Disperse Black 9 is a monoazo dye used in hair dyes at a concentration not exceeding 0.4%. In acute toxicity studies, Disperse Black 9 was slightly toxic to practically nontoxic when administered orally and practically nontoxic when administered intraperitoneally. At a concentration of 100% the dye was nonirritating to rabbit eyes and was nonirritating to both the intact and abraded skin of rabbits at concentrations up to 0.38%. Disperse Black 9 at 25% did not produce either irritation or sensitization in guinea pigs. In subchronic oral studies Disperse Black 9 was toxic at 1% but not at 0.1 %. There were no signs of local or systemic toxicity at concentrations up to 0.24% in formulations. In chronic studies, dye containing 0.13% Disperse Black 9 was nontoxic to dogs. A hair dye formulation containing 0.5% Disperse Black 9 produced no significant toxicological effects when applied dermally to mice for 20 months. Disperse Black 9 (0.13% in a dye composite) produced neither teratogenic nor reproductive effects in rats or rabbits. Disperse Black 9 was nonmutagenic in four different assay systems. Disperse Black 9, 0.5% in a hair dye, was not carcinogenic when dermally applied to mice. A 3% suspension of the dye produced no irritation or sensitization in human subjects. On the basis of the available data, it is concluded that Disperse Black 9 is safe for use as a cosmeticingredient.
References
1.
1. Estrin, N.F., Crosley, P.A., and Haynes, C.R. (eds.) (1982). CTFA CosmeticIngredient Dictionary. Washington, DC: Cosmetic, Toiletry, and Fragrance Assoc.
2.
2. COSMETIC, TOILETRY AND FRAGRANCE ASSOCIATION (CTFA). (October 15, 1982). Submission of unpublished data. CosmeticIngredient Chemical Description.
3.
3. Zuckerman, S. (1974). Color in cosmetics. In: Cosmetics: Science and Technology, 2nd ed.M.S. Balsam and E. Sagarin (eds.). New York: Wiley, Vol. 3, pp. 539–72.
4.
4. COLOUR INDEX. (1971). 3rd ed. The Society of Dyers and Colourists and the American Assoc. of Textile Chemists and Colorists, Great Britain, Vol. 5.
5.
5. CTFA. (March 16, 1984). Submission of data. Correspondence to G. McEwen dated March 12, 1984 re: Disperse Black 9.
6.
6. FOOD and DRUG ADMINISTRATION (FDA). (December 1981). Product formulation data. Computer printout.
7.
7. Corbett, J.F., and Menkart, J. (1973). Hair coloring. Cutis12, 190–7.
8.
8. FDA. (May 15, 1984). Correspondence to Robert Elder from Heinz J. Eiermann, Director, Division of Cosmetics Technology.
9.
9. Wall, F.E. (1972). Bleaches, hair colorings, and dye removers. In: Cosmetics: Science and Technology, 2nd ed.M.S. Balsam and E. Sagarin (eds.). New York: Wiley, Vol. 2, pp. 279–343.
10.
10. FEDERAL REGISTER. (October 16, 1979). Cosmetic Product Warning Statements; Coal Tar Hair Dyes Containing 4-Methoxy-M-Phenylenediamine (2,4-Diaminoanisole) or 4-Methoxy-M-Phenylenediamine Sulfate (2,4-Diaminoanisole Sulfate). 44(201), 59509–10.
11.
11. CLAIROLR LOVING CARE. (1968–81). No peroxide color-lotion.
23. Draize, J.H. (1959). Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Austin, Texas: Assoc. of Food and Drug Officials of the United States.
28. CTFA. (May 4, 1982). Submission of unpublished data. Hair coloring carcinogenesis study in mice. Omaha, Nebraska: Eppley Institute for Research in Cancer, University of Nebraska Medical Center.
30. SPRINGBORN INSTITUTE FOR BIORESEARCH, INC. (December 20, 1984). Final report-Photoallergy contact dermatitis in guinea pigs. Lab Study No. 3125.1 Disperse Black 9.
31.
31. Gibson, J.P., Staples, R.E., and Newberne, J.W. (1966). Use of the rabbit in teratology studies. Toxicol. Appl. Pharmacol.9, 398–408.
33. Burnett, C.M., Fuchs, C.M., and Corbett, J.F. (1979). Mutagenicity studies on urine concentrates from female users of dark hair color products. Drug Chem. Toxicol.2(3), 283–93.
34.
34. Burnett, C., Loehr, R., and Corbett, J. (1981). Heritable translocation study on two hair dye formulations. Fund. Appl. Toxicol.1, 325–8.
35.
35. FEDERAL FOOD, DRUG AND COSMETIC ACT. (As amended January 1980). Section 601. 21 U.S.C 361. Adulterated Cosmetics.
36.
36. Marzulli, F.N., Green, S., and Maibach, H.I. (1978). Hair dye toxicity-A review. J. Environ. Pathol. Toxicol.1, 509–30.
37.
37. TKL RESEARCH. (December 23, 1983). Repeated insult patch test on Disperse Black 9. Study No. 831018. New York, NY.
38.
38. TKL RESEARCH. (February 29, 1984). Repeated insult patch test on Disperse Black 9. Study No. 841002. New York, NY.
39.
39. Anthony, H.M., and Thomas, G.M. (1970). Tumors of the urinary bladder: An analysis of the occupations of 1,030 patients in Leeds, England. J. Natl. Cancer Inst.45, 879–98.
40.
40. Cole, P., Hoover, R., and Friedall, C.H. (1972). Occupation and cancer of the lower urinary tact. Cancer29, 1250–60.
41.
41. Dunham, L.J., Rabson, A.S., Stewart, H.L., Frank A.S., and Young, J.L. (1968). Rate, interview, and pathology study of cancer of the urinary bladder in New Orleans, La. J. Natl. Cancer Inst.41, 683–709.
42.
42. Wynder, E.L., Onderdonk, J., and Mantel, N. (1963). An epidemiological investigation of cancer of the bladder. Cancer16, 1388–407.
43.
43. Garfinkel, J., Selvin, S., and Brown, S.M. (1977). Possible increased risk of lung cancer among beauticians. J. Natl. Cancer Inst.58, 141–3.
44.
44. Menck, H.R., Pike, M.C., Henderson, B.E., and Jing, J.S. (1977). Lung cancer risk among beauticians and other female workers. J. Natl. Cancer Inst.59, 1423–5.
45.
45. Jain, M., Morgan, R.W., and Elinson, L. (1977). Hair dyes and bladder cancer. Can. Med. Assoc. J.117, 1131–3.
46.
46. Hennekens, C.H., Speizer, F.E., Rosner, B., Bain, C.J., Belanger, C., and Peto, R. (1979). Use of permanent hair dyes and cancer among registered nurses. Lancet1, 1390–3.
47.
47. Kinlen, L.J., Harris, R., Garrod, A., and Rodriguez, K. (1977). Use of hair dyes by patients with breast cancer: A case-control study. Br. Med. J.2, 366–8.
48.
48. Nasca, P.C., Lawrence, C.E., Greenwald, P., Chorost, S., Arbuckle, J.T., and Paulson, A. (1979). Relationship of hair dye use, benign breast disease, and breast cancer. J. Natl. Cancer Inst.64, 23–8.
49.
49. Shafer, N., and Shafer, R.W. (1976). Potential of carcinogenic effects of hair dyes. NY State J. Med76, 394–6.
50.
50. Shore, R.E., Pasternack, B.S., Thiessen, E.U., Sadow, M., Forbes, R., and Albert, R.E. (1979). A case-control study of hair dye use and breast cancer. J. Natl. Cancer Inst.62, 277–83.
51.
51. Wynder, E.L., and Goodman, M. (1983). Epidemiology of breast cancer and hair dyes. J. Natl. Cancer Inst.71.
52.
52. Clemmesen, J. (1981). Epidemiological studies into the possible carcinogenicity of hair dyes. Mutat. Res.87, 65–79.
