Safety Assessment of Dimethicone Crosspolymers as Used in Cosmetics

2014 ◽  
Vol 33 (2_suppl) ◽  
pp. 65S-115S
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Bulking Agents ◽  
Surface Modifiers ◽  
Human Data

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.

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.

Safety Assessment of Silk Protein Ingredients as Used in Cosmetics

2020 ◽  
Vol 39 (3_suppl) ◽  
pp. 127S-144S
Author(s):  
Wilbur Johnson ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Silk Protein ◽  
Bulking Agents ◽  
Cosmetic Products ◽  
Silkworm Cocoon

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of Hydrolyzed Silk and 9 other silk protein ingredients, which function primarily as skin and hair conditioning agents and bulking agents in cosmetic products. The Panel reviewed relevant data relating to the safety of these ingredients and concluded that 8 ingredients are safe in the present practices of use and concentration in cosmetics, as described in this safety assessment, but that the available data are insufficient for determining the safety of 2 silk protein ingredients in cosmetic products, MEA-Hydrolyzed Silk and Silkworm Cocoon Extract.

Amended Safety Assessment of Hypericum Perforatum-Derived Ingredients as Used in Cosmetics

2014 ◽  
Vol 33 (3_suppl) ◽  
pp. 5S-23S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Hypericum Perforatum ◽  
Antimicrobial Agents ◽  
Expert Panel ◽  
Human Data ◽  
Cosmetic Ingredients

The Cosmetic Ingredient Review Expert Panel (Panel) has issued an amended safety assessment of 7 Hypericum perforatum-derived ingredients as used in cosmetics. A common name for this plant is St John wort. These ingredients function in cosmetics as skin-conditioning agents—miscellaneous and antimicrobial agents. The Panel reviewed relevant animal and human data related to the H perforatum-derived ingredients. Because formulators may use more than 1 botanical ingredient in a formulation, caution was urged to avoid levels of toxicological concern for constituent chemicals and impurities. The Panel concluded that H perforatum-derived ingredients were safe as cosmetic ingredients in the practices of use and concentration as described in this safety assessment.

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.

Safety Assessment of Pentaerythrityl Tetraesters as Used in Cosmetics

2015 ◽  
Vol 34 (2_suppl) ◽  
pp. 99S-112S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Fatty Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
The Other ◽  
Human Data ◽  
Safety Assessments

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of 16 pentaerythrityl tetraester compounds as used in cosmetics. These ingredients mostly function as hair-conditioning agents, skin-conditioning agents—miscellaneous and binders, skin-conditioning agents–occlusive, viscosity-increasing agents–nonaqueous, and skin-conditioning agents—emollient. The Panel reviewed the available animal and human data related to these ingredients and previous safety assessments of the fatty acid moieties. The Panel concluded that pentaerythrityl tetraisostearate and the other pentaerythrityl tetraester compounds were safe in the practices of use and concentration as given in this safety assessment.

scholarly journals Safety Assessment of Hydroxypropyl Bis(N-Hydroxyethyl-p-Phenylenediamine) HCl as Used in Cosmetics

2016 ◽  
Vol 35 (2_suppl) ◽  
pp. 5S-11S
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Hair Dye ◽  
Human Data ◽  
Oxidative Hair Dye

The Cosmetic Ingredient Review Expert Panel (CIR Panel) reviewed the safety of hydroxypropyl bis( N-Hydroxyethyl- p-Phenylenediamine) HCl, which functions as an oxidative hair dye ingredient. The Panel considered relevant animal and human data provided in this safety assessment and concluded that hydroxypropyl bis( N-hydroxyethyl- p-phenylenediamine) HCl is safe for use in oxidative hair dye formulations as described in this safety assessment.

Safety Assessment of Silylates and Surface-Modified Siloxysilicates

2013 ◽  
Vol 32 (3_suppl) ◽  
pp. 5S-24S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Respiratory Tract ◽  
Clinical Data ◽  
Amorphous Silica ◽  
Safety Assessment ◽  
Expert Panel ◽  
Bulking Agents ◽  
Surface Modified

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.

Safety Assessment of Modified Terephthalate Polymers as Used in Cosmetics

2014 ◽  
Vol 33 (3_suppl) ◽  
pp. 36S-47S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Medical Devices ◽  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Bulking Agents ◽  
Ocular Irritation ◽  
Cosmetic Ingredients ◽  
Animal Safety ◽  
Use Studies

The safety of 6 modified terephthalate polymers as cosmetic ingredients was assessed. These ingredients mostly function as exfoliants, bulking agents, hair fixatives, and viscosity-increasing agents—nonaqueous. Polyethylene terephthalate (PET) is used in leave-on products up to 100% and in rinse-off products up to 2%. The Cosmetic Ingredient Review Expert Panel (Panel) considered that the PET used in cosmetics is chemically equivalent to that used in medical devices. The Panel determined that the Food and Drug Administration’s determination of safety of PET in several medical devices, which included human and animal safety data, can be used as the basis for the determination of safety of PET and related polymers used in cosmetics. Use studies of cosmetic eye products that contain PET demonstrated no ocular irritation or dermal sensitization. The Panel concluded that modified terephthalate polymers were safe as cosmetic ingredients in the practices of use and concentration described in this safety assessment.

Safety Assessment of Dialkyl Malates as Used in Cosmetics

2015 ◽  
Vol 34 (1_suppl) ◽  
pp. 5S-17S
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Malic Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
Entire Group ◽  
Human Data ◽  
Toxicological Data ◽  
Structure Properties

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 6 dialkyl malate compounds used in cosmetics. These ingredients function mostly as skin-conditioning agents—emollients. The Panel reviewed relevant animal and human data related to the ingredients along with a previous safety assessment of malic acid. The similar structure, properties, functions, and uses of these ingredients enabled grouping them and using the available toxicological data to assess the safety of the entire group. The Panel concluded that these dialkyl maleate compounds are safe in the present practices of use and concentration as given in this safety assessment.

Safety Assessment of 2-Amino-3-Hydroxypyridine as Used in Cosmetics

2020 ◽  
Vol 39 (2_suppl) ◽  
pp. 91S-97S
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Hair Dye ◽  
Human Data ◽  
Oxidative Hair Dye

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 2-Amino-3-Hydroxypyridine, which is reported to function as an oxidative hair dye ingredient. The Panel reviewed relevant animal and human data provided in this safety assessment, and concluded that 2-Amino-3-Hydroxypyridine is safe in the present practices of use and concentration for use in oxidative hair dye formulations.

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