Registration Dossier
Registration Dossier
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EC number: 204-116-4 | CAS number: 115-95-7
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
Additional information
No key study for carcinogenicity data is available for linalyl acetate. Limited evidence from literature is available with shortcomings in the study design (duration of exposure and route of exposure).
Linalyl acetate was tested in A/He mices receiving an i.p. injection 3 times per week (200 or 1000 mg/kg bw) for 8 weeks. Total observation time was 24 weeks. Full histopathology was performed in the lungs only. Liver, kidney, spleen, thymus, intestine and salivary and endocrine glands were investigated macroscopically. No increase in tumour bearing animals was reported (Stoner 1973).
According to REACH, additional data on carcinogenicity need to be provided if the substance has a widespread dispersive use or frequent/long-term human exposure is given and the substance is a mutagen category 3 or there is evidence for a capacity to induce hyperplasia and/or preneoplastic lesions from repeated dose studies.
Linalylacetate or the structurally related linalool was determined to be non-genotoxic in bacterial and mammalian cell mutagenicity tests in vitro and in vivo. Additionally, there is no evidence from repeated dose studies using linalool, that the substance is able to induce hyperplasia and/or pre-neoplastic lesions, beyond its local topical irritative effects.
As a consequence, there is no indication for further testing linalyl acetate in a carcinogenicity study.
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