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PubMed1978

Cosmetic regulatory activities in the United States: past, present and future.

To protect consumers from unsafe or decptively labeled cosmetics, the Food and Drug Administration promulgates regulations, conducts factory inspections, investigates mardeted products, evaluates consumer complaints, maintains registries of voluntarily submitted formulation and adverse reaction information, and carries out analytical, microbiological and toxicological studies. There has been a significant shift in program priorities from surveillance activities to scientific research and the determination of systemic hazards to health. Major scientific efforts involve studies to determine the dermal toxicity of cosmetics, develop methods for predicting the efficacy of preservatives, and answer questions about the skin penetration and carcinogenicity of nitrosodiethanolamine. A further issue of concern is the carcinogenic hazard of hair dyes.

Animals↗
PubMed1984

Antioxidants in cosmetics.

Antioxidants are commonly added to cosmetics. Allergy to these substances will be missed unless specifically looked for. During a 2-year period, patients with facial dermatitis have been routinely tested with butylhydroxyanisole and tertiary butylhydroquinone. 7 patients are reported who have been shown to have an allergic contact dermatitis to an antioxidant in their cosmetics or toiletries.

Aged↗
PubMed1985

Kathon CG: cosmetic allergy and patch test sensitization.

Three cases of contact allergy to Kathon CG, a preservative for cosmetics and toiletries containing, as active ingredients, 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one are presented. In two patients, Kathon CG was contained in a moisturizing cream, and the third was sensitized by a diagnostic patch test. Although it has been used extensively in cosmetics and toiletries for 9 years in Europe and 4 years in the USA, these appear to be the first case reports of non-occupational sensitization to Kathon CG.

Adult↗
PubMed1990

Sensitization to fragrance materials in Indonesian cosmetics.

2 different groups of patients were patch tested with 2 test series (A and B) containing extracts of fragrance raw materials, traditionally used in Indonesian cosmetics. Series A consisted of diluted extracts of commercially available Indonesian fragrances. Series B consisted of extracts prepared in our department from corresponding indigenous flowers and fruits. Group 1 consisted of 32 patients positive to fragrance-mix, of whom 8 (25%) had positive tests to 1 or more of the different extracts of fragrance raw materials. Reactions were observed to extracts of: Rosa hybrida Hort (7); Canangium odoratum Baill (5); Citrus aurantifolia Swingle (4); Jasminum sambac Ait (2). 6 of the 8 patients had reactions to 1 or more of the components of fragrance-mix: oakmoss (3); cinnamic alcohol (2), isoeugenol (1); cinnamic aldehyde (1) and geraniol (1). Group 2 consisted of 159 patients patch tested on suspicion of contact dermatitis, who were fragrance-mix negative. Only 2 (1.2%) had a positive patch test to the extracts of fragrance raw materials. Specimens taken (as is) from the flowers and citrus fruits (being the basis sources of the fragrance raw materials) were less antigenic. The use of additional test series in Indonesia to detect allergy to traditional cosmetics and perfumes merits further investigation.

Allergens↗
PubMed1996

Natural ingredients based cosmetics. Content of selected fragrance sensitizers.

In the present study, we have investigated 42 cosmetic products based on natural ingredients for content of 11 fragrance substances: geraniol, hydroxycitronellal, eugenol, isoeugenol, cinnamic aldehyde, cinnamic alcohol, alpha-amylcinnamic aldehyde, citral, coumarin, dihydrocoumarin and alpha-hexylcinnamic aldehyde. The study revealed that the 91% (20/22) of the natural ingredients based perfumes contained 0.027%-7.706% of 1 to 7 of the target fragrances. Between 1 and 5 of the chemically defined synthetic constituents of fragrance mix were found in 82% (18/22) of the perfumes. 35% (7/20) of the other cosmetic products (shampoos, creams, tonics, etc) were found to contain 0.0003-0.0820% of 1 to 3 of the target fragrances. Relatively high concentrations of hydroxycitronellal, coumarin, cinnamic alcohol and alpha-amyl cinnamic aldehyde were found in some of the investigated products. The detection of hydroxycitronellal and alpha-hexylcinnamic aldehyde in some of the products demonstrates that artificial fragrances, i.e., compounds not yet regarded as natural substances, may be present in products claimed to be based on natural ingredients.

1-Propanol↗
PubMedDate not supplied

Protection against endogenous and UVB-induced oxidative damage in stratum corneum lipids by an antioxidant-containing cosmetic formulation.

A 16-week human clinical study was carried out to determine the ability of antioxidants in a cosmetic vehicle to inhibit the induction of lipid peroxidation in stratum corneum lipids. The study consisted of a twice daily application of material for 12 weeks followed by a 4-week regression phase. Stratum corneum lipids were collected and then exposed to 500 mJ/cm2 of ultraviolet B (UVB) radiation in order to avoid excessive erythemal damage to the subjects. Lipid peroxides were assayed by a methylene blue derivative assay and expressed per unit area of skin. During the treatment period, decreases in the level of lipid peroxides were observed on the sites treated with the compositions containing antioxidants, as compared to the untreated sites, and expressed as percent differences. Decreases were observed in endogenous as well as UV-induced lipid peroxides followed by a return to baseline levels. These results demonstrate that antioxidants in a topical cosmetic formulation were effective in protecting human stratum corneum lipids against endogenous oxidation or if challenged by 500 mJ/cm2 UVB.

Antioxidants↗
PubMed1975

Microwave sanitization of color additives used in cosmetics: feasibility study.

Microwave exposure has been explored as a method of microbiologically sanitizing color additives used in cosmetic products. Selected microbiologically unacceptable cosmetic color additives, D&C red no. 7 Ca lake (certified synthetic organic color), carmine (natural organic color not subject to certification), and chromium hydroxide green (inorganic color not subject to certification), were submitted to microwave exposure. Gram-negative bacteria were eliminated, as verified by enrichment procedures, and levels of gram-positive bacteria were reduced. Generally, analytical and dermal safety studies indicated no significant alterations in physical, chemical, and toxicological properties of the colors. Sanitization was also successfully performed on other colors (D&C red no. 9 Ba lake, D&C red no. 12 Ba lake, D&C green no. 5, and FD&C red no. 4); initial physical and chemical tests were satisfactory. Results indicated that this method of sanitization is feasible and warrants further investigation.

Bacteria↗
PubMed2002

Comparison of cutaneous bioavailability of cosmetic preparations containing caffeine or alpha-tocopherol applied on human skin models or human skin ex vivo at finite doses.

The use of human skin models for performing cutaneous bioavailability studies has been little investigated. For instance, only few studies have been reported on human skin models dealing with vehicle effects on percutaneous penetration. The present study aimed at evaluating the influence on caffeine's and alpha-tocopherol's cutaneous bioavailability of cosmetic vehicles such as a water-in-oil emulsion, an oil-in-water emulsion, a liposome dispersion and a hydrogel applied at finite dose using the reconstructed human skin models EpiDerm and Episkin. The results were compared with those obtained in human skin ex vivo using similar experimental conditions. It was demonstrated that the rank order of solute permeability could be correctly predicted when the preparation was applied at a finite dose in human skin models, at least when solutes with far different physicochemical properties such as caffeine and alpha-tocopherol were used. If only slight effects of cosmetic vehicle on skin bioavailability were observed in human skin ex vivo, they were less predictable using skin models. Especially, alcohol-containing vehicles seemed to behave differently in EpiDerm as well as in Episkin than on human skin ex vivo. Stratum corneum intercellular lipid composition and organization of human skin models differ to some extent from that of human stratum corneum ex vivo, which contributes to less pronounced barrier properties, together with the increased hydration of the outermost stratum corneum layers of the models. These features, as well as still unknown factors, may explain the differences observed in vehicle effects in human skin ex vivo versus human skin models.

Biological Availability↗
PubMed1993

Ingestion of caustic cosmetic products.

Twelve children over a 6-year period (1985 to 1991) underwent aerodigestive tract endoscopy after ingestion of lye-containing cosmetic products. All children were less than 2 years of age and had facial and/or oral cavity burns. Eleven of these patients ingested alkaline hair products such as "activators" or "relaxers." Endoscopy revealed pharyngeal burns in five patients but no laryngeal or esophageal burns in any patient. Erythema of the esophageal mucosa was seen in one patient. One patient ingested a solution used in fingernail decorating. This patient sustained extensive superficial burns of the pharynx, larynx, and esophagus and required intubation and admission to the intensive care unit. No long-term sequelae developed. Cosmetic products containing caustic chemicals represent a significant health risk to small children, especially because child-proof packaging is not standard for these products.

Burns, Chemical↗
PubMed1988

The safety-in-use of cosmetics and toiletries.

1. Manufacturers of cosmetics and toiletries have a clear responsibility under Article 2 of the EEC Cosmetics Directive to ensure that their products are safe for use. 2. They have shown that they are able to discharge this responsibility, as illustrated by the type of safety assessment programme described in this paper and by market-place experience. 3. Considerable resources are invested by industry in safety assurance. As might be expected, this is particularly true of larger companies which have been responsible for many recent technological advances. 4. Industry will continue to regard the safety of its products as paramount, and contends that existing legislation is more than adequate to ensure continued safety-in-use.

Consumer Product Safety↗
PubMed2004

A randomized, controlled trial comparing long-term cosmetic outcomes of traumatic pediatric lacerations repaired with absorbable plain gut versus nonabsorbable nylon sutures.

OBJECTIVES: To show that the use of absorbable sutures in pediatric traumatic lacerations affords good long-term cosmesis and no increase in complications (infection, dehiscence rates, and need for surgical scar revision) when compared with wounds sutured with nonabsorbable sutures. METHODS: This was a randomized clinical trial conducted in a pediatric emergency department. Patients 1-18 years of age who presented to the emergency department with lacerations < 12 hours old were recruited between January 1999 and December 2001. Exclusion criteria were the following: wounds that could be approximated by tissue adhesives, animal/human bites, gross contamination, puncture/crush wounds, wounds crossing joints, lacerations of tendon/nerve/cartilage, collagen vascular disease, immunodeficiency, diabetes mellitus, bleeding disorder, and scalp lacerations. Patients were randomized into one of two groups: those receiving absorbable plain gut sutures (group A) and those receiving nonabsorbable nylon sutures (group NA). Board-eligible/certified pediatric emergency physicians or clinical fellows performed laceration repair in a standardized approach. All wounds were reevaluated within ten days by a single research nurse who assessed the wounds using a previously validated wound evaluation score (WES) composed of six items (presence of step-off, contour irregularities, margin separation, edge inversion, extensive distortion, and overall cosmetic appearance). A score of 6/6 was considered optimal. The study nurse also noted the presence of infection and dehiscence. The patients were then seen by a single blinded plastic surgeon at four or five months who evaluated the wound using a previously validated visual analog scale of cosmesis (VAS). In addition, the surgeon repeated the WES and assessed the need for surgical scar revision. RESULTS: A total of 147 patients were eligible, and 52 patients declined to participate. Of the 95 patients enrolled, 50 were randomized to group A and 45 to group NA. The two groups had similar ages, gender distributions, rates of use of sedation or steri-strips, wound lengths and widths, mechanisms of injury, and wound locations. At the short-term follow-up, no difference was found in the proportion of optimal WES scores between group A (63% of patients) and group NA (49% of patients) (relative risk = 0.73; 95% confidence interval [95% CI] = 0.45 to 1.17). No difference was found in the rates of infection and dehiscence between the two groups. Sixty-three of the 95 patients presented for long-term follow-up. The groups remained similar with respect to patient and wound characteristics as well as wound location. The average VAS score at four months was 79 (95% CI = 73 to 85) for group A and 66 (95% CI = 55 to 76) for group NA. In addition, no differences were found in the proportion of optimal WES between group A (36% of patients) and group NA (28% of patients) at four months (relative risk = 0.88; 95% CI = 0.62 to 1.26). Surgical scar revision was recommended for only three patients, of whom two were in group A. No patients chose to have their scars revised. No differences were found between group A and group NA for the rates of dehiscence (2% vs. 11%; p = 0.07) and infection (0 vs. 2; p = 0.3). CONCLUSIONS: The use of plain catgut absorbable sutures in the repair of traumatic lacerations in children appears to be an acceptable alternative to nonabsorbable sutures because the long-term cosmetic outcome seems to be at least as good. In this study, plain gut suture material seemed to provide slightly better cosmesis. In addition, no difference was found in the rate of dehiscence or infection between the groups.

Absorbable Implants↗
PubMed1991

[High performance liquid chromatographic analysis of typical ultraviolet absorbers in cosmetic products].

Typical 11 ultraviolet (UV) absorbers in cosmetic products were separated and determined by high performance liquid chromatography. The recommended conditions for the analysis were as follows: column, 4.6 mm i.d. x 250 mm, Capcell Pak C18 SG (5 microns); detector, UV spectrophotometer (280 nm); column temperature, 40 degrees C; mobile phase, H2O-CH3OH (15:85 v/v) containing 3 mM stearyltrimethyl ammonium chloride; flow rate, 1.0 ml/min. In the case of the products containing 2-ethylhexyl p-methoxycinnamate (OMC) and/or 4-tert-butyl-4'-methoxydibenzoylmethane (BMD), it was necessary to use H2O-1,4-dioxane (34:66 v/v) containing 6 mM stearyltrimethyl ammonium chloride as the mobile phase in order to separate OMC and BMD. Anthracene and 9,10-dimethylanthracene were used as an internal standard for the H2O-CH3OH mobile phase and the H2O-1,4-dioxane mobile phase, respectively. Calibration curves were linear within a range of 50-150 micrograms/ml for the 11 UV absorbers. Recoveries and reproducibilities of the method were satisfactory. By using this method, typical UV absorbers in several commercial cosmetic products such as lip creams, sun oils, lotions and emulsions were able to be rapidly determined without any interference.

Chromatography, High Pressure Liquid↗
PubMed1987

Artifacts caused by cosmetics in MR imaging of the head.

Cosmetics can produce severe distortion of the orbital contents in MR imaging. This distortion, typical of compounds that exhibit a permanent magnetic moment, results from iron oxide in the pigments used to produce dark shades of makeup. In general, the artifact created by cosmetics does not interfere with interpreting routine head scans. However, if the orbital contents are the subject of clinical concern, the images may then be rendered nondiagnostic. The artifact created by the makeup is propagated along the frequency-encoding axis of the images.

Cosmetics↗
PubMed1998

[Free formaldehyde determination in cosmetic products by the HPLC method].

In order to standardize the analytical methods and procedures with the ones used in the EU, a method of free formaldehyde determination in cosmetic products preserved with formaldehyde donors, recommended by Commission Directive (90/207/EEC of 4th April, 1990), has been tested. The free formaldehyde level is determined by HPLC using post column derivatisation with acetylacetone. Formaldehyde content was determined in 44 fortified samples of cosmetic emulsions and shampoos. Recoveries ranged from 94.8-97.5%. Relative Standard Deviation 1-2.3%.

Chromatography, High Pressure Liquid↗
PubMedDate not supplied

Molecular detection of Burkholderia cepacia in toiletry, cosmetic, and pharmaceutical raw materials and finished products.

A polymerase chain reaction (PCR) assay was developed and compared with standard methods for rapid detection of Burkholderia cepacia, a major industrial contaminant, in cosmetic and pharmaceutical raw materials and finished products. Artificially contaminated samples were incubated for 24 h in trypticase soy broth containing 4% Tween 20 and 0.5% soy lecithin. DNA was extracted from each sample using a proteinase K-tris-EDTA-Tween 20 treatment at 35 degrees C. The extracted DNA was added to Ready-To-Go PCR beads and specific DNA primers for B. cepacia. The B. cepacia DNA primers coded for a 209-base pair (bp) fragment of the 16S rRNA ribosomal gene. No DNA amplification was observed in samples that were not spiked with B. cepacia. However, all contaminated samples showed the specific 209-bp fragment for B. cepacia. There was a 100% correlation between standard methods and the PCR assay. Standard microbiological methods required 5-6 days for isolation and identification of spiked microorganisms, whereas PCR detection and identification was completed in 27 h. PCR detection of B. cepacia allows for rapid quality evaluation of cosmetic and pharmaceutical raw materials and finished products.

Burkholderia cepacia↗
PubMed2001

Micropigmentation as an adjuvant in cosmetic surgery of the scalp.

BACKGROUND: Unsightly scalp scars, refractory to surgical revision, can pose a difficult therapeutic problem. Application of cosmetics for camouflage is time consuming, repetitive, expensive, and seldom satisfactory. Treatment of scalp scars with micropigmentation has never been reported. OBJECTIVE: To show that iron oxide micropigmentation of scalp scars is simple, safe, and effective. METHODS: A commercially available micropigmentation system, sterile needle assemblies, and appropriately colored iron oxide pigments were used in all procedures. Due to the varying textures of scalp scars, greater force was required in some areas to achieve proper needle penetration. Once the scar area was pigmented, the surrounding scalp was also pigmented to obtain a "feathering" effect. RESULTS: The cosmetic improvement after micropigmentation was always dramatic and all patients were pleased with the results. About 22% of the patients requested a touch-up of the micropigmentation to reinforce the residual pigment. Frontal edema was the only complication and was seen in one patient. CONCLUSION: Micropigmentation of the scalp is a safe and effective technique for camouflaging scalp scars.

Cicatrix↗