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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.