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Toxicological information

Endpoint summary

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Administrative data

Description of key information

Based on a guinea pig maximization study, performed according to the OECD guideline 406 (Allen, 1996; Klimisch 2) , the test substance is considered not sensitising to the skin.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Only one GLP study conducted in accordance with OECD guideline 406 is available (Allen, 1996). The study examined the skin sensitising effect on guinea pigs, using 15 animals in total. Positive, solvent and negative controls were included in the study. Animals were induced 3 times with 0.5% the test substance. A challenge was performed using a 50% or 75% solution in vehicle (water). At both 24 and 48 hours after the challenge at 50% or 75%, none of the animals expressed positive reactions. Furthermore all controls showed expected results, resulting in a valid assay. Based on this study, it was concluded that the substance did not cause delayed contact hypersensitivity in guinea pigs and is therefore considered not sensitizing.

No in vitro skin sensitisation studies were performed.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data and the criteria laid down in the CLP regulation, the test substance does not need to be classified as a skin sensitising substance.

No reliable data are available on respiratory sensitisation. Therefore, no conclusion can be made on the classification for this endpoint.