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Amended Safety Assessment of Malic Acid and Sodium Malate as Used in Cosmetics
Burnett, Christina L; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Heldreth, Bart
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.
PMID: 35993419
ISSN: 1092-874x
CID: 5642812
Amended Safety Assessment of Persulfates as Used in Cosmetics
Johnson, Wilbur; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Heldreth, Bart
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.
PMID: 36165404
ISSN: 1092-874x
CID: 5642822
Safety Assessment of Panthenol, Pantothenic Acid, and Derivatives as Used in Cosmetics
Scott, Laura N; Fiume, Monice; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Heldreth, Bart
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.
PMID: 36177798
ISSN: 1092-874x
CID: 5642832
Amended Safety Assessment of Triglycerides as Used in Cosmetics
Fiume, Monice M; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Heldreth, Bart
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.
PMID: 36189772
ISSN: 1092-874x
CID: 5642842
Prevalence and trend of allergen sensitization in patients with a diagnosis of stasis dermatitis referred for patch testing, North American contact dermatitis group data, 2001-2016
Silverberg, Jonathan I; Hou, Alexander; Warshaw, Erin M; Maibach, Howard I; Belsito, Donald V; DeKoven, Joel G; Zug, Kathryn A; Taylor, James S; Sasseville, Denis; Fransway, Anthony F; DeLeo, Vincent A; Pratt, Melanie D; Reeder, Margo J; Atwater, Amber R; Fowler, Joseph F; Zirwas, Matthew J; Marks, James G
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/CONCLUSIONS:Nearly half of patients with a final SD diagnosis were also diagnosed with ACD, supporting the role of patch testing in select SD patients.
PMID: 34748058
ISSN: 1432-069x
CID: 5642662
Patch testing with cobalt in children and adolescents: North American contact dermatitis group experience, 2001-2018
Silverberg, Jonathan I; Patel, Nisha; Warshaw, Erin M; Maibach, Howard I; Belsito, Donald V; DeKoven, Joel G; Zug, Kathryn A; Taylor, James S; Sasseville, Denis; DeLeo, Vincent A; Pratt, Melanie D; Reeder, Margo J; Atwater, Amber R; Fowler, Joseph F; Houle, Marie-Claude
BACKGROUND:Allergic contact dermatitis (ACD) to cobalt is more common in children and adolescents than adults. However, detailed information on sites and sources of cobalt ACD is limited. OBJECTIVES/OBJECTIVE:To assess trends in positive and clinically relevant patch test reactions to cobalt in children and associated patient characteristics, common sources and body sites affected. METHODS:A retrospective analysis of children (<18 years) patch tested to cobalt by the North American Contact Dermatitis Group between 2001 and 2018. RESULTS:Of 1919 children patch tested, 228 (11.9%) and 127 (6.6%) had a positive/allergic or currently relevant patch test reaction to cobalt, respectively. The most common primary body sites affected were scattered generalized (30.0%), face, not otherwise specified (10.6%) and trunk (10.1%). Patients with allergic and currently relevant allergic patch test reactions were more likely to have a primary site of trunk (p = 0.0160 and p = 0.0008) and ears (p = 0.0005 and p < 0.0001). Affected body site(s) varied by cobalt source among patients with currently relevant reactions, especially for less common sources. The most commonly identified sources of cobalt included jewellery, belts and clothing. CONCLUSIONS:Positive patch test reactions to cobalt were common in children. The most common body site was scattered generalized and the sources of cobalt varied by body site.
PMID: 35801686
ISSN: 1600-0536
CID: 5642802
Safety Assessment of Bovine Milk Proteins and Protein Derivatives as Used in Cosmetics
Burnett, Christina L; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Heldreth, Bart
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.
PMID: 35510869
ISSN: 1092-874x
CID: 5642732
Safety Assessment of Ethers and Esters of Ascorbic Acid as Used in Cosmetics
Johnson, Wilbur; Boyer, Ivan J; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Heldreth, Bart
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.
PMID: 35549580
ISSN: 1092-874x
CID: 5642762
Safety Assessment of Hydroxyethyl-3,4-Methylenedioxyaniline HCl as Used in Cosmetics
Scott, Laura N; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Heldreth, Bart
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.
PMID: 35574591
ISSN: 1092-874x
CID: 5642772
Safety Assessment of Plant-Derived Proteins and Peptides as Used in Cosmetics
Burnett, Christina L; Boyer, Ivan J; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Heldreth, Bart
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.
PMID: 35604030
ISSN: 1092-874x
CID: 5642782