{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T10:26:24Z","timestamp":1777717584621,"version":"3.51.4"},"reference-count":66,"publisher":"SAGE Publications","issue":"2_suppl","license":[{"start":{"date-parts":[[2007,3,1]],"date-time":"2007-03-01T00:00:00Z","timestamp":1172707200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Int J Toxicol"],"published-print":{"date-parts":[[2007,3]]},"abstract":"<jats:p>Disperse Blue 7 is an anthraquinone dye used in cosmetics as a hair colorant in five hair dye and color products reported to the Food and Drug Administration (FDA). Hair dyes containing Disperse Blue 7, as \u201ccoal tar\u201d hair dye products, are exempt from the principal adulteration provision and from the color additive provision in sections 601 and 706 of the Federal Food, Drug, and Cosmetic Act of 1938 when the label bears a caution statement and \u201cpatch test\u201d instructions for determining whether the product causes skin irritation. Disperse Blue 7 is also used as a textile dye. The components of Disperse Blue 7 reportedly include Disperse Turquoise ALF Granules, Disperse Turquoise LF2G, Reax 83A, Tamol SW, and Twitchell Oil. No data were available that addressed the acute, short-term, or chronic toxicity of Disperse Blue 7. A mouse lymph node assay used to predict the sensitization potential of Disperse Blue 7 was negative. Although most bacterial assays for genotoxicity were negative in the absence of metabolic activation, consistently positive results were found with metabolic activation in Salmonella strains TA1537, TA1538, and TA98, which were interpreted as indicative of point mutations. Studies using L5178Y mouse lymphoma cells appeared to confirm this muta-genic activity. Mammalian assays for chromosome damage, however, were negative and animal tests found no evidence of dominant lethal mutations. Cases reports describe patients patch tested with Disperse Blue 7 to determine the source of apparent adverse reactions to textiles. In most patients, patch tests were negative, but there are examples in which the patch test for Disperse Blue 7 was positive. In general, anthraquinone dyes are considered frequent causes of clothing dermatitis. The Cosmetic Ingredient Review Expert Panel determined that there was a paucity of data regarding the safety of Disperse Blue 7 as used in cosmetics. The following data are needed in order to arrive at a conclusion on the safety of Disperse Blue 7 in cosmetic products: (1) methods of manufacture, including clarification of the relationship between Disperse Blue 7 and Disperse Turquoise ALF and Disperse Turquoise LF2G mixed with Reax 83A, Tamol SW, and Twitchell Oil; (2) analytical methods by which Disperse Blue 7 is measured; (3) impurities; (4) concentration of use as a function of product type; (5) confirmation that this is a direct hair dye; and (6) clarification of genotoxicity study results (e.g., Disperse Turquoise ALF and Disperse Turquoise LF2G were genotoxic in bacteria\u2014what is the specific relation to Disperse Blue 7? Disperse Blue 7 at 60% purity was genotoxic in bacteria\u2014is the other 40% the inert Reax 83A, Tamol SW, and Twitchell Oil?). Until such data are provided, the available data are insufficient to support the safety of Disperse Blue 7 as a hair dye ingredient in cosmetic formulations.<\/jats:p>","DOI":"10.1080\/10915810701351202","type":"journal-article","created":{"date-parts":[[2007,7,6]],"date-time":"2007-07-06T09:53:17Z","timestamp":1183715597000},"page":"51-63","source":"Crossref","is-referenced-by-count":7,"title":["Final Report on the Safety Assessment of Disperse Blue 71"],"prefix":"10.1177","volume":"26","member":"179","published-online":{"date-parts":[[2007,3,1]]},"reference":[{"key":"atypb1","doi-asserted-by":"publisher","DOI":"10.1016\/S0190-9622(85)70258-7"},{"key":"atypb2","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.11729"},{"key":"atypb3","unstructured":"Banduhn N. 1987. Aranior Steel Blue. Pr\u00fcfung auf Mutagenit\u00e4t im Mikrokern-Test in vivo. Unpublished data submitted by Henkel, English summary. 27 pages."},{"key":"atypb4","unstructured":"Batelle-Institut. 1975. Pr\u00fcfung des Farbstoffes \u201cDirektblau\u201d auf Mutagenit\u00e4t im Bakterientest. Unpublished data submitted by Henkel, translated from the original German. 9 pages."},{"key":"atypb5","first-page":"5","year":"2005","journal-title":"Int. J. Epidemiol."},{"key":"atypb6","unstructured":"Calvert Preclinical Services, Inc. 2002. Local lymph node assay. Unpublished data submitted by CTFA 5\/12\/02. 28 pages."},{"key":"atypb7","unstructured":"ChemIDplus. 2001. Basic Blue 99 entry.\n                      ChemID database.\n                      Bethesda, MD: National Library of Medicine."},{"key":"atypb8","unstructured":"Cosmetic, Toiletry, and Fragrance Association (CTFA). 2002. Concentration of use data. Unpublished data submitted by CTFA 06\/20\/2002. 2 pages."},{"key":"atypb9","unstructured":"Cytotest Cell Research GmbH. 2000.\n                      Salmonella typhimurium\n                      reverse mutation assay with Arianor Steel Blue. RCC-CCR Project 680901. 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Toxicol.\n                      4: 203-266.","DOI":"10.3109\/10915818509078673"},{"key":"atypb16","unstructured":"European Union On-Line. 2000. First update of the inventory of ingredients employedincosmetic products (section 1). http: \/\/ec.europa.eu\/health\/ph risk\/ committees\/sccp\/documents\/out123cm en.pdf."},{"key":"atypb17","unstructured":"Food and Drug Administration (FDA). 1979. Cosmetic Product Warning Statements: Coal tar hair dyes containing 4-methoxy-\n                      m\n                      -phenylenediamine (2,4-diaminoanisole) or 4-methoxy-\n                      m\n                      -phenylenediamine sulfate (2,4-diaminoanisole sulfate).\n                      Federal Register\n                      44: 59509-59510."},{"key":"atypb18","unstructured":"FDA. 1992. Modification in voluntary filing of cosmetic product ingredient and cosmetic raw composition statements. 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Unpublished data submitted by Henkel, translated from the original German. 67 pages."},{"key":"atypb26","unstructured":"Henkel. 1990a. Arianor Steel Blue. Pr\u00fcfung der akuten Toxizit\u00e4t nach einmaliger oraler Applikation au M\u00e4usen. Unpublished data submitted by Henkel, English summary. 8 pages."},{"key":"atypb27","unstructured":"Henkel. 1990b. Arianor Steel Blue. Embryotoxicity Study (including terato-genicity) in the Rat. Unpublished data submitted by Henkel. 41 pages."},{"key":"atypb28","doi-asserted-by":"crossref","unstructured":"Henkel. 1992. Arianor Steel Blue, August 1992. Unpublished data submitted by Henkel. 32 pages.","DOI":"10.1515\/zfw.1992.0004"},{"key":"atypb29","unstructured":"Hossack, D. J. N., M. Richold, E. Jones, and R. P. Bellamy. 1977. Ames metabolic activation test to assess the potential mutagenic effect of 1,5-Diamino-3-(1\u2032-aminophenylene-3-'trimethyl ammonium chloride)-7-Br-naphthoquinone-4,8 (compound no. 8). 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Lyon, France: IARC."},{"key":"atypb32","first-page":"52","volume":"36","year":"1996","journal-title":"Contact Dermatitis"},{"key":"atypb33","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjc.6602473"},{"key":"atypb34","doi-asserted-by":"publisher","DOI":"10.1002\/ijc.21195"},{"key":"atypb35","unstructured":"Keystone Aniline Corporation. 1999.\n                      Te c hnical guide and formulary.\n                      Chicago: Keystone Aniline Corporation."},{"key":"atypb36","unstructured":"Keystone Aniline Corporation. 2002. Personal communication from John A. Andrews to Dr. F. Alan Andersen. 1 page."},{"key":"atypb37","unstructured":"Kynoch, S. R. 1986. Acute oral toxicity to rats of Arianor Steel Blue. Huntingdon Research Centre Report No. 86131D\/WLH 4\/AC. Unpublished data submitted by Henkel. 7 pages."},{"key":"atypb38","unstructured":"Kynoch, S. R., and P. H. Elliott. 1977. Screening test for delayed contact hy-persensitivity with Steel Blue 9-1440E in the albino guinea-pig. Huntingdon Research Centre Report No. 8044\/D5\/77. Unpublished data submitted by Henkel. 7 pages."},{"key":"atypb39","unstructured":"Kynoch, S. R., and M. P. Liggett. 1977. Irritant effects of Steel Blue 9-1440E on rabbit skin. Huntingdon Research Centre Report No. 7908\/4D\/77. Unpublished data submitted by Henkel. 4 pages."},{"key":"atypb40","unstructured":"Kynoch, S. R., and G. K. Lloyd. 1977. Acute oral toxicity to rats of Steel Blue. Huntingdon Research Centre, Report No. 8282\/D2\/77. September 1977. Unpublished data submitted by Henkel."},{"key":"atypb41","unstructured":"Leuschner, F. 1967a. Irritant effects of five Arianor dyes on rabbit eye mucosa. Unpublished data submitted by Henkel, translated from the original German. 3 pages."},{"key":"atypb42","unstructured":"Leuschner, F. 1967b. Irritant effects of five Arianor dyes on rabbit skin. Unpublished data submitted by Henkel, translated from the original German. 3 pages."},{"key":"atypb43","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.EPI-06-0156"},{"key":"atypb44","doi-asserted-by":"publisher","DOI":"10.1007\/s10552-005-1229-y"},{"key":"atypb45","first-page":"117","volume":"55","year":"2005","journal-title":"Zbl. Ar-beitsmed."},{"key":"atypb46","unstructured":"Michalke, H. 1991. Mutagenicity study of Arainor Steel Blue (Basic Blue 99) in the mammalian cell gene mutation test with V-79 Chinese hamster cells in vitro (Project No. HG0591V). Unpublished data submitted by Henkel. 21 pages."},{"key":"atypb47","unstructured":"North American Contact Dermatitis Group. 1980.\n                      Patch testing in allergic contact dermatitis.\n                      Evanston, IL: American Academy of Dermatology."},{"key":"atypb48","unstructured":"Notox Ltd. 2002. 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