Safety assessment of cosmetic ingredients

摘要: Alcohol Denat. is the generic term used by cosmetics industry to describe denatured alcohol. and various specially (SD) alcohols are as cosmetic ingredients in a wide variety of products. Many denaturants have been previously considered, on an individual basis, Cosmetic Ingredient Review (CIR) Expert Panel, whereas others, including Brucine Sulfate, Denatonium Benzoate, Quassin, not evaluated. Quassin bitter alkaloid obtained from wood Quassia amara. has insect antifeedant insecticide several studies demonstrate its effectiveness. At oral doses up 1000 mg/kg using rats, was toxic acute short-term tests, but some reversible piloerection, decrease motor activity, partial loss righting reflex were found mice at 500 mg/kg. given intraperitoneally (i.p.), all died within 24 h receiving treatment. In cytotoxicity test with brine shrimp, 1 mg/ml did possess any cytotoxic or antiplasmodial activity. administered rat Leydig cells vitro concentrations 5-25 ng/ml inhibited both basal luteinizing hormone (LH)-stimulated testosterone secretion dose-related fashion. 2.0 g/kg drinking water rats produced no significant effect body weights, mean weights testes, seminal vesicles, epididymides significantly reduced, anterior pituitary glands increased. The sperm counts levels LH, follicle-stimulating (FSH), lower groups treated Quassin. derivative 2-hydroxystrychnine. Swiss-Webster base, 30 ml/kg, had LD 50 150 mg/kg, central nervous system depression followed convulsions seizures cases. those animals that died, respiratory arrest cause. i.p. for 15 ml/kg base 62.0 prior onset convulwas 12.0 nonmutagenic Ames assay 6666 μg/plate, without metabolic activation. repeat-insult patch test, hair care product containing 47% SD 40 (95%), it reported Sulfate may be considered nonprimary irritant sensitizer. Three different sunscreen products (35% 40-B, 72.4% 40, 74.5% 40) show signs photoallergy human subjects. Also, these three formulas exhibit evidence phototoxicity humans. Benzoate substance detectable concentration 10 ppb, discernibly unpleasantly ppm. distribution topically applied lidocaine, topical anesthetic chemically related demonstrated virtually lidocaine appears plasma, suggesting larger molecule also would little systemic exposure. (0.1%) adverse effects inhalation toxicity 0.005% 0.05% nonirritating ocular mucosa 6 albino rabbits. male 640 females, 584 rabbits 508 female rabbits, two chronic studies, (by gavage) 1.6, 8, 16 mg/kg/day, one cynomologus monkeys other resulted compound-related toxicity. Alcohols tested, implications particular denaturant used. An irritation 55.65% 40-B minimal effects. A spray formula 12% when evaluated vaginal mucosal New Zealand white formulations (denatured Benzoate) sensitizers repeated insult tests. gel 29% liquid induce photoallergy, dermal sensitization, phototoxic response Although absorption ethanol (aka purposes ingredient labeling) occurs through skin, does appear affect integrity skin barrier nor reach very high following Ethanol bloodstream result exposure ingestion. Topically applied, can act penetration enhancer. Most associated abuse make unfit consumption, there reports intentional unintentional consumption reproductive developmental toxicant. genotoxic systems proposed mediated via metabolite, acetaldehyde. brief summary provided ingestion alcohol intoxication, liver damage, brain possible carcinogenicity. CIR Panel recognizes certain this group reportedly category, use available. Because application will produce ethanol, concluded safety should predicated known included assessment do suggest concern because presence denaturants, which added express purpose making unpotable. conducted assessments t-Butyl Alcohol, Diethyl Phthalate, Methyl Salicylic Acid, Sodium Salicylate, each affirmed safe qualifications. Given their low determined Salicylate Likewise, they either 3-A, 30, 39-B, 39-C, 40-C available data sufficient support cosmetics. sufficiently effective only 0.0006%. recognized available, smaller structurally chemical, indicates measurable data, however, Brucine, 39 (SD and/or Sulfate), order conclusion additional needed.