Isostearyl Neopentanoate, the ester of Isostearyl Alcohol and Neopentanoic Acid, is used in cosmetic products as an emollient at concentrations up to 50 percent. The undiluted ingredient at doses up to 4 ml/kg was shown to be relatively non-toxic in short-and long-term feeding studies. Test data from animal and clinical studies indicate the undiluted ingredient is neither an irritant nor a sensitizer. A cosmetic formulation containing 16 percent Isostearyl Neopentanoate produced no phototoxicity and no photoallergenicity. Mutagenicity, carcinogenicity, and teratogenicity data were not available. Isostearyl Neopentanoate was not considered to be a significant comedogenic agent. On the basis of available data, it is concluded that this ingredient is safe as a cosmetic ingredient in its present practices of use.
References
1.
1. Estrin, N.F., Crosley, P.A., and Haynes, C.R. (1982). CTFA Cosmetic Ingredient Dictionary, 3rd ed.Washington, DC: The Cosmetic, Toiletry and Fragrance Association, Inc.
2.
2. CTFA. (October 1980). Submission of unpublished data by CTFA. Cosmetic ingredient chemical description: Isostearyl Neopentanoate. CTFA Code No. 2.*
3.
3. COSMETECH LABORATORIES, INC. (April 26, 1983). Submission of unpublished data by CTFA. Gaschromatic analysis of Isostearyl Neopentanoate and accompanying letter from David Garlen, President (Cosmetech Lab. Inc.) to Dr. Gerald McEwen, Cosmetic, Toiletry and Fragrance Assoc.).*
4.
4. VAN DYK and COMPANY. (April 25, 1983). Submission of unpublished data by CTFA. Letter from Ken Klein, Director of Technical Services (Van Dyk and Co.) to David Garlen, President (Cosmetech Lab. Inc.) regarding Isostearyl Neopentanoate.*
5.
5. AVON PRODUCTS, INC. (January 31, 1983). Submission of unpublished data by CTFA. Thirteen week subchronic oral toxicity study in albino rats. The toxicological evaluation of Isostearyl Neopentanoate (R.I. Code 0187). Study Project Code AT0202. Phase II. Final Report.*
6.
6. VAN DYK and COMPANY, INC. (January 1976). Submission of unpublished data by CTFA. Technical Bulletin. Ceraphyl 375. CTFA Code No. 2.*
7.
7. FOOD and DRUG ADMINISTRATION (FDA). (December 22, 1981). Cosmetic product formulation data: ingredients used in each product category. Computer printout. Washington, DC.
8.
8. FDA. (January 5, 1982). (a) Frequency of Trade Name Ingredients in the Cosmetic Product File and (b) Frequency of Common, Usual, or Chemical Names in the Cosmetic Product File. Computer printout. Washington, DC.
9.
9. CFR. (Revised as of April 1, 1982). Title 21, Part 720.4. Voluntary Filing of Cosmetic Product Ingredient and Cosmetic Raw Material Composition Statement. Information requested about cosmetic products.
10.
10. VAN DYK and COMPANY. (January 4, 1982). Submission of unpublished data by CTFA. UV Absorption Scan (210 nm to 500 nm). Isostearyl Neopentanoate (Ceraphyl 375) in Isopropyl Alcohol solvent. Concentration: 10,000, 2,500, 1,250 mg/L/1 cm. Batch No. 9305. Approx. molecular weight 348–90.*
11.
11. Boulogne, J., Koulbanis, C., and Michelet, J. (January 2, 1982). Cosmetic composition in the form of an anhydrous cream of oily consistency. Fr. demande Patent No. 2486800. Oreal S.A.
12.
12. FOOD and DRUG RESEARCH LABORATORIES, INC. (FDRL). (April 6, 1976). Submission of unpublished data by CTFA. Acute oral toxicity in rats. Isostearyl Neopentanoate. CTFA Code No. 3.*
13.
13. BIO-TOXICOLOGY LABORATORIES, INC. (BTL). (April 7, 1972). Submission of unpublished data by CTFA. Primary skin irritation in rabbits. Isostearyl Neopentanoate. CTFA Code No. 5.*
14.
14. CTFA. (May 20, 1980). Submission of unpublished data by CTFA. Toxicology Summary Report: Animal Tests. Skin and eye irritancy in rabbits. Isostearyl Neopentanoate. Batch No. 2985. CTFA Code No. 4.*
15.
15. CTFA. (May 20, 1980). Submission of unpublished data by CTFA. Toxicology Summary Report: Animal tests. Primary skin irritation in rabbits. Isostearyl Neopentanoate. Code No. 0187. CTFA Code No. 6.*
16.
16. Magnusson, B., and Kligman, A.M. (1969). The identification of contact allergens by animal assay. The guinea pig maximization test. J. Invest. Dermatol.52(3), 268–76.
17.
17. COSMETIC, TOILETRY and FRAGRANCE ASSOCIATION. (CTFA). (February 1977). Submission of unpublished data by CTFA. Face makeup foundation containing 36 percent Isostearyl Neopentanoate. Acute oral toxicity. Acute eye irritation. Human patch test. In-House Code: FCR-10/1011B. CTFA Code No. 10.*
18.
18. CTFA. (May 9, 1979). Submission of unpublished data by CTFA. CIR safety data test summary response form. Acute oral toxicity in rats. Lip product containing 16.05 percent Isostearyl Neopentanoate. Company Test Code: CSE 138.*
19.
19. APPLIED BIOLOGICAL SCIENCES LABORATORY. (October 29, 1980). Submission of unpublished data by CTFA. Biological testing request. Acute oral toxicity in rats. Formula 2213–62-A containing 25 percent Isostearyl Neopentanoate in sesame oil. No. ABO-19.*
20.
20. CTFA. (September 8, 1978). Submission of unpublished data by CTFA. Blusher containing 32 percent Isostearyl Neopentanoate. Acute oral, dermal, and ocular testing of BB-006, Lot 344–06a.*
21.
21. FDRL. (May 1, 1979). Submission of unpublished data by CTFA. Acute oral toxicity in rats. Night cream containing 3 percent Isostearyl Neopentanoate. Laboratory No. 6205e.*
23. LEBERCO LABORATORIES. (October 23, 1979). Submission of unpublished data by CTFA. Acute oral toxicity in mice. Body oil containing 2.5 percent Isostearyl Neopentanoate. CTFA Code No. 22.*
24.
24. Draize, J.H., Woodard, G., and Calvery, H.O. (1944). Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membrane. J. Pharmacol. Exp. Ther.82, 377–90.
25.
25. CTFA. (May 5, 1979). Submission of unpublished data by CTFA. Skin irritation test. CIR safety data test summary response form. Lip product containing 16.05 percent Isostearyl Neopentanoate. Company Test Code: CSE 138.*
26.
26. CTFA. (March 7, 1980). Submission of unpublished data by CTFA. Toxicology summary report: Animal tests. Skin and eye irritation in rabbits. Moisturizer containing 5 percent Isostearyl Neopentanoate. Code No. 16434–11. CTFA Code No. 14.*
27.
27. FDRL. (May 21, 1979). Submission of unpublished data by CTFA. Primary dermal phototoxic irritation study with New Zealand white rabbits. Laboratory No. 6164. CTFA Code No. 9.*
28.
28. Draize, J.H. (1959). Dermal toxicity in appraisal of the safety of chemicals. In: Foods, Drugs and Cosmetics. Div. of Pharmacology, FDA, Dept. of HEW. The Assoc. of Food and Drug Officials of the US Business Office, Bureau of Food and Drugs, Austin, Texas, pp. 46–59.
29.
29. LEBERCO LABORATORIES. (October 12, 1979). Submission of unpublished data by CTFA. Skin irritation in rabbits. Body oil containing 2.5 percent Isostearyl Neopentanoate. CTFA Code No. 23.*
30.
30. CTFA. (March 31, 1980). Submission of unpublished data by CTFA. Toxicology summary report: Animal test. Skin and eye irritation in rabbits. Eye shadow containing 1.2 percent Isostearyl Neopentanoate. Code No. 18234–02. CTFA Code No. 27.*
31.
31. CTFA. (February 15, 1978). Submission of unpublished data by CTFA. Guinea pig allergy study. Isostearyl Neopentanoate. Study Code GPA-12–78. CTFA Code Nos. 8 and 14.*
32.
32. Landsteiner, K., and Jacobs, J. (1935). Sensitization of animals with simple chemical compounds. J. Exp. Med.61, 643.
33.
33. BTL. (May 16, 1972). Submission of unpublished data by CTFA. Landsteiner and Jacobs guinea pig sensitization study. Isostearyl Neopentanoate.*
34.
34. CTFA. (September 9, 1980). Submission of unpublished data by CTFA. Comedogenic assay. Rabbit ear. Four-week assay. Samples 176–01 and 176–02. Mary Kay Cosmetics. CTFA Code No. 10.*
35.
35. CTFA. (June 28, 1979). Submission of unpublished data by CTFA. Comedogenic assay. Rabbit ear. Night cream containing 3 percent Isostearyl Neopentanoate. CTFA Code No. 6.*
36.
36. BTL. (April 11, 1972). Submission of unpublished data by CTFA. Eye irritation in rabbits. Isostearyl Neopentanoate. CTFA Code No. 7.*
37.
37. CODE OF FEDERAL REGULATIONS (CFR). (Revised as of April 1979). Title 16 Part 1500.42. (16 CFR 1500. 42). Federal Hazardous Substances Act Regulations. Test for eye irritants.
38.
38. CTFA. (April 13, 1979). Submission of unpublished data by CTFA. CIR safety data test summary response form. Eye irritation test. Lip product containing 16.05 percent Isostearyl Neopentanoate. Company Test Code: CSE 138.*
39.
39. LEBERCO LABORATORIES, INC. (October 2, 1979). Submission of unpublished data by CTFA. Eye irritation in rabbits. Moisturizer containing 5 percent Isostearyl Neopentanoate. CTFA Code No. 15.*
40.
40. FDRL. (April 5, 1979). Submission of unpublished data by CTFA. Eye irritation test in rabbits. Night cream (light pink cream) containing 3 percent Isostearyl Neopentanoate. Laboratory No. 6205e. CTFA Code No. 11.*
41.
41. LEBERCO LABORATORIES. (October 15, 1979). Submission of unpublished data by CTFA. Eye irritation in rabbits. Body oil containing 2.5 percent Isostearyl Neopentanoate. CTFA Code No. 24.*
42.
42. Herndon, J.H. (April 28, 1980). Submission of unpublished data by CTFA. Herndon: Associate Professor, Internal Medicine; Chairman, Division of Dermatology. University of Texas/Southwestern Medical School. Forty-eight hour patch test with 100 percent Isostearyl Neopentanoate. Protocol No. 001–167.*
43.
43. Herndon, J.H. (February 27, 1979). Submission of unpublished data by CTFA. Herndon: Associate Professor, Internal Medicine; Chairman, Division of Dermatology. University of Texas/Southwestern Medical School. Forty-eight hour patch test with night cream containing 3 percent Isostearyl Neopentanoate. Protocol No. 001–123.*
44.
44. Herndon, J.H. (February 12, 1981). Submission of unpublished data by CTFA. Herndon: Associate Professor, Internal Medicine; Chairman, Division of Dermatology. University of Texas/Southwestern Medical School. Forty-eight hour patch test with night cream containing 3 percent Isostearyl Neopentanoate. Protocol No. 001–210.*
45.
45. TESTKIT LABORATORIES, INC. (TKL). (June 22, 1979). Submission of unpublished data by CTFA. Human skin irritation. Forty-eight hour patch test. Moisturizer containing 5 percent Isostearyl Neopentanoate. CTFA Code No. 17.*
46.
46. CTFA. (March 13, 1980). Submission of unpublished data by CTFA. Clinical evaluation report: Human patch test. Moisturizer containing 5 percent Isostearyl Neopentanoate. Test Material: 16434–11. CTFA Code No. 16.*
47.
47. CTFA. (January 24, 1980). Submission of unpublished data by CTFA. Evaluation report: Human patch test. Lotion containing 4 percent Isostearyl Neopentanoate. Test Material: 17043–03. CTFA Code No. 20.*
48.
48. CTFA. (April 10, 1980). Submission of unpublished data by CTFA. Clinical evaluation report: Human patch test. Eyeshadow containing 1.2 percent Isostearyl Neopentanoate. Test Material: 18234–02. CTFA Code No. 26.*
50. CTFA. (February 7, 1977). Submission of unpublished data by CTFA. Moisturizing lotion containing 1.5 percent Isostearyl Neopentanoate. Human patch test. In-House Code FCR-10/1011C. CTFA Code No. 25.*
51.
51. CTFA. (June 4, 1980). Submission of unpublished data by CTFA. Study No. APTC-121–80. Three week product use test. Moisturizer 16434–12 containing 5 percent Isostearyl Neopentanoate.*
52.
52. INTERNATIONAL RESEARCH SERVICES, INC. (July, 1979). Submission of unpublished data by CTFA. Twenty-one day cumulative irritation study of fourteen products. Study 130. Cream containing 3 percent Isostearyl Neopentanoate.*
53.
53. UNIVERSITY OF CALIFORNIA, LOS ANGELES (UCLA). (July 19, 1977). Submission of unpublished data by CTFA. Modified Draize-Shelanski Patch Test. Isostearyl Neopentanoate (100 percent). UCLA File No. 975.*
54.
54. CTFA. (February 26, 1982). Submission of unpublished data by CTFA. Repeat insult sensitization study. Raw material 81–81: Mineral oil (40 percent) and Isostearyl Neopentanoate (60 percent).*
55.
55. LEO WINTER ASSOCIATES, INC. (November 24, 1980). Submission of unpublished data by CTFA. Repeated insult patch testing. Shelanski-Jordan procedure. Blusher containing 32 percent Isostearyl Neopentanoate. Lot No. 344–06-A. Project-BB 006. CTFA Code No. 12.*
56.
56. LEO WINTER ASSOCIATES, INC. (November 24, 1980). Submission of unpublished data by CTFA. Repeated insult patch testing and in-use testing. Modified Draize-Shelanski procedure. Blusher containing 32 percent Isostearyl Neopentanoate. BB-006. CTFA Code No. 13.*
57.
57. UCLA. (November 17, 1980). Submission of unpublished data by CTFA. Modified Draize-Shelanski-Jordan patch test. Face product containing 25 percent Isostearyl Neopentanoate. UCLA File No. 2207. Project No. H80–6–2E.*
58.
58. CTFA. (July/August 1979). Submission of unpublished data by CTFA. CIR safety data test summary response form. Modified Draize-Shelanski repeat insult patch test. Lip product containing 16.05 percent Isostearyl Neopentanoate. Company Test Code CSE 138.*
59.
59. CTFA. (May 30, 1980). Submission of unpublished data by CTFA. Allergic contact sensitization test. Test No. APTC-112–80. Moisturizer 16434–12 containing 5 percent Isostearyl Neopentanoate. (Also titled: Contact allergy test report. CTFA Code No. 19).*
60.
60. TKL. (September 7, 1980). Submission of unpublished data by CTFA. Repeated insult patch test. Moisturizer containing 5 percent Isostearyl Neopentanoate. CTFA Code No. 18.*
61.
61. FEDERAL REGISTER. (1978). August 25, 38206–38369.
62.
62. CTFA. (July/August 1979). Submission of unpublished data by CTFA. Human photosensitization study. Lip product containing 16.05 percent Isostearyl Neopentanoate. Company Test Code CSE 138.* Available upon request: Administrator, Cosmetic Ingredient Review, 1110 Vermont Ave., NW, Suite 810, Washington, DC 20005.
