Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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