Registration Dossier

Administrative data

Description of key information

The skin and eye irritancy of the test substance was tested in New Zealand White rabbits. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced erythema and oedema but all treated skin site appeared normal at the 14-day observation. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour aboservation. There are no information available to assess irritation of the substance in the respiratory tract.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

The test material is classified as R38 Irritating to skin but does not meet the criteria for classification of eye irritation according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).

The irritation/corrosion tests described above meet the requirements of OECD Test Guidelines and are assigned to be reliability 1 data according to the scoring system of Klimisch et al (Klimisch et al., 1997). This ranking was deemed appropriate because the studies were conducted the GLP certified laboratory and were in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

There are no information available to assess irritation of the substance in the respiratory tract.


Effects on skin irritation/corrosion: irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

The test material is classified as R38 Irritating to skin under Council Directive 67/548/EEC but does not meet the criteria under Regulation (EC) No 1272/2008. The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).