scholarly journals Safety Assessment of Sorbitan Esters as Used in Cosmetics

2019 ◽  
Vol 38 (2_suppl) ◽  
pp. 60S-80S
Author(s):  
Monice M. Fiume ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Additional Data ◽  
Expert Panel ◽  
Sorbitan Ester ◽  
Sorbitan Esters

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 20 sorbitan esters; this report included sorbitan esters that were reviewed in 1985 and 2002, as well as 3 previously unreviewed sorbitan esters (sorbitan undecylenate, sorbitan sesquicaprylate, and sorbitan palmate). Most of the sorbitan esters are reported to function in cosmetics as surfactant-emulsifying agents. The Panel reviewed the data from previous sorbitan ester reports, as well as additional data included in this report, to determine the safety of these ingredients. The Panel concluded that the sorbitan esters included in this safety assessment are safe in cosmetics in the present practices of use and concentration.

scholarly journals Safety Assessment of PCA (2-Pyrrolidone-5-Carboxylic Acid) and Its Salts as Used in Cosmetics

2019 ◽  
Vol 38 (2_suppl) ◽  
pp. 5S-11S
Author(s):  
Monice M. Fiume ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Carboxylic Acid ◽  
Safety Assessment ◽  
Additional Data ◽  
Expert Panel ◽  
Nitroso Compounds ◽  
Cosmetic Products ◽  
Calcium Magnesium

The Cosmetic Ingredient Review Expert Panel (Panel) reassessed the safety of 2-pyrrolidone-5-carboxylic acid (PCA) and sodium PCA; the Panel added 3 previously unreviewed salts (calcium, magnesium, and potassium) of PCA to this safety assessment. 2-Pyrrolidone-5-carboxylic acid and its salts are reported to function in cosmetics as skin conditioning agents—humectants. The Panel reviewed the data from the 1999 report of PCA and sodium PCA, as well as additional data included in this report, to determine the safety of these ingredients. The Panel concluded that PCA and its salts are safe in cosmetics in the present practices of use and concentration; additionally, these ingredients should not be used in cosmetic products in which N-nitroso compounds can be formed.

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 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).

Final Report of the Safety Assessment of Kojic Acid as Used in Cosmetics

2010 ◽  
Vol 29 (6_suppl) ◽  
pp. 244S-273S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Expert Panel ◽  
Kojic Acid ◽  
Tumor Promotion ◽  
Final Report ◽  
Cosmetic Products ◽  
Pig Skin ◽  
Animal Data ◽  
Skin Lightening

Kojic acid functions as an antioxidant in cosmetic products. Kojic acid was not a toxicant in acute, chronic, reproductive, and genotoxicity studies. While some animal data suggested tumor promotion and weak carcinogenicity, kojic acid is slowly absorbed into the circulation from human skin and likely would not reach the threshold at which these effects were seen. The available human sensitization data supported the safety of kojic acid at a use concentration of 2% in leave-on cosmetics. Kojic acid depigmented black guinea pig skin at a concentration of 4%, but this effect was not seen at 1%. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that the 2 end points of concern, dermal sensitization and skin lightening, would not be seen at use concentrations below 1%; therefore, this ingredient is safe for use in cosmetic products up to that level.

Safety Assessment of Talc as Used in Cosmetics

2015 ◽  
Vol 34 (1_suppl) ◽  
pp. 66S-129S ◽  
Author(s):  
Monice M. Fiume ◽  
Ivan Boyer ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Clinical Data ◽  
Safety Assessment ◽  
Expert Panel ◽  
Cosmetic Products ◽  
Epidermal Barrier ◽  
The Subject ◽  
The Relationship

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of talc for use in cosmetics. The safety of talc has been the subject of much debate through the years, partly because the relationship between talc and asbestos is commonly misunderstood. Industry specifications state that cosmetic-grade talc must contain no detectable fibrous, asbestos minerals. Therefore, the large amount of available animal and clinical data the Panel relied on in assessing the safety of talc only included those studies on talc that did not contain asbestos. The Panel concluded that talc is safe for use in cosmetics in the present practices of use and concentration (some cosmetic products are entirely composed of talc). Talc should not be applied to the skin when the epidermal barrier is missing or significantly disrupted.

Safety Assessment ofVitis vinifera(Grape)-Derived Ingredients as Used in Cosmetics

2014 ◽  
Vol 33 (3_suppl) ◽  
pp. 48S-83S ◽  
Author(s):  
Monice M. Fiume ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Vitis Vinifera ◽  
Clinical Data ◽  
Safety Assessment ◽  
Expert Panel ◽  
Cosmetic Ingredients ◽  
Safety Assessments

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 24 Vitis vinifera (grape)-derived ingredients and found them safe in the present practices of use and concentration in cosmetics. These ingredients function in cosmetics mostly as skin-conditioning agents, but some function as antioxidants, flavoring agents, and/or colorants. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients. Additionally, some constituents of grapes have been assessed previously for safety as cosmetic ingredients by the Panel, and others are compounds that have been discussed in previous Panel safety assessments.

scholarly journals Safety Assessment of Hydrolyzed Wheat Protein and Hydrolyzed Wheat Gluten as Used in Cosmetics

2018 ◽  
Vol 37 (1_suppl) ◽  
pp. 55S-66S ◽  
Author(s):  
Christina Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Average Molecular Weight ◽  
Wheat Gluten ◽  
Safety Data ◽  
Hypersensitivity Reactions ◽  
Wheat Protein ◽  
Laboratory Studies ◽  
Immediate Hypersensitivity

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the product use, formulation, and safety data on hydrolyzed wheat protein and hydrolyzed wheat gluten, which function as skin- and hair-conditioning agents. The Panel determined that data from clinical and laboratory studies were sufficient to demonstrate that these ingredients will not elicit type 1 immediate hypersensitivity reactions in sensitized individuals and will not induce sensitization when the polypeptide lengths of the hydrolysates do not exceed 30 amino acids. The Panel concluded that hydrolyzed wheat gluten and hydrolyzed wheat protein are safe for use in cosmetics when formulated to restrict peptides to an average molecular weight of 3,500 Da or less.

Safety Assessment of Alkyl PEG Sulfosuccinates as Used in Cosmetics

2015 ◽  
Vol 34 (2_suppl) ◽  
pp. 70S-83S
Author(s):  
Wilbur Johnson ◽  
Bart Heldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Developmental Toxicity ◽  
Skin Irritation ◽  
Molecular Size ◽  
Skin Sensitization ◽  
Toxicity Data ◽  
Cosmetic Products ◽  
Dermal Penetration ◽  
Repeated Dose Toxicity

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of alkyl polyethylene glycol (PEG) sulfosuccinates, which function in cosmetics mostly as surfactants/cleansing agents. Although these ingredients may cause ocular and skin irritation, dermal penetration is unlikely because of the substantial polarity and molecular size of these ingredients. The Panel considered the negative oral carcinogenicity and reproductive and developmental toxicity data on chemically related laureths (PEG lauryl ethers) and negative repeated dose toxicity and skin sensitization data on disodium laureth sulfosuccinate supported the safety of these alkyl PEG sulfosuccinates in cosmetic products, but. The CIR Expert Panel concluded that the alkyl PEG sulfosuccinates are safe in the present practices of use and concentration when formulated to be nonirritating.

Amended Safety Assessment of Acid Violet 43 as Used in Cosmetics

2021 ◽  
Vol 40 (2_suppl) ◽  
pp. 5S-15S
Author(s):  
Monice M Fiume ◽  
Wilma F Bergfeld ◽  
Donald V Belsito ◽  
Ronald A Hill ◽  
Curtis D Klaassen ◽  
...  
Keyword(s):  
Chemical Structure ◽  
Safety Assessment ◽  
Expert Panel ◽  
Hair Dye ◽  
Anthraquinone Dye ◽  
Previous Conclusion ◽  
Acid Violet

The Expert Panel for Cosmetic Ingredient Safety (Panel) reopened the safety assessment of Acid Violet 43, a cosmetic ingredient that is an anthraquinone dye reported to function in cosmetics as a colorant. This colorant has the same chemical structure as Ext. D&C Violet No. 2, which is a certified colorant; however, Acid Violet 43 is not a certified color and it could have impurities that are not allowed in the certified color. The Panel reviewed relevant new data related to this ingredient and concluded that Acid Violet 43 is safe in the present practices of use and concentration for use in hair dye formulations. This conclusion supersedes the previous conclusion for Acid Violet 43 that included impurity specifications indicated for the certified color.

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