Registration Dossier

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Administrative data

Description of key information

Guinea Pig Maximization Test (GPMT, in vivo), guinea pig: not sensitising (GLP, OECD 406)

Key value for chemical safety assessment

Skin sensitisation

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

In order to assess the cutaneous allergenic potential under GLP conditions, the Maximisation-Test was performed in 30 (20 test and 10 control) Pirbright white guinea pigs, in accordance with OECD Guideline 406 (Ciba-Geigy 1993a). Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 5% concentration in 20% aqueous PEG and epidermally exposed to a 50% concentration in Vaseline. Ten control animals were similarly treated, but with vehicle alone. As determined in the range-finder test, the test item causes skin irritation at 50% in vaseline. Two weeks after the epidermal application all animals were challenged with a non-irritant dose (20%) and the vehicle. No skin reactions were observed in response to the 20% test substance concentration. No skin reactions were evident in the control animals.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No. 1272/2008.