Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The test substance is not irritating or corrosive to the rabbit skin (OECD 404, GLP). 
The test substance is not irritating to the rabbits eye (OECD 405, GLP).

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 irritation:

In a primary dermal irritation study conducted according to OECD 404 and GLP, three NZW rabbits were dermally exposed to the test substance for 4 hours. Animals then were observed for three days and additional observations were made on day 4. The single semi-occlusive application elicited very slight oedema in all animals at the 48 and/or 72 hour reading, but no erythema. All reactions had resolved by day 4. The observed signs of skin irritation were not relevant for classification and labelling.

Eye irritation:

In a primary eye irritation study according to OECD TG 405 and GLP, 0.07g of the test substance was singly instilled into the rabbits eye. 24 hrs after exposure, the maximum response observed was grade 2 reddening of the eyelids of one rabbit, while the two other animals showed very slight reddening. Very slight chemosis was observed during the first 24 hours. All animals showed lacrimation in response to the test substance (maximum at 24 hours), while the treated eyes stained intensely black. No adverse effects to the cornea and the iris were observed in any of the animals during the entire observation period. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any corneal epithelial damage. No signs of systemic intoxication were observed in any of the rabbits. All reactions had resolved 7 days after instillation.

Justification for classification or non-classification

Based on the results of the skin and eye irritation key toxicity studies, the test substance is not subject to classification and labelling for skin irritation or eye irritation according to Directive 67/548/EEC and Regulation 1272/2008/EC.