{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,2]],"date-time":"2026-05-02T10:27:33Z","timestamp":1777717653286,"version":"3.51.4"},"reference-count":57,"publisher":"SAGE Publications","issue":"1_suppl","license":[{"start":{"date-parts":[[2008,1,1]],"date-time":"2008-01-01T00:00:00Z","timestamp":1199145600000},"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":[[2008,1]]},"abstract":"<jats:p>Drometrizole is used in cosmetics as an ultraviolet (UV) light absorber and stabilizer. In an earlier safety assessment, the available data were found insufficient to support the safety of this ingredient, but new data have been provided and assessed. In voluntary industry reports to the Food and Drug Administration, this ingredient is reported to be used in noncoloring hair care products, and in an industry use concentration survey, uses in nail care products at 0.07% were reported. Drometrizole has absorbance maxima at 243, 298, and 340 nm. Drometrizole is used widely as a UV absorber and stabilizer in plastics, polyesters, celluloses, acrylates, dyes, rubber, synthetic and natural fibers, waxes, detergent solutions, and orthodontic adhesives. It is similarly used in agricultural products and insecticides. Drometrizole is approved as an indirect food additive for use as an antioxidant and\/or stabilizer in polymers. Shortterm studies using rats reported liver weight increases, increases in the activities of enzymes aminopyrine N-demethylase, and UDP glucuronosyl transferase, but no significant effects were noted in the activities of acid hydrolases or in hepatocyte organelles. Although Drometrizole is insoluble in water and soluble in a wide range of organic solvents, a distribution and elimination study using rats indicated that some Drometrizole was absorbed, then metabolized and excreted in the urine. Drometrizole and products containing Drometrizole were nontoxic in acute oral, inhalation, and dermal studies using animals. No increase in mortality or local and\/or systemic toxicity were observed in a 13-week oral toxicity study using dogs; the no observed effect level (NOEL) was 31.75 mg\/kg day-1 for males and 34.6 mg\/kg day-1 for females. In a 2-year feeding study using rats, a NOEL of 47 to 58 mg\/kg day-1 was reported. Developmental studies of Drometrizole in rats and mice found no teratogenic effects and a NOEL of 1000 mg\/kg day-1 was reported. Drometrizole was not genotoxic in Ames tests, a mouse bone marrow micronucleus test, or somatic mutation assays observing interphase nuclei and chromosomal aberrations using Chinese hamsters. There was no evidence of dominant lethal effects in studies using mice or rats. Drometrizole at a 1% concentration was minimally to moderately irritating to rabbit eyes, if followed by rinsing, but mildly to severely irritating in unrinsed eyes. A nail product containing 0.03% Drometrizole, however, was nonirritating to unrinsed rabbit eyes. A nail polish containing 1.0% Drometrizole was nonirritating to rabbit skin and Drometrizole was negative for sensitization in two Magnusson-Kligman maximization tests in guinea pigs. In clinical tests, Drometrizole at 1% was nonirritating in a single-insult patch test. No irritation or eczematous reactions were observed in 300 patients (with or without dermatosis) treated with daily applications of Drometrizole for 8 weeks. In a 3-year clinical therapeutic trial conducted to evaluate the effectiveness of two UVabsorbing preparations containing up to5%Drometrizole, two hypersensitivity reactions were observed during 445 applications. Although there are case reports in which Drometrizole was considered the sensitizing agent, clinical tests of cosmetic products containing 0.03% to 1.0% Drometrizole produced no irritation, sensitization, photosensitization, or phototoxicity in a total of 436 subjects. The Cosmetic Ingredient Review (CIR) Expert Panel assumes that Drometrizole is used in both noncoloring hair care and nail care products at low concentrations. The available safety test data do not suggest any adverse effects associated with exposure to Drometrizole. This toxicologic profile, coupled with the low concentration of use and the unlikely dermal penetration of a chemical that is insoluble in water, support the conclusion that Drometrizole can be safely used in cosmetics.<\/jats:p>","DOI":"10.1080\/10915810802032412","type":"journal-article","created":{"date-parts":[[2008,6,21]],"date-time":"2008-06-21T08:29:33Z","timestamp":1214036973000},"page":"63-75","source":"Crossref","is-referenced-by-count":5,"title":["Amended Final Report of the Safety Assessment of Drometrizole as used in Cosmetics1"],"prefix":"10.1177","volume":"27","member":"179","published-online":{"date-parts":[[2008,1,1]]},"reference":[{"key":"atypb1","unstructured":"Balazs, E., A. Toth, E. Bogsch, B. Stefko, I. Gebhardt, and D. Mathe. 1981. Method and composition for the prophylaxis of apple peel spot. Pat. Specif. (Aust.) Patent No. 514160 (Richter, Gedeon, Vegyeszeti Gyar Rt.)."},{"key":"atypb2","unstructured":"Berg, E. P. 1979. Oligomeric methacrylic-substituted alkylsiloxanes. Ger. Offen. Patent No. 2922932 (Minnesota Mining and Mfg. Co.)."},{"key":"atypb3","doi-asserted-by":"crossref","unstructured":"Chu, C. C., and T. E. Fischer. 1978.Evaluation of sunlight stability of polyurethane elastomers for maxillofacial use. I. J. Biomed. Mater. Res.","DOI":"10.1002\/jbm.820120308"},{"key":"atypb4","unstructured":"Cosmetic, Toiletry and Fragrance Association (CTFA). 1978a. Submission of unpublished data. Oral intubation and dermal toxicity studies (2-38-19)."},{"key":"atypb5","unstructured":"CTFA. 1978b. Draize eye irritation test. Unpublished data submitted by CTFA (2-38-3)."},{"key":"atypb6","unstructured":"CTFA. 1978c. Draize eye irritation test Unpublished data submitted by CTFA (2-38-2)."},{"key":"atypb7","unstructured":"CTFA. 1978d. Primary skin irritation testin rabbits. Unpublished data submitted by CTFA (2-38-4)."},{"key":"atypb8","unstructured":"CTFA. 1978e. Guinea pig allergy study. Unpublished data submitted by CTFA (2-38-12)."},{"key":"atypb9","unstructured":"CTFA. 1978f. Guinea pig allergy study. Unpublished data submitted by CTFA (2-38-16)."},{"key":"atypb10","unstructured":"CTFA. 1978g. Clinical skin irritation test. Unpublished data submitted by CTFA (2-38-5)."},{"key":"atypb11","unstructured":"CTFA. 1979a. Acute oral toxicity test in rats. Unpublished data submitted by CTFA (2-38-1)."},{"key":"atypb12","unstructured":"CTFA. 1979b. Acute dermal toxicity test in guinea pigs. Unpublished data sub-2"},{"key":"atypb13","unstructured":"CTFA. 1980a. Acute oral toxicity in rats. Unpublished data submitted by CTFA (2-38-6)."},{"key":"atypb14","unstructured":"CTFA. 1980b. Draize eye irritation test. Unpublished data submitted by CTFA (2-38-8)."},{"key":"atypb15","unstructured":"CTFA. 1980c. Draize eye irritation test. Unpublished data submitted by CTFA (2-38-9)."},{"key":"atypb16","unstructured":"CTFA. 1980d. Clinical Repeat Insult Patch Test. Unpublished data submitted by CTFA (2-38-10)."},{"key":"atypb17","unstructured":"CTFA. 1983a. Clinical phototoxicity test. Unpublished data submitted by CTFA (2-38-14)."},{"key":"atypb18","unstructured":"CTFA. 1983b. Clinical phototoxicity test. Unpublished data submitted by CTFA (2-38-15)."},{"key":"atypb19","unstructured":"CTFA. 1984a. Cosmetic ingredient chemical description. Unpublished data submitted by CTFA (2-38-13)."},{"key":"atypb20","unstructured":"CTFA. 1984b. Oral intubation and ocular irritation tests. Unpublished data submitted by CTFA (2-38-17)."},{"key":"atypb21","unstructured":"CTFA. 1984c. Clinical Single Insult Patch Test. Unpublished data submitted by CTFA (2-38-11)."},{"key":"atypb22","unstructured":"CTFA. 1984d. Clinical controlled use study. Unpublished data submitted by CTFA (2-38-20)."},{"key":"atypb23","unstructured":"CTFA. 1984e. Clinical controlled use study. Unpublished data submitted by CTFA (2-38-21)."},{"key":"atypb24","unstructured":"CTFA. 1984f. Prophetic patch and Repeat Insult Patch Test with UV exposure. Unpublished data submitted by CTFA (2-38-18)."},{"key":"atypb25","unstructured":"CTFA. 2004. Concentration of use of drometrizole in cosmetic products. Unpublished data submitted by CTFA."},{"key":"atypb26","unstructured":"Cronin, E.1980.Contact dermatitis, 102. New York: Churchill Livingstone."},{"key":"atypb27","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0536.1983.tb04410.x"},{"key":"atypb28","doi-asserted-by":"publisher","DOI":"10.1002\/app.1959.070020621"},{"key":"atypb29","doi-asserted-by":"publisher","DOI":"10.3109\/10915818609141920"},{"key":"atypb30","unstructured":"Engel, M. R. 1981. Durable, polishable direct filling material. U. S. Patent No. 4288221. http:\/\/www.uspto.gov"},{"key":"atypb31","unstructured":"Environmental Protection Agency (EPA). 2004. Robust summaries and test plans: Phenolic benzotriazoles category. High Production Volume (HPV) Challenge Program. http:\/\/www.epa.gov\/chemtrk\/phenbenz\/c13266tc.htm (accessed September, 2005)."},{"key":"atypb32","first-page":"238","volume":"14","year":"1967","journal-title":"Tetrahymena pyriformis. J. Protozool."},{"key":"atypb33","doi-asserted-by":"publisher","DOI":"10.1038\/208655a0"},{"key":"atypb34","unstructured":"European Economic Community (EEC). 2005. EEC Cosmetics Directive 76\/768\/EEC, as amended through the Adapting Commission Directive 2005\/42\/EC (June 20, 2005), Annexes I-VII. Annex VI. List of preservatives which cosmetic products may contain. Brussels: EEC."},{"key":"atypb35","unstructured":"Food and Drug Administration (FDA). 1981. Product formulation data.\n                      FDA database.\n                      Washington, DC: FDA."},{"key":"atypb36","unstructured":"FDA. 2005. Frequency of use of cosmetic ingredients.\n                      FDA database.\n                      Washington, DC: FDA."},{"key":"atypb37","first-page":"27","volume":"54","year":"1982","journal-title":"J. Coatings Tech."},{"key":"atypb38","volume-title":"International cosmetic ingredient dictionary and handbook","year":"2006"},{"key":"atypb39","first-page":"236","volume":"29","year":"1982","journal-title":"Nippon Koshu Eisei Zasshi"},{"key":"atypb40","volume-title":"The condensed chemical dictionary","year":"1971"},{"key":"atypb41","first-page":"63","volume-title":"American Chemical Society Symposium Series No. 94. Monitoring Toxic Substances","year":"1977"},{"key":"atypb42","unstructured":"Japan Cosmetic Industry Association (JCIA). 1967.\n                      Japanese Standards of Cosmetic Ingredients.\n                      To kyo, Japan: Yakuji Nippo Ltd. (Translated from the Japanese.)"},{"key":"atypb43","first-page":"333","volume":"1","year":"1980","journal-title":"Adv. Biomater."},{"key":"atypb44","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1007\/BF00595276","volume":"249","year":"1974","journal-title":"Arch. Dermatol. Forsch."},{"key":"atypb45","first-page":"25","volume":"1","year":"1979","journal-title":"P. Khim. Prom-st. Ser. Toksikol. Sanit. Khim. Plastmass."},{"key":"atypb46","unstructured":"Labor Hygiene and Occupational Diseases. 1966.\n                      Gigiena Truda i Professional'nye Zabolevaniia.\n                      (Vlo' Mezhdunarodnaya Kniga,' Kuznetskii Most 18, Moscow G-200, U. S. S. R.). 10:49. (Translated from the Russian.)"},{"key":"atypb47","unstructured":"Letchworth, P. E., and F. M. Pallos. 1972. Stabilized insecticidally active compounds. S. African Patent No. 71 05370. http:\/\/www.european-patent-office.org\/index.en.php"},{"key":"atypb48","unstructured":"Letchworth, P. E., and Pallos, F. M. 1976. Benzotriazoles as stabilizers for certain insecticidal epoxy compounds, U. S. Patent No. 3984541. http:\/\/www.uspto.gov"},{"key":"atypb49","unstructured":"Marhold, J. V. 1972.\n                      Sbornik Vysledku Toxixologick eho Vysetreni Latek A Pripravku\n                      , lnstitut Pro Vychovu Vedoucicn Pracovniku Chemickeho Prumy-clu, Czechoslovakia. 146. (Translated from the oridinal Czech.)"},{"key":"atypb50","unstructured":"Ministry of Health, Labor and Welfare (MHLW). 2005a. MHLW Ordinance No. 331, Appendix 1. List of ingredients that cosmetics shall not contain. Ministry of Health, Labor and Welfare, Pharmaceutical and Medical Safety Bureau, Inspection and Guidance Division, 2-2, 1-chome, Kasumigaseki, Chiyoda-ku, Tokyo 100-8045. Japan. (Translated from Japanese.)"},{"key":"atypb51","unstructured":"MHLW. 2005b. MHW Ordinance No. 331, Appendices 2-4. Restricted lists. Ministry of Health, Labor and Welfare, Pharmaceutical and Medical Safety Bureau, Inspection and Guidance Division, 2-2, 1-chome, Kasumigaseki, Chiyoda-ku, Tokyo 100-8045. Japan. (Translated from Japanese.)"},{"key":"atypb52","unstructured":"Motoyoshi, M., T. Ito, M. Yukutomi, Y. Tanaka, and A. Iyama. 1975. Agricultural composition for prevention of leaf burn. Japan Patent No. 75 19465. http:\/\/library.dialog.com\/bluesheets\/htmlaa\/bl0347.html"},{"key":"atypb53","unstructured":"Randklev, R. M. 1981. Orthodontic bracket adhesive and abrasive for its removal. Eur. Pat. Appl. Patent No. 37677. http:\/\/www.european-patent-office.org\/index.en.php"},{"key":"atypb54","doi-asserted-by":"publisher","DOI":"10.1016\/0015-6264(80)90102-9"},{"key":"atypb55","unstructured":"Schmitz, J. R., M. Walkowiak, H. H. Schulz, B. Boemer, and C. Sueling. 1980. Cold-hardened material for dental uses. Cer. Offen. Patent No. 2913220. http:\/\/www.european-patent-office.org\/index.en.php"},{"key":"atypb56","unstructured":"Stubbs, V. K., F. S. Downing, and G. J. Marrs. 1979. Tickicidal pyrethroid mixtures and stabilizer. U. S. 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