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.

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.

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 6-Hydroxyindole as Used in Cosmetics

2014 ◽  
Vol 33 (3_suppl) ◽  
pp. 24S-35S
Author(s):  
Christina L. Burnett ◽  
Bart Heldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Hair Dye ◽  
Human Data ◽  
Oxidative Hair Dye

The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of 6-hydroxyindole, which functions as an oxidative hair dye ingredient. The Panel considered relevant animal and human data provided in this safety assessment and concluded that 6-hydroxyindole is safe for use in oxidative hair dye formulations.

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 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.

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 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.

Final Report on the Safety Assessment of Sodium Picramate

1992 ◽  
Vol 11 (4) ◽  
pp. 447-464 ◽  
Keyword(s):  
Safety Assessment ◽  
Final Report ◽  
Mouse Bone Marrow ◽  
Skin Sensitization ◽  
Cosmetic Products ◽  
Hair Dye ◽  
Mouse Lymphoma Cells ◽  
Dominant Lethal Assay ◽  
Oxidative Hair Dye ◽  
Mouse Lymphoma

Sodium Picramate is used as a colorant in cosmetic products at concentrations up to 1.0%. The LD50 for Picramic Acid as assayed in mice was 378 mg/kg. The percutaneous toxicity of an oxidative hair dye formulation containing 0.1 % Sodium Picramate on abraded and nonabraded skin applied biweekly for 13 weeks produced neither gross nor microscopic changes. A 2.5% aqueous solution of this cosmetic ingredient was neither an ocular nor skin irritant. In a skin sensitization study, 2% Picramic Acid induced mild sensitization reactions in four of 15 guinea pigs. Picramic Acid was mutagenic in the Ames assay but nonmutagenic at the TK locus in L5178Y mouse lymphoma cells, in the mouse dominant lethal assay or in the mouse bone marrow cytogenetic assay. An oxidative hair dye containing 0.01 % Picramic Acid applied weekly for 2 years to the skin of mice was noncarcinogenic. A hair dye containing 0.1% Sodium Picramate was nonteratogenic when applied dermally. The studies cited indicate that 0.2% Sodium Picramate may be a mild sensitizer in humans. Due to this potential for sensitization, it is recommended that the safe use limit of Sodium Picramate in cosmetic products be set at 0.1 %.

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.

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