Registration Dossier
Registration Dossier
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EC number: 222-376-7 | CAS number: 3452-97-9
Endpoint summary
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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