CIR Final Report on the Safety Assessment of Benzyl Alcohol, Benzoic Acid, and Sodium Benzoate

[Guest guest]

International Journal of Toxicology

Volume 20, Number 2 Supplement 3/January 02, 2001

Pages: 23 - 50

Final Report on the Safety Assessment of Benzyl Alcohol, Benzoic Acid,

and Sodium Benzoate

Abstract:

Benzyl Alcohol is an aromatic alcohol used in a wide variety of

cosmetic formulations as a fragrance component, preservative, solvent,

and viscosity-decreasing agent. Benzoic Acid is an aromatic acid used

in a wide variety of cosmetics as a pH adjuster and preservative.

Sodium Benzoate is the sodium salt of Benzoic Acid used as a

preservative, also in a wide range of cosmetic product types. Benzyl

Alcohol is metabolized to Benzoic Acid, which reacts with glycine and

excreted as hippuric acid in the human body. Acceptable daily intakes

were established by the World Health Organization at 5 mg/kg for Benzyl

Alcohol, Benzoic Acid, and Sodium Benzoate. Benzoic Acid and Sodium

Benzoate are generally recognized as safe in foods according to the

U.S. Food and Drug Administration. No adverse effects of Benzyl Alcohol

were seen in chronic exposure animal studies using rats and mice.

Effects of Benzoic Acid and Sodium Benzoate in chronic exposure animal

studies were limited to reduced feed intake and reduced growth. Some

differences between control and Benzyl Alcohol-treated populations were

noted in one reproductive toxicity study using mice, but these were

limited to lower maternal body weights and decreased mean litter

weights. Another study also noted that fetal weight was decreased

compared to controls, but a third study showed no differences between

control and Benzyl Alcohol-treated groups. Benzoic Acid was associated

with an increased number of resorptions and malformations in hamsters,

but there were no reproductive or developmental toxicty findings in

studies using mice and rats exposed to Sodium Benzoate, and, likewise,

Benzoic Acid was negative in two rat studies. Genotoxicity tests for

these ingredients were mostly negative, but there were some assays that

were positive. Carcinogenicity studies, however, were negative.

Clinical data indicated that these ingredients can produce

nonimmunologic contact urticaria and nonimmunologic immediate contact

reactions, characterized by the appearance of wheals, erythema, and

pruritis. In one study, 5% Benzyl Alcohol elicited a reaction, and in

another study, 2% Benzoic Acid did likewise. Benzyl Alcohol,

however,was not a sensitizer at 10%, nor was Benzoic Acid a sensitizer

at 2%. Recognizing that the nonimmunologic reactions are strictly

cutaneous, likely involving a cholinergic mechanism, it was concluded

that these ingredients could be used safely at concentrations up to 5%,

but that manufacturers should consider the nonimmunologic phenomena

when using these ingredients in cosmetic formulations designed for

infants and children. Additionally, Benzyl Alcohol was considered safe

up to 10% for use in hair dyes. The limited body exposure, the

duration of use, and the frequency of use were considered in concluding

that the nonim munologic reactions would not be a concern. Because of

the wide variety of product types in which these ingredients may be

used, it is likely that inhalation may be a route of exposure. The

available safety tests are not considered sufficient to support the

safety of these ingredients in formulations where inhalation is a route

of exposure. Inhalation toxicity data are needed to complete the

safety assessment of these ingredients where inhalation can occur.

Maurice

--------------------------------------------------------

Maurice O. Hevey

Convergent Cosmetics, Inc.

http://www.ConvergentCosmetics.com

-------------------------------------------------------