Donald V Belsito

Cosmetic Ingredient Review, Washington, Washington, D.C., United States

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Publications (196)484.5 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 62 dimethicone crosspolymer ingredients as used in cosmetics. These ingredients function mostly as absorbents, bulking agents, film formers, hair-conditioning agents, emollient skin-conditioning agents, slip modifiers, surface modifiers, and nonaqueous viscosity-increasing agents. The Panel reviewed available animal and human data related to these polymers and addressed the issue of residual monomers. The Panel concluded that these dimethicone crosspolymer ingredients are safe in the practices of use and concentration as given in this safety assessment.
    International journal of toxicology. 05/2014; 33(2 suppl):65S-115S.
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    ABSTRACT: The CIR Expert Panel assessed the safety of 6 Cucumis sativus (cucumber)-derived ingredients and found them safe in cosmetic formulations in the present practices of use and concentration. These ingredients are reported to function in cosmetics as skin-conditioning agents. Cucumber is a commonly consumed food with no history of significant adverse effects, suggesting that its ingredients should not pose any major safety issues following oral exposure. This assessment focused on the dermal exposure to the low concentrations of these ingredients as used in cosmetics. Some of the constituents of cucumbers have been assessed previously for safe use as cosmetic ingredients.
    International journal of toxicology. 05/2014; 33(2 suppl):47S-64S.
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    ABSTRACT: Chlorphenesin functions as a biocide in cosmetics and is used at concentrations up to 0.32% in rinse-off products and up to 0.3% in leave-on products. The Cosmetic Ingredient Review Expert Panel (Panel) noted that chlorphenesin was well absorbed when applied to the skin of rats; however, any safety concern was minimized because available data demonstrated an absence of toxicity. The Panel concluded that chlorphenesin is safe in the present practices of use and concentration.
    International journal of toxicology. 05/2014; 33(2 suppl):5S-15S.
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    ABSTRACT: The CIR Expert Panel (Panel) assessed the safety of citric acid, 12 inorganic citrate salts, and 20 alkyl citrate esters as used in cosmetics, concluding that these ingredients are safe in the present practices of use and concentration. Citric acid is reported to function as a pH adjuster, chelating agent, or fragrance ingredient. Some of the salts are also reported to function as chelating agents, and a number of the citrates are reported to function as skin-conditioning agents but other functions are also reported. The Panel reviewed available animal and clinical data, but because citric acid, calcium citrate, ferric citrate, manganese citrate, potassium citrate, sodium citrate, diammonium citrate, isopropyl citrate, stearyl citrate, and triethyl citrate are generally recognized as safe direct food additives, dermal exposure was the focus for these ingredients in this cosmetic ingredient safety assessment.
    International journal of toxicology. 05/2014; 33(2 suppl):16S-46S.
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    ABSTRACT: Patients with atopic dermatitis (AD) have chronic dry skin to which they frequently apply skin care products containing preservatives, and they are predisposed to developing cutaneous delayed-type hypersensitivity. We sought to compare the rates of positive patch test reactions to allergens on the North American Contact Dermatitis Group (NACDG) standard tray among patients with and without AD and to assess whether atopic patients in our database were more likely to patch test positive to preservatives. A total of 2453 patients underwent patch testing to the NACDG standard screening series. The incidence of positive patch test reaction among patients with AD (n = 342) and without AD (n = 2111) was assessed. Statistical analysis was done using a χ(2) test. Compared with nonatopic patients, patients with AD were statistically more likely to have positive patch tests. AD was associated with contact hypersensitivity to quaternium-15, imidazolidinyl urea, DMDM hydantoin, and 2-bromo-2-nitropropane-1,3-diol but not to parabens, formaldehyde, or diazolidinyl urea. Only patients suspected of having allergic contact dermatitis were tested. Our population was geographically limited to metropolitan Kansas City, MO, and metropolitan New York City, NY. Patients with AD should avoid the use of skin care products preserved with formaldehyde releasers.
    Journal of the American Academy of Dermatology 11/2013; · 4.91 Impact Factor
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    ABSTRACT: Mercaptobenzothiazole (MBT) and mercapto compounds are primarily used in rubber products. This study aimed to examine concomitant-positive rates of MBT (1% pet) and the 4-part mercapto mix (MM) (1% pet). This is a retrospective cross-sectional data from the North American Contact Dermatitis Group. A total of 30,880 patients were patch tested to MM and MBT. There were 333 positive reactions to MM and 427 positive reactions to MBT. Ninety-eight patients were positive to MM alone, 192 to MBT alone, and 235 reacted to both. Forty-five percent (192/427) of MBT reactions would have been missed by only testing to MM, and 29% (98/333) of MM reactions would have been missed by testing to MBT alone. Most of these "missed" reactions, however, were doubtful (+/-) or mild (+) (MBT, 65%; MM, 78%), whereas most reactions in patients who reacted to both were moderate (++) and/or strong (+++) (52.3%). Gloves were the most common source. Mercaptobenzothiazole is the preferential screening allergen for mercapto compounds because of the following: (1) greater proportion of missed reactions with MM; (2) greater proportion of doubtful/mild reactions in the missed group for MM; and (3) in the group positive to both, the low rate (2%) of moderate/strong reactions to MM and doubtful/mild reactions to MBT as compared with the converse (21%). Mercapto mix may be useful in an auxiliary rubber series.
    Dermatitis 11/2013; · 0.93 Impact Factor
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    ABSTRACT: The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 4 ammonium hectorite compounds used in cosmetics: disteardimonium hectorite, dihydrogenated tallow benzylmonium hectorite, stearalkonium hectorite, and quaternium-18 hectorite. These ingredients function in cosmetics mainly as nonsurfactant suspending agents. The Panel reviewed available animal and human data and concluded that these ammonium hectorite compounds were safe as cosmetic ingredients in the practices of use and concentration as given in this safety assessment.
    International Journal of Toxicology 11/2013; 32(6 Suppl):33S-40S. · 1.35 Impact Factor
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    ABSTRACT: The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of α-amino acids, which function primarily as hair- and skin-conditioning agents in cosmetic products. The safety of α-amino acids as direct food additives has been well established based on extensive research through acute and chronic dietary exposures. The Panel focused its review on dermal irritation and sensitization data relevant to the use of these ingredients in topical cosmetics. The Panel concluded that α-amino acids were safe as cosmetic ingredients in the practices of use and concentration of this safety assessment.
    International Journal of Toxicology 11/2013; 32(6 Suppl):41S-64S. · 1.35 Impact Factor
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    ABSTRACT: Formaldehyde and methylene glycol may be used safely in cosmetics if established limits are not exceeded and are safe for use in nail hardeners in the present practices of use and concentration, which include instructions to avoid skin contact. In hair-smoothing products, however, in the present practices of use and concentration, formaldehyde and methylene glycol are unsafe. Methylene glycol is continuously converted to formaldehyde, and vice versa, even at equilibrium, which can be easily shifted by heating, drying, and other conditions to increase the amount of formaldehyde. This rapid, reversible formaldehyde/methylene glycol equilibrium is distinguished from the slow, irreversible release of formaldehyde resulting from the so-called formaldehyde releaser preservatives, which are not addressed in this safety assessment (formaldehyde releasers may continue to be safely used in cosmetics at the levels established in their individual Cosmetic Ingredient Review safety assessments).
    International Journal of Toxicology 11/2013; 32(6 Suppl):5S-32S. · 1.35 Impact Factor
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    ABSTRACT: Carba mix (CM) contains 3 chemicals used as accelerators in manufacturing of rubber products and agricultural chemicals. Iodopropynyl butylcarbamate (IPBC) is a preservative used in industrial and personal care products. Potential cross-reactivity between these allergens is unclear. This study aimed to determine concomitant reaction rates between CM (3% petrolatum [pet]) and IPBC (0.1% pet and/or 0.5% pet). A retrospective cross-sectional analysis of data from the North American Contact Dermatitis Group from 1998 to 2008 was conducted. Frequencies of positive reactions, strength of reactions, and concomitant reaction rates were calculated. A total of 25,435 patients were tested. There were 1131 allergic reactions to CM and 346 positive reactions to IPBC (either 0.1% pet and/or 0.5% pet). Fifty-two patients reacted to both allergens. Most reactions (>69%) were doubtful/weakly positive, and of those who reacted to both, most (58%) had doubtful and/or weakly positive reactions. There was a statistically significant association of concomitant reactions between CM and IPBC; formaldehyde positivity was used as control and showed statistically significant concomitant reactions. Overall, concomitant reactions to CM and IPBC were low, and rates varied by strength of reaction. True cross-reactivity is unlikely; statistical association is likely due to frequent low-grade reactions to irritant patch test preparations.
    Dermatitis 09/2013; · 0.93 Impact Factor
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    ABSTRACT: Both active and inactive ingredients in sunscreen may cause contact dermatitis. This study aimed to describe allergens associated with a sunscreen source. A cross-sectional analysis of patients patch tested by the North American Contact Dermatitis Group between 2001 and 2010 was performed. Of 23,908 patients patch tested, 219 (0.9%) had sunscreen coded as an allergen source. Patients who were male, with occupational dermatitis, or older (older than 40 years) had significantly lower rates of allergic reactions to sunscreens; the most commonly affected areas were the face and exposed sites (P < 0.0001). The top 3 most frequent allergens in sunscreens were benzophenone-3 (70.2% for 10% concentration, 64.4% for 3% concentration), DL-alpha-tocopherol (4.8%), and fragrance mix I (4.0%). Less than 40% of positive patch test reactions were detected by the North American Contact Dermatitis Group screening series of 65 to 70 allergens. A supplemental antigen series is important in detecting allergy to sunscreens.
    Dermatitis 07/2013; 24(4):176-182. · 0.93 Impact Factor
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    ABSTRACT: 2-Amino-4-hydroxyethylaminoanisole and its salt, 2-amino-4-hydroxyethylaminoanisole sulfate, are used as coupling agents in oxidative hair dyes. The Cosmetic Ingredient Review Expert Panel reviewed relevant animal and human data related to the ingredient. The Expert Panel concluded that 2-amino-4-hydroxyethylaminoanisole and 2-amino-4-hydroxyethylaminoanisole sulfate are safe for use in oxidative hair dye formulations. The Expert Panel cautioned that these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed.
    International Journal of Toxicology 05/2013; 32(3 Suppl):25S-35S. · 1.35 Impact Factor
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    ABSTRACT: The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of silica silylate, silica dimethyl silylate, trimethylsiloxysilicate, and trifluoropropyldimethyl/trimethylsiloxysilicate as used in cosmetics. These silylates and surface-modified siloxysilicates function in cosmetics as antifoaming agents, anticaking agents, bulking agents, binders, skin-conditioning agents-emollient, skin-conditioning agents-occlusive, slip modifiers, suspension agents-nonsurfactant, and viscosity increasing agents-nonaqueous. The Expert Panel reviewed the available animal and clinical data as well as information from a previous CIR safety assessment of amorphous silica. The CIR Expert Panel concluded that silica silylate, silica dimethyl silylate, trimethylsiloxysilicate, and trifluoropropyldimethyl/trimethylsiloxysilicate are safe as used when formulated and delivered in the final product not to be irritating or sensitizing to the respiratory tract.
    International Journal of Toxicology 05/2013; 32(3 Suppl):5S-24S. · 1.35 Impact Factor
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    ABSTRACT: The Cosmetic Ingredient Review Expert Panel assessed the safety of triethanolamine (TEA) and 31 related TEA-containing ingredients as used in cosmetics. The TEA is reported to function as a surfactant or pH adjuster; the related TEA-containing ingredients included in this safety assessment are reported to function as surfactants and hair- or skin-conditioning agents. The exception is TEA-sorbate, which is reported to function as a preservative. The Panel reviewed the available animal and clinical data. Although data were not available for all the ingredients, the panel relied on the information available for TEA in conjunction with previous safety assessments of components of TEA-containing ingredients. These data could be extrapolated to support the safety of all included ingredients. The panel concluded that TEA and related TEA-containing ingredients named in this report are safe as used when formulated to be nonirritating. These ingredients should not be used in cosmetic products in which N-nitroso compounds can be formed.
    International Journal of Toxicology 05/2013; 32(3 Suppl):59S-83S. · 1.35 Impact Factor
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    ABSTRACT: Cocamide diethanolamine (DEA) and some of the other diethanolamides are mainly used as surfactant foam boosters or viscosity increasing agents in cosmetics, although a few are reported to be used as hair and skin conditioning agents, surfactant-cleansing or surfactant-emulsifying agents, or as an opacifying agent. The Cosmetic Ingredient Review (CIR) Expert Panel considered new data and information from previous CIR reports to assess the concerns about the potential for amidases in human skin to convert these diethanolamides into DEA and the corresponding fatty acids. The Expert Panel concluded that these diethanolamides are safe as used when formulated to be nonirritating and when the levels of free DEA in the diethanolamides do not exceed those considered safe by the Panel. The Panel also recommended that these ingredients not be used in cosmetic products in which N-nitroso compounds can be formed.
    International Journal of Toxicology 05/2013; 32(3 Suppl):36S-58S. · 1.35 Impact Factor
  • Dana Malajian, Donald V Belsito
    [Show abstract] [Hide abstract]
    ABSTRACT: BACKGROUND: Literature on the relationship between atopic dermatitis (AD) and cutaneous delayed-type hypersensitivity is inconclusive. OBJECTIVE: We sought to compare the rates of positive patch test reactions to allergens on the North American Contact Dermatitis Group (NACDG) standard tray among patients with and without AD, and, to assess whether atopic patients in our database were more likely to patch test positive to certain classes of allergens. METHODS: A total of 2305 patients underwent patch testing to the NACDG standard screening series. The incidence of positive patch test reactions among patients with AD (n = 297) and without AD (n = 2008) was assessed. Statistical analysis was done using a χ(2) test with Yates continuity correction. RESULTS: Compared with nonatopic patients, those with AD were statistically more likely to have positive patch tests. AD was associated with contact hypersensitivity to nickel, cobalt, and chromium, but was not associated with contact sensitization to fragrances. LIMITATIONS: Only patients suspected of having allergic contact dermatitis were tested. Our population was geographically limited to metropolitan Kansas City (including Kansas City, MO, Kansas City, KS, and the adjoining suburbs). CONCLUSION: Compared with nonatopics, patients with AD are significantly more likely to have at least 1 positive patch test reaction and to develop contact hypersensitivity to metal allergens.
    Journal of the American Academy of Dermatology 04/2013; · 4.91 Impact Factor
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    ABSTRACT: BACKGROUND: Patch testing is an important diagnostic tool for determination of substances responsible for allergic contact dermatitis. OBJECTIVE: This study reports the North American Contact Dermatitis Group (NACDG) patch testing results from January 1, 2009, to December 31, 2010. METHODS: At 12 centers in North America, patients were tested in a standardized manner with a screening series of 70 allergens. Data were manually verified and entered into a central database. Descriptive frequencies were calculated, and trends were analyzed using χ statistics. RESULTS: A total of 4308 patients were tested. Of these, 2614 (60.7%) had at least 1 positive reaction, and 2284 (46.3%) were ultimately determined to have a primary diagnosis of allergic contact dermatitis. Four hundred twenty-seven (9.9%) patients had occupationally related skin disease. There were 6855 positive allergic reactions. As compared with the previous reporting period (2007-2008), the positive reaction rates statistically decreased for 20 allergens (nickel, neomycin, Myroxylon pereirae, cobalt, formaldehyde, quaternium 15, methydibromoglutaronitrile/phenoxyethanol, methylchlorisothiazolinone/methylisothiazolinone, potassium dichromate, diazolidinyl urea, propolis, dimethylol dimethylhydantoin, 2-bromo-2-nitro-1,3-propanediol, methyl methacrylate, ethyl acrylate, glyceryl thioglycolate, dibucaine, amidoamine, clobetasol, and dimethyloldihydroxyethyleneurea; P < 0.05) and statistically increased for 4 allergens (fragrance mix II, iodopropynyl butylcarbamate, propylene glycol, and benzocaine; P < 0.05). Approximately one quarter of tested patients had at least 1 relevant allergic reaction to a non-NACDG allergen. Hypothetically, approximately one quarter of reactions detected by NACDG allergens would have been missed by TRUE TEST (SmartPractice Denmark, Hillerød, Denmark). CONCLUSIONS: These results affirm the value of patch testing with many allergens.
    Dermatitis 03/2013; 24(2):50-59. · 0.93 Impact Factor
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    ABSTRACT: The North American Contact Dermatitis Group (NACDG) tests patients with suspected allergic contact dermatitis to a broad series of screening allergens and publishes periodic reports. The aims of this study were to report the NACDG patch-testing results from January 1, 2007, to December 31, 2008, and to compare results to pooled test data from the previous 2 and 10 years to analyze trends in allergen sensitivity. Standardized patch testing with 65 allergens was used at 13 centers in North America. χ analysis was used for comparisons. A total of 5085 patients were tested; 11.8% (598) had an occupationally related skin condition, and 65.3% (3319) had at least 1 allergic patch test reaction, which is identical to the NACDG data from 2005 to 2006. The top 15 most frequently positive allergens were nickel sulfate (19.5%), Myroxylon pereirae (11.0%), neomycin (10.1%), fragrance mix I (9.4%), quaternium-15 (8.6%), cobalt chloride (8.4%), bacitracin (7.9%), formaldehyde (7.7%), methyldibromoglutaronitrile/phenoxyethanol (5.5%), p-phenylenediamine (5.3%), propolis (4.9%), carba mix (4.5%), potassium dichromate (4.1%), fragrance mix II (3.6%), and methylchloroisothiazolinone/methylisothiazolinone (3.6%). There were significant increases in positivity rates to nickel, methylchloroisothiazolinone/methylisothiazolinone, and benzophenone-3. During the same period of study, there were significant decreases in positivity rates to neomycin, fragrance mix I, formaldehyde, thiuram mix, cinnamic aldehyde, propylene glycol, epoxy resin, diazolidinyl urea, amidoamine, ethylenediamine, benzocaine, p-tert-butylphenol formaldehyde resin, dimethylol dimethyl hydantoin, cocamidopropyl betaine, glutaraldehyde, mercaptobenzothiazole, tosylamide formaldehyde resin, budesonide, disperse blue 106, mercapto mix, and chloroxylenol. Twenty-four percent (1221) had a relevant positive reaction to a non-NACDG supplementary allergen; and 180 of these reactions were occupationally relevant. Periodic analysis, surveillance, and publication of multicenter study data sets document trends in allergen reactivity incidence assessed in the patch test clinic setting and provide information on new allergens of relevance.
    Dermatitis 01/2013; 24(1):10-21. · 0.93 Impact Factor
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    ABSTRACT: BACKGROUND: Contact dermatoses are common in food service workers (FSWs). OBJECTIVES: This study aims to (1) determine the prevalence of occupationally related contact dermatitis among FSWs patch tested by the North American Contact Dermatitis Group (NACDG) and (2) characterize responsible allergens and irritants as well as sources. METHODS: Cross-sectional analysis of patients patch tested by the NACDG, 1994 to 2010, was conducted. RESULTS: Of 35,872 patients patch tested, 1237 (3.4%) were FSWs. Occupationally related skin disease was significantly more common in FSWs when compared with employed non-FSWs. Food service workers were significantly more likely to have hand (P < 0.0001) and arm (P < 0.0006) involvement. The rates for irritant and allergic contact dermatitis in FSWs were 30.6% and 54.7%, respectively. Although the final diagnosis of irritant contact dermatitis was statistically higher in FSWs as compared with non-FSWs, allergic contact dermatitis was lower in FSWs as compared with non-FSWs. The most frequent currently relevant and occupationally related allergens were thiuram mix (32.5%) and carba mix (28.9%). Gloves were the most common source of responsible allergens. The NACDG standard tray missed at least 1 occupationally related allergen in 38 patients (4.3%). CONCLUSIONS: Among FSWs patch tested by the NACDG between 1994 and 2010, the most common allergens were thiuram mix and carba mix. Gloves were the most common source of responsible allergens.
    Dermatitis 01/2013; 24(1):22-28. · 0.93 Impact Factor
  • Dermatitis 11/2012; 23(6):301-303. · 0.93 Impact Factor

Publication Stats

2k Citations
484.50 Total Impact Points

Institutions

  • 2009–2014
    • Cosmetic Ingredient Review
      Washington, Washington, D.C., United States
  • 1995–2013
    • CUNY Graduate Center
      New York City, New York, United States
  • 2011–2012
    • Columbia University
      • Department of Dermatology
      New York City, NY, United States
  • 2006–2012
    • University of Missouri - Kansas City
      • Department of Internal Medicine
      Kansas City, Missouri, United States
  • 2007–2011
    • Minneapolis Veterans Affairs Hospital
      Minneapolis, Minnesota, United States
  • 2008
    • University of Minnesota Twin Cities
      • Department of Dermatology
      Minneapolis, MN, United States
    • Dartmouth–Hitchcock Medical Center
      Lebanon, New Hampshire, United States
  • 1998–2006
    • Kansas City VA Medical Center
      Kansas City, Missouri, United States
  • 2005
    • Cleveland Clinic
      • Department of Dermatology
      Cleveland, OH, United States
  • 2004
    • University of Missouri - St. Louis
      Saint Louis, Michigan, United States
  • 2003
    • Penn State Hershey Medical Center and Penn State College of Medicine
      • Dermatology
      Hershey, Pennsylvania, United States
  • 2002
    • Saint Luke's Hospital (NY, USA)
      New York City, New York, United States
    • New York University
      • Department of Pathology
      New York City, NY, United States
  • 2001–2002
    • Kansas City University of Medicine and Biosciences
      Kansas City, Missouri, United States
    • Wake Forest School of Medicine
      • Department of Dermatology
      Winston-Salem, NC, United States
  • 1995–1998
    • Pennsylvania State University
      • Department of Dermatology
      University Park, MD, United States
  • 1991–1996
    • NYU Langone Medical Center
      • • Department of Pathology
      • • Department of Dermatology
      New York City, NY, United States
  • 1993
    • University of Louisville
      • Department of Medicine
      Louisville, KY, United States
  • 1987–1990
    • State University of New York Downstate Medical Center
      • Department of Dermatology
      Brooklyn, NY, United States