Registration Dossier

Administrative data

Description of key information

Skin:
Under the experimental conditions of the test, the mean score for erythema was found to be 0.0 and the mean score for edema was found to be 0.0. Thus, the substance is not irritating to the skin.
Eye:
Based on the results of the study, the test item has not to be classified as irritating to 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:
no adverse effect observed (not irritating)

Additional information

Skin:

The skin irritant effect of the test item was investigated according to the method recommended in the OECD Guideline No. 404 "Acute Dermal Irritation/Corrosion", 2002, the Commission Directive 2004/73/EC "B.4. Acute Toxicity: Dermal Irritation/Corrosion", 2004, and OECD document "Harmonised Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures", 2001.

Based on a weight-of-the evidence analysis of all existing relevant iformation, the in vivo testing of the test item was considered to be justified.

During an initial test using one female albino rabbit a sequential application /exposuer time 3 min., . and 4 h.) of the test item was carried out on one site of the right back area each. The skin was examined for signs of irritation straight after as well as 1 h., 24 h., 48 h., and 72 h after the termination of the exposure. Since the animal did not show signs of skin irritation at any observation time it was decided to carry out a confirmatory test with two additional animals in order to allow a categorization of the test item based on classification criteria.

Two female albino rabbits were exposed to the test item at one skin site on the back during the confirmatory test. After 4-hour exposure time the test item was removed and the skin was examined 1 h., 24 h., 48 h. and 72 h. after the termination of exposure. No skin reactions wre observed in these animals, too. Under the experimental conditions described in the study, the mean score for erythema was 0.0 and for edema 0.0. Thus, the substance is not irritating to the skin.

Eye:

The local effect of the test item was investigated according to the method recommended in the OECD Guideline No. 405, "Acute Eye Irritation/Corrosion", April 2002, the Commission Directive 2004/73/EC "B.5. Acute Toxicity: Eye Irritation/Corrosion", April 2004, and the OECD document "Harmonised Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures", August 2001. Based on a weight-of-evidence analysis, the in vivo testing of the test item was considered to be justified.

At first only one female albino rabbit was exposed to 0.1 mL of the test item in one eye during an initial test. The eye was examined and the changes were graded according to a numerical scale 1 h., 24 h., 48 h., and 72 h. after dosing. Very slight changes were observed in the treated eye. Based on these findings two more female albino rabbits were treated with 0.1 mL of the test item each. Likewise ocular effects were graded 1 h., 24 h., 48 h., and 72 h. after dosing. Both of the test animals showed very slight changes in the eyes.

All observed effects were fully reversible within 48 hours. The following mean values were calculated:

Cornea opacity: 0.0

Iris lesion: 0.0

Redness of conjunctiva: 0.2

Oedema of conjunctiva: 0.0

Based of the results of the study, the test item is not classified as eye irritating.

Justification for classification or non-classification

No classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.