Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

The skin sensitising potential of Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol was investigated in the guinea pig maximisation test according to OECD TG 406 and GLP. Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol was applied to 10 male and 10 female animals in the test groups and to 5 male and 5 female animals in the negative control group with vehicle.

Sensitisation was induced in guinea pigs by intradermal injections of both test substance (1% Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol) and Freund´s Complete Adjuvant. The induction process was supplemented seven days later by application of Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol with a test concentration of 99% to the shoulder injection sites under occlusion for 48 hours. The selected concentrations were the highest to cause mild to moderated skin irritation. Twelve days later the test group and control animals were challenged for 24 -hours with an occluded patch application of the test substance at 25 % in vehicle (70 % acetone; 30 % polyethylene glycol 400). This concentration was the highest non-irritating dose. Following challenge application, no dermal reactions were seen in any of the test or control animals. Consequently the test item was considered as non sensitising.


Migrated from Short description of key information:
Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol did not show any skin sensitising activity.

Justification for classification or non-classification

Based on the results of the skin sensitising study, Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol is not subjected to classification and labelling according to Directive 67/548/EEC and Regulation 1272/2008/EC.