Final Report on the Safety Assessment of Cocoyl Sarcosine, Lauroyl Sarcosine, Myristoyl Sarcosine, Oleoyl Sarcosine, Stearoyl Sarcosine, Sodium Cocoyl Sarcosinate, Sodium Lauroyl Sarcosinate, Sodium Myristoyl Sarcosinate, Ammonium Cocoyl Sarcosinate, and Ammonium Lauroyl Sarcosinate

2001 ◽  
Vol 20 (1_suppl) ◽  
pp. 1-14 ◽  
Keyword(s):  
Fatty Acids ◽  
Fatty Acid ◽  
Safety Assessment ◽  
Final Report ◽  
Inhalation Toxicity ◽  
Cosmetic Products ◽  
Cells In Culture ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations ◽  
Lauroyl Sarcosinate

This safety assessment addresses cosmetic ingredients that are N-acyl derivatives of sarcosine and are generally referred to as acyl sarcosines, and those that are salts, known generally as acyl sar-cosinates. Previous assessments have addressed the safety of each of the fatty acids that appear in these acyl sarcosines and sarcosinates (Coconut Acid, Oleic Acid, Lauric Acid, and Myristic Acid). In each case the fatty acid was either safe for use or safe as used in cosmetic formulations. Acyl sarcosines are considered modified fatty acids with greater solubility and increased acidity of the carboxylic acid group compared to the parent fatty acid. They are used in a large number of cosmetic formulations as hair-conditioning agents and surfactant-cleansing agents. In soaps, concentrations are reported to be as high as 12.9%. These ingredients have low oral toxicity in rats. Although cytotoxic to Chinese hamster cells in culture, acyl sarcosines and sarcosinates are not mutagenic in those cells, nor in bacterial cells in culture. Carcinogenicity data were not available. These ingredients are nonirritating and nonsen-sitizing to animal and human skin, although they can enhance the penetration of other ingredients through the skin. For that reason, caution should be exhibited in formulating cosmetic products that contain these ingredients in combination with other ingredients whose safety is based on their lack of absorption or where dermal absorption is a concern (e.g., HC Yellow No. 4, Disperse Yellow 3). Because sarcosine can be nitrosated to form N-nitrososarcosine, a known animal carcinogen, these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed. With the above caveat, and based on the available data, it was concluded that these acyl sarcosines and sarcosinates are safe as used in rinse-off products. They may be safely used in leave-on products at concentrations up to 5%, the highest concentration tested in clinical irritation and sensitization studies. Oleoyl Sarcosine is used as a corrosion inhibitor in some aerosol products, at extremely low concentrations. In this circumstance, the ingredient is not being used as a cosmetic ingredient and this report is not intended to limit that use. Because of the absence of data on inhalation toxicity, however, it was concluded that the available data were not sufficient to support the safety of acyl sarcosines and sarcosinates as cosmetic ingredients in products where they are likely to be inhaled.

4 Final Report on the Safety Assessment of Butyl Stearate, Cetyl Stearate, Isobutyl Stearate, Isocetyl Stearate, Isopropyl Stearate, Myristyl Stearate, and Octyl Stearate

1985 ◽  
Vol 4 (5) ◽  
pp. 107-146 ◽  
Keyword(s):  
Safety Assessment ◽  
Animal Studies ◽  
Health Effect ◽  
Final Report ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Potential Health ◽  
Rabbit Skin ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations

The 7 Stearates described in this report are either oily liquids or waxy solids that are primarily used in cosmetics as skin emollients at concentrations up to 25 percent. The toxicology of the Stearates has been assessed in a number of animal studies. They have low acute oral toxicity and are essentially nonirritating to the rabbit eye when tested at and above use concentration. At cosmetic use concentrations the Stearates are, at most, minimally irritating to rabbit skin. In clinical studies the Stearates and cosmetic products containing them were at most minimally to mildly irritating to the human skin, essentially nonsensitizing, nonphototoxic and nonphotosensitizing. Comedogenicity is a potential health effect that should be considered when the Stearate ingredients are used in cosmetic formulations. On the basis of the information in this report, it is concluded that Butyl, Cetyl, Isobutyl, Isocetyl, Isopropyl, Myristyl, and Octyl Stearate are safe as cosmetic ingredients in the present practices of use.

scholarly journals Final Amended Report on Safety Assessment on Aminomethyl Propanol and Aminomethyl Propanediol

2009 ◽  
Vol 28 (2_suppl) ◽  
pp. 141S-161S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Curtis D. Klaassen ◽  
James G. Marks ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Secondary Amines ◽  
Primary Amines ◽  
Inhalation Toxicity ◽  
Toxicity Data ◽  
Oral Toxicity ◽  
Dermal Irritation ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations ◽  
Allergic Contact

Aminomethyl propanol and aminomethyl propanediol are substituted aliphatic alcohols that function as pH adjusters in cosmetic products at concentrations less than 10%; additionally, aminomethyl propanediol is a fragrance. Extensive oral toxicity data are reviewed, with fewer inhalation toxicity data. Dermal toxicity data are presented that demonstrate, for example, that a mascara with 1.92% aminomethyl propanediol does not cause dermal irritation or allergic contact sensitization, suggesting that the maximum reported use concentration of 2% in mascara would be safe. Although these ingredients are primary amines that are not substrates for N-nitrosation, they may contain secondary amines as impurities in finished products that may undergo N-nitrosation. These ingredients should not be included in cosmetic formulations containing N-nitrosating agents. The Cosmetic Ingredient Review Expert Panel concludes that aminomethyl propanol and aminomethyl propanediol are safe as cosmetic ingredients in the practices of use and concentrations as described in this safety assessment.

Final Report on the Safety Assessment of Sorbitan Caprylate, Sorbitan Cocoate, Sorbitan Diisostearate, Sorbitan Dioleate, Sorbitan Distearate, Sorbitan Isostearate, Sorbitan Olivate, Sorbitan Sesquiisostearate, Sorbitan Sesquistearate, and Sorbitan Triisostearate

2002 ◽  
Vol 21 (1_suppl) ◽  
pp. 93-112 ◽  
Keyword(s):  
Fatty Acids ◽  
Fatty Acid ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Fatty Acid Esters ◽  
High Exposure ◽  
Cosmetic Formulations ◽  
Sorbitan Fatty Acid Esters ◽  
Skin Irritants ◽  
Acid Esters

Sorbitan fatty acid esters are mono-, di-, and triesters of fatty acids and sorbitol-derived hexitol anhydrides. They function as surfactants in cosmetic formulations. Previously, the Cosmetic Ingredient Review (CIR) Expert Panel had reviewed the safety of several of these sorbitan fatty acid esters (Sorbitan Laurate, Sorbitan Oleate, Sorbitan Palmitate, Sorbitan Sesquioleate, Sorbitan Stearate, Sorbitan Trioleate, and Sorbitan Tristearate). This safety assessment is an addendum to that report that includes Sorbitan Caprylate, Sorbitan Cocoate, Sorbitan Diisostearate, Sorbitan Dioleate, Sorbitan Distearate, Sorbitan Isostearate, Sorbitan Olivate, Sorbitan Sesquiisostearate, Sorbitan Sesquistearate, and Sorbitan Triisostearate. Although concentrations of these ingredients up to 25% have been reported to be used, most commonly they are used at less than 10%. These esters may be hydrolyzed to the fatty acid and anhydrides of Sorbitol. Fatty Acids are absorbed and metabolized. Sorbitan fatty acid esters were relatively nontoxic via ingestion in acute and long-term studies. They were generally minimal to mild skin irritants in animal studies, except that Sorbitan Isostearate applied to the skin was a moderate irritant in one rabbit study and when injected intradermally caused mild to severe irritation in guinea pigs. Sorbitan fatty acid esters did not sensitize guinea pigs. The fatty acid component, tested alone, typically caused only slight irritation and sensitization, and was not photosensitizing. Sorbitan fatty acid esters were not ocular irritants. Fatty acids are normal components of diet for which no data were available concerning reproductive or developmental toxicity, but Sorbitol had no adverse effects on the reproduction of CD rats during a multigeneration feeding study and was not a reproductive toxin at doses of 3000 to 7000 mg/kg/day for 2 years. Overall these esters and their corresponding fatty acids were not mutagenic, but Sorbitan Oleate was reported to reduce DNA repair following ultraviolet radiation exposure in human lymphocytes in culture. Sorbitan Laurate and Sorbitan Trioleate were cocarcinogens in one mouse study, but Sorbitan Trioleate and Sorbitan Oleate were not tumor promoters in another study. In clinical tests, Sorbitan fatty acid esters were generally minimal to mild skin irritants and were nonsensitizing, but Sorbitan Sesquioleate did produce an allergic reaction in fewer than 1% of patients with suspected contact dermatitis and addition of Sorbitan Sesquioleate to the components of a fragrance mix used in patch testing increased both irritant and allergic reactions to the fragrance mix. Careful consideration was made of the data on the cocarcinogenesis of Sorbitan Laurate and Sorbitan Trioleate, but the high exposure levels, high frequency of exposure, and absence of a dose-response led to the conclusion that there was not a cocarcinogenesis risk with the use of these ingredients in cosmetic formulations. Accordingly, these ingredients were considered safe for use in cosmetic formulations under the present practices of use.

5 Final Report on the Safety Assessment of Propylene Glycol Stearate and Propylene Glycol Stearate Self-Emulsifying

1983 ◽  
Vol 2 (5) ◽  
pp. 101-124 ◽  
Keyword(s):  
Propylene Glycol ◽  
Safety Assessment ◽  
Animal Studies ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Cosmetic Ingredients ◽  
Available Information

Propylene Glycol Stearates (PGS) are a mixture of the mono- and diesters of triple-pressed stearic acid and propylene glycol and are used in a wide variety of cosmetic products. Studies with 14C-labeled PGS show that it is readily metabolized following ingestion. In rats, the acute oral LD50 has been shown to be approximately 25.8 g/kg. The raw ingredient produced no significant dermal toxicity, skin irritation, or eye irritation in acute tests with rabbits. Subchronic animal studies produced no evidence of oral or dermal toxicity. Propylene glycol monostea-rate was negative in in vitro microbial assays for mutagenicity. In clinical studies, PGS produced no significant skin irritation at concentrations up to 55% nor skin sensitization on formulations containing 2.5%. Photo-contact allergenicity tests on product formulations containing 1.5% PGS were negative. From the available information, it is concluded that Propylene Glycol Stearates are safe as cosmetic ingredients in the present practices of use.

Final Report of the Cosmetic Ingredient Review Expert Panel on the Safety Assessment of Cocamidopropyl betaine (CAPB)

2012 ◽  
Vol 31 (4_suppl) ◽  
pp. 77S-111S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Fatty Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
Quantitative Risk Assessment ◽  
Final Report ◽  
Significant Toxicity ◽  
Cosmetic Ingredients ◽  
Cocamidopropyl Betaine

Cocamidopropyl betaine (CAPB) and related amidopropyl betaines are zwitterions used mainly as surfactants in cosmetics. These cosmetic ingredients are similar in their chemistry, in particular with respect to the presence of 3,3-dimethylamino-propylamine (DMAPA) and fatty acid amidopropyl dimethylamine (amidoamine) impurities, which are known as sensitizers. The CIR Expert Panel concluded that because these ingredients present no other significant toxicity, when formulated to be nonsensitizing (which may be based on a quantitative risk assessment), these ingredients are safe for use as cosmetic ingredients in the practices of use and concentration of this safety assessment.

1 Final Report on the Safety Assessment of Sodium Laureth Sulfate and Ammonium Laureth Sulfate

1983 ◽  
Vol 2 (5) ◽  
pp. 1-34 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Experimental Animals ◽  
Cosmetic Formulations ◽  
Available Information ◽  
Toxicological Testing

Sodium Laureth Sulfate and Ammonium Laureth Sulfate are used in cosmetic products as cleansing agents, emulsifiers, stabilizers, and solubilizers. The ingredients have been shown to produce eye and/or skin irritation in experimental animals and in some human test subjects; irritation may occur in some users of cosmetic formulations containing the ingredients under consideration. The irritant effects are similar to those produced by other detergents, and the severity of the irritation appears to increase directly with concentration. However, Sodium and Ammonium Laureth Sulfate have not evoked adverse responses in any other toxicological testing. On the basis of available information, the Panel concludes that Sodium Laureth Sulfate and Ammonium Laureth Sulfate are safe as presently used in cosmetic products.

5: Final Report on the Safety Assessment of Steareth-2,-4,-6,-7,-10,-11,-13,-15, and-20

1988 ◽  
Vol 7 (6) ◽  
pp. 881-910 ◽  
Keyword(s):  
Safety Assessment ◽  
Final Report ◽  
Stearyl Alcohol ◽  
Tumor Promoters ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations ◽  
Alkyl Ethers ◽  
Mild Irritants

The steareth group is a series of compounds prepared by reacting stearyl alcohol with ethylene oxide to form polyoxyethylene stearyl ethers. Steareths are waxy solids used primarily as emulsifiers in cosmetics at concentrations of up to 25%. Steareth-2 and-10 were nontoxic to rats in acute oral toxicity studies. In subchronic testing, steareth-20 was nontoxic to rabbits when administered dermally at concentrations of 4%. Steareth-2 and-10, at concentrations of up to 60% in water, were at most mildly irritating to rabbit eyes and only mild irritants when tested in cosmetic formulations at concentrations of up to 60%. Structurally similar polyoxyethylene alkyl ethers were neither mutagenic nor tumor promoters. Steareth-2,-10, and-20 in water were neither primary irritants nor sensitizers to human skin. Steareth-20 was not phototoxic. On the basis of the available data it is concluded that steareths-2,-4,-6,-7,-10,-11,-13,-15, and-20 are safe as cosmetic ingredients in the present practices of use and concentration.

3 Final Report on the Safety Assessment of Tallow, Tallow Glyceride, Tallow Glycerides, Hydrogenated Tallow Glyceride, and Hydrogenated Tallow Glycerides

1990 ◽  
Vol 9 (2) ◽  
pp. 153-164 ◽  
Keyword(s):  
Fatty Acid ◽  
Drug Administration ◽  
Safety Assessment ◽  
Expert Panel ◽  
Food And Drug Administration ◽  
Consumer Products ◽  
Skin Care ◽  
Final Report ◽  
Cosmetic Ingredients ◽  
The Individual

Tallow, Tallow Glyceride, Tallow Glycerides, Hydrogenated Tallow Glyceride, and Hydrogenated Tallow Glycerides are used in eye and face makeup preparations and in skin care preparations. Concentrations of use range from ≤0.1 % to > 50%. The fatty acid constituents of Tallow, and some of the corresponding fatty acid alcohols have been evaluated for safety by the Federation of American Societies of Experimental Biology, the Food and Drug Administration, and by an Expert Panel of the Cosmetic Ingredient Review. In all cases, the ingredients were found safe in present practices of use. None of these constituents of Tallow were toxic through oral and dermal exposure, they were not ocular or dermal irritants, and they were neither dermal sensitizers nor photosensitizers. The same was true for other oils which contain varying concentrations of the constituents of Tallow. Based on the CIR safety evaluations of the individual constituents of Tallow and of cosmetic ingredients containing the constituents of Tallow, and on the approval of Tallow for use in foods and other consumer products, it is concluded that Tallow, Tallow Glyceride, Tallow Glycerides, Hydrogenated Tallow Glyceride, and Hydrogenated Tallow Glycerides are safe as cosmetic ingredients in the present practices of use.

Final Amended Report on Safety Assessment on Aminomethyl Propanol and Aminomethyl Propanediol

2009 ◽  
Vol 28 (6_suppl) ◽  
pp. 141S-161S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Curtis D. Klaassen ◽  
James G. Marks ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Secondary Amines ◽  
Primary Amines ◽  
Inhalation Toxicity ◽  
Toxicity Data ◽  
Oral Toxicity ◽  
Dermal Irritation ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations ◽  
Allergic Contact

Aminomethyl propanol and aminomethyl propanediol are substituted aliphatic alcohols that function as pH adjusters in cosmetic products at concentrations less than 10%; additionally, aminomethyl propanediol is a fragrance. Extensive oral toxicity data are reviewed, with fewer inhalation toxicity data. Dermal toxicity data are presented that demonstrate, for example, that a mascara with 1.92% aminomethyl propanediol does not cause dermal irritation or allergic contact sensitization, suggesting that the maximum reported use concentration of 2% in mascara would be safe. Although these ingredients are primary amines that are not substrates for N-nitrosation, they may contain secondary amines as impurities in finished products that may undergo N-nitrosation. These ingredients should not be included in cosmetic formulations containing N-nitrosating agents. The Cosmetic Ingredient Review Expert Panel concludes that aminomethyl propanol and aminomethyl propanediol are safe as cosmetic ingredients in the practices of use and concentrations as described in this safety assessment.

5 Final Report on the Safety Assessment of Potassium-Coco-Hydrolyzed Animal Protein and Triethanolamine-Coco-Hydrolyzed Animal Protein

1983 ◽  
Vol 2 (7) ◽  
pp. 75-86 ◽  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Condensation Product ◽  
Animal Protein ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Cosmetic Ingredients ◽  
Available Information

Potassium and TEA-Coco-Hydrolyzed Animal Proteins (PCHAP and TEA-CHAP) are salts of the condensation product of coconut acid and hydrolyzed animal protein. They are used in cosmetic products as detergents, foamers, and levelers. Acute oral toxicity studies showed that both PCHAP and TEA-CHAP were practically nontoxic when ingested. Both ingredients at concentrations of 10%-100% were practically nonirritating to moderately irritating when instilled in the eyes of rabbits. Both were nonirritating to mildly irritating when applied at concentrations of 10%-50% to the skin of rabbits. Guinea pig sensitization studies with both PCHAP and TEA-CHAP were negative. PCHAP and TEA-CHAP, at concentrations of 2% 10% were nonirritating to practically nonirritating in humans. In a repeated insult patch test, PCHAP gave a positive sensitization reaction in two of 168 subjects; two additional subjects showed cumulative irritation and one other was reported to have a nonspecific irritation. One subject out of 28 tested did not demonstrate significant irritation or sensitivity to either PCHAP or TEA-CHAP, but was photosensitized to both ingredients. On the basis of the available information, the Panel concludes that Potas-sium-Coco-Hydrolyzed Animal Protein and TEA-Coco-Hydrolyzed Animal Protein are safe as cosmetic ingredients in the present practices of use as recorded in this report.

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