Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-228-5 | CAS number: 79-81-2
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
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.
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.
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.
