Registration Dossier

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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

In a Guinea Pig Maximization Test according to OECD TG 406 (Magnusson and Klingman) male guinea pigs were tested with following concentrations of the test substance:

1st application: Induction 2.5 % intracutaneous

2nd application: Induction 12 % occlusive epicutaneous

3rd application: Challenge 6 % and 3% occlusive epicutaneous

The test substance was formulated as an emulsion with Cremophor EL in sterile physiological saline solution (2% V/V).

No skin reddening was observed after the provocation with 6% and 3% of test substance neither in the test animals nor in the control animals. The test substance therefore shows no skin sensitisation potential (Bayer AG 1993).

Migrated from Short description of key information:
The test substance shows no skin sensitisation potential.

Respiratory sensitisation

Endpoint conclusion
Additional information:

no data

Justification for classification or non-classification

Skin Sensitization

Based on the available data, no classification is required according to the classification criteria 67/548/EWG and

EU Regulation 1272/2008 (CLP/GHS).