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.

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.

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 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.

4 Final Report on the Safety Assessment of o-Cymen-5-ol

1984 ◽  
Vol 3 (3) ◽  
pp. 131-138
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Safety Evaluation ◽  
Final Report ◽  
Cosmetic Products

The safety on o-Cymen-5-ol has not been documented and substantiated. The Cosmetic Ingredient Review Expert Panel cannot conclude that o-Cymen-5-ol is safe for use in cosmetic products until such time that the appropriate safety data have been obtained and evaluated. The data that were available are documented in the report as well as the types of data that are required before a safety evaluation may be undertaken.

3 Final Report on the Safety Assessment of t-Butyl Alcohol

1989 ◽  
Vol 8 (4) ◽  
pp. 627-641 ◽  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Safety Evaluation ◽  
Butyl Alcohol ◽  
Final Report ◽  
Cosmetic Products

The safety of this ingredient has not been documented and substantiated. The Cosmetic Ingredient Review Expert Panel cannot conclude that t-Butyl Alcohol is safe for use in cosmetic products until such time that the appropriate safety data have been obtained and evaluated. The data that were available are documented in the report as well as the types of data that are required before a safety evaluation may be undertaken.

scholarly journals 1 Final Report on the Safety Assessment of Benzylparaben

1986 ◽  
Vol 5 (5) ◽  
pp. 301-307 ◽  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Safety Evaluation ◽  
Final Report ◽  
Cosmetic Products

The safety of this ingredient has not been documented and substantiated. The Cosmetic Ingredient Review Expert Panel cannot conclude that Benzylparaben is safe for use in cosmetic products until such time that the appropriate safety data have been obtained and evaluated. The data that were available are documented in the report as well as the types of data that are required before a safety evaluation may be undertaken.

scholarly journals 3 Final Report on the Safety Assessment of t-Butyl Hydroquinone

1986 ◽  
Vol 5 (5) ◽  
pp. 329-351 ◽  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Safety Evaluation ◽  
Final Report ◽  
Cosmetic Products

The safety of this ingredient has not been documented and substantiated. The Cosmetic Ingredient Review Expert Panel cannot conclude that t-Butyl Hydroquinone is safe for use in cosmetic products until such time that the appropriate safety data have been obtained and evaluated. The data that were available are documented in the report as well as the types of data that are required before a safety evaluation may be undertaken.

Final Report on the Safety Assessment of Hexamidine and Hexamidine Diisethionate1

2007 ◽  
Vol 26 (3_suppl) ◽  
pp. 79-88 ◽  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Expert Panel ◽  
Developmental Toxicity ◽  
The Body ◽  
Tissue Type ◽  
Clinical Test ◽  
Final Report ◽  
Contact Sensitivity ◽  
Cosmetic Products

Hexamidine Diisethionate functions as a biocide in cosmetics at concentrations of 0.03% to 0.1% in 38 cosmetic products. Hexamidine functions as a biocide and preservative in cosmetics, but is not in current use in cosmetics, but it is used in over-the-counter (OTC) drug products. Hexamidine was poorly absorbed by human cadaver skin when in water-oil formulations or in a gel that simulated a cosmetic product formulation. Hexamidine Diisethionate was poorly absorbed by the skin of live rats and was not stored in any tissue type. Hexamidine Diisethionate given to rats intravenously was rapidly metabolized to Hexamidine. Excretion was primarily via the feces, with a small amount excreted in the urine. Acute oral LD50 values of Hexamidine Diisethionate were 0.71 to 2.5 g/kg in mice and 0.75 g/kg in rats. Dermal exposure to 4 g/kg Hexamidine Diisethionate in rats or up to 9.4 ml/kg of a 0.1% Hexamidine Diisethionate solution under occlusion in rabbits produced no mortality or other signs of toxicity. The no-observed-effect level (NOEL) for oral subchronic toxicity of Hexamidine Diisethionate in rats was 50 mg/kg/day. No signs of toxicity were observed with 2% Hexamidine Diisethionate in subchronic studies using rabbits. Application of 0.1 ml of 0.11% Hexamidine Diisethionate in aqueous solution to the eyes of rabbits produced transient reactions; 0.05% produced no reactions. Slight erythema was observed with 0.10% Hexamidine Diisethionate applied to the abraded skin of 1/11 albino rabbits. A 40% solution of Hexamidine Diisethionate applied to 10% of the body surface of rats produced slight erythema, slight edema, and scabbing in some animals at varying times after treatment. Hexamidine Diisethionate was not a sensitizer in the guinea pig maximization test or in an intracutaneous guinea pig sensitization test. Hexamidine Diisethionate was not a photosensitizer in albino rabbits. Hexamidine Diisethionate was not mutagenic in a bacterial reverse mutagenicity assay or clastogenic in mammalian cells. Hexamidine Diisethionate at 0.10% did not provoke primary irritation, inflammation, or sensitization in a clinical test of 200 human subjects. One case report of photosensitivity to Hexamidine and one of contact sensitivity to Hexamidine were reported. There were nine case reports of contact sensitivity to Hexamidine Diisethionate. A European safety assessment recommended a limit of 0.1% Hexamidine Diisethionate in leave-on and rinse-off cosmetic products. In considering the available data, the Cosmetic Ingredient Review (CIR) Expert Panel acknowledged the lack of carcinogenicity and reproductive/developmental toxicity data. Because genotoxicity studies were negative, and there were no structural alerts, the Panel concluded that it was unlikely that these ingredientswould be carcinogenic. Because the rate of absorption of Hexamidine and Hexamidine Diisethionate is slow, there is no tissue accumulation, and excretion is rapid and complete, and there was no toxicity in a subchronic study, the Panel concluded that dermal exposures would not likely present a risk of reproductive/ developmental toxicity. The Panel noted that a guinea pig maximization study using Hexamidine Diisethionate produced no dermal reactions and that a clinical test at 0.1% produced no irritation or sensitization. The Panel also expressed concern regarding the possible presence of 1,4-dioxane as an impurity, and stressed that the cosmetic industry should continue to use the necessary purification procedures to remove these impurities from the ingredient before blending into cosmetic formulations. The Panel noted that there are no data for concentration of use for eye makeup and baby products, and was concerned that there should not be unrestricted concentration levels in these product categories. Although there are gaps in knowledge about product use, the overall information available on the types of products in which these ingredients are used and at what concentration indicate a pattern of use. Within this overall pattern of use, the Expert Panel considers all ingredients in this group to be safe at concentrations up to and including 0.1%.

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.

Final Report on the Safety Assessment of Maleic Acid1

2007 ◽  
Vol 26 (2_suppl) ◽  
pp. 125-130 ◽  
Keyword(s):  
Maleic Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
Human Subjects ◽  
Final Report ◽  
Solution Ph ◽  
Low Concentrations ◽  
Cosmetic Formulations ◽  
Sperm Penetration ◽  
Positive Pattern

Maleic Acid is a dicarboxylic acid that functions as a fragrance ingredient and pH adjuster in cosmetics—it is used in a few cosmetic product formulations at low concentrations. Maleic Acid is commonly used in research studies to induce Fanconi syndrome in rats and dogs in an attempt to study the mechanism of this disease. One such study found decreased glomerular filtration rate in rats given 9.0 mmol/kg, but not with 1.5 mmol/kg, Maleic Acid intraperitoneally. Preincubation with 0.75 mmol/L of Maleic Acid reduced sperm penetration of golden hamster eggs to zero. Maleic Acid failed to induce any significant increases in revertant count in strains TA1535, TA1537, TA98, and TA100 at concentrations up to 7500 µg/plate. A concentration of 2.0 × 10 -2 M Maleic Acid did show a positive pattern in a DNA synthesis inhibition test. Maleic Acid at 10%, pH 1.0, applied for 30 s on rabbit eyes, caused permanent opacity. A 1% solution, pH 1.0, applied for 2 min caused cloudiness of the cornea, but no lasting injury, and a 5% solution, also at pH 1.0, had a similar but more intense effect, with recovery delayed 6 to 7 days. Application of 10µl Maleic Acid (pH not stated) to the volar forearm and labia majora of 21 female Caucasians produced an inflammatory response at 24 and 48 h, which varied from minimal erythema to marked erythema with marked vesiculation. Maleic Acid at 20% (pH not stated) applied to one forearm daily for a period of 6 weeks to 50 human subjects produced acute vesicular dermatitis in 17 subjects, who were dropped from the study. Only five of the remaining subjects accommodated to the treatment, the rest had varying degrees of inflammation or hyperirritable skin. Although Maleic Acid itself may be a dermal and/or ocular irritant, its use as a pH adjustor in cosmetic formulations dictates that most of the acid will be neutralized into various maleate salts. Therefore, the concentration of free Maleic Acid is expected to be low, and dermal or systemic toxicity is not expected to be a concern. The safety of Maleic Acid as a pH adjustor should not be based on the concentration of use, but on the amount of free Maleic Acid that remains after neutralizing the formulation. There is no reason to expect this ingredient to induce any toxicity when used for this purpose. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that Maleic Acid is safe for use in cosmetic formulations as a pH adjustor in the practices of use as described in this safety assessment.

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