 animals, 1 in 2/6 animals, 1.67 in 1/6 animals, 2.67 in 1/6 animals. The individual mean iris scores in the animals were: 0 in 1/6 animals, 1 in 5/6 animals. The individual mean conjunctivae scores in the animals were: 0.67 in 1/6 animals, 1.67 in 1/6 animals, 2 in 4/6 animals and the individual mean chemosis scores in the animals were: 0.67 in 1/6 animals, 1 in 1/6 animals, 2.33 in 2/6 animals, 3 in 1/6 animals, 3.67 in 1/6 animals. As the cornea and iris lesions were not fully reversible at the end of the observation period of 7 days, the test substance poses the risk of serious damage to the eye. It is hower unknown if the observed effects would have been reversible after a 21 day observation periode.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the available data, a classification as irritating to the skin (R38 according to Directive 67/548/EECand Skin Cat. 2 according to the CLP Regulation (EC) No. 1272/2008) and posing the risk of serious eye damage (R41 according toDirective 67/548/EEC and Eye Cat. 1 according to the CLP Regulation (EC) No. 1272/2008) is warranted.