Amended Safety Assessment of Methylchloroisothiazolinone and Methylisothiazolinone as Used in Cosmetics

2021 ◽  
Vol 40 (1_suppl) ◽  
pp. 20S-33S
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Curtis D. Klaassen ◽  
Daniel C. Liebler ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Safety Assessment ◽  
Expert Panel ◽  
Quantitative Risk Assessment ◽  
Cosmetic Products ◽  
Human Data

The Expert Panel for Cosmetic Ingredient Safety (Panel) reassessed the safety of the mixture Methylchloroisothiazolinone (MCI)/Methylisothiazolinone (MI), which functions as a preservative in cosmetic products. The Panel reviewed relevant animal and human data provided in this safety assessment, and data from the previously published safety assessment of this mixture, and concluded that MCI/MI is safe in cosmetics when formulated to be nonsensitizing, based on the results of a quantitative risk assessment or similar methodology; however, at no point should concentrations exceed 7.5 ppm in leave-on products or 15 ppm in rinse-off products.

Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics

2021 ◽  
Vol 40 (1_suppl) ◽  
pp. 5S-19S
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
David Cohen ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Safety Assessment ◽  
Expert Panel ◽  
Quantitative Risk Assessment ◽  
Cosmetic Products ◽  
Human Data ◽  
Safety Assessments

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.

scholarly journals Safety Assessment of Fatty Acid Amidopropyl Dimethylamines as Used in Cosmetics

2019 ◽  
Vol 38 (1_suppl) ◽  
pp. 39S-69S ◽  
Author(s):  
Christina L. Burnett ◽  
Ivan Boyer ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Fatty Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
Quantitative Risk Assessment ◽  
Cosmetic Products ◽  
Human Data ◽  
Cosmetic Ingredients

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of fatty acid amidopropyl dimethylamines, which function primarily as antistatic agents in cosmetic products. The relevant animal and human data reviewed for these ingredients indicate that they are potential dermal sensitizers that may be due in part by the sensitizing impurity, 3,3-dimethylaminopropylamine. The Panel concluded that fatty acid amidopropyl dimethylamines were safe as cosmetic ingredients when they are formulated to be nonsensitizing, which may be based on a quantitative risk assessment.

scholarly journals Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics

2019 ◽  
Vol 38 (1_suppl) ◽  
pp. 70S-84S ◽  
Author(s):  
Christina L. Burnett ◽  
Ivan Boyer ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Safety Assessment ◽  
Expert Panel ◽  
Quantitative Risk Assessment ◽  
Cosmetic Products ◽  
Human Data

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of methylisothiazolinone (MI), which functions as a preservative. The Panel reviewed relevant animal and human data provided in this safety assessment and in a previously published safety assessment of MI and concluded that MI is safe for use in rinse-off cosmetic products at concentrations up to 100 ppm and safe in leave-on cosmetic products when they are formulated to be nonsensitizing, which may be determined based on a quantitative risk assessment.

Safety Assessment of Polyaminopropyl Biguanide (Polyhexamethylene Biguanide Hydrochloride) as Used in Cosmetics

2020 ◽  
Vol 39 (3_suppl) ◽  
pp. 26S-73S
Author(s):  
Wilbur Johnson ◽  
Ivan Boyer ◽  
Jinqiu Zhu ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Safety Assessment ◽  
Expert Panel ◽  
Quantitative Risk Assessment ◽  
Cosmetic Products ◽  
Polyhexamethylene Biguanide

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of Polyaminopropyl Biguanide (polyhexamethylene biguanide hydrochloride), which functions as a preservative in cosmetic products. The Panel reviewed relevant data relating to the safety of this ingredient and concluded that Polyaminopropyl Biguanide is safe in cosmetics in the present practices of use and concentration described in the safety assessment, when formulated to be nonirritating and nonsensitizing, which may be based on a quantitative risk assessment or other accepted methodologies. The Panel also concluded that the data are insufficient to determine the safety of Polyaminopropyl Biguanide in products that may be incidentally inhaled.

Safety Assessment of 2-Amino-4-Hydroxyethylaminoanisole and 2-Amino-4-Hydroxyethylaminoanisole Sulfate as Used in Cosmetics

2013 ◽  
Vol 32 (3_suppl) ◽  
pp. 25S-35S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Nitroso Compounds ◽  
Coupling Agents ◽  
Cosmetic Products ◽  
Hair Dyes ◽  
Hair Dye ◽  
Human Data ◽  
Oxidative Hair Dye

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.

Final Report of the Cosmetic Ingredient Review Expert Panel on the Safety Assessment of Cocamidopropyl betaine (CAPB)

2012 ◽  
Vol 31 (4_suppl) ◽  
pp. 77S-111S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Fatty Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
Quantitative Risk Assessment ◽  
Final Report ◽  
Significant Toxicity ◽  
Cosmetic Ingredients ◽  
Cocamidopropyl Betaine

Cocamidopropyl betaine (CAPB) and related amidopropyl betaines are zwitterions used mainly as surfactants in cosmetics. These cosmetic ingredients are similar in their chemistry, in particular with respect to the presence of 3,3-dimethylamino-propylamine (DMAPA) and fatty acid amidopropyl dimethylamine (amidoamine) impurities, which are known as sensitizers. The CIR Expert Panel concluded that because these ingredients present no other significant toxicity, when formulated to be nonsensitizing (which may be based on a quantitative risk assessment), these ingredients are safe for use as cosmetic ingredients in the practices of use and concentration of this safety assessment.

scholarly journals Final Report of the Amended Safety Assessment of PVM/MA Copolymer and Its Related Salts and Esters as Used in Cosmetics

2011 ◽  
Vol 30 (5_suppl) ◽  
pp. 128S-144S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Methyl Ether ◽  
Maleic Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
Final Report ◽  
Cosmetic Products ◽  
Human Data ◽  
Polyvinyl Methyl Ether

Polyvinyl methyl ether/maleic acid (PVM/MA) copolymer, and its related salts and esters, are used in cosmetics, mainly as binders, film formers, and hair fixatives. Animal and human data relevant to the use of these ingredients in cosmetic products were reviewed by the CIR Expert Panel. The Panel concluded that these ingredients are safe for use in cosmetic products.

Safety Assessment of PEGylated Oils as Used in Cosmetics

2014 ◽  
Vol 33 (4_suppl) ◽  
pp. 13S-39S ◽  
Author(s):  
Christina L. Burnett ◽  
Bart Heldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Ethylene Oxide ◽  
Safety Assessment ◽  
Expert Panel ◽  
Cosmetic Products ◽  
Human Data ◽  
Cosmetic Ingredients

PEGylated oil is a terminology used to describe cosmetic ingredients that are the etherification and esterification products of glycerides and fatty acids with ethylene oxide. The Cosmetic Ingredient Review Expert Panel (Panel) considered the safety of PEGylated oils, which function primarily as surfactants in cosmetic products. The Panel reviewed relevant animal and human data provided in this safety assessment and concluded that the 130 chemically related PEGylated oils were safe as cosmetic ingredients in the present practices of use and concentration when formulated to be nonirritating.

Amended Safety Assessment of Fatty Acyl Sarcosines and Sarcosinate Salts as Used in Cosmetics

2021 ◽  
pp. 109158182110238
Author(s):  
Monice M. Fiume ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Fatty Acyl ◽  
Nitroso Compounds ◽  
Acyl Residue ◽  
Cosmetic Products ◽  
Panel Report ◽  
Fatty Acyl Residue

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.

Safety Assessment of Citrus Peel-Derived Ingredients as Used in Cosmetics

2021 ◽  
pp. 109158182110326
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Cosmetic Products ◽  
Citrus Peel ◽  
Good Manufacturing Practices

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).

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