Soybean oil, deodorizer distillate

Endpoint summary

Description of key information

Oral NOAEL for risk assessment purposes: 19% in feed, equivalent to an estimated 9,250 mg/kg bw/day for fatty acids and gylcerides and ADI 0.15- 2.0 mg/kd/day for unsaponifiable matter. 
The dermal toxicology is based on the oral NOAEL.
No significant respiratory exposure.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

9 250 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Justification for classification or non-classification

There is no published information on the repeated dose oral toxicity of 'soybean oil, deodorizer distillates' in animals. However, a large number of studies have been conducted on the individual constituents, particularly in the context of nutritional research.

At doses ranging from 7.5 to 19% in diet, no significant toxicity was seen for various glycerides and fatty acids with chain lengths varying between C16-18 or C8-18, including C18-unsatd. and C18-unsatd. hydroxy (Morin, 1967; Harkins and Sarrett, 1968; Nolen, 1981; Manorama and Rukmini, 1991; Coquet et al., 1977; Speijers et al., 2009; Irwin, 1992; HERA, 2002). The most appropriate oral NOAEL (soybean oil) could therefore be considered to be 19% in diet, i.e. ca. 9,250 mg/kg bw/day. In certain studies (also others not reported here), differences may be observed compared to controls on bodyweight gain, food consumption and certain measured parameters depending on the chain length distribution of the fatty acids (associated to the glycerides or free) and their degree of unsaturation. However, research indicates that when consumed at nutritionally relevant concentrations, there are no adverse effects on health and longevity. It is worth noting that, due to their innocuous nature, fats and oils are commonly used as controls and as vehicles in animal toxicity studies. For example, OECD Guideline 408 (repeated dose 90-day oral toxicity study in rodents) recommends the use of “a solution/emulsion in oil (e.g. corn oil)” as a vehicle where an aqueous vehicle is not suitable (OECD, 1993). 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).

Tocopherols have been tested in numerous repeated dose oral toxicity studies. Overall, animals appear to tolerate high levels (i.e. at least two orders of magnitude above nutritional Vitamin E levels, e.g. 1,000 - 2,000 IU/kg diet) without adverse effects. At very high doses, signs indicative of antagonism with the function of other fat-soluble vitamins, for example impaired bone mineralisation, reduced hepatic storage of Vitamin A and coagulopathies, occur (Tomassi and Silano, 1986; Fiume, 2002; EFSA, 2008). These can be counterbalanced by increasing intake of the other vitamins. A NOAEL of 125 mg/kg bw/day was reported for a 64 week feeding study in rat with tocopheryl acetate.

In animal studies, sterols and sterol esters demonstrate low repeated dose oral toxicity (ANZFA, 2001). The lowest NOAEL in a long term study was equivalent to ca. 2,500 mg sterols/kg bw/day in a 22 month trial with rats (SCF, 2003).

No data could be located on the repeated dose oral toxicity of squalene. This substance is however poorly absorbed through the gastrointestinal tract, therefore repeated dose toxicity is not expected under normal and foreseeable use conditions.

Repeated dose oral, inhalation or dermal exposure to glycerides or fatty acids is not expected to pose an issue for human health under normal and foreseeable handling and use conditions. The Joint FAO/WHO Expert Committeee on Food Additives (JECFA, 1987) established an Acceptable Daily Intake (ADI) of 0.15 - 2.0 mg/kg bw for dl-α-tocopherol on the basis of clinical experience in man and the fact that α-tocopherol may be an essential nutrient. The EU Scientific Committee on Food set a tolerable upper intake level of Vitamin E for adults of 300 mg α-tocopherol equivalents /day (EFSA, 2008).

Exposure via the inhalation route is not expected given the low vapour pressure of the substance and the risk management measures implemented, where necessary, if the substance is used in aerosilized or spray form.

 Based on the above information, the substance is not considered to qualify for repeated dose toxicity classification according to Directive 67/548/EC or Regulation (EC) No. 1272/2008.