Publications (4)7.92 Total impact
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Article: Safety of botanical ingredients in personal care products/cosmetics.
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ABSTRACT: The key issue of the safety assessment of botanical ingredients in personal care products (PCP) is the phytochemical characterisation of the plant source, data on contamination, adulteration and hazardous residues. The comparative approach used in the safety assessment of GM-plants may be applied to novel botanical PCP ingredients. Comparator(s) are the parent plant or varieties of the same species. Chemical grouping includes definition of chemical groups suitable for a read-across approach; it allows the estimation of toxicological endpoints on the basis of data from related substances (congeneric groups) with physical/chemical properties producing similar toxicities. The Threshold of Toxicological Concern (TTC) and Dermal Sensitisation Threshold (DST) are tools for the assessment of trace substances or minor ingredients. The evaluation of skin penetration of substances present in human food is unnecessary, whereas mixtures may be assessed on the basis of physical/chemical properties of individual substances. Adverse dermal effects of botanicals include irritation, sensitisation, phototoxicity and immediate-type allergy. The experience from dietary supplements or herbal medicines showed that being natural is not equivalent to being safe. Pragmatic approaches for quality and safety standards of botanical ingredients are needed; consumer safety should be the first objective of conventional and botanical PCP ingredients.Food and chemical toxicology: an international journal published for the British Industrial Biological Research Association 02/2011; 49(2):324-41. · 2.99 Impact Factor -
Article: Lack of effect of butylparaben and methylparaben on the reproductive system in male rats.
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ABSTRACT: Parabens are widely used preservatives in cosmetics and pharmaceutical products, and approved as food additives. Parabens have been considered safe for these uses for many years. Recently, adverse effects on male reproductive parameters in rats have been reported when parabens were given orally for 8 weeks starting at three weeks of age. Our studies used two representative parabens, methyl- and butylparaben, to try to replicate these studies and thereby evaluate potential reproductive effects in male Wistar rats. Diets containing 0, 100, 1000 or 10,000 ppm of either butyl- or methylparaben were fed to male rats for eight weeks. Rats were 22 days of age at the start of exposure. Parameters evaluated included organ weights, histopathology of reproductive tissues, sperm production, motility, morphology and reproductive hormone levels (butylparaben only). None of the parameters evaluated for either paraben showed compound- or dosage-dependent adverse effects. Metabolism experiments of butylparaben indicate that it is rapidly metabolized by non-specific esterases to p-hydroxybenzoic acid and butanol, neither of which is estrogenic. Exposure to methyl- or butylparaben in the diet for eight weeks did not affect any male reproductive organs or parameters at exposures as high as 10,000 ppm, corresponding to a mean daily dose of 1,141.1+/-58.9 or 1,087.6+/-67.8 mg/kg/day for methyl- and butylparaben, respectively. The rapid metabolism of parabens by esterases probably explains why these weakly estrogenic substances elicit no in vivo effects when administered by relevant exposure routes (i.e., topical and oral).Birth Defects Research Part B Developmental and Reproductive Toxicology 05/2008; 83(2):123-33. · 1.93 Impact Factor -
Article: Exposure data for personal care products: hairspray, spray perfume, liquid foundation, shampoo, body wash, and solid antiperspirant.
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ABSTRACT: Reliable exposure information for cosmetic and other personal care products and ingredients is needed in order to conduct safety assessments. Essential information includes both the amount of product applied, and the frequency of use. To obtain current data, studies to assess consumer use practices were undertaken. Six widely used personal care product types were included in the studies. Five of the products were cosmetics (spray perfume, hairspray, liquid foundation, shampoo, body wash) and one product was a cosmetic/over-the-counter drug product (solid antiperspirant). Three hundred and sixty women, ages 19-65 years, who regularly use the products of interest, were recruited at 10 different geographical locations within the US. The number of recruits was chosen to ensure a minimum of three hundred completed responses per product type. Subjects were provided with a new container of the brand of product they normally use and kept diaries and recorded detailed daily usage information over a two week period. Products were weighed at the start and completion of the study in order to determine the total amount of product used. Statistical analyses of the data were conducted to derive summary distributions of use patterns. The geometric mean and median usage per application, respectively, for the six product types were: spray perfume, 0.33 g and 0.23 g; hairspray, 2.58 g and 1.83 g (aerosol); 3.64 g and 2.66 g (pump); liquid foundation, 0.54 g and 0.36 g; shampoo, 11.76 g and 9.56 g; body wash, 11.3g and 9.5 g; and solid antiperspirant, 0.61 g and 0.45 g. The mean and median usage per day for the six product types were: spray perfume, 0.53 g and 0.34 g; hairspray, 3.57 g and 2.71 g (aerosol); 5.18 g and 3.74 g (pump); liquid foundation, 0.67 g and 0.45 g; shampoo, 12.80 g and 10.75 g; body wash, 14.5 g and 12.9 g; and solid antiperspirant, 0.79 g and 0.59 g. The mean number of applications per day for spray perfume, hairspray, liquid foundation, shampoo, body wash, and solid antiperspirant was 1.67, 1.49 (aerosol) and 1.51 (pump), 1.24, 1.11, 1.37, and 1.3, respectively. This study provides current exposure information for commonly used products which will be useful for risk assessment purposes.Food and Chemical Toxicology 01/2007; 44(12):2008-18. · 3.00 Impact Factor -
Article: Safety assessment of personal care products/cosmetics and their ingredients
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ABSTRACT: We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO2 and ZnO in sunscreens. However, current evidence suggests that these particles are non-toxic, do not penetrate into or through normal or compromised human skin and, therefore, pose no risk to human health. The increasing use of natural plant ingredients in personal care products raised new safety issues that require novel approaches to their safety evaluation similar to those of plant-derived food ingredients. For example, the Threshold of Toxicological Concern (TTC) is a promising tool to assess the safety of substances present at trace levels as well as minor ingredients of plant-derived substances. The potential human systemic exposure to PCP ingredients is increasingly estimated on the basis of in vitro skin penetration data. However, new evidence suggests that the in vitro test may overestimate human systemic exposure to PCP ingredients due to the absence of metabolism in cadaver skin or misclassification of skin residues that, in vivo, remain in the stratum corneum or hair follicle openings, i.e. outside the living skin. Overall, today's safety assessment of PCP and their ingredients is not only based on science, but also on their respective regulatory status as well as other issues, such as the ethics of animal testing. Nevertheless, the record shows that today's PCP are safe and offer multiple benefits to quality of life and health of the consumer. In the interest of all stakeholders, consumers, regulatory bodies and producers, there is an urgent need for an international harmonization on the status and safety requirements of these products and their ingredients.Toxicology and Applied Pharmacology.
