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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

The substance is a complex residue resulting from the distillation of C16 -18 and C18 unsatd. fatty acids methyl esters which is derived from natural fats having a carbon range of C16 -18 and C18 unsatd. It consists predominantly of mono, di, triglycedides of satd. and unsatd. fatty acids, corresponding methyl esters , dimerization products, and wax esters.

Fatty acid methyl esters are metabolised as other dietary fats to fatty acids and methanol, neither of which have been shown to be reproductive toxins. Higher molecular weight aliphatic esters are readily hydrolysed to the corresponding alcohol and acid and then generally oxidised to carbon dioxide and water[1]. In addition there is data from human and animal studies that shows rapid absorption in the liver and breakdown of the substance into methanol and fatty acids; there is absence of the substance itself in the plasma/blood and in the urine. Methanol has been shown to not be a reproductive toxin.

Topically applied fatty acid methyl esters can penetrate to the living cells of normal epidermis, enter into metabolism and modify endogenous epidermal lipids, in a reversible way and without espressing any adverse effect[2].

 There is no direct evidence that exposure of people to methanol adversely affects reproduction or development. The NTP[3]states that there is minimal concern for adverse developmental effects when humans are exposed to methanol levels that result in low blood methanol concentrations, i.e., < 10 mg/L blood. Blood methanol levels of 10 mg/L or greater are not expected to result from normal dietary or occupational exposures.


[1]         Mattison et al (J. Nutrition 102, 1171 (1972), J. Lipid Res 13, 325 (1972).

[2]         Philip W. Wertz and Donald T. Downing Metabolism of topically applied fatty acid methyl esters in BALB/C mouse epidermis Journal of Dermatological Science Volume 1, Issue 1, January 1990, Pages 33-37

[3]         NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Methanol September 2003 NIH Publication No. 03-4478 National Toxicology Program (NTP).