Search

This is a safety assessment of 6 Eucalyptus globulus (eucalyptus)-derived ingredients as used in cosmetics. The reported functions of the Eucalyptus globulus (eucalyptus)-derived ingredients include abrasive, fragrance ingredient, and skin-conditioning agent (miscellaneous and occlusive). The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the relevant data on these ingredients. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Industry should use good manufacturing practices to limit impurities. The Panel concluded that Eucalyptus globulus (eucalyptus)-derived ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-sensitizing.

This is a review of the scientific literature and unpublished data that are relevant for assessing the safety of 12 Helianthus annuus (sunflower)-derived ingredients as used in cosmetics. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid levels that may be hazardous to consumers. Helianthus annuus (sunflower)-derived ingredients may contain allergens, including 2S albumins and sesquiterpene lactones. Industry should use current good manufacturing practices (cGMP) to limit impurities and constituents of concern. The Expert Panel for Cosmetic Ingredient Safety (Panel) concluded that 9 Helianthus annuus (sunflower) seed- and flower-derived ingredients are safe as used in cosmetics in the present practices of use and concentration described in this safety assessment. The data are insufficient to evaluate the safety of 3 ingredients that are derived from other plant parts.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 11 Cocos nucifera (coconut)-derived ingredients, most of which are reported to function as skin-conditioning agents in cosmetic products. The Panel reviewed the available data to determine the safety of these ingredients. The Panel concluded that 10 ingredients, derived from coconut flower, fruit, and liquid endosperm, are safe in cosmetics in the present practices of use and concentration described in this safety assessment, and that the available data are insufficient to make a determination of safety for Cocos Nucifera (Coconut) Shell Powder under the intended conditions of use in cosmetic formulations.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 9 Centella asiatica-derived ingredients, which reportedly function primarily as skin conditioning agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients. The Panel concluded that Centella Asiatica Extract, Centella Asiatica Callus Culture, Centella Asiatica Flower/Leaf/Stem Extract, Centella Asiatica Leaf Cell Culture Extract, Centella Asiatica Leaf Extract, Centella Asiatica Leaf Water, Centella Asiatica Meristem Cell Culture, Centella Asiatica Meristem Cell Culture Extract, and Centella Asiatica Root Extract are safe in the present practices of use and concentration in cosmetics, as described in this safety assessment, when formulated to be non-sensitizing.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 26 apple-derived ingredients, which reportedly function mostly as skin conditioning agents in cosmetic products. Because apple-derived ingredients may be obtained from different apple cultivars, the composition of ingredients derived from different cultivars should be similar to that of ingredients reviewed in this safety assessment. Additionally, industry should continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel reviewed the available data to determine the safety of these ingredients and concluded that 21 of these ingredients are safe in cosmetics in the present practices of use and concentrations described in this safety assessment. However, the Panel also determined that the available data are insufficient to determine the safety of Pyrus Malus (Apple) Root Extract, Pyrus Malus (or Malus Domestica) (Apple) Stem Extract, Malus Domestica (Apple) Callus Extract, and Malus Domestica (Apple) Oil.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of 3 persulfate ingredients, which function as oxidizing agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients and concluded that Ammonium, Potassium, and Sodium Persulfate are safe as used as oxidizing agents in hair colorants and hair lighteners designed for brief discontinuous use followed by thorough rinsing from the hair and skin. The Panel also concluded that the available data are insufficient for determining the safety of these persulfates in leave-on products and dentifrices.

The Expert Panel for Cosmetic Ingredient Safety (Panel) re-reviewed the safety of Malic Acid and Sodium Malate in cosmetics. Malic Acid is reported to function in cosmetics as a fragrance ingredient and a pH adjuster and Sodium Malate functions as a skin-conditioning agent - humectant. The Panel reviewed the available data to determine the safety of these ingredients. The Panel concluded that Malic Acid and Sodium Malate are safe in cosmetics in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 12 Rosa canina-derived ingredients, which are reported to function as skin conditioning agents, fragrance ingredients, cosmetic astringents, anti-acne agents, abrasives, humectants, and exfoliants in cosmetic products. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching cumulative levels that may be hazardous to consumers. The Panel reviewed relevant data relating to the safety of these ingredients and concluded that these ingredients are safe in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating and non-sensitizing.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 16 bovine milk proteins and protein-derived ingredients, which function mainly as skin and hair conditioning agents in personal care products. The Panel reviewed relevant data provided in this safety assessment, and concluded that these ingredients are safe in the present practices of use and concentration.

Toxicodendron dermatitis (TD) is a common form of allergic contact dermatitis that affects millions of Americans every year. Studies have shown that although there are general recommendations for the treatment of TD, there are no treatment algorithms for clinicians to follow when patients present with TD.The objective of this study was to achieve consensus on the treatment of TD to create practical guidelines for physicians who treat TD.Data were collected from March 2020 to April 2021. This study included semistructured focus groups and a Delphi Study with dermatologists to achieve consensus.A total of 51 dermatologists were included in the Delphi. Final agreement with proposed severity criteria ranged from 90.9% to 100.0%. Primary indicators of disease severity were body surface area, presence and severity of pruritus, and anatomic locations of eruptions with 77.4% agreement. Final agreement for the treatment algorithm was over the threshold majority agreement at 67.6%.Literature guiding the treatment of TD is scarce. The use of the Delphi method and focus groups can help expand dermatological resources both within dermatology and to other specialties that may need to treat skin conditions.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of Hydrofluorocarbon 152a, which functions as a propellant in personal care products. The Panel reviewed relevant data provided in this safety assessment, and concluded that Hydrofluorocarbon 152a is safe in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate, which functions as an oxidative hair dye ingredient. The Panel reviewed relevant data provided in this safety assessment, and concluded that 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate is safe in the present practices of use and concentration in oxidative hair dye formulations.

BACKGROUND Few studies explored the relationship between stasis dermatitis (SD) and allergic contact dermatitis (ACD). OBJECTIVE To examine trends, associations, and clinical relevance of ACD in patients referred for patch testing who had a final SD diagnosis. METHODS Retrospective analysis from 2001 to 2016 of 38,723 patients from the North American Contact Dermatitis Group. RESULTS After patch testing, 303 (0.7%) patients were diagnosed with SD; 46.7% had a concomitant diagnosis of ACD. Patients with vs. without a final SD diagnosis had similar proportions of ≥ 1 positive allergic reaction (59.7% vs. 64.7%; Chi-square, P = 0.0724) but higher odds of allergic reactions to fragrance mix I, bacitracin, quaternium-15, Myroxylon pereirae, benzalkonium chloride, ethyleneurea melamine formaldehyde, diazolidinyl urea, and propylene glycol. The most commonly relevant allergens in patients with final SD diagnosis were fragrance mix I, Myroxylon pereirae, bacitracin, quaternium-15, and formaldehyde. The most common allergen sources were personal care products, topical medications and other health aid products. CONCLUSION Nearly half of patients with a final SD diagnosis were also diagnosed with ACD, supporting the role of patch testing in select SD patients.

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) assessed the safety of 33 Citrus flower- and leaf-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin-conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Citrus flower- and leaf-derived ingredients, the Panel was concerned about the presence of the hydroperoxides of limonene and linalool in cosmetics. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing.

Photoallergic contact dermatitis (PACD) is an unusual but not rare form of photosensitivity with an etiology similar to that of allergic contact dermatitis (ACD), with the added requirement of concomitant exposure to ultraviolet (UV) light.1 Photopatch testing (PPT) is a critical tool for diagnosing PACD. There are only a few large studies of photoallergens from North America.2-4 We present a retrospective analysis of North American Contact Dermatitis Group (NACDG) PPT results from 1999-2009.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reopened the safety assessment of Acid Violet 43, a cosmetic ingredient that is an anthraquinone dye reported to function in cosmetics as a colorant. This colorant has the same chemical structure as Ext. D&C Violet No. 2, which is a certified colorant; however, Acid Violet 43 is not a certified color and it could have impurities that are not allowed in the certified color. The Panel reviewed relevant new data related to this ingredient and concluded that Acid Violet 43 is safe in the present practices of use and concentration for use in hair dye formulations. This conclusion supersedes the previous conclusion for Acid Violet 43 that included impurity specifications indicated for the certified color.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 8 keratin-derived ingredients, which function mainly as skin and hair conditioning agents in personal care products. The Panel reviewed relevant data provided in this safety assessment and concluded that the 8 keratin-derived ingredients are safe in the present practices of use and concentration described in this safety assessment.

This is a safety assessment of 40 saccharide ester ingredients as used in cosmetics. The saccharide esters are reported to function in cosmetics as emollients, skin-conditioning agents, fragrance ingredients, and emulsion stabilizers. The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the relevant data for these ingredients. The Panel concluded that the saccharide esters are safe in cosmetics in the present practices of use and concentrations described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 80 Citrus fruit-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin-conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that these ingredients are safe for use in both rinse-off and leave-on cosmetic products when formulated to be non-sensitizing and non-irritating, provided that leave-on products do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen (5-MOP).

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 30 Citrus plant- and seed-derived ingredients, which are most frequently reported to function in cosmetics as fragrances and/or skin conditioning agents. Because final product formulations may contain multiple botanicals, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. With Citrus plant- and seed-derived ingredients, the Panel was concerned about the presence of the hydroperoxides of limonene and linalool in cosmetics. Industry should use good manufacturing practices to limit impurities. The Panel reviewed the available data presented and concluded that 18 of these ingredients are safe in the present practices of use and concentration when formulated to be non-irritating and non-sensitizing. The data for the remaining 12 ingredients are insufficient to determine safety.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 51 triglycerides; 25 of these ingredients were previously reviewed by the Panel, and 26 are reviewed herein for the first time. The majority of the ingredients named in this assessment have several functions, with most reported to function as skin conditioning agents (occlusive or emollient) and/or viscosity increasing agents in cosmetics; some are also reported to function as a fragrance or solvent. The Panel reviewed relevant new data, including frequency and concentration of use, and considered the data from previous reports. The Panel concluded the 51 triglycerides reviewed in this report are safe in cosmetics in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Panthenol, Pantothenic Acid, and 5 derivatives as used in cosmetics. These ingredients named in this report are reported to function in cosmetics as hair conditioning agents, and Panthenol also is reported to function as a skin-conditioning agent-humectant and a solvent. The Panel reviewed relevant data for these ingredients, and concluded that these 7 ingredients are safe in cosmetics in the present practices of use concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of 8 dialkyl dimer dilinoleates as used in cosmetics. These ingredients are diesters formed from the reaction of straight-chained or branched alkyl alcohols and dilinoleic acid; these ingredients are reported to function in cosmetics as skin-conditioning agents. The Panel reviewed data relevant to the safety of these ingredients and concluded that Diisopropyl Dimer Dilinoleate, Dicetearyl Dimer Dilinoleate, Diisostearyl Dimer Dilinoleate, Diethylhexyl Dimer Dilinoleate, Dioctyldodecyl Dimer Dilinoleate, Ditridecyl Dimer Dilinoleate, Di-C16-18 Alkyl Dimer Dilinoleate, and Di-C20-40 Alkyl Dimer Dilinoleate are safe in cosmetics in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 47 Citrus peel-derived ingredients, which are most frequently reported to function in cosmetics as skin conditioning agents. The Panel reviewed the available data to determine the safety of these ingredients. Because final product formulations may contain multiple botanical ingredients, each containing similar constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may be hazardous to consumers. Industry should use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that Citrus peel-derived ingredients are safe in the present practices of use and concentration in both rinse-off and leave-on cosmetic products when formulated to be non-sensitizing and non-irritating, provided that leave-on products do not contain more than 0.0015% (15 ppm) 5-methoxypsoralen (5-MOP).

The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of Methylisothiazolinone, which functions as a preservative in cosmetics. The Panel reviewed relevant animal and human data provided in this safety assessment, and data from the previously published safety assessments of Methylisothiazolinone, and concluded that Methylisothiazolinone is safe for use in rinse-off cosmetic products at concentrations up to 100 ppm (ie, 0.01%) and safe in leave-on cosmetic products when they are formulated to be nonsensitizing, which may be determined based on a quantitative risk assessment or similar methodology.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 5 acyl sarcosines and 9 sarcosinate salts as used in cosmetics; all of these ingredients are reported to function in cosmetics as hair conditioning agents and most also can function as surfactants—cleansing agents. The ingredients reviewed in this assessment are composed of an amide comprising a fatty acyl residue and sarcosine and are either free acids or simple salts thereof. The Panel relied on relevant new data, including concentration of use, and considered data from the previous Panel report, such as the reaction of sarcosine with oxidizing materials possibly resulting in nitrosation and the formation of N-nitrososarcosine. The Panel concluded that these ingredients are safe as used in cosmetics when formulated to be non-irritating, but these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed.

Background Little is known about the relationship between psoriasis and allergic contact dermatitis (ACD). Objective To examine the associations with ACD, related clinical characteristics, and common positive and clinically relevant allergens of patients with a final diagnosis of psoriasis who were referred for patch testing. Methods Retrospective analysis of 38,723 patients from the North American Contact Dermatitis Group. Results Patients with a final diagnosis of psoriasis had lower proportions of ACD than those without psoriasis (32.7% vs 57.8%). In multivariable logistic regression models, psoriasis was inversely associated with female sex, black or Asian race, history of atopic dermatitis and hay fever. Patients with a final diagnosis of psoriasis were less likely to have one or more positive allergic patch test reactions or to have a current clinically relevant patch test reaction to the majority of the most commonly positive and/or relevant allergens. The most clinically relevant allergens included nickel sulfate, methylisothiazolinone, and fragrance mix I. Conclusion Approximately one-third of patients who were referred for patch testing with a final diagnosis of psoriasis were also diagnosed with ACD. In select patients with suspected psoriasis who also have a clinical presentation suggestive of ACD, patch testing may be helpful. This article is protected by copyright. All rights reserved.

Background Data regarding teledermatology for patch testing are limited. Objectives Compare patch test readings and final interpretation by two in-person dermatologists (IPDs) with eight teledermatologists (TDs). Methods Patch tested patients had photographs taken of 70 screening series of allergens at 48 hours and second readings. Eight TDs reviewed photos and graded reactions (negative, irritant, doubtful, +, ++, +++) at 48 hours and second readings; in addition, they coded a final interpretation (allergic, indeterminant, irritant, negative) for each reaction. TDs rated overall image quality and confidence level for each patient and patch test reaction, respectively. Percentage of TD-IPD agreement based on clinical significance (success, indeterminate, and failure) was calculated. Primary outcome was agreement at the second reading. Results Data were available for 99, 101, and 66 participants at 48 hours, second reading, and final interpretation, respectively. Pooled failure (+/++/+++ vs negative) at second reading was 13.6% (range 7.9%-20.4%). Pooled failure at 48 hours and final interpretation was 5.4% (range 2.9%-6.8%) and 24.6% (range 10.2%-36.8%), respectively. Confidence in readings was statistically correlated with quality of images and disagreement. Conclusion For patch testing, teledermatology has significant limitations including clinically significant pooled failure percentages of 13.6% for second readings and 24.6% for final interpretation.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 19 skin and connective tissue-derived proteins and peptides, which are reported to function mainly as skin and/or hair conditioning agents in cosmetics. The Panel reviewed the relevant data provided and concluded that these ingredients are safe in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 19 plant-derived proteins and peptides, which function mainly as skin and/or hair conditioning agents in personal care products. The Panel concluded that 18 plant-derived proteins and peptides are safe as used in the present practices of use and concentration as described in this safety assessment, while the data on Hydrolyzed Maple Sycamore Protein are insufficient to determine safety.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of Hydroxyethyl-3,4-Methylenedioxyaniline HCl, which is reported to function as a hair dye ingredient. The Panel reviewed relevant data provided in this safety assessment, and concluded that Hydroxyethyl-3,4-Methylenedioxyaniline HCl is safe for use as a hair dye ingredient in the present practices of use and concentrations described in this report. The Panel cautions that this ingredient should not be used in cosmetic products in which N-nitroso compounds can be formed.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 7 ethers and esters of ascorbic acid, which collectively function as antioxidants, skin-conditioning agents, skin protectants, fragrance ingredients, and skin bleaching agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients, and concluded that the ethers and esters of ascorbic acid are safe in the present practices of use and concentration, as described in this safety assessment.

Eyelid dermatitis is a common dermatologic complaint.To characterize patients with eyelid dermatitis.Retrospective analysis (1994-2016) of North American Contact Dermatitis Group data.Of 50,795 patients, 2332 (4.6%) had eyelid dermatitis only, whereas 1623 (3.2%) also had dermatitis of the eyelids and head or neck. Compared with patients without eyelid involvement (n = 26,130), groups with eyelid dermatitis only and dermatitis of the eyelid and head or neck were significantly more likely to be female, white, and older than 40 years, and to have a history of hay fever, atopic dermatitis, or both (P .01). Final primary diagnoses included allergic contact dermatitis (eyelid dermatitis only: 43.4%; dermatitis of the eyelid and head or neck: 53.5%), irritant contact dermatitis (eyelid dermatitis only: 17.0%; dermatitis of the eyelid and head or neck: 9.8%), and atopic dermatitis (eyelid dermatitis only: 13.1%; dermatitis of the eyelid and head or neck: 13.8%). Top 5 currently relevant allergens included nickel sulfate (eyelid dermatitis only: 18.6%; dermatitis of the eyelid and head or neck: 22.5%), fragrance mix I (eyelid dermatitis only: 16.5%; dermatitis of the eyelid and head or neck: 18.3%), methylisothiazolinone (eyelid dermatitis only: 16.5%; dermatitis of the eyelid and head or neck: 17.7%), gold sodium thiosulfate (eyelid dermatitis only: 14.7%; dermatitis of the eyelid and head or neck: 11.4%), and balsam of Peru (eyelid dermatitis only: 11.9%; dermatitis of the eyelid and head or neck: 12.6%). Both eyelid-involvement groups were significantly more likely to react to gold sodium thiosulfate, carmine, shellac, dimethylaminopropylamine, oleamidopropyl dimethylamine, and thimerosal (P .05) compared with the no eyelid involvement group.Lack of specific distribution patterns of eyelid dermatitis and no long-term follow-up data.Patch testing remains a critical tool in evaluating patients with eyelid dermatitis.

Background Hand eczema (HE) is a heterogeneous and burdensome disorder. Objective To characterize the clinical characteristics, etiologies and allergen relevance in adults with HE referred for patch testing. Methods Retrospective analysis (2000-2016) of North American Contact Dermatitis Group data (n = 37,113). Results Overall, 10,034 patients had HE, with differences of overlap between allergic contact, irritant contact, and atopic dermatitis. Allergic contact HE fluctuated, whereas atopic HE steadily increased, and irritant HE decreased over time. HE was associated with higher proportions of positive patch tests (67.5% vs 63.8%; χ2, P Limitations No data on HE phenotype. Conclusion HE in adults was associated with higher proportions of positive patch tests, with a heterogeneous profile of allergens. Patch testing remains an important tool in the evaluation of patients with HE.

Background Few studies examined the relationship between nummular (discoid) eczema (NE) and allergic contact dermatitis (ACD). Objective To examine the trends, associations, and clinical relevance of ACD in NE patients referred for patch testing. Methods Retrospective analysis of 38,723 patients from the North American Contact Dermatitis Group. Results Overall, 748 (1.9%) patients were diagnosed with NE; 23.9% had a concomitant diagnosis of ACD. The prevalence of NE fluctuated over time between 2001-2016, with no overall change in prevalence in diagnosed NE. In multivariable logistic regression models, NE steadily increased with age and was associated with male sex, Asian and other race/ethnicity, and inversely associated with a history of AD and hay fever. Patients with NE had lower proportions of ≥1 positive allergic reaction and lower odds of a positive reaction in multiple, individual allergens. The most commonly relevant allergens in patients with NE were formaldehyde 2.0% aq., methylisothiazolinone, quaternium-15, fragrance mix I, and propylene glycol. Conclusion NE is a heterogeneous disorder with distinct subsets of lesional distribution and profile of relevant allergens, especially formaldehyde and formaldehyde releasers. Nearly 1 in 4 NE patients had ACD, supporting the role of patch testing in NE patients. This article is protected by copyright. All rights reserved.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 44 monoglyceryl monoesters that are structurally constituted as the esterification products of glycerin and carboxylic acids (the majority of which are fatty acids); 36 of these monoesters were previously reviewed by the Panel, and 8 are reviewed herein for the first time. Most of the monoglyceryl monoesters have several reported functions in cosmetics, but the most common function among the ingredients is skin conditioning agent; a few are reported to function only as surfactant–emulsifying agents. The Panel reviewed relevant new data, including frequency and concentration of use and considered the data from previous Cosmetic Ingredient Review reports. The Panel concluded that these ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 46 butyl polyoxyalkylene ethers that share a common structural motif, namely a butyl chain (4 carbon alkyl chain) bound to a polyoxyalkylene (PPG, PEG, or both); 23 of these ethers were previously reviewed by the Panel, and 23 are reviewed herein for the first time. Most of the butyl polyoxyalkylene ethers have several functions in cosmetics, but the most common reported functions include hair conditioning agent and skin conditioning agent, and many reportedly function as solvents. Upon review of new data, including frequency and concentration of use, and data from previous Panel reports and on read-across analogs, the Panel concluded that these ingredients are safe in the present practices of use and concentration in cosmetics when formulated to be non-irritating.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of polyenes, which are reported to function in cosmetics primarily as film formers and viscosity increasing agents. The Panel reviewed relevant data related to these ingredients, not inggaps in the available safety data for some of the polyenes in this safety assessment. The data available for many of the ingredients are sufficient and can be extrapolated to support the safety of the entire group because of the similarities in the chemical structures, chemical properties, use concentrations, and reported functions across the group. The Panel concluded that polyenes were safe in cosmetics in the present practices of use and concentration described in this safety assessment.

The prevalence of occupational contact dermatitis is estimated to be between 6.7% and 10.6% and can lead to missed work and job loss. Although treatment may provide temporary relief, identifying the culprit allergen may help the clinician counsel on how to avoid or reduce exposure. Some of the most common high-risk occupations for allergic contact dermatitis include agricultural workers, construction workers, health care workers, hairdressers, mechanics, and machinists. In this article, we discuss the common occupational exposures of these high-risk professions, and summarize the common culprit allergens.

BACKGROUND Hair care products (HCPs) may cause both allergic contact dermatitis (ACD) and irritant contact dermatitis (ICD). OBJECTIVES The aims of the study were to determine the prevalence of HCP-associated ICD/ACD and to characterize relevant allergens. METHODS This study is a retrospective analysis of North American Contact Dermatitis Group (NACDG) patch test data, 2001-2016. RESULTS Of 38,775 patients tested, 3481 (9.0%) had positive patch test reactions associated with HCPs. The HCP-positive patients were significantly more likely to be female (79.9% vs 66.0%) and/or have primary sites of dermatitis on the face (32.0% vs 27.8%) or scalp (15.4% vs 2.2%) compared with the HCP-negative patients (P < 0.0001). Of 4908 HCP-associated positive patch test reactions, 86.9% (n = 4263) were due to allergens on the NACDG screening series; p-phenylenediamine (35.8%), methylisothiazolinone (9.7%), methylchloroisothiazolinone/methylisothiazolinone (8.7%), and cocamidopropyl betaine (5.9%) were the most frequent. Most reactions (87.7%, 3736/4263) were currently clinically relevant. The most common job associated with 366 occupationally related NACDG HCP-associated allergens was hairdresser/cosmetologist (71.9%). Two hundred eighty-two patients (0.7%) had ICD associated with HCPs. Shampoo/conditioners were the most frequent source of NACDG HCP-associated reactions (47.3%) and HCP-associated ICD (45.0%). CONCLUSIONS Of the HCP-positive patients, 18.5% had HCP reactions to allergens not on the NACDG screening series, underscoring the importance of patch testing to expanded series in patients suspected of HCP allergy.

This is a safety assessment of glycerin as used in cosmetics. Glycerin functions as a denaturant, fragrance ingredient, hair conditioning agent, humectant, oral care agent, oral health-care drug, skin protectant, skin conditioning agent—humectant, and viscosity-decreasing agent. The Cosmetic Ingredient Review Expert Panel (Panel) reviewed relevant animal and human data. The Panel concluded that glycerin is safe as a cosmetic ingredient in the practices of use and concentration described in this safety assessment.

This is a safety assessment of Avena sativa (oat)–derived ingredients. The reported functions of these ingredients in cosmetics include abrasives, antioxidant, skin conditioning agents, absorbents, and bulking agents. The Panel reviewed relevant animal and human data related to these ingredients. Because final product formulations may contain multiple botanicals, each containing the same constituents of concern, formulators are advised to be aware of these constituents and to avoid reaching levels that may lead to sensitization or other toxic effects. The Panel stated that industry should continue to use good manufacturing practices to limit impurities and concluded that all but one of the Avena sativa (oat)–derived ingredients are safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment when formulated to be nonsensitizing; data are insufficient to come to a conclusion of safety for Avena Sativa (Oat) Meristem Cell Extract.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of inorganic hydroxides, which function in cosmetics primarily as pH adjusters. Representatives from the cosmetic industry have indicated these ingredients are used in depilating and hair waving/straightening formulations to raise pH values. The Panel considered relevant data related to these ingredients. The Panel concluded that these inorganic hydroxides are safe in hair straighteners and depilatories under conditions of recommended use; users should minimize skin contact. These ingredients are safe for all other present practices of use and concentration described in this safety assessment when formulated to be nonirritating.

The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Phosphoric Acid and its salts (31 ingredients), which are reported to function as buffering agents, corrosion inhibitors, chelating agents, and pH adjusters in cosmetic products. The Panel reviewed data relating to the safety of these ingredients and concluded that Phosphoric Acid and its salts are safe in the present practices of use and concentration in cosmetics when formulated to be nonirritating.

The Expert Panel for Cosmetic Ingredient Safety (Panel) reopened the safety assessment of Sodium Sulfate, a cosmetic ingredient that is an inorganic salt reported to function in cosmetics as a viscosity increasing agent—aqueous. The Panel reviewed the relevant new data for the ingredient, including frequency of use and concentration of use, and considered data from the previous Panel assessment. The Panel concluded that Sodium Sulfate is safe in cosmetics in the present practices of use and concentrations described in this safety assessment when formulated to be nonirritating.

BACKGROUND Methylchloroisothiazolinone/methylisothiazolinone (MCI/MI) allergy has increased for the last decade, mostly not only because of high concentrations in cosmetics but also because of its use as a biocide in industrial settings. OBJECTIVE We report an outbreak of allergic contact dermatitis in 8 workers at a water bottling plant secondary to excess levels of MCI/MI in the cooling system, found to be at levels 5 times the manufacturer's recommendations. METHODS Of 15 workers in the plastic bottle manufacturing area, 8 developed dermatitis, and 4 were referred for patch testing using a 100-allergen panel applied and interpreted in the standardized method according to the North American Contact Dermatitis Group. RESULTS Four workers had a positive reaction to MCI/MI. An investigation at the plant revealed that the concentration of MCI/MI was 365 ppm. The manufacturer's recommended level was 48 ppm. The cooling system was subsequently flushed, and biocide levels decreased to recommended levels. Afterward, all the affected workers experienced clearance of their allergic contact dermatitis. CONCLUSIONS Occupational sensitization to MCI/MI is on the rise, in this instance, because of excess levels in the cooling system. Our findings demonstrate the continued need for awareness of the allergenicity of this preservative in the occupational setting.

BACKGROUND The epidemiology of nickel allergy in occupational settings is not well understood. OBJECTIVE The aim of the study was to characterize occupationally related nickel allergy (ORNA). METHODS This is a retrospective cross-sectional analysis of 44,378 patients patch tested by the North American Contact Dermatitis Group from 1998 to 2016. Characteristics of individuals with ORNA were compared with those with non-ORNA (NORNA). RESULTS A total of 7928 (18.2%) individuals were positive to nickel sulfate 2.5%. Two hundred sixty-eight (3.4%) had ORNA. As compared with NORNA, ORNA was statistically associated with the male sex (41.0% vs 12.9%, P < 0.001), a diagnosis of irritant contact dermatitis (22.4% vs 12.0%, P < 0.001), and no history of eczema (81.7% vs 75.7%, P = 0.0217). The most common sites of ORNA dermatitis were hand (39.9%) and arm (18.1%), which were significantly more common than in NORNA (P < 0.0001). Sixteen industry categories and 22 occupation categories were identified for ORNA; the most common industries were durable goods manufacturing (24.6%) and personal services (15.7%), and the most frequent occupations were hairdressers/cosmetologists/barbers (14.3%), machine operators (9.3%), and health care workers (7.1%). Overall 30% of ORNA occupations were in metalworking. Of 215 ORNA sources identified, instruments/phones/other equipment (16.3%), vehicles/machinery (15.8%), and tools (15.3%) were the most common. CONCLUSIONS Occupational nickel allergy is distinct from nonoccupational nickel allergy.

The Cosmetic Ingredient Review Expert Panel (Panel) reassessed the safety of 2-pyrrolidone-5-carboxylic acid (PCA) and sodium PCA; the Panel added 3 previously unreviewed salts (calcium, magnesium, and potassium) of PCA to this safety assessment. 2-Pyrrolidone-5-carboxylic acid and its salts are reported to function in cosmetics as skin conditioning agents—humectants. The Panel reviewed the data from the 1999 report of PCA and sodium PCA, as well as additional data included in this report, to determine the safety of these ingredients. The Panel concluded that PCA and its salts are safe in cosmetics in the present practices of use and concentration; additionally, these ingredients should not be used in cosmetic products in which N-nitroso compounds can be formed.