Registration Dossier

Administrative data

Description of key information

Skin irritation: In a rabbit skin irritation/corrosion test according to OECD TG 404 and EC B.4, the test substance was mildly irritating according to the Draize classification scheme (Allen, 1996), but is not to be classified as irritant to the skin according to the CLP Regulation.
Eye irritation: Based on the data of the key study (performed according to EPA OPPTS 870.2400 and EC Method B.5)and according to the criteria of the CLP Regulation, the test substance is classified as irritating to the eyes (category 2A).

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 (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The skin irritation potential of the test substance is investigated in a key, reliable study performed according to OECD guideline 404 (Allen, 1994; Klimisch 2) in 3 rabbits. Semiocclusive patches were removed from shaved test sites after exposure periods of 3 min, 1h, and 4h to 0.5mL of the test substance. The Draize scoring system was used to evaluate the results. No erythema/eschar formation and no oedema formation is observed after 3 min and 1 hour exposure. After 4 hours of exposure, very slight erythema in all 3 animals and very slight oedema in 2 animals was observed, but this was fully reversible within 24 -48 hrs.

No in vitro skin irritation studies were performed.

Eye irritation:

Calvert Laboratories, Inc. (2010) investigated the eye irritation potential of the test substance in a key, reliable study performed according to EU method B.5 (Klimisch 1) in 3 rabbits. The treated eyes (with 0.1mL test substance) will remain unrinsed for at least 24 ours after instillation. The 24 -, 48- and 72 -hours scores will be added seperately for each animal and each total divided by 3 to yield the individual mean scores for each animal. Based on the data and according to the criterial of the CLP regulation, the test substance is classified as irritant to the eyes (category 2).

No in vitro eye irritation studies were performed.

Justification for classification or non-classification

Based on the available data and according to the criteria laid down in the CLP Regulation (EC) 1272/2008, the test substance is not to be classified as irritant to skin. The test substance does not need to be classified for skin irritation or skin corrosion, as the substance proved to be only mildly irritating in a rabbit skin irritation/corrosion study.

Based on the data and according to the criteria of the CLP Regulation, the test substance is classified as irritating to eyes (category 2A).