Registration Dossier

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:

Trioxane proofed not to be sensitizing in a guinea pig maximization test (BASF AG, 1989). The study was performed according to the OECD guideline 406 and GLP.

Additionally an epicutaneous test on 84 dentists, dental technicians and specialist auxilliary staff with contact eczema was performed (Berova et al., 1990). Trioxane was included as desinfectant in dental applications. 31 patients were diagnosed with a work related contact dermatitis, only one of them (1.2%) with an allergy against trioxane.

Even though trioxane proofed not to be sensitizing in guinea pig tests and from human experience, it is known that trioxane degradation results in the release of small amounts of formaldehyde (formaldehyde-releasing agent). Formaldehyde is a well known human skin sensitizer and from this perspective possible implications for formaldehyde-susceptible individuals should be indicated in the hazard communication (MSDS). 


Migrated from Short description of key information:
Not sensitizing in a guinea pig maximization test (OECD guideline 406, GLP)

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available:

Justification for classification or non-classification

No classification for sensitization indicated according to Directive 67/548/EEC and Directive 1272/2008.