Registration Dossier

Administrative data

Description of key information

Slightly skin irritating, non-classifiable, rabbit, OECD 404, Johnson 1999
Slightly eye irritating, non-classifiable, rabbit, OECD 405, Johnson 1999

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

In a GLP compliant skin irritation study, performed according to OECD guideline 404, an amount of test substance (500 mg) was moistened and applied under occlusion to the skin of three New Zealand White rabbits for 4 hours. After 4 hours, the dressing was removed and the skin was cleansed. After this, observations were made for an additional 10 days. The test substance showed an edema score of 0 during the whole observation period. An erythema score of 1 was observed in two animals (one male and one female) 1 hour after decontamination only, and was seen in the remaining male animal for 7 days. In addition, slight thickening of the skin was seen in one animal from 3 to 7 days after application.No corrosive effects were noted.Under the conditions of this experiment, the test substance was found to be slightly irritating. All observed effects were non-classifiable.

Eye irritation:

In a GLP compliant eye irritation study, performed according to OECD guideline 405, the test substance (100 mg) was applied into one eye of three New Zealand White rabbits. An assessment of initial pain was made and the eyes were examined for 4 days to assess the grade of ocular reaction. Application into the eye caused practically no or slight initial pain (class 1 - 2 on a 0 - 5 scale). There were no corneal effects. Slight iritis was seen in all animals for up to 3 days. Conjunctivae effects were seen in all animals and consisted of slight or moderate redness for 3 days, slight or mild chemosis for up to 2 days and a slight or moderate discharge for up to 1 day. Additional signs of irritation comprised lachrymatory or mucoid discharge and dried secretion around the periorbital skin. One animal was holding its dosed eye closed approximately 1 hour after application, which may be indicative of pain. All signs of irritation had completely resolved 4 days after application. Under the conditions of this experiment, the test substance was found to be slightly irritating. All observed effects were non-classifiable.


Justification for selection of skin irritation / corrosion endpoint:
Only study available, GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Justification for selection of eye irritation endpoint:
Only study available, GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the skin irritation study, classification for skin corrosion/irritation is not warranted according to Directive 67/548/EEC.

Based on the eye irritation study, classification for ocular lesions is not warranted according to Directive 67/548/EEC.

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

Based on the eye irritation study, classification for serious eye damage/eye irritation is not warranted according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.