Registration Dossier
Registration Dossier
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EC number: 701-188-3 | CAS number: -
Carcinogenicity
Administrative data
Description of key information
alpha-Terpineol and beta-terpineol injected intraperitoneally to mice were not found to be carcinogenic.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Terpineol multiconstituent is not classified as a mutagen and there is no evidence from the repeated dose studies that terpineol multiconstituent but also alpha-terpineol and beta-terpineol are able to induce hyperplasia or pre-neoplastic lesions. Therefore, terpineol multiconstituent is not classified according to directive 67/548/EEC and CLP regulation (EC) No 1272/2008.
Additional information
Female mice were given intraperitoneal injections of alpha-terpineol or beta-terpineol at 1900 and 9600 mg/kg bw in tricaprylin, 3 times a week for a total of 24 doses. Animals were then observed for mortality and bodyweights for 24 weeks after first injection and were all macroscopically necropsied after death or sacrifice. No dose-related increase was observed in tumor formation.
Justification for selection of carcinogenicity via oral route endpoint:
Further testing is not required under Annex X, column 2, section 8.9.1. Terpineol multiconstituent is not classified as a mutagen and there is no evidence from the repeated dose studies that terpineol multiconstituent but also alpha- and beta-terpineol are able to induce hyperplasia or pre-neoplastic lesions. Therefore, no further study is deemed necessary.
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