Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In order to study a possible skin sensitisation potential of 4,4’-Diamino-3,3’,5,5’-tetramethyl-dicyclohexylmethane, three groups each of five female mice were treated once daily with the test item at concentrations of 0.25, 0.5, and 1% (w/w) in acetone:olive oil (4+1 v/v) by topical application to the dorsum of each ear once daily for three consecutive days. The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 1.00, 1.04, and 4.08 were determined with the test item. A test item is regarded as a sensitiser in the LLNA, if exposure to one or more test item concentration results in a 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated test item concentration required to produce a S.I. of 3 is referred to as the EC3 value. An EC3 value of 0.8% (w/w) was calculated. [BASF, 2011]


Migrated from Short description of key information:
The test item 4,4’-Diamino-3,3’,5,5’-tetramethyl-dicyclohexylmethane shows a skin sensitising potential.

Justification for classification or non-classification

4,4’-Diamino-3,3’,5,5’-tetramethyl-dicyclohexylmethane is considered to be skin sensitising (EU: R43; GHS: cat.1A H317) according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.