CIR Final Report on the Safety Assessment of Ascorbyl Palmitate and Similar Antioxidants

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International Journal of Toxicology

Volume 18, Supplement 3/November 1, 1999

Pages: 1 - 26

Final Report on the Safety Assessment of Ascorbyl Palmitate, Ascorbyl

Dipalmitate, Ascorbyl Stearate, Erythorbic Acid, and Sodium Erythorbate

Abstract:

Ascorbyl Palmitate, Ascorbyl Dipalmitate, Ascorbyl Stearate, Erythorbic

Acid, and Sodium Erythorbate are related ingredients that function as

antioxidants in cosmetic formulations. Ascorbyl Palmitate, Ascorbyl

Dipalmitate, and Ascorbyl Stearate are esters and diesters of ascorbic

acid with long-chain fatty acids. Erythorbic Acid is a stereoisomer of

ascorbic acid and Sodium Erythorbate is the sodiumsalt of Erythorbic

Acid.Although all ofthese ingredients are used, uses of Ascorbyl

Palmitate and Erythorbic Acid predominate, with combined uses in over a

thousand cosmetic formulations at low concentrations. Ascorbyl

Palmitate is used at concentrations between 0.01 and 0.2%, and

Erythorbic Acid is used at concentrations of 0.5-1%. Ascorbyl Palmitate

has vitamin C activity approximately equal to that of L-ascorbic acid,

whereas Erythorbic Acid has only 5% activity. The esters are likely to

penetrate the skin readily, but the acid and its salt are not likely to

penetrate. These ingredients exhibit low acute oral toxicity in

animals. In chronic feeding studies, decreased body weight gain, the

formation of oxalate stones in the bladder, and hyperplasia were seen

in rats fed high levels of Ascorbyl Palmitate. Ascorbyl Palmitate (10%)

and Ascorbyl Dipalmitate (100%) were not irritating to the intact skin

of albino rabbits.Ascorbic Acid (30%) itself caused barely perceptible

erythema and Sodium Erythorbate powder caused no irritation to the

intact and abraded skin of rabbits. In animal studies, Ascorbic acid

was not a sensitizer, and Erythorbic Acid (10%) applied topically to

porcine skin reduced ultraviolet B (UVB)-induced phototoxicity. In

clinical studies, Ascorbyl Palmitate caused no dermal irritation or

sensitization. These ingredients are minimally irritating to the eye.

Sodium Erythorbate did not cause fetal or maternal toxicity or

developmental toxicity in rats and mice fed high levels. Although these

ingredients were generally negative in a wide range of genotoxicity

tests, Erythorbic Acid and Sodium Erythorbate did produce isolated

positive genotoxicity test results. As antioxidants, these ingredients

have been studied in animals after initiation with various carcinogens.

In some cases reductions in tumor incidence were seen, in others no

effect was noted. In no case did treatment with these ingredients

increase tumor incidence. The highest use concentrations of Erythorbic

Acid and Sodium Erythorbate are in oxidative hair dyes, where they are

completely consumed in the chemical reaction that takes place at

mixing. The fatty acid esters of ascorbic acid are used at lower

concentrations in leave-on formulations. In consideration of these uses

and based on the available safety test data, Ascorbyl Palmitate,

Ascorbyl Dipalmitate, Ascorbyl Stearate, Erythorbic Acid, and Sodium

Erythorbate are safe for use as cosmetic ingredients in the present

practices of use.

Maurice

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Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

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