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:

There is no conclusive study known to exist for this endpoint, but isononanol is considerd to lack a skin sensitising potential for the following reasons.

1.) 3,5,5- trimethylhexanol was tested in a maximisation study for its skin sensitising potential in 25 healthy volunteers. The test substance (8% in petrolatum) was applied to the skin for 48 hours under an occlusive dressing. No sensitisation reactions were noted (Belsito et al. 2010; p. S33 and Table 10 on p. S41). A synopsis of the study is available(Kligman1977). The study is considered to be reliable and suitable for assessment of this endpoint.

2.) Related substances lack a skin sensitising potential.

Long chain saturates primary alcohols lack a skin sensitizing potential (OECD 2006)(Cronin and Basketter 1994, p.171).

1-nonanol (2% in petrolatum) was reportedly neither a skin irritant nor a skin sensitizer to humans (Opdyke, 1973), and no sensitization reactions were produced in 25 volunteers after patch testing with nonanoic acid (12% in petrolatum) (Opdyke, 1978).

 

To summarise:

3,5,5 -trimethylhexanol was not sensitising in a valid human maximisation test.



Migrated from Short description of key information:
3,5,5 -trimethylhexanol is not sensitising

Justification for classification or non-classification

Regulation 67/548/EEC, Regulation 1272/2007/EC: skin sensitisation: no classification required