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105


Safety Assessment of Skin and Connective Tissue-Derived Proteins and Peptides 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 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.
PMID: 35668614
ISSN: 1092-874x
CID: 5642792

Sun Protection Factor Testing: A Call for an In Vitro Method

Breneman, Alyssa; Belsito, Donald V
PMID: 36219639
ISSN: 2326-6929
CID: 5642852

Amended Safety Assessment of Butyl Polyoxyalkylene Ethers 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; Gill, Lillian J; Heldreth, Bart
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.
PMID: 35144504
ISSN: 1092-874x
CID: 5642692

Safety Assessment of 1-Hydroxyethyl 4,5-Diamino Pyrazole Sulfate 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; Gill, Lillian J; Heldreth, Bart
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.
PMID: 35435034
ISSN: 1092-874x
CID: 5642702

Safety Assessment of Hydrofluorocarbon 152a 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; Gill, Lillian J; Heldreth, Bart
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.
PMID: 35437046
ISSN: 1092-874x
CID: 5642712

Safety Assessment of Rosa canina-derived Ingredients 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; Gill, Lillian J; Heldreth, Bart
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.
PMID: 35531605
ISSN: 1092-874x
CID: 5642742

Safety Assessment of Carbonate Salts 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; Gill, Lillian J; Heldreth, Bart
The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of 6 carbonate salts which function as absorbents, bulking agents, opacifying agents, pH adjusters, buffering agents, abrasives, and oral care agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients, and concluded that these carbonate salts are safe in the present practices of use and concentration in cosmetics when formulated to be non-irritating.
PMID: 35531773
ISSN: 1092-874x
CID: 5642752

Photopatch test results of the North American contact dermatitis group, 1999-2009 [Letter]

DeLeo, Vincent A; Adler, Brandon L; Warshaw, Erin M; Maibach, Howard I; Belsito, Donald V; Fowler, Joseph F; Fransway, Anthony F; Marks, James G; Mathias, C G Toby; Pratt, Melanie D; Rietschel, Robert L; Storrs, Frances J; Zug, Kathryn A; Sasseville, Denis
PMID: 34651348
ISSN: 1600-0781
CID: 5642642

Lanolin Allergic Reactions: North American Contact Dermatitis Group Experience, 2001 to 2018

Silverberg, Jonathan I; Patel, Nisha; Warshaw, Erin M; DeKoven, Joel G; Atwater, Amber R; Belsito, Donald V; Dunnick, Cory A; Houle, Marie-Claude; Reeder, Margo J; Maibach, Howard I; Zug, Kathryn A; Taylor, James S; Sasseville, Denis; Fransway, Anthony F; DeLeo, Vincent A; Pratt, Melanie D; Fowler, Joseph F; Zirwas, Matthew J
BACKGROUND:Lanolin is an important cause of allergic contact dermatitis. OBJECTIVES/OBJECTIVE:The aims of this study were to describe the epidemiology of lanolin allergy and to assess trends in patch test reactions to lanolin over time. METHODS:This study used a retrospective analysis of patients patch tested with lanolin alcohol 30% or Amerchol L-101 50% in petrolatum by the North American Contact Dermatitis Group between 2001 and 2018 (n = 43,691). RESULTS:Overall, 1431 (3.3%) had a positive reaction, and 1238 (2.8%) were currently relevant. Prevalence of lanolin allergy was 4.63% between 2011 and 2018 (P < 0.0001). Most lanolin-allergic patients had + (52%) reactions; 18%, and 6% had ++ and +++ reactions, respectively. Common primary anatomic sites of dermatitis were the hands (20.7%), scattered/generalized distribution (19.6%), and face (17.0%). Allergic reactions to lanolin were more common in children (4.5%) than in adults (3.2%, P = 0.0018). Compared with nonallergic patients, lanolin-allergic patients were more likely to have history of eczema or hay fever, male sex, older than 40 years, or Black race (P < 0.05). Common lanolin sources were personal care products and drugs/medications. Only 2.24% of the positive reactions were linked to occupation. CONCLUSIONS:Lanolin sensitivity was common. Reactions were often clinically relevant and linked to personal care products and medications.
PMID: 35481824
ISSN: 2162-5220
CID: 5642722

Patch Test Reactions Associated With Topical Medications: A Retrospective Analysis of the North American Contact Dermatitis Group Data (2001-2018)

Warshaw, Erin M; Shaver, Rob L; DeKoven, Joel G; Taylor, James S; Atwater, Amber R; Fransway, Anthony F; Maibach, Howard I; Belsito, Donald V; Silverberg, Jonathan I; Houle, Marie-Claude; Reeder, Margo J; Zug, Kathryn A; Fowler, Joseph F; Sasseville, Denis; Pratt, Melanie D; Dunnick, Cory A; DeLeo, Vincent A
BACKGROUND/OBJECTIVES/OBJECTIVE:Topical medications may lead to allergic contact dermatitis. This study characterized positive patch test reactions associated with medications in patients evaluated by the North American Contact Dermatitis Group (NACDG). METHODS:This study is a retrospective analysis of the NACDG data (2001-2018). Patients with at least 1 positive patch test reaction associated with a medication source were included. Allergens, reaction characteristics, clinical relevance, and source details were tabulated. RESULTS:Of 43,722 patients, 6374 (14.6%) had positive allergic patch test reactions associated with 1 or more topical medication sources. Patients with versus without allergic reactions to medications were more likely to be older than 40 years (P < 0.0001) and/or have primary sites of dermatitis on the legs, anal/genital region, or trunk (P < 0.0001). There were 8787 reactions to NACDG allergens; the most common were neomycin (29.4%), bacitracin (29.1%), propylene glycol 100% (10.6%), tixocortol-17-pivalate (10.0%), lidocaine (7.9%), budesonide (4.9%), and dibucaine (4.4%). Propylene glycol 100% was the most common inactive ingredient (10.6%). Current relevance was present in 61.0%. A total of 6.5% of the individuals with medication allergy would have had 1 or more positive patch test reactions missed if only tested to the NACDG screening series. CONCLUSIONS:Positive patch test reactions associated with topical medications were common (14.6%), and most were clinically relevant. Patients with topical medication allergy were twice as likely to have anal/genital involvement. Active ingredients, especially neomycin, bacitracin, and tixocortol-17-pivalate, were frequent culprits.
PMID: 34405832
ISSN: 2162-5220
CID: 5642562