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.

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 Report on the Safety Assessment of Glyceryl Stearate and Glyceryl Stearate/SE

1982 ◽  
Vol 1 (4) ◽  
pp. 169-192 ◽  
Keyword(s):  
Adverse Effects ◽  
Safety Assessment ◽  
Mouse Skin ◽  
Toxicity Tests ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Patch Tests ◽  
Cosmetic Formulations

Glyceryl Stearate and Glyceryl Stearate/SE are the esterification products of glycerine and stearic acid, and are used in cosmetic formulations as emollients, emulsifiers, and stabilizers. In acute oral toxicity studies in rats, both ingredients were slightly toxic. Glyceryl Stearate in the diet of rats for three consecutive generations had no adverse effects. Five percent Glyceryl Stearate did not promote the carcinogenicity of DMBA in mouse skin. In subchronic and chronic dermal toxicity tests, Glyceryl Stearate was nontoxic to rabbits but did cause moderate irritation. Primary eye irritation studies, at concentrations up to 100%, were mildly irritating or nonirritating to rabbits. Single and Repeated Insult Patch Tests showed both ingredients to be nonsensitizing and nonirritating. Products containing 2% Glyceryl Stearate were nonphototoxic and nonphotoallergenic. On the basis of the available data, it is concluded that Glyceryl Stearate and Glyceryl Stearate/SE are safe for topical application to humans in the present practices of use and concentration.

scholarly journals 1 Final Report on the Safety Assessment of Cocoamphoacetate, Cocoamphopropionate, Cocoamphodiacetate, and Cocoamphodipropionate

1990 ◽  
Vol 9 (2) ◽  
pp. 121-142 ◽  
Keyword(s):  
Patch Test ◽  
Organic Compounds ◽  
Safety Assessment ◽  
Metabolic Activation ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
Ocular Irritation ◽  
Cosmetic Ingredients ◽  
Rats And Mice

Cocoamphoacetate (CAA), Cocoamphopropionate (CAP), Cocoamphodiacetate (CADA), and Cocoamphodipropionate (CADP) are imidazoline-derived amphoteric organic compounds. These amphoteric compounds are used in cosmetics as surfactants, mild foaming and cleansing agents, detoxifying agents, and conditioners at concentrations ranging from ≤ 0.1 to 50 percent. In acute oral toxicity studies, CADA and CAA were nontoxic in rats and mice, CADP was nontoxic in rats, and CAP was nontoxic in mice. An oral LD50 of 7.8 ml/kg was reported for mice dosed with 70% CADP. The results of ocular irritation studies of these compounds, as commercially supplied, varied widely. CADA was moderately to severely irritating when eyes were not rinsed and practically nonirritating to mildly irritating when rinsed. CADP was practically nonirritating under unrinsed conditions. CAA was minimally to severely irritating and CAP was practically nonirritating to minimally irritating under unrinsed conditions. In a clinical ocular study, 1,3, and 10% dilutions of a shampoo containing 28.1% CADA were nonirritating to the human eye. CAP, CADA, and CADP were nonmutagenic in the Ames assay, both with and without metabolic activation. CAA and CAP, at a concentration of 10%, were neither irritants nor sensitizers in a repeated insult patch test on 141 subjects. Based upon the available data, it is concluded that CAA, CAP, CADA, and CADP are safe for use as cosmetic ingredients.

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.

Final Report on the Safety Assessment of Glycol Stearate, Glycol Stearate SE, and Glycol Distearate

1990 ◽  
Vol 1 (2) ◽  
pp. 1-11 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Laboratory Animals ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Animal Data ◽  
Cosmetic Ingredients ◽  
Available Information

Glycol Stearate, Glycol Stearate SE, and Glycol Distearate consist primarily of the mono- and diesters of triple-pressed stearic acid. They are used in numerous categories of cosmetic products at concentrations ranging from less than 0.1 to 10%. Animal data for acute oral toxicity, skin and eye irritation, and sensitization show that these ingredients have low acute toxicity. A repeated insult patch test with 50% Glycol Distearate on 125 subjects presented no evidence of skin irritation or hypersensitivity. Human studies using formulations containing Glycol Stearate at levels of 2-5% reported no skin irritation or sensitization. Subchronic testing has not been adequately investigated in laboratory animals. Human test data for formulations containing > 4% Glycol Stearate or Glycol Distearate should be considered. Based on the available information presented herein, it is concluded that Glycol Stearate, Glycol Stearate SE, and Glycol Distearate are safe as cosmetic ingredients in the present practices of use and concentration.

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.

scholarly journals Final Report on the Safety Assessment of Polybutene

1982 ◽  
Vol 1 (4) ◽  
pp. 103-118 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Skin Tests ◽  
Toxicity Tests ◽  
Final Report ◽  
Test Results ◽  
Oral Toxicity ◽  
Cosmetic Formulations ◽  
Successive Generations ◽  
Available Information

Polybutenes are the isotactic polymers of isobutene and n-butene. Polybutenes provide viscosity or emulsifiability to more than 80 cosmetic products in concentrations up to 50%. The results of acute oral and percutaneous toxicity tests of Polybutenes show these materials to be relatively harmless. Acute skin irritation tests on rabbits showed no or mild irritation. Other test results indicate that Polybutenes are not toxic: (a) there were no observable effects in rats after inhalation at concentrations up to 18.5 mg/l of air; (b) there was only mild, transient eye irritation in rabbits; (c) intravaginal application of concentrated Polybutene daily for 30 days produced no observable effect in rabbits. Chronic oral toxicity in rats fed up to 20,000 ppm for three successive generations showed no impairment in reproduction. The available human clinical data indicated only very mild effects. Skin tests for sensitization, irritancy, phototoxicity, and photosensitization were limited to cosmetic formulations. On the basis of the available information, it was concluded that Polybutenes are safe as presently used in cosmetics.

scholarly journals Final Report on the Safety Assessment of Propylene Glycol (PG) Dicaprylate, PG Dicaprylate/Dicaprate, PG Dicocoate, PG Dipelargonate, PG Isostearate, PG Laurate, PG Myristate, PG Oleate, PG Oleate SE, PG Dioleate, PG Dicaprate, PG Diisostearate, and PG Dilaurate

1999 ◽  
Vol 18 (2_suppl) ◽  
pp. 35-52 ◽  
Author(s):  
Wilbur Johnson
Keyword(s):  
Polyethylene Glycol ◽  
Propylene Glycol ◽  
Skin Irritation ◽  
Skin Penetration ◽  
Final Report ◽  
Limited Data ◽  
Oral Toxicity ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations ◽  
Safety Assessments

The Propylene Glycol Dicaprylate family of ingredients includes several esters and diesters of Propylene Glycol and fatty acids. These ingredients are used in cosmetic formulations as skin conditioning agents, viscosity increasing agents, and surfactants. Two skin irritation studies (minimal to no irritation) and a comedogenicity study (insignificant comedogen) on Propylene Glycol Dicaprylate/Dicaprate and a skin irritation study (slight) and an acute oral toxicity study (nontoxic) on Propylene Glycol Laurate were available. Available data were also found indicating that Propylene Glycol Dicaprylate/Dicaprate and Propylene Glycol Dipelargonate may enhance the skin penetration of other chemicals. Because of the ability of these Polyethylene Glycol esters and diesters to enhance penetration of other agents, it was recommended that care be taken in using these and other Polyethylene Glycol esters and diesters in cosmetic products. Previous Cosmetic Ingredient Review safety assessments of related ingredients, including Polyethylene Glycol, Polyethylene Glycol Stearate, Coconut Oils and Acids, Isostearic Acid, Lauric Acid, Myristic Acid, Oleic Acid, and Caprylic/Capric Triglyceride, were summarized. Included were mutagenicity, chronic toxicity, and skin irritation and sensitization data. Based in part on the limited data available on the ingredients included in the report, but more so on the previous reviews of chemically similar moieties, it was concluded that Propylene Glycol Dicaprylate, Propylene Glycol Dicaprylate/Dicaprate, Propylene Glycol Dicocoate, Propylene Glycol Dipelargonate, Propylene Glycol Isostearate, Propylene Glycol Laurate, Propylene Glycol Myristate, Propylene Glycol Oleate, Propylene Glycol Oleate SE, Propylene Glycol Dioleate, Propylene Glycol Dicaprate, Propylene Glycol Diisostearate, and Propylene Glycol Dilaurate are safe for use as cosmetic ingredients in the present practices of use.

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.

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.

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