Drometrizole

The Food and Drug Administration (FDA) includes Drometrizole on its list of indirect food additives. It is permited for use as an antioxidantIngredients that prevent or slow deterioration due to chemical reaction with oxygen. and/or stabilizer in polymers having contact with food. The safety of Drometrizole has been assessed by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Drometrizole was safe as a cosmetic ingredient.

CIR Safety Review: Short-term studies 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. While Drometrizole is insoluble in water and soluble in a wide range of organic solvents, a distribution and elimination study 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. No increases in mortality or local and/or systemic toxicity were observed in a 13-week oral toxicity study. Developmental studies of Drometrizole found no developmental effects. Drometrizole was not genotoxic in bacteria, a bone marrow micronucleus test, or somatic mutation assays observing interphase nuclei and chromosomal aberrations. There was no evidence of dominant lethal effects. Drometrizole at a 1% concentration was minimally to moderately irritating to 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 eyes. A nail polish containing 1% Drometrizole was nonirritating to skin and Drometrizole was negative for sensitization in two Magnusson-Kligman maximization tests. 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 UV-absorbing preparations containing up to 5% Drometrizole, two hypersensitivity reactions were observed during 445 applications. Although there were case reports in which Drometrizole was considered the sensitizing agent, clinical tests of cosmetics and personal care products containing 0.03-1.0% Drometrizole produced no irritation, sensitization, photosensitization, or phototoxicity in a total of 436 subjects. The toxicological 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 and personal care products.

Link to FDA Code of Federal Regulations for 2(2–Hydroxy-5–methylphenyl)benzotriazole, or Drometrizole
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Drometrizole may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…