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Description of key information

Key value for chemical safety assessment

Additional information

No key study addressing carcinogenicity according to current standard protocols are available for retinyl acetate.

However, retinol and respective ester have been reported in literature and reviewed in the context of their putative potential to exert cancer preventive activity (IARC 1998). A limited evidence for cancer preventive activity has been noted in animal studies on the basis of consistent inhibitory effects in rat mammary cancer models and equivocal effects in mouse mammary cancer models. A limited number of animal studies showed increased tumor incidences, i.e. mammary adenocarcinomas, benign/malignant phaeochromocytomas after long term maintenance with retinyl palmitiate and/or retinyl acetate.

Oral administration of relatively high dose levels of retinyl acetate of 0.125% and 0.25%

via the drinking water (approx. 70 mg/kg bw/day and 140 mg/kg bw/day) to male and female rats for 104 weeks resulted in an increased incidence of benign and/or malignant adrenal gland neoplasms in form of phaeochromocytoma in both treated groups and sex (Kurokawa 1985). In contrast, statistically significant lower incidences were found for mammary gland tumors in males of the high dose group, for thyroid tumors in females of the high dose group and for clitoral gland tumors in females of both treated groups.

On the basis of human studies, evidences suggest a lack of cancer preventive activity for cancers at the aero-digestive tract, lung, breast, colorectal, bladder, prostate and stomach. However, according to observational epidemiological studies, no consistent evidence for a relation between dietary retinol and increased cancer rates was shown (IARC 1998).

Justification for classification or non-classification

The present data on carcinogenicity are not sufficient to fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC and therefore, a non-classification is warranted.