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Performance of porcine corneal opacity and permeability assay to predict eye irritation for water-soluble cosmetic ingredients.

The purpose of this paper is to report on the ability of an in-house porcine corneal opacity and permeability assay (PCOP) to predict eye irritation for cosmetic ingredients. Preliminary studies showed that the PCOP assay could accurately predict eye irritation class for liquid and water soluble materials. To broaden our experience a larger study on 50 cosmetic ingredients of this group was conducted. A prediction model (PM) was obtained based on only one endpoint-permeability measured after 30-min exposure O.D.30. This PM allows to distinguish nonirritating compounds (if O.D.30 < 0.35) from irritating (if O.D.30 > or = 0.35). Forty-nine of the 50 ingredients tested in the PCOP assay were accurately classified. The agreement was high (concordance 98%-kappa = 0.96). For 43 of the test substances an equation PM was obtained to predict the MAS. Despite satisfactory statistical coefficients this algorithm is not recommended due to wide 95% confidence intervals. These results confirm the usefulness of the PCOP for water-soluble cosmetic ingredients to discriminate nonirritants (MAS < or = 15) and irritants (MAS >15). For this type of ingredients the PCOP seems to be better than the BCOP to predict irritation class. Future work will be done to compare the BCOP and PCOP performances and to develop an appropriate protocol for water insoluble compounds.

Animals↗

Reconstituted human corneal epithelium: a new alternative to the Draize eye test for the assessment of the eye irritation potential of chemicals and cosmetic products.

The aim of this study was to evaluate the interest of a new three-dimensional epithelial model cultivated from human corneal cells to replace animal testing in the assessment of eye tolerance. To this end, 65 formulated cosmetic products and 36 chemicals were tested by means of this in vitro model using a simplified toxicokinetic approach. The chemicals were selected from the ECETOC data bank and the EC/HO International validation study list. Very satisfactory results were obtained in terms of concordance with the Draize test data for the formulated cosmetic products. Moreover, the response of the corneal model appeared predictive of human ocular response clinically observed by ophthalmologists. The in vitro scores for the chemicals tested strongly correlated with their respective scores in vivo. For all the compounds tested, the response of the corneal model to irritants was similar regardless of their chemical structure, suggesting a good robustness of the prediction model proposed. We concluded that this new three-dimensional epithelial model, developed from human corneal cells, could be promising for the prediction of eye irritation induced by chemicals and complex formulated products, and that these two types of materials should be tested using a similar protocol. A simple shortening of the exposure period was required for the chemicals assumed to be more aggressively irritant to the epithelial tissues than the cosmetic formulae.

Animal Testing Alternatives↗

Determination of zinc pyrithione in cosmetic products by high-performance liquid chromatography with pre-labelling.

A high-performance liquid chromatographic (HPLC) method has been developed for the determination of zinc pyrithione (Zpt) in commercial cosmetic products. Zpt was pre-labelled with N-dansylaziridine and determined by reversed-phase HPLC. Ingredients in cosmetic products did not interfere in the pre-labelling reaction. The calibration graph for Zpt was linear in the range 1.4-66 ng. The coefficient of variation was 0.9% for 17-ng injections. Using the proposed method, Zpt in commercial cosmetic products was determined with high sensitivity and high selectivity. The proposed method is also applicable to the determination of trace amounts of Zpt adsorbed on human hair.

Chromatography, High Pressure Liquid↗

Determination of glycolic acid in cosmetic products by solid-phase extraction and reversed-phase ion-pair high-performance liquid chromatography.

A procedure has been developed for the assay of glycolic acid in cosmetic products by reversed-phase high-performance liquid chromatography using an ion-pairing method. After dissolution in tetrahydrofuran-water (90:10, v/v), samples were purified by solid-phase extraction using silica-based strong anion-exchange cartridges and analysed directly on an Ultrasphere ODS column with UV detection at 210 nm and methanol-phosphate buffer (2:98, v/v), containing tetrabutylammonium iodide, as the mobile phase. Recovery of glycolic acid from different cosmetic matrices was between 92.4 and 96.2% and the precision of the method was better than 5.4% relative standard deviation. The procedure is rapid, simple, selective and it is suitable for routine analyses of commercial cosmetics.

Buffers↗

A five-year study of cosmetic reactions.

During 64 months (1977 to 1983), twelve dermatologists from various sections of the United States studied a total of 713 patients with cosmetic dermatitis out of an estimated total of 13,216 patients with contact dermatitis. The number of patients seen for all causes during this period was 281,100. An important finding was that half of the patients or physicians were unaware that a cosmetic was responsible for their dermatitis. Skin care products, hair preparations (including colors), and facial makeup were responsible for the majority of the reactions. The most important objective was identification of causative ingredients. Eighty-seven percent of the subjects had patch tests. Fragrance, preservatives (Quaternium-15, formaldehyde, imidazolidinyl urea, and parabens), p-phenylenediamine, and glyceryl monothioglycolate were the most frequently identified allergic sensitizers, in that order. In addition to the clinical data, the study permitted assessment of the frequency of cosmetic reactions, although the data may not be entirely representative of the country at large because of the special interests of the dermatologists involved.

Adult↗

Methyldibromoglutaronitrile (Euxyl K 400): an important "new" allergen in cosmetics.

Euxyl K 400 is a preservative system for cosmetics and toiletries that contains phenoxyethanol and methyldibromoglutaronitrile in a 4:1 ratio. In The Netherlands, Italy, and Germany, the prevalence of allergy to Euxyl K 400 has risen in the past 4 years and is currently 2% to 4% in patients suspected of having contact dermatitis. The allergenic ingredient is nearly always methyldibromoglutaronitrile. Causative products include both stay-on and rinse-off cosmetics and moistened toilet tissue. Because the causative products usually give false-negative reactions, the allergen, methyldibromoglutaronitrile, should be tested in all patients suspected of having cosmetic dermatitis and in those with perianal dermatitis. We suggest a test concentration of 0.3% to 0.5% in petrolatum.

Allergens↗

Simultaneous analysis of dehydroacetic acid, benzoic acid, sorbic acid and salicylic acid in cosmetic products by solid-phase extraction and high-performance liquid chromatography.

A high-performance liquid chromatographic (HPLC) method for simultaneous determination of dehydroacetic acid (DHA), benzoic acid (BA), sorbic acid (SOA) and salicylic acid (SA) was developed for application to cosmetic products. Isocratic reversed-phase HPLC was employed for quantitative analysis using tetra-n-butylammonium (TBA) hydroxide as an ion-pair reagent. Cosmetic samples were purified by solid-phase extraction using Bond-Elut SI cartridges. Four acidic preservatives were eluted with methanol from cartridges. The HPLC assay was carried out using TSK gel ODS-80TM column (5 microm, 150 x 4.6 mm I.D.). The mobile phase consisted of a mixture of water and methanol (65:35, v/v) containing 2.5 mM TBA hydroxide adjusted with phosphoric acid to pH 7.0. The calibration curves of these preservatives showed good linearity with UV detection (235 nm). The correlation coefficients were better than 0.999 in all cases. The lower limits of detection (defined as a signal-to-noise ratio of about 3) were approximately 2.5 ng for DHA, 4.0 ng for BA, 2.0 ng for SOA and 5.5 ng for SA. The procedure described here is simple, selective and is suitable for quality control of finished cosmetic products.

Benzoic Acid↗

Nail cosmetic issues.

Nail cosmetics are a part of good hygiene and self adornment. These cosmetics can provide solutions to problems involving the nail plate and also can create disease. This article provides a diagnosis and treatment-oriented approach to nail cosmetic issues.

Beauty Culture↗

A new approach to the evaluation of whitening effect of a cosmetic using computer analysis of video-captured image.

Whitening effects of cosmetics have been evaluated with change of skin reflectance of the colorimeter. However, skin color implies Hue (H) and Saturation (S) as well as skin reflectance (Value). We have developed a new evaluation method of change of skin color using computer analysis of the video-captured digital image. We have also investigated whitening effects of a new whitening cosmetic essence, 'Concentre anti-tache nuit' (CAN; Parfums Christian Dior, France), which contained 3% magnesium l-ascorbyl 2-phosphate, on skin color of the face in 15 healthy Japanese females. Measurement was performed after 6 weeks application. Whitening effects were also evaluated with the combination of observation and photographs. CAN showed significant improvement in Saturation of the forehead and left cheek and Value of the forehead. CAN showed greater whitening effects both on the forehead and left cheek in eight (53%) of 15 subjects with the combination of observation and photographs. These results indicated that CAN may have a whitening effect on skin of the face after 6 weeks application. This method may be useful to evaluate the whitening effect of cosmetics and color change of cutaneous disorders.

Adolescent↗

Quantitative analysis of the 26 allergens for cosmetic labeling in fragrance raw materials and perfume oils.

The adoption of the 7th amendment of the European Cosmetic Directive 76/768/EEC requires any cosmetic product containing any of 26 raw materials identified by the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers as likely to cause a contact allergy when present above certain trigger levels to be declared on the package label. Of these 26, 24 are volatile and can be analyzed by GC. This paper describes a method for the quantitative analysis of these volatile raw materials in perfume ingredients as well as complex perfume compositions. The method uses sequential dual-column GC-MS analysis. The full-scan data acquired minimize the false-positive and false-negative identifications that can be observed with alternate methods based on data acquired in the SIM mode. For each sample, allergen levels are determined on both columns sequentially, leading to two numerical results for each allergen. Quantification limits for each allergen in a perfume mixture based on the analysis of a standard are <4 mg/kg. This is well below the level that would trigger label declaration on the consumer good. Calibration curves for all allergens are linear (r > 0.999) and stable for multiple days. Studies on perfumes spiked with multiple allergens at 30, 50, and 70 mg/kg show recoveries close to nominal values.

Allergens↗

Colorimetric evaluation of phenolic content and GC-MS characterization of phenolic composition of alimentary and cosmetic argan oil and press cake.

The global phenolic content of argan oil and press cake samples (alimentary and cosmetic) was evaluated using the Folin-Ciocalteu colorimetric method and the phenolic composition of argan oil (alimentary and cosmetic) and press cake (alimentary) samples were analyzed by GC-MS after extraction with 80:20 (v/v) methanol:water and silylation. Identification of chromatographic peaks was made by mass selective detection. Nineteen simple phenols were detected, 16 in press cake, 6 in the alimentary oil, and 7 in the cosmetic oil, among which 15 compounds [3-hydroxypyridine (3-pyridinol), 6-methyl-3-hydroxypyridine, catechol, resorcinol, 4-hydroxybenzyl alcohol, vanillin, 4-hydroxyphenylacetic acid, vanillyl alcohol, 3,4-dihydroxybenzyl alcohol, 4-hydroxy-3-methoxyphenethyl alcohol, methyl 3,4-dihydroxybenzoate, hydroxytyrosol, protocatechuic acid, epicatechin, and catechin] were identified for the first time in such materials.

Colorimetry↗

Determination of antioxidant efficacy of cosmetic formulations by non-invasive measurements.

BACKGROUND/AIMS: Antioxidants have been proposed, over the last decade, as functional ingredients for anti aging preparations and to prevent and modulate oxidative skin damages. Up to date, beside the photo-induced oxidative skin damages model, none in vivo protocols have shown sufficient reproducibility for the validation of the antioxidant claim for a cosmetic finished product. To this aim, we have recently anticipated a new in vivo protocol based on a microinflammatory model, driven by reactive oxygen species. In the present study our model was validated by comparison with four different instrumental methods. METHODS: The effects of a pre-treatment of two different formulations based on antioxidant functional ingredients, were investigated on forearm skin of 15 healthy volunteers, and compared to a cosmetic base and control area. The instruments considered in the study were Chromameter (CR-300 Minolta), Tewameter TM 210 (Courage-khazaka, Cologne, Germany), Laser Doppler Perfusion Imager (PIM1.0 Lisca Development AB, Sweden), in comparison to DermAnalyzer(R), an easy to use software program developed by us, using the CIE L*a*b* color space parameters. RESULTS: The comparative measurements showed that the antioxidant formulations tested were all able to reduce, in different but statistically significant extent, the intensity of skin redness, and of cutaneous blood flow, when compared to control area (P < 0.0001). CONCLUSIONS: The methyl nicotinate (MN) based microinflammatory model, in conjunction with objective measure- ments, resulted an effective tool for in vivo assessment of oxidative skin injuries. In view of the high level of repeatability, short time of answer and simplicity, the procedure by us developed, is proposed as a possible protocol for the evaluation of in vivo efficacy of antioxidant functional ingredients in cosmetic formulations.

Adult↗

Determination of 1,4-dioxane in cosmetic products by high-performance liquid chromatography.

A rapid high-performance liquid chromatographic procedure has been developed for the assay of 1,4-dioxane in cosmetic products. After solid-phase extraction, using Bond Elut CN and Bond Elut C18 cartridges, samples were analysed directly on a LiChrospher CH-8 reversed-phase column with spectrophotometric detection at 200 nm and acetonitrile - water as eluent. Recovery of 1,4-dioxane from different cosmetic matrices was between 81.5 and 90.1% in the 30-90 microgram g(-1) range. The minimum quantifiable amount was 6.5 microgram g(-1). The method is simple, reproducible and specific and is suitable for routine analyses of commercial cosmetics.

Chromatography, High Pressure Liquid↗

Stopped-flow Fourier-transform infra-red spectrometric speciation of glycolic and lactic acids in cosmetic formulations.

The dermatological activity of cosmetic formulations containing alpha-hydroxyacids depends on their different chemical forms, and it is therefore useful to determine these species in the finished products. In the present report a new procedure for studying the protonation equilibria of glycolic and lactic acids by stopped-flow Fourier-transform infra-red (FTIR) spectrometry is described. The procedure was validated for use in the speciation of glycolic and lactic acids in cosmetic formulations, with preferential attention given to glycolic acid, which is the most widely used. Species of these alpha-hydroxyacids can be approximately determined at different pHs and the total content of each alpha-hydroxyacid can be accurately determined (according to the Student t-test at 5% significance level). The recovery of the total content of glycolic acid from commercial cosmetic formulations was 101+/-4%. The RSD of the determinations of the total content and those of the species was of the order of 2-7%.

Cosmetics↗

Skin diseases associated with the cosmetic use of bleaching products in women from Dakar, Senegal.

BACKGROUND: The cosmetic use of bleaching products is considered a common practice in dark-skinned women from sub-Saharan Africa. However, there are few studies on this subject. OBJECTIVES: To increase the knowledge about the dermatological consequences of this practice in Dakar, the capital of Senegal. METHODS: A representative sample of 368 adult women presenting at our dermatological centre was selected. Each woman was questioned about her cosmetic use of bleaching products. Next, the following data were recorded in 425 women who used bleaching products: names and types of products used; modalities of the skin bleaching practice; skin diseases motivating the dermatological visit, with recording of their clinical features; and results of a full skin examination. The active substances of the bleaching products were determined mainly by reading the indications on their packages; with products of unknown composition, a pharmacological analysis of samples was done. A statistical analysis was performed. RESULTS: Of the 368 women questioned, 194 (52.7%) were current users of bleaching products. Concerning the 425 users enrolled, products were applied on the whole body in 92% of users, with a median duration of use of 4 years. The active principles used included hydroquinone (used by 89% of users), glucocorticoids (70%), mercury iodide (10%) and caustic agents (17%); 13% of users used products of unknown composition. In the samples that were analysed, hydroquinone was found at concentrations of between 4% and 8.7%. Concerning steroids, superpotent (class 1) glucocorticoids predominated. The main skin complaints in bleaching products users included dermatophyte infections (n = 105) and scabies (n = 69), both often unusually extensive and severe; acne (n = 42), often severe; eczema (n = 41); irritant dermatitis (n = 14); and dyschromia (n = 26, including 14 cases of exogenous ochronosis). The skin examination noted features apparently disregarded by users: striae (noticed in 39% of users), and macular hyperchromia involving the face, mainly the periocular area (33%). The statistical analysis showed that glucocorticoid use was associated with the presence and severity of infectious skin diseases, and of acne. CONCLUSIONS: More than half of the adult women presenting at our dermatology centre were using bleaching products. Most skin diseases observed in bleaching products users appeared to be induced, aggravated or modified by this practice. Superpotent topical glucocorticoids appeared to be the main agents responsible for the observed complications. The cosmetic use of bleaching products therefore has a major impact on our current dermatological practice.

Acne Vulgaris↗

The field of cosmetic dermatology: the need for a patient-centred approach.

Similar of knowledge and skills are required to deal with certain skin disorders and their corresponding cosmetic complaints. The field of cosmetic dermatology is growing as an overlap between the medical treatment of skin diseases and traditional cosmetology. This poses problems for dermatologists and other professionals, including regulation agencies. Dermatology should be able patients to benefit from all that is necessary for their care, whether that be surgery, drugs or cosmetics. There is no need to modify current regulations. A patient-orientated approach is advocated.

Cosmetic Techniques↗

Content of fragrance mix ingredients and customer complaints of cosmetic products.

BACKGROUND: In relation to the wide use of cosmetics, serious adverse effects are rare. Occasionally, unwanted effects such as contact dermatitis are reported. Allergic reactions to cosmetics are often caused by fragrances. OBJECTIVE: The aim was to investigate the content of fragrance mix (FM) ingredients in cosmetic products of the brand ACO HUD (Stockholm, Sweden) and the frequency of customer skin complaints about fragranced and unfragranced products over 4.5 years. METHOD: Content of FM ingredients in the fragrances used was both analyzed and requested from the suppliers. Customer complaints were those reported to the company. RESULTS: Between 1 and 7 of FM ingredients were present in levels of less than 0.1 to 770 ppm. The ingredients, in order of frequency, were geraniol, eugenol, hydroxycitronellal, alpha-amyl cinnamic aldehyde, isoeugenol, cinnamic alcohol, and oak moss. Cinnamic aldehyde was not found. No significant difference was found either between the frequency of complaints about products with and without fragrance (P = .21) or in a paired comparison of 17 formulas marketed with and without fragrance (P = .24). CONCLUSION: The study suggests that the investigated fragranced products had a low content of FM ingredients, which might explain the absence of a higher frequency of adversities. Furthermore, it appears that under such circumstances fragrances may be used without introducing an increased rate of spontaneous complaints of skin reactions.

Allergens↗

Lead concentrations in maternal and cord blood in women users of surma eye cosmetics.

A prospective study was undertaken to analyse the lead concentrations in maternal and cord blood of 71 pregnant Arab women at term who used eye cosmetics, particularly "surma". A total of 64 mothers (90%) used eye cosmetics throughout pregnancy, and, of these, 45% used surma. The lead content of the cosmetics available in the market was found to vary between zero and 88%. The mean lead concentrations in all blood samples were higher than the accepted natural levels of 0.001 mumol/l, but lower than the subtoxic level of 1.9 mumol/l. The mean lead concentration of all samples was lower than the subtoxic level of 1.9 mumol/l but higher than that quoted in the literature and suggested to be a natural level (0.001 mumol/l). This indicates that other lead pollutants may be involved. Lead concentrations in maternal and cord blood correlated well, but did not show any significant difference between surma and non-surma users. None of the newborns showed apparent congenital anomalies and their birthweights were comparable to average Saudi birthweights.

Birth Weight↗