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Methacrylate Ester Monomers
Johnson, Wilbur; Bergfeld, Wilma F; Belsito, Donald V; Cohen, David E; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Peterson, Lisa A; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Fiume, Monice; Heldreth, Bart
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 2005, along with updated information regarding product types and concentrations of use, and confirmed that these 22 methacrylate ester monomers are safe as used in nail enhancement products in the practices of use and concentration as described in this report, when skin contact is avoided.
PMID: 37794531
ISSN: 1092-874x
CID: 5643342
Amended Safety Assessment of Mentha piperita (Peppermint)-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; Fiume, Monice; Heldreth, Bart
The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of M piperita (peppermint)-derived ingredients. The Panel reviewed data relevant to the safety of these ingredients. Because final product formulations may contain multiple botanicals, each containing the same constituent(s) of concern, formulators are advised to be aware of these constituents and avoid reaching levels that may be hazardous to consumers. Industry should continue to use good manufacturing practices to limit impurities that could be present in botanical ingredients. The Panel concluded that M piperita (Peppermint) Oil, Extract, Leaf, and leaf-derived ingredients are safe in cosmetics in the present practices of use and concentration when formulated to be non-sensitizing, and that the available data are insufficient for determining that M piperita (Peppermint) Flower/Leaf/Stem Extract, M piperita (Peppermint) Flower/Leaf/Stem Water, and M piperita (Peppermint) Meristem Cell Culture are safe under the intended conditions of use in cosmetic formulations.
PMID: 37800357
ISSN: 1092-874x
CID: 5643352
Sulfites
Johnson, Wilbur; Bergfeld, Wilma F; Belsito, Donald V; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Peterson, Lisa A; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Fiume, Monice; Heldreth, Bart
The Expert Panel for Cosmetic Ingredient Safety reviewed newly available studies since their original assessment in 1998, along with updated information regarding product types and concentrations of use, and confirmed that Sodium Sulfite, Potassium Sulfite, Ammonium Sulfite, Sodium Bisulfite, Ammonium Bisulfite, Sodium Metabisulfite, and Potassium Metabisulfite are safe as cosmetic ingredients in the practices of use and concentration as described in this report.
PMID: 37843013
ISSN: 1092-874x
CID: 5643362
Safety Assessment of Polyfluorinated Polymers 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; Fiume, Monice; Heldreth, Bart
The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 12 polyfluorinated polymers in cosmetic products; most of these ingredients have the reported function of film former in common. However, PTFE, the only ingredient that is reported as currently used in cosmetics, functions as a bulking agent and slip modifier, but not as a film former. The Panel reviewed data relevant to the safety of these ingredients under the intended conditions of use in cosmetic formulations, and concluded that PTFE and Hexafluoropropylene/Tetrafluoroethylene Copolymer are safe in cosmetics in the present practices of use and concentration described in the safety assessment; the data are insufficient to determine the safety of the 4 fluorinated-side-chain polymers and 6 fluorinated polyethers.
PMID: 37978581
ISSN: 1092-874x
CID: 5643392
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
Patch Testing to Ethylhexylglycerin: The North American Contact Dermatitis Group Experience, 2013-2018
Warshaw, Erin M; Buonomo, Michele; Maibach, Howard I; Taylor, James S; Zug, Kathryn A; Atwater, Amber R; Silverberg, Jonathan I; Belsito, Donald V; Fransway, Anthony F; DeKoven, Joel G; Reeder, Margo J; Sasseville, Denis; Fowler, Joseph F; Pratt, Melanie D; DeLeo, Vincent A
BACKGROUND:Ethylhexylglycerin (EHG) is a recently recognized contact allergen. OBJECTIVE:The aims of the study were to characterize individuals with positive patch test reactions to EHG and to analyze reaction strength, clinical relevance, and allergen sources. METHODS:This study was a retrospective analysis of the patients patch tested to EHG (5% petrolatum) by the North American Contact Dermatitis Group (2013-2018). RESULTS:Of 15,560 patients tested to EHG, 39 (0.25%) had positive (final interpretation of "allergic") reactions. Most were female (71.8%) and/or older than 40 years (76.9%). There were no statistically significant differences between age, sex, or atopic history when compared with EHG-negative patients. The most common anatomic sites of dermatitis were the face (28.2%) and scattered generalized distribution (25.6%). Most EHG-positive reactions were + (35.9%) or ++ (33.3%). Current clinical relevance was high (79.5%); none, however, were related to occupation. Personal care products were the most common source of exposure to EHG (59.0%). CONCLUSIONS:Ethylhexylglycerin is a rare contact allergen; the positive frequency of 0.25% is similar to other low allergenic preservatives including parabens, benzyl alcohol, and phenoxyethanol. The patch test concentration of 5.0% seems to be nonirritating. Although relatively uncommon, EHG reactions were usually clinically relevant (79.5%), often because of moisturizers/lotions/creams.
PMID: 34570737
ISSN: 2162-5220
CID: 5642622
Allergens in patients with a diagnosis of seborrheic dermatitis, North American Contact Dermatitis Group data, 2001-2016 [Letter]
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; Dunnick, Cory A; Houle, Marie-Claude
PMID: 34582838
ISSN: 1097-6787
CID: 5642632
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
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
Occupational Contact Dermatitis in Dental Personnel: A Retrospective Analysis of the North American Contact Dermatitis Group Data, 2001 to 2018
Warshaw, Erin M; Ruggiero, Jenna L; Atwater, Amber R; DeKoven, Joel G; Zug, Kathryn A; Reeder, Margo J; Silverberg, Jonathan I; Taylor, James S; Pratt, Melanie D; Maibach, Howard I; Houle, Marie-Claude; Belsito, Donald V; Fowler, Joseph F; Dunnick, Cory A; DeLeo, Vincent A; Sasseville, Denis; Fransway, Anthony F
BACKGROUND:Dental personnel are at risk of developing occupational contact dermatitis. OBJECTIVES/OBJECTIVE:The aims of the study were to determine prevalence of occupational contact dermatitis in dental personnel referred for patch testing and to characterize relevant allergens and sources. METHODS:The study used a retrospective, cross-sectional analysis of the North American Contact Dermatitis Group (NACDG) data, 2001-2018. RESULTS:Of 41,109 patients, 585 (1.4%) were dental personnel. Dental personnel were significantly more likely than nondental personnel to be female (75.7% vs 67.4%, P < 0.0001), have occupationally related dermatitis (35.7% vs 11.5%, P < 0.0001), and/or have primary hand involvement (48.6% vs 22.5%, P < 0.0001). More than one quarter of dental personnel (62/585, 27.7%) had 1 or more occupationally related allergic patch test reaction(s). There were 249 occupationally related reactions to NACDG screening allergens, most commonly glutaraldehyde (18.1%), thiuram mix (16.1%), and carba mix (14.1%). The most common sources of NACDG screening allergens were gloves (30.7%), dental materials (26.6%), and sterilizing solutions (13.1%). Seventy-three dental personnel (12.5%) had 1 or more positive patch test reactions to occupationally related allergen(s)/substances not on the screening series. Occupationally related irritant contact dermatitis was identified in 22.2% (n = 130) of dental personnel, most commonly to nonskin soaps/detergents/disinfectants (32.0%). CONCLUSIONS:Occupational contact dermatitis is common in dental personnel referred for patch testing. Comprehensive testing beyond screening series is important in these patients.
PMID: 35029351
ISSN: 2162-5220
CID: 5642682