Fatty acids, palm-oil, hydrogenated

Endpoint summary

Description of key information

Oral NOAEL for risk assessment purposes: 15% in feed, equivalent to an estimated 7,500 mg/kg bw/day. 
Dermal exposure and DNEL to be 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

7 500 mg/kg bw/day

Study duration:

chronic

Species:

rat

Justification for classification or non-classification

There is no published information on the repeated dose oral toxicity of ‘fatty acids, palm-oil, hydrogenated’ in animals. However, a large number of studies have been conducted on the individual constituents, particularly in the context of nutritional research. For practical reasons, only a limited number of studies are reported.

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 C16-18or 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 highest oral NOAEL for C16-C18 fatty acids could therefore be considered to be 15% in diet, i.e. ca. 7500 mg/kg bw/day fed as oleic acid (C18).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 with the glycerides or free fatty acids) 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 (C16-C18)” 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).

The repeated dose toxicity potential of ‘fatty acids, palm-oil, hydrogenated’ can be deduced based on information available for its individual constituents. Studies conducted on fatty acids and glycerides indicate low overall toxicity.

In the UK, the Department of Health have set dietary reference values for fatty acids and recommend that total fatty acid intake should average 30 per cent of total dietary energy including alcohol (DoH, 1991). This equates to about 100 g of fatty acids per day or 1.7 g (1700 mg) of fatty acids per kg body weight per day. The available data demonstrate the low toxicity of fatty acids and their salts, which is consistent with the long history of safe use in foods for both fatty acids and glycerides.

The fatty acids as a group are permitted as direct food additives (21 CFR 172.210, 172.860, 173.340); There are no limitations other than the observance of current good manufacturing practice (21 CFR 174.5) on the use of oleic acid and stearic acids as indirect food additives (21 CFR 175.105, 176.200 and 21 CFR 175.105, 175.300, respectively) (CIR, 1987).

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.

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