Registration Dossier

Administrative data

Description of key information

skin irritation 
in vivo, rabbit, occlusive, 4h: not irritant (standardized method, OECD 404, BASF AG, 1982)

eye irritation
in vivo, rabbit: not irritant according to 67/548/EEC; Cat. 2 according to 1272/2008/EC CLP (standardized method, OECD 405, BASF AG, 1982)
respiratory irritation
no data available

Key value for chemical safety assessment

Additional information

There are reliable studies available to assess the potential of the substance for skin and eye irritation.

 

Skin irritation:

An OECD 404 guideline conform study was performed to assess the acute dermal irritation or corrosion potential of the test substance Oxooel 13 in Vienna White rabbits (BASF AG, 1982). Three rabbits were dermally exposed to 0.5 ml of the test substance for 4 hours under occlusive conditions. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean score for the 24, 48 and 72 h reading for erythema were 1.3, 1.7 and 2 in the three animals. Edema was not observed in any animal at any reading. The findings were fully reversible in all animals within 8 days after application, thus the study was terminated.

Under the conditions of this study, the test substance is not considered to be a dermal irritant.

 

Eye irritation:

To assess the acute eye irritation potential of the test substance Oxooel 13 in vivo an eye irritation test in Vienna White rabbits was performed according to the method described in OECD guideline 405 (BASF AG, 1982).

An amount of 0.1 ml of the test substance was single ocular applied to three rabbits and left unwashed after application. The average scores (24 to 72 hours) were calculated to be 0.0 for corneal opacity and iris, 1.9 for conjunctivae redness and 0.8 for chemosis. The findings were reversible in all animals at the latest within 8 days after application, thus the study was terminated. Redness of the conjunctiva with a score of 2 was observed in two of three animals, therefore GHS classification is required (category 2). Slightly discharge in two animals and clearly discharge in one male animal increased 24 hrs after application but were reversible within 48 hrs after application. In addition, constricted pupil 24 hours after application was observed in one female. These symptoms were reversible within 48 hours.

Under the test conditions chosen and considering the described findings the test substance does not give indication of an irritant property to the eye under 67/548/EEC. According to 1272/2008/EC CLP, Oxooel 13 has to be classified as irritating to eye (Category 2).

respiratory irritation

no data available


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

skin irritation:

Dangerous Substance Directive (67/548/EEC):

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin irritation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin irritation under Regulation (EC) No. 1272/2008.

eye irritation:

Dangerous Substance Directive (67/548/EEC):

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for eye irritation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified as irritating to eye (Cat. 2) under Regulation (EC) No. 1272/2008.

respiratory irritation

no data available