Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
