The ester Stearyl Heptanoate, a waxy solid that is insoluble in water, is used as a skin conditioning agent-occlusive in a wide variety of cosmetic formulations at varying concentrations (e.g., up to 25% in lip balms, up to 5% in ointments). Studies report a high oral LD50, ≥ 5 g/kg, for rats. Animal data indicate potential for mild skin irritation, but none for sensitization. Undiluted Stearyl Heptanoate did produce some ocular irritation in rabbits, but a 1.5% solution produced no effects. Mutagenesis assays (Ames and micronucleus test) were negative. Clinical data showed no evidence of irritation or sensitization or comedogenicity. Although animal and clinical sensitization studies were done at a low concentration compared with expected use concentrations, the data suggest that it would not be a sensitizer even at higher concentrations. Data on ocular irritation show only mild reactions to undiluted Stearyl Heptanoate, suggesting that expected use concentrations should not produce significant ocular irritation. On the basis of the available animal and clinical data, it is concluded that Stearyl Heptanoate is safe for use as a cosmetic ingredient in the present practice of use.
Concordia Research Labs Inc. (1990a) Submission of Modified Draize human repeated insult patch test of a cosmetic formulation containing 1.5% Stearyl Heptanoate (Study No. MKC-043 A). Unpublished data submitted by CTFA. 9 pp.*
2.
Concordia Research Labs Inc. (19906) Modified Draize human repeated insult patch test of a cosmetic formulation containing 1.5% Stearyl Heptanoate (Study No. MKC-045 A). Unpublished data submitted by CTFA. (8 pp).*
3.
Cosmetic, Toiletry, and Fragrance Association (CTFA). (1987a) Submission of unpublished data by CTFA. Modified Draize skin sensitization study using human subjects of a cosmetic formulation containing 0.7% Stearyl Heptanoate (Study No. HIM 87-MK-D-3). Unpublished data submitted by CTFA. 61 pp.*
4.
CTFA. (19876) Human repeated insult patch test of a cosmetic formulation containing 1.5% Stearyl Heptanoate (Study No. HIM 87-MK-D-4). Unpublished data submitted by CTFA. 68 pp.*
5.
Croda Inc. (1985) Crodata: Crodamol Cap and Crodamol W. Unpublished data submitted by Croda Inc., Parsippany, NJ.2 pp.*
6.
Croda Inc. (1991) Material Safety Data Sheet for Stearyl Heptanoate. Unpublished data submitted by Croda Inc., Parsippany, NJ. 5 pp.*
7.
Di Carlo FJ. (1990) Structure-activity relationships (SAR) and structure-metabolism relationships (SMR) affecting the teratogenicity of carboxylic acids. Drug Metab Rev22:411–49.
8.
Dragoco. (1993) Concentration of use, impurities, and UV absorption data. Unpublished data submitted by Dragoco. 1 p.*
9.
Dragoco (1994). UV absorption spectrum. Unpublished data submitted by Dragoco. 1 p.*
10.
Draize JH. (1959) Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics–Dermal Toxicity. Austin, TX: Association of Food and Drug Officials of the U.S., 46–59.
11.
Elder RL, ed. (1985) Final report on the safety assessment of Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol. J Am Coll Toxicol 4:1-29.
12.
FDA. (1994) Frequency of use of cosmetic ingredients. FDA computer program. Washington, DC: FDA.
13.
Hazleton Laboratories America Inc. (1987a) Delayed contact hypersensitivity in guinea pigs (Buehler method, modified) of a cosmetic formulation containing 1.5% Stearyl Heptanoate. Unpublished data submitted by CTFA. 21 pp.*
14.
Hazleton Laboratories America Inc. (19876) FHSA–Eye irritation in rabbits of a cosmetic formulation containing 1.5% Stearyl Heptanoate. Unpublished data submitted by CTFA. 20 pp.*
15.
Hazelton Laboratories America Inc. (1988a) Acute oral toxicity in rats of a cosmetic formulation containing 0.7% Stearyl Heptanoate. Unpublished data submitted by CTFA. 13 pp.*
16.
Hazleton Laboratories America Inc. (19886) FHSA–Eye irritation in rabbits of a cosmetic formulation containing 0.7% Stearyl Heptanoate. Unpublished data submitted by CTFA. 19 pp.*
17.
Hilltop Biolabs Inc. (1987a) Comedogenicity screen using rabbits of a cosmetic formulation containing 1.5% Stearyl Heptanoate (Project No. 87-0927-21). Unpublished data submitted by CTFA. 29 pp.*
18.
Hilltop Biolabs Inc. (19876) Human assay for comedogenic potential of a cosmetic formulation containing 1.5% Stearyl Heptanoate. Project No. 87-0882-74. Unpublished data submitted by CTFA. 10 pp.*
19.
Hodge HC, Sterner JH. (1949) Tabulation of toxicity classes. Am Ind Hyg Q10:93–6.
20.
Inveresk Research International. (1977) Safety tests on Crodamol W DP1222. (IRI Project No. 108745-Report No. 936). Unpublished data submitted by Croda Inc., Parsippany, NJ. 20 pp.*
21.
Labor L&S Gmbh. (1993a) Final report of the study to determine the ability of the test compound Stearyl Heptanoate (and) Stearyl Caprylate (PCL-Solid 2/066220 to induce mutations in the Ames Salmonella/microsome plate incorporation assay (Study No. 07173333). Unpublished data submitted by Dragoco. 25 pp.*
22.
Labor L&S Gmbh. (1993b) Final report. In vivo micronucleus test of Stearyl Heptanoate (and) Stearyl Caprylate (PCL-Solid 2/066220) in mice (Study No. 08186923). Unpublished data submitted by Dragoco. 31 pp.*
23.
Mills OH, Kligman AM. (1982) A human model for assessing comedogenic substances. Arch Dermatol118:903–5.
24.
Nikko Chemicals Co., Ltd. (1992) The Newest List of Japanese Cosmetic Ingredients, Vol. VI. (1991/92). Tokyo: Nikko Chemicals Co., 58.
25.
Pradhan M. (1993) Correspondence regarding the composition of PCL Solid 2/066220. 1 p.*
26.
Pradhan M. (1994) Correspondence concerning the concentration of Stearyl Heptanoate in PCL Solid 2/066220. 1 p.*
27.
Wenninger JA, Mc Ewen GN Jr, eds. (1992) Cosmetic Ingredient Handbook. 2nd Ed., Washington, DC: CTFA, 432.
28.
Wenninger JA, Mc Ewen GN Jr, eds. (1993) International Cosmetic Ingredient Dictionary, 5th Ed., Vol. 1. Washington, DC: CTFA, 716.
29.
Yakuji Nippo Ltd. (1987) The Comprehensive Licensing Standards of Cosmetics by Category, Part 2. Tokyo: Yakuji Nippo Ltd., 396.
