Optimization of a Gas Chromatography–Mass Spectrometry (GCMS) Method for Detecting 28 Allergens in Various Personal Care Products

Kathon CG is a commonly used cosmetic-grade preservative that contains active ingredients methylchloroisothiazolinone (MCI) and methylisothiazolinone (MI). The aim of the study was to perform a skin sensitization induction risk assessment of daily exposure to Kathon CG after use of various personal care and cosmetic products. We calculated an estimated daily consumer exposure level for rinse-off and leave-on products using the amount of product applied per application, number of applications per day, a retention factor, the MCI/MI concentration, and body surface area values. We assumed that the products contained the maximum recommended safe concentration of MCI/MI: 15 ppm in rinse-off products and 7.5 ppm in leave-on products. We compared estimated consumer exposure levels with the no expected sensitization induction level for MCI/MI and applied sensitization assessment factors to calculate product-specific margins of safety (MOSs). The MOSs for rinse-off products ranged from 5 to 63, whereas the MOSs for leave-on products ranged from 0.03 to 1.49. Overall, our results provide evidence that some leave-on products containing the maximum recommended safe concentration of Kathon CG may increase the risk of sensitization induction due to exposure to MCI/MI. In contrast, rinse-off products were not associated with a potential increased risk of skin sensitization induction.

Phthalates in cosmetic and personal care products: Concentrations and possible dermal exposure

Cocamide DEA is a mixture of ethanolamides of Coconut Acid that is used as a surfactant-foam booster and viscosity-increasing agent-aqueous in cosmetic products. Production formulation data submitted to the Food and Drug Administration in 1994 indicated that this ingredient was used in 745 products. The Cosmetic Ingredient Review (CIR) Expert Panel had previously evaluated the safety of Cocamide DEA, Lauramide DEA, Linoleamide DEA, and Oleamide DEA in cosmetics and concluded that they were safe as cosmetic ingredients at the concentrations that were currently being used (50%). CIR's decision to reevaluate the safety of Cocamide DEA in cosmetics is based on occupational studies indicating that this ingredient may have sensitization potential; however, the Expert Panel has determined that these studies are not relevant to cosmetic use. Furthermore, the Panel agreed that its original conclusion on Cocamide DEA should be clarified relative to use of this ingredient in rinse-off and leave-on products. Clarification of the original conclusion is based on the results of a skin irritation test in which 15 volunteers were tested with a surfactant solution containing 10% Cocamide DEA, the highest concentration tested in predictive patch tests. Additional comments that were made during the Panel's review of other data in the present report include that the severe ocular irritation reactions induced by a chemical (p H 9–10.5) containing >64% Cocamide DEA were likely a result of p H; that the renal effects noted in Fischer 344 rats in the National Toxicology Program (NTP) subchronic dermal toxicity study may be species-related and not test substance-related; and with reference to an ongoing NTP two-year chronic study that was initiated in 1993, that the results will be reviewed when the study is available. On the basis of the animal and clinical data presented in the present report, the Expert Panel concluded that Cocamide DEA is safe as used in rinse-off products and safe at concentrations 10% in leave-on cosmetic products. It was also concluded that Cocamide DEA should not be used as an ingredient in cosmetic products in which N-nitroso compounds are formed.

There was a global epidemic of methylchloroisothiazolinone (MCI) and/or methylisothiazolinone (MI) contact allergy from 2009 to 2015. In response, the Thai Ministry of Public Health regulated the use of MCI/MI in cosmetics. To survey the presence of MCI/MI and MI alone, as labelled on cosmetics sold on the Thai market, before and after the ministerial directive. The presence of MCI and/or MI in leave-on and rinse-off cosmetics sold on the market, based on the labelling of ingredients in 3445 products, was analysed. Before the implementation date, most leave-on products contained MCI/MI. After the regulations came into force, the only leave-on cosmetic subcategories that complied with the law were facial skin-care, sunscreen and make-up products. MCI/MI and MI alone were found on the labels of both leave-on and rinse-off products, the presence of each varying between product subcategories. Despite the ministerial regulations restricting their use, MCI and/or MI are still found in cosmetics sold on the Thai market. Dermatologists should be aware of this situation, and counsel patients to avoid products containing MCI and/or MI.

Low molecular weight cyclic volatile methylsiloxanes in cosmetic products sold in Canada: Implication for dermal exposure

Polyacrylate crosspolymer-11 enhances soil clay dispersibility: An indication for inadvertent environmental impacts from personal care and cosmetic ingredients

Background: Many personal care products, and particularly cosmetic products, contain preservatives that release formaldehyde. These are potentially harmful to consumer health, especially considering that the levels of formaldehyde in some products are hidden and excessive. Objectives: To study the formaldehyde levels of preservatives in personal care products and cosmetics on the UAE market and determine the extent of compliance with health and safety requirements. Methods and Materials: Sixty-nine personal care and cosmetic product samples from the UAE market were collected and prepared to determine their formaldehyde content. According to the Second European Commission Directive 82/434/EEC of 2000 and as per the Gulf Technical Regulation, Safety Requirements of Cosmetics and Personal Care Products in GSO 1943:2016, quantitative analyses were performed to identify and quantify the content of formaldehyde as free formaldehyde. Results: With a maximum permissible limit of ≤0.2% w/w, the average formaldehyde content was found to be 0.083 with a 95% CI (0.039–0.13). Nine of the tested personal care and cosmetic products exceeded the recommended formaldehyde level, corresponding to 13% of all samples. None of these samples listed the free formaldehyde content or formaldehyde releaser. Conclusion: Applying good manufacturing practices (GMP), education, and regulatory control to improve the regulation and inspection of cosmetics containing formaldehyde releasers as preservatives, conducting research, and reporting the adverse side effects are highly recommended. There is an urgent need to monitor the incidence of skin sensitivity resulting from the use of cosmetics containing formaldehyde releasers as preservatives.

Application of the expanded Creme RIFM consumer exposure model to fragrance ingredients in cosmetic, personal care and air care products

Organic UV filters in personal care products in Switzerland: A survey of occurrence and concentrations

Novel database for exposure to fragrance ingredients in cosmetics and personal care products

This safety assessment addresses cosmetic ingredients that are N-acyl derivatives of sarcosine and are generally referred to as acyl sarcosines, and those that are salts, known generally as acyl sar-cosinates. Previous assessments have addressed the safety of each of the fatty acids that appear in these acyl sarcosines and sarcosinates (Coconut Acid, Oleic Acid, Lauric Acid, and Myristic Acid). In each case the fatty acid was either safe for use or safe as used in cosmetic formulations. Acyl sarcosines are considered modified fatty acids with greater solubility and increased acidity of the carboxylic acid group compared to the parent fatty acid. They are used in a large number of cosmetic formulations as hair-conditioning agents and surfactant-cleansing agents. In soaps, concentrations are reported to be as high as 12.9%. These ingredients have low oral toxicity in rats. Although cytotoxic to Chinese hamster cells in culture, acyl sarcosines and sarcosinates are not mutagenic in those cells, nor in bacterial cells in culture. Carcinogenicity data were not available. These ingredients are nonirritating and nonsen-sitizing to animal and human skin, although they can enhance the penetration of other ingredients through the skin. For that reason, caution should be exhibited in formulating cosmetic products that contain these ingredients in combination with other ingredients whose safety is based on their lack of absorption or where dermal absorption is a concern (e.g., HC Yellow No. 4, Disperse Yellow 3). Because sarcosine can be nitrosated to form N-nitrososarcosine, a known animal carcinogen, these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed. With the above caveat, and based on the available data, it was concluded that these acyl sarcosines and sarcosinates are safe as used in rinse-off products. They may be safely used in leave-on products at concentrations up to 5%, the highest concentration tested in clinical irritation and sensitization studies. Oleoyl Sarcosine is used as a corrosion inhibitor in some aerosol products, at extremely low concentrations. In this circumstance, the ingredient is not being used as a cosmetic ingredient and this report is not intended to limit that use. Because of the absence of data on inhalation toxicity, however, it was concluded that the available data were not sufficient to support the safety of acyl sarcosines and sarcosinates as cosmetic ingredients in products where they are likely to be inhaled.

This safety assessment addresses cosmetic ingredients that are N-acyl derivatives of sarcosine and are generally referred to as acyl sarcosines, and those that are salts, known generally as acyl sar-cosinates. Previous assessments have addressed the safety of each of the fatty acids that appear in these acyl sarcosines and sarcosinates (Coconut Acid, Oleic Acid, Lauric Acid, and Myristic Acid). In each case the fatty acid was either safe for use or safe as used in cosmetic formulations. Acyl sarcosines are considered modified fatty acids with greater solubility and increased acidity of the carboxylic acid group compared to the parent fatty acid. They are used in a large number of cosmetic formulations as hair-conditioning agents and surfactant-cleansing agents. In soaps, concentrations are reported to be as high as 12.9%. These ingredients have low oral toxicity in rats. Although cytotoxic to Chinese hamster cells in culture, acyl sarcosines and sarcosinates are not mutagenic in those cells, nor in bacterial cells in culture. Carcinogenicity data were not available. These ingredients are nonirritating and nonsen-sitizing to animal and human skin, although they can enhance the penetration of other ingredients through the skin. For that reason, caution should be exhibited in formulating cosmetic products that contain these ingredients in combination with other ingredients whose safety is based on their lack of absorption or where dermal absorption is a concern (e.g., HC Yellow No. 4, Disperse Yellow 3). Because sarcosine can be nitrosated to form N-nitrososarcosine, a known animal carcinogen, these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed. With the above caveat, and based on the available data, it was concluded that these acyl sarcosines and sarcosinates are safe as used in rinse-off products. They may be safely used in leave-on products at concentrations up to 5%, the highest concentration tested in clinical irritation and sensitization studies. Oleoyl Sarcosine is used as a corrosion inhibitor in some aerosol products, at extremely low concentrations. In this circumstance, the ingredient is not being used as a cosmetic ingredient and this report is not intended to limit that use. Because of the absence of data on inhalation toxicity, however, it was concluded that the available data were not sufficient to support the safety of acyl sarcosines and sarcosinates as cosmetic ingredients in products where they are likely to be inhaled.

PEGs Glyceryl Cocoate polymers are the polyethylene glycol ethers of glyceryl cocoate. They function as skin conditioning agents, emollients, surfactants, nonionic emulsifying agents, and solubilizing agents in cosmetic formulations. Only limited data on the safety of PEG-7 Glyceryl Cocoate were found, and no data were available on the higher molecular weight polymers in this group. Data from previous safety assessments of Polyethylene Glycol (PEG), and several fatty acids (Stearic Acid, Oleic Acid, Lauric Acid, Palmitic Acid, and Myristic Acid) were considered relevant and added to the review. PEG has low oral and dermal toxicity. The fatty acids have slight oral toxicity, but little or no dermal toxicity. Dermal application of PEG-7 Glyceryl Cocoate at a concentration of SO% did not produce irritation in mice and guinea pigs, but did produce slight irritation in rabbits. Intracutaneous injection of PEG-7 Glyceryl Cocoate at a concentration of 10% did not produce sensitization. This same concentration was not an ocular irritant in animal tests. PEG-7 Glyceryl Cocoate was not phototoxic at a concentration of SO%. Although monoalkyl ethers of ethylene glycol are reproductive and developmental toxins, given the methods of manufacture of PEG-7 Glyceryl Cocoate, there is no likelihood of such compounds being present as impurities. The structure of the PEGs Glyceryl Cocoate polymers is such that it is unlikely that they would cause reproductive or developmental effects. PEG did not produce reproductive toxicity in oral toxicity studies. Oleic Acid in feed at a concentration of 15% did impair reproductive capacity in female rats, but growth and general health were not affected. No data were available on genotoxicity or carcinogenicity of PEGs Glyceryl Cocoate. PEG was not genotoxic. The fatty acids were generally not genotoxic, but positive results were seen for Oleic Acid in one assay. Neither PEG nor the fatty acids were carcinogenic in animals tests. Of concern was the possible presence of 1,4-dioxane and ethylene oxide impurities. The importance of using the necessary purification procedures to remove these impurities was stressed. In clinical studies PEG-7 Glyceryl Cocoate was neither a dermal irritant nor a photosensitizer. The principal clinical finding related to PEGs is based on data in burn patients—PEGs were mild irritant/sensitizers and there was evidence of nephrotoxicity. No such effects were seen in animal studies on intact skin. Cosmetic manufacturers should adjust product formulations containing Polyethylene Glycol to minimize any untoward effects when products are used on damaged skin. In recognition that PEG-7 Glyceryl Cocoate can enhance the skin penetration of other chemicals, care should also be exercised in using these ingredients in products where the penetration of other ingredients is aconcern. Based on the limited data on PEGs Glyceryl Cocoate and on safety assessments of other related ingredients, it was concluded that PEG-7, -30, -40, -70, and -80 Glyceryl Cocoate are safe as used in rinse-off products and safe at concentrations up to 10% in leave-on products.

Lipsticks and lip care products may contain saturated hydrocarbons which either stem from mineral oil saturated hydrocarbons (MOSH) or are synthetic, that is polyolefin oligomeric saturated hydrocarbons (POSH). Some of these hydrocarbons are strongly accumulated and form granulomas in human tissues, which prompted Cosmetics Europe (former Colipa) to issue a recommendation for their use in lip care and oral products. From 2012 to 2014, MOSH+POSH were determined in 175 cosmetic lip products taken from the Swiss market in order to estimate their contribution to human exposure. Mineral oil saturated hydrocarbons and POSH were extracted and analysed by GC with FID. Areas were integrated as a total as well as by mass ranges with cuts at n-C25 and n-C34 to characterize the molecular mass distribution. About 68% of the products contained at least 5% MOSH+POSH (total concentration). For regular users, these products would be major contributors to their MOSH+POSH exposure. About 31% of the products contained more than 32% MOSH+POSH. Their regular usage would amount in an estimated MOSH+POSH exposure exceeding the highest estimated dietary exposure. The majority of the products contained hydrocarbons with a molecular mass range which was not in line with the recommendations of Cosmetics Europe. Taking into account that material applied to the lips largely ends up being ingested, MOSH and POSH levels should be reduced in the majority of cosmetic lip products. As the extensive evaluation of the data available on MOSH (EFSA J., 10, 2012, 2704) did not enable the specification of limits considered as safe, the present level of dietary exposure and its evaluation as 'of potential concern' provide the relevant bench mark, which means that lip products should contain clearly less than 5% MOSH+POSH.

The repeated open application test (ROAT) provides useful information regarding allergens in suspected cases of allergic contact dermatitis; however, standardized methodology has not been established. The aim of this study was to assess how ROAT is used in clinical and research settings. We distributed a survey regarding ROAT practice to the American Contact Dermatitis Society and conducted a literature review of ROAT utilization in research. A total of 67 American Contact Dermatitis Society members participated in the survey. Respondents most frequently recommend application of leave-on products twice daily (46.0%) and rinse-off products once daily (43.5%). The most commonly used anatomical sites include the forearm (38.7%) and antecubital fossa (32.3%). Most respondents continue ROAT for 1 (49.2%) or 2 weeks (31.7%). Literature review of 32 studies (26 leave-on, 6 rinse-off) revealed that application frequency is most common at twice daily for both leave-on (96.2%) and rinse-off (50.0%) products. The most common anatomical site is the forearm (62.5%), with an overall study duration of 3 to 4 weeks (65.6%). When comparing ROAT clinical and research practice, the majority trend was consistent for leave-on product application frequency and anatomical site, but not for rinse-off product application frequency, or overall duration. Further research is needed to determine best practice recommendations.