5 Addendum to the Final Report on the Safety Assessment of 2-Bromo-2-Nitropropane-1,3-Diol

1984 ◽  
Vol 3 (3) ◽  
pp. 139-155 ◽  

A literature review of test data that have become available since the 1979 toxicological safety report on 2-Bromo-2-Nitropropane-1,3-Diol (BNPD) is presented and discussed. The earlier conclusion that BNPD is safe as a cosmetic ingredient at concentrations up to 0.1% except under circumstances where its action with amines or amides can result in the formation of nitrosamines or nitrosamides is reaffirmed. The new data suggest the possibility that when it is absorbed, this ingredient may contribute to endogenous formation of nitrosamines in humans.

1985 ◽  
Vol 4 (3) ◽  
pp. 1-22 ◽  

Isostearyl Neopentanoate, the ester of Isostearyl Alcohol and Neopentanoic Acid, is used in cosmetic products as an emollient at concentrations up to 50 percent. The undiluted ingredient at doses up to 4 ml/kg was shown to be relatively non-toxic in short-and long-term feeding studies. Test data from animal and clinical studies indicate the undiluted ingredient is neither an irritant nor a sensitizer. A cosmetic formulation containing 16 percent Isostearyl Neopentanoate produced no phototoxicity and no photoallergenicity. Mutagenicity, carcinogenicity, and teratogenicity data were not available. Isostearyl Neopentanoate was not considered to be a significant comedogenic agent. On the basis of available data, it is concluded that this ingredient is safe as a cosmetic ingredient in its present practices of use.


1984 ◽  
Vol 3 (3) ◽  
pp. 43-99 ◽  

Toxicological test data on Ozokerite, Ceresin, Montan Wax, Paraffin, Microcrystalline Wax, Emulsifying Wax N.F., Synthetic Wax and Synthetic Beeswax are presented. Based on the documented animal and clinical test data, it is concluded that these waxes are safe for use as cosmetic ingredients in the present practices of concentration and use.


1984 ◽  
Vol 3 (3) ◽  
pp. 1-41 ◽  

Toxicological test data on four waxes-Candelilla, Carnauba, Japan, and Beeswax, singularly and in combination are presented. On the basis of the documented animal and clinical test data, it is concluded that these waxes are safe for cosmetic use.


1992 ◽  
Vol 11 (1) ◽  
pp. 145-155 ◽  

Sodium Cetearyl Sulfate is the sodium salt of a mixture of cetyl and stearyl sulfate which is used as a surfactant and cleansing agent in cosmetics at concentrations ranging from ≥ 0.1 to 25.0%. The LD50 was not achieved in two studies in which rats received a single oral dose of 5.0 ml/kg. In ocular irritation tests, 20.0% aqueous Sodium Cetearyl Sulfate was not irritating to the eyes of rabbits. Twenty percent Sodium Cetearyl Sulfate was not irritating to the skin of rabbits. In a guinea pig sensitization study, Sodium Cetearyl Sulfate was not a sensitizer. Sodium Cetearyl Sulfate is less irritating to the skin than Sodium Lauryl Sulfate, whose safety test data are summarized in the report. Due to the chemical similarity of these two cosmetic ingredients, the safety test data on Sodium Lauryl Sulfate was considered to be applicable to the safety evaluation of this ingredient. On the basis of the animal and clinical data on Sodium Cetearyl Sulfate and Sodium Lauryl Sulfate as presented in the report, it is concluded that Sodium Cetearyl Sulfate is safe as a cosmetic ingredient in the present practices of use and concentration.


1992 ◽  
Vol 11 (1) ◽  
pp. 43-49 ◽  

Isopropyl Isostearate, the ester of isopropyl alcohol and isostearic acid, is used as a skin conditioning agent-emollient in cosmetic products. Undiluted Isopropyl Isostearate was classified as a slight ocular irritant. Repeated applications of a 10.0% aqueous suspension of Isopropyl Isostearate to the skin of albino rabbits was well-tolerated. Based upon the safety test data on chemically similar isopropyl esters that is summarized in the report, it is concluded that Isopropyl Isostearate is safe as a cosmetic ingredient in the present practices of use and concentration.


1992 ◽  
Vol 11 (1) ◽  
pp. 157-163 ◽  

Sodium Myreth Sulfate is the sodium salt of sulfated, ethoxylated myristyl alcohol which is used as a surfactant and cleansing agent in cosmetics at concentrations ranging from > 1.0–5.0% to > 50.0%. A formulation containing 7.0% Sodium Myreth Sulfate was shown to be an ocular irritant in experimental animals and in some human test subjects. These irritant effects were similar to those previously reported for the chemically similar compound Sodium Laureth Sulfate which was shown to be safe for use in cosmetics. The report summarizes the safety test data on Sodium Laureth Sulfate. Based upon the combined data cited in the report on both cosmetic ingredients, it is concluded that Sodium Myreth Sulfate is safe as a cosmetic ingredient in the present practices of use and concentration.


1991 ◽  
Vol 10 (1) ◽  
pp. 99-101

Stearic Hydrazide is reported to be used in 17 cosmetic products at concentrations of use of less than 1.0%. Hydrazides and their salts are prohibited for use in cosmetic products by the European Economic Community. The report concludes that the safety of use of Stearic Hydrazide has not been documented and substantiated and that it is not possible to conclude that the ingredient is safe for use in cosmetic products. The report documents the types of safety test data that are needed to substantiate the safety of use of Stearic Hydrazide in cosmetic products.


1992 ◽  
Vol 11 (1) ◽  
pp. 51-56 ◽  

Isopropyl Linoleate is the ester of isopropyl alcohol and linoleic acid. In cosmetics, it is used as a skin conditioning agent and emollient at concentrations ranging from 0.1 % to 10.0%. In an acute oral toxicity study, none of the albino rabbits that received doses of 10.0% Isopropyl Linoleate in corn oil died. Isopropyl Linoleate (undiluted and 10.0% suspension) were classified as slight ocular irritants. Undiluted Isopropyl Linoleate was classified as a slight skin irritant. The report concludes that the safety of use of Isopropyl Linoleate has not been documented and substantiated, and that it is not possible to conclude that the ingredient is safe for use in cosmetic products. The report details the type of safety test data that is needed to substantiate the safety of use of Isopropyl Linoleate in cosmetic products.


2016 ◽  
Author(s):  
Michael Villaran ◽  
◽  
Meng Yue ◽  
Robert Lofaro ◽  
Athi Varuttamaseni ◽  
...  

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 ◽  
...  

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.


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