Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Cholesterol has been tested in several in vitro genotoxicty studies for its genotoxic potential, such as Ames reversion assays, oncotest, mammalian cell transformation tests. These tests were performed in the absence of metabolic activation. In addition, 2 Ames tests and 1 mammalian cell transformation test were performed in the presence of metabolic activation. No genotoxic potential of cholesterol was observed.

In addition, air-aged auto-oxidation products of cholesterol have been tested in Salmonella typhymurium strains and Chinese hamster lung fibroblasts (V79 cells). These auto-oxidation products showed a remarkable cytotoxicity and slight mutagenic response. Cholesterol oxidation products (oxysterols) were examined for their cytotoxicity and ability to increase the frequencey of DNA strand breaks and sister chromatid exchanges (SCE) in two mammalian fibroblast cell lines (CHO and Indian Muntjac fibroblasts). Short exposure resulted in induction of toxicity without induction of DNA lesions (measured by comet assy), whereas the SCE assay also showed no genotoxic potential.

Although some oxidation products showed a slight mutagenic response, no genotoxicity was obeserved with cholesterol in the presence of metabolic activity. Moreover, evaluation of all available information on carcinogenic potential of cholesterol by IARC of both animal data and human data showed no adequate evidence for carcinogenicity by a genotoxic working mechanism in human (see 7.7).

Justification for selection of genetic toxicity endpoint
For the overall conclusion a weight of evidence approach based on all available information is applied.

Short description of key information:
WoE of all available information on genotoxicity of cholesterol.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the absence of clear positive results in several in vitro genotoxicity tests and no clear evidence for carcinogenicity with a genotoxic working mechanism in animal studies and human studies, cholesterol does not need to be classified and has no obligatory labelling requirements for genetic toxicity according to

-Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),

-Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures