Final Report on the Safety Assessment of Aldioxa

Abstract

Aldioxa is a heterocyclic organic compound used in cosmetic products as an astringent and skin conditioning agent. The oral LD50 for mice exceeds 23 mg/kg, and 8 g/kg for rats. All of the toxicologic parameters investigated in a 94-day subchronic feeding study in rats were similar in the test and the control group. No significant macroscopic adverse results were obtained in a three generation study in which rats were fed diets containing 10% Aldioxa. A suspension containing 25% Aldioxa was not a sensitizer when applied to the shaved backs of 3 male guinea pigs, nor when 10 animals were given intradermal injections of a 2% Aldioxa suspension on alternating days for a total of 10 applications and challenged after a 10-day nontreatment period. A hydrophilic unguent containing 4% Aldioxa was neither an irritant nor a sensitizer when evaluated on 200 human volunteers. The safety of Aldioxa has not been completely documented and substantiated. It cannot be concluded that this ingredient is safe for use in cosmetic products until the appropriate needed safety data cited in the report have been obtained and evaluated.

References

Estrin, N.F. , Crosley, P.A. , and Haynes, C.R. (Ed.) (1982). CTFA Cosmetic Ingredient Dictionary, 3rd Edition. Washington, DC: The Cosmetic, Toiletry and Fragrance Association, p. 8.

FEDERAL REGISTER . (February 15, 1983). Skin protectant drug products for over-the-counter human use; tentative final monograph; proposed rule. 21(347):6819–33.

FEDERAL REGISTER . (June 20, 1990). Skin protectant drug products for over-the-counter human use; diaper rash products; Proposed Rule. 21(347):25203–32.

FEDERAL REGISTER . (January 28, 1992). Modification in voluntary filing of cosmetic product ingredient and cosmetic raw material composition statements. Final rule. 57(18):3128–30.

FOOD AND DRUG ADMINISTRATION (FDA) . (1984). FDA product formulation data. Computer print out. Washington, D.C.: FDA.

FOOD AND DRUG ADMINISTRATION (FDA). (1990). OTC Drug Review Ingredient Status Report. 06/21/90.

FOOD AND DRUG ADMINISTRATION (FDA) . (1992). FDA product formulation data. Computer print out. Washington, D.C.: FDA.

Mecca, S.B. (1959). Allantoin and the newer aluminum allantoinates. Proc. Sci. Sec. Toilet Goods Assoc. Number 31.

Mecca, S.B. (1963). The function and applicability of the allantoins. Proc. Sci. Sec. Toilet Goods Assoc. 39:7–15.

10.

Meixell, D.W. , and Mecca, S.B. (1966). The Allantoins. J. Am. Podiatry Assoc. 56(B):357–64.

11.

Nikitakis, J.M. (Ed.) (1988). CTFA Cosmetic Ingredient Handbook, 1st Edition. Washington, DC: The Cosmetic, Toiletry and Fragrance Association, p. 108.

12.

NIKKO CHEMICALS CO., LTD . (1992). The Newest List of Japanese Cosmetic Ingredients. VI. 1991/1992. Tokyo, Japan: Nikko Chemicals Co., p. 3.

13.

ORENTREICH RESEARCH CORPORATION. (1985a). Submission of unpublished data by CTFA. Predictive patch test study. Body powder SN #1243/18 (11 pp).1

14.

ORENTREICH RESEARCH CORPORATION. (1985b). Submission of unpublished data by CTFA. Predictive patch test study. Eye makeup SN #1263/14 (26 pp).1

15.

Rona. (1992). Submission of unpublished data by RONA. Pharmacological study of dihydroxyaluminum allantoinate and chlorohydroxyaluminum allantoinate. I. Toxicity. Abstract presented at L'Académie de Pharmacie, April 1, 1962 (translation) (19 pp).1