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.

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 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.

scholarly journals 4 Final Report on the Safety Assessment of 2,3-Naphthalenediol

1988 ◽  
Vol 7 (3) ◽  
pp. 353-357
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Safety Evaluation ◽  
Final Report ◽  
Cosmetic Products

The safety of 2,3-Naphthalenediol 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 as 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 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.

Final Report on the Safety Assessment of Aldioxa

1993 ◽  
Vol 12 (3) ◽  
pp. 237-242
Keyword(s):  
Organic Compound ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Safety Data ◽  
Control Group ◽  
Final Report ◽  
Cosmetic Products ◽  
Feeding Study ◽  
Human Volunteers

Aldioxa is a heterocyclic organic compound used in cosmetic products as an astringent and skin conditioning agent. The oral LD50 for mice exceeds 23 mg/kg, and 8 g/kg for rats. All of the toxicologic parameters investigated in a 94-day subchronic feeding study in rats were similar in the test and the control group. No significant macroscopic adverse results were obtained in a three generation study in which rats were fed diets containing 10% Aldioxa. A suspension containing 25% Aldioxa was not a sensitizer when applied to the shaved backs of 3 male guinea pigs, nor when 10 animals were given intradermal injections of a 2% Aldioxa suspension on alternating days for a total of 10 applications and challenged after a 10-day nontreatment period. A hydrophilic unguent containing 4% Aldioxa was neither an irritant nor a sensitizer when evaluated on 200 human volunteers. The safety of Aldioxa has not been completely documented and substantiated. It cannot be concluded that this ingredient is safe for use in cosmetic products until the appropriate needed safety data cited in the report have been obtained and evaluated.

Final Report on the Safety Assessment of Polyvinyl Acetate

1992 ◽  
Vol 11 (4) ◽  
pp. 465-473 ◽  
Keyword(s):  
Safety Assessment ◽  
Polyvinyl Acetate ◽  
Chinese Hamster ◽  
Safety Evaluation ◽  
Fibroblast Cell ◽  
Final Report ◽  
Cosmetic Products ◽  
Ames Assay ◽  
Negative Results ◽  
Chinese Hamster Fibroblast

Polyvinyl Acetate, as used in cosmetic products, is a latex emulsion known as the homopolymer of ethenyl acetate. It is used as a binder, emulsion stabilizer, and hair fixative at concentrations less than 25%. Polyvinyl Acetate was nonmutagenic in the Ames assay, with and without activation, and in the Chinese Hamster fibroblast cell assay. Carcinogenic implantation studies using mice gave negative results. It is concluded that the data available are insufficient to support the safety of Polyvinyl Acetate as currently used in cosmetic products. The types of data needed to complete the safety evaluation are listed in the report.

Final Report On the Safety Assessment of Benzoxiquine1

1997 ◽  
Vol 16 (1_suppl) ◽  
pp. 117-122
Author(s):  
F. Alan Andersen
Keyword(s):  
Safety Assessment ◽  
Safety Data ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Products ◽  
Over The Counter ◽  
Drug Products ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Mammalian System

Benzoxiquine is described as a biocide for use in cosmetic products. It is currently reported to be used in only one product. In a separate finding, the Food and Drug Administration determined that Benzoxiquine is not generally recognized as safe and effective in over-the-counter topical antifungal drug products. The only data available on the toxicity of Benzoxiquine indicates that it is mutagenic in the Ames test without metabolic activation. Because of the lack of data, the safety of Benzoxiquine could not be substantiated. The data needed to make a safety assessment include purity/impurities, ultraviolet absorption (if there is absorption, then photosensitization data will be needed), 28-day dermal toxicity, dermal teratogenicity, ocular irritation (if already available only), dermal irritation and sensitization, and two different genotoxicity studies (one using a mammalian system). If the latter data are positive, dermal carcinogenesis data using the methods of the National Toxicology Program will be needed. It cannot be concluded that Benzoxiquine is safe for use in cosmetic products until these safety data have been obtained and evaluated.

scholarly journals Final Report of the Cosmetic Ingredient Review Expert Panel on the Safety Assessment of Dicarboxylic Acids, Salts, and Esters

2012 ◽  
Vol 31 (4_suppl) ◽  
pp. 5S-76S ◽  
Author(s):  
Monice M. Fiume ◽  
HBart eldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Dicarboxylic Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Dicarboxylic Acids ◽  
Entire Group ◽  
Final Report ◽  
Product Usage ◽  
Cosmetic Product

The CIR Expert Panel assessed the safety of dicarboxylic acids and their salts and esters as used in cosmetics. Most dicarboxylic acids function in cosmetics as pH adjusters or fragrance ingredients, but the functions of most of the salts in cosmetics are not reported. Some of the esters function as skin conditioning or fragrance ingredients, plasticizers, solvents, or emollients. The Expert Panel noted gaps in the available safety data for some of the dicarboxylic acid and their salts and esters in this safety assessment. The available data on many of the ingredients are sufficient, however, and similar structural activity relationships, biologic functions, and cosmetic product usage suggest that the available data may be extrapolated to support the safety of the entire group. The Panel concluded that the ingredients named in this report are safe in the present practices of use and concentration.

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.

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