Registration Dossier

Administrative data

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 palmitate. 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.

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.

On the basis of all available information on genotoxicity of retinyl palmitate and relevant studies on its respective structural and metabolic analoges retinol and retinyl acetate, retinyl palmitate is defined to be non-genotoxic in a weight of evidence.

Taken together, no indication is given for further testing retinyl palmitate in a carcinogenicity study.

Justification for classification or non-classification

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