Registration Dossier
Registration Dossier
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EC number: 207-975-3 | CAS number: 503-74-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Reportedly isovaleric acid was not sensitising in 39 human volunteers who underwent a maximization test (Opdyke, 1979). The available information is, however, scarce. More important are the findings that
i) saturated aliphatic acids are only in very rare cases skin senitizers [Cragg ST (2001) in: Patty’s Industrial Hygiene and Toxicology (2005)], and that
ii) isovaleric acid is corrosive to the intact skin (CAT 1B). In-vivo testing for skin sensitisation is therefore not allowed under REACH (Annex VII; No. 8.3, column).
Overall, isovaleric is unlikely to have a skin sensitising potential. Because of the corrosive property skin contact must be avoided, and this will also help to avoid any potential sensitisation.
Migrated from Short description of key information:
Isovaleric acid is not considered to be a skin sensitizer. It is, however, corrosive to the skin. Skin protection is therefore required.
Justification for selection of skin sensitisation endpoint:
REACH does not allow in-vivo testing of skin corrosives like isovaleric acid (proposed: skin corrosion CAT 1B).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Isovaleric acid is not considered to have sensitising properties.
Migrated from Short description of key information:
No study available but isovaleric acid is not considered to be a sensitiser.
Justification for classification or non-classification
Classification for sensitisation is not proposed.
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.
