Soybean oil, deodorizer distillate

Carcinogenicity

Description of key information

Not considered to be carcinogenic.

Justification for classification or non-classification

There is no published information on the carcinogenicity of 'soybean oil, deodorizer distillates'. However, data is available for some of its constituents. Numerous carcinogenicity studies have been conducted on fatty acids and their salts (in particular oleic acid), a number of which are summarised in CIR (1987) and HERA (2002). Although differences compared to controls are observed in individual trials, these are generally reported to be within normal background variation. Several fatty acids (stearic acid; oleic acid and sodium palmitate) are Generally Recognised as Safe (GRAS) by the U.S. Food and Drug Administration (US FDA). Also, fatty acids as a group are permitted as direct food additives (HERA, 2002). Overall, fatty acids are not expected to be carcinogenic.

Glycerides with unbranched fatty acids of overall chain lengths in the range of C16-18, including C18-unsatd. revealed non-promoting effect on chemically induced mammary carcinogenesis in rats (Sylvester et al., 1986; Sundram et al., 1989). Glycerides with chain lengths ranging between C8-18, including C18-unsatd. were tested for carcinogenicity in rat (lifetime) at a dose representing 54% of the calories in diet (Vles and Gottenbos, 1972). There were no significant differences in lifespan, growth or food consumption between rats exposed to coconut oil, butter fat or soybean oil (hydrogenated or non-hydrogenated). Pathological changes were randomly distributed and, considering the total population, the number of tumour bearers was comparable between groups. Furthermore, the’glycerides’ (in the form of triglycerides such as olive oil, corn oil, sunflower oil, etc.) are also well known to be frequently employed as vehicles in toxicity studies following international testing guidelines (e.g. OECD) for the evaluation of repeated dose toxicity, carcinogenicity or reproductive/developmental toxicity of chemical substances, without any apparent adverse effects (CIR, 1997 and 2001b). They are also found toinhibit tumor promotion induced by standard promoters.

Tocopheryl acetate did not reveal any neoplastic effects when tested in a 2 year carcinogenicity trial in rats. Studies conducted in mice and rats suggest that tocopherols may in some cases have antitumourigenic properties. It is of note that tocopherols have often been used as a negative control in tumour promotion studies (Fiume, 2002).

No specific information could be found for sterols and sterol esters. However, given their long history of safe use in nutritional and cosmetic applications, carcinogenicity is not expected.

The carcinogenicity of squalene was evaluated in several skin painting studies in mice, as summarised in CIR (1982). Results were not consistent between studies; some indicated potential effects whereas others showed a protective role against carcinogens. Overall, based on its history of safe use in nutritional and cosmetic applications, squalene is not expected to be carcinogenic under normal and foreseeable use conditions.

Moreover, predictions for ‘fatty acids, C16-18 and C18-unsatd. and glycerides, C16-18 and C18-unsatd.’ (based on the main constituents) from the Danish QSAR database and Toxtree (v.1.6) model did not reveal any structural alerts for carcinogenicity.

Taken together, the above evidence suggests that soybean oil, deodorizer distillates do not have carcinogenic potentialand therefore do not not qualify for classification according to Directive 67/548/EC or Regulation (EC) No. 1272/2008.