Registration Dossier

Administrative data

Description of key information

For both eye and skin irritancy testing a study is available. Both studies are performed according to the relevant OECD guideline and GLP principles. 

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” and method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC. The 3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema and slight oedema. Other skin reactions noted were light brown discolouration of the epidermis, loss of skin elasticity and flexibility and crust formation. All treated skin sites appeared normal at the 14-day observation. No corrosive effects were noted. The average erythema score at 24, 48 and 72 hours was found to be 2, the average oedema score was found to be 1.66.

Eye irritation:

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” and method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC. A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 48-hour observation.


Justification for selection of skin irritation / corrosion endpoint:
One study available with Klimisch score 1.

Justification for selection of eye irritation endpoint:
One study available with Klimisch score 1.

Justification for classification or non-classification

Based on the available studies, the test substance is not classified for skin or eye irritation according to EC Regulation No. 1272/2008.

In accordance with EC Directive No. 67/548, the substance should be classified with Xi; R38.

Based on the results obtained in the skin irritation study, the substance should be labelled with EUH066 – “Repeated exposure may cause skin dryness or cracking”