4 Final Report on the Safety Assessment of Sodium Dehydroacetate and Dehydroacetic Acid

1985 ◽  
Vol 4 (3) ◽  
pp. 123-159 ◽  
Keyword(s):  
Weight Loss ◽  
Safety Assessment ◽  
Inhibitory Effect ◽  
Final Report ◽  
Clinical Tests ◽  
Tumor Induction ◽  
Rabbit Skin ◽  
Dehydroacetic Acid ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations

Sodium Dehydroacetate and Dehydroacetic Acid are used as preservatives in cosmetic formulations at concentrations of 1.0 percent or less. Both compounds are rapidly absorbed when administered orally or on the skin of test animals. Acute toxicity studies indicate that Sodium Dehydroacetate and Dehydroacetic Acid are slightly toxic when administered orally to rats. Neither compound was an irritant when applied to rabbit skin. Sodium Dehydroacetate was found to exhibit minimal eye irritation. Subchronic and chronic studies reveal various toxic effects, primarily due to the incurred lack of appetite and weight loss. No evidence of mutagenicity was reported for either ingredient use. No evidence of tumor induction by Dehydroacetic Acid was detected in a 64-week study. Dehydroacetic Acid had an inhibitory effect on hepatoma induction in rats when fed 4-(dimethylamino)azobenzene. A teratogenicity study in mice revealed no significant findings when compared to untreated controls. Sodium Dehydroacetate, Dehydroacetic Acid, and cosmetics containing these ingredients were found practically nonirritating, nonsensitizing, nonphotosensitizing, and nonphototoxic in numerous clinical tests. On the basis of the available animal and clinical data, it is concluded that Sodium Dehydroacetate and Dehydroacetic Acid 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.

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.

scholarly journals Final Report on the Safety Assessment of Octyl Palmitate, Cetyl Palmitate and Isopropyl Palmitate

1990 ◽  
Vol 1 (2) ◽  
pp. 13-35 ◽  
Keyword(s):  
Safety Assessment ◽  
Isopropyl Alcohol ◽  
Skin Tests ◽  
Final Report ◽  
Dermal Toxicity ◽  
Rabbit Skin ◽  
Ocular Irritation ◽  
Cosmetic Ingredients ◽  
Cetyl Palmitate ◽  
Available Information

The Palmitates used in cosmetic products are esters of palmitic acid and octyl, cetyl, or isopropyl alcohol. The acute oral LD50 is estimated from studies with rats to be greater than 14.4 g/kg for Cetyl Palmitate and greater than 64.0 g/kg for Octyl and Isopropyl Palmitates. Acute studies with rabbits showed no evidence of dermal toxicity for any of the Palmitates. Isopropyl Palmitate was “well tolerated” and Octyl Palmitate was nontoxic in separate subchronic dermal studies. Rabbit skin tests with the Palmitates showed that they are nonirritating and nonsensitizing. Also, Draize rabbit eye irritation tests on the Palmitates produced either no or only very slight ocular irritation. One of three formulations containing Octyl Palmitate at concentrations between 40% and 50% produced mild irritation. Formulations containing Cetyl Palmitate at concentration of 2.7% were minimally irritating and produced no signs of sensitization, phototoxicity, or photo contact allergenicity. A formulation containing 45.6% Isopropyl Palmitate produced no signs of irritation, sensitization, phototoxicity, or photo contact allergenicity. From the available information, it is concluded that Octyl Palmitate, Cetyl Palmitate, and Isopropyl Palmitate are safe as cosmetic ingredients in the present practices of use and concentration.

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 Report on the Safety Assessment of Squalane and Squalene

1990 ◽  
Vol 1 (2) ◽  
pp. 37-56 ◽  
Keyword(s):  
Gastrointestinal Tract ◽  
Safety Assessment ◽  
Animal Studies ◽  
Final Report ◽  
Contact Sensitization ◽  
Rabbit Skin ◽  
Cosmetic Ingredients ◽  
Contact Allergen ◽  
Natural Components ◽  
Animal Toxicity

Squalane and Squalene have been identified as natural components of human sebum. Both ingredients are used in a variety of cosmetics at concentrations ranging from ≤0.1 to >50%. Animal studies indicate Squalene is slowly absorbed through the skin, while both compounds are poorly absorbed from the gastrointestinal tract. The acute animal toxicity of these ingredients by all routes is low. Both compounds are nonirritants to rabbit skin and eye at 100% concentration. Formulations containing Squalene indicate it is not a significant human skin irritant or sensitizer. Limited contact sensitization tests indicate Squalene is not a significant contact allergen or irritant. It is concluded that both Squalane and Squalene are safe as cosmetic ingredients in the present practices of use and concentration.

6 Final Report on the Safety Assessment of Aminomethylpropanol and Aminomethylpropanediol

1990 ◽  
Vol 9 (2) ◽  
pp. 203-228 ◽  
Keyword(s):  
Salmonella Typhimurium ◽  
Safety Assessment ◽  
Adverse Reactions ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Products ◽  
Rabbit Skin ◽  
Cosmetic Formulations ◽  
Rats And Mice ◽  
Primary Irritation

AMP and AMPD are substituted aliphatic alcohols. AMP is used in cosmetic products at concentrations up to 10%, AMPD is used at concentrations up to 5%. AMP and AMPD when buffered, and orally administered, are practically nontoxic to rats and mice. In primary irritation studies, AMP and formulations containing AMP were, at most, minimally irritating to abraded and nonabraded rabbit skin. Cosmetic formulations containing AMPD were only minimally irritating to rabbit skin. AMP was not an intradermal sensitizer in guinea pigs. Cosmetic formulations containing AMPD and/or AMP were minimal to moderate ocular irritants. AMP and AMPD were nonmutagenic, both with and without metabolic activation, in Salmonella typhimurium strains. In clinical studies, AMP was neither a primary dermal irritant nor a contact sensitizer. AMPD was neither a primary irritant, fatiguing agent, nor sensitizer when tested in humans. AMP and AMPD are highly alkaline in pure form, they are buffered in cosmetic formulations, and, therefore, the adverse reactions seen with the undiluted chemical would not be expected with the cosmetic product. The highest level of both AMP and AMPD for which test data were available was 1.0%, therefore the safe use of these two compounds should be limited to this test value. Neither ingredient should be used in cosmetic products containing nitrosating agents.

scholarly journals Addendum to the Final Report on the Safety Assessment of PEGs Lanolin to Include PEG-5, -10, -24, -25, -35, -55, -100, and -150 Lanolin; PEG-5, -10, -20, -24, -30, and -70 Hydrogenated Lanolin; PEG-75 Lanolin Oil; and PEG-75 Lanolin Wax1

1999 ◽  
Vol 18 (1_suppl) ◽  
pp. 61-68
Keyword(s):  
Safety Assessment ◽  
Animal Studies ◽  
Developmental Toxicity ◽  
Final Report ◽  
Clinical Safety ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations ◽  
Hydroxy Esters ◽  
Few Data ◽  
Related Compounds

The safety of selected polyethylene glycols (PEGS) Lanolin polymers was previously reviewed. This review completes the safety assessment of all the PEGs Lanolin polymers and related cosmetic ingredients. PEGs Lanolin are prepared by ethoxylating the hydroxy fatty acids, hydroxy esters, sterols, and alcohols present in whole lanolin. The number of moles of ethylene oxide reacted with each respective lanolin component corresponds to the average polyethylene glycol chain length. PEGs Lanolins, PEGs Hydrogenated Lanolins, PEG Lanolin Oil, and PEG Lanolin Wax are used as emulsifying, soluhilizing, and cleansing agents. PEGs Hydrogenated Lanolins are also hair-conditioning agents and skin-conditioning emollients. Few data on the PEGs Lanolin were available regarding systemic toxicity, mutagenicity, carcinogenicity, and clinical safety. Related compounds including PEGs, Lanolin, and Lanolin Oil have been previously reviewed. Based on clinical data in burn patients, PEGs were mild irritants/sensitizers and there was evidence of nephrotoxicity. No such effects were seen in animal studies on intact skin. Cosmetic manufacturers should continue to adjust product formulations to minimize any untoward effects when products are used on damaged skin. No evidence of phototoxic effects was found in clinical studies. Comedogenic effects have resulted from the use of cosmetic products containing lanolin compounds. No evidence of mutagenicity, carcinogenicity, or reproductive and developmental toxicity was found with these related compounds. Although metabolites of ethylene glycol monoalkyl ethers are reproductive and developmental toxins, it was considered unlikely that the relevant metabolites would be found in or produced from the use of PEGs Cocamine in cosmetic formulations. Based primarily on data from ingredients with related structures, it was concluded that PEG-S, -10, -24, -25, -35, -55, -100, and -150 Lanolin; PEG-S, -10, -20, -24, -30, and -70 Hydrogenated Lanolin; PEG-75 Lanolin Oil; and PEG-75 Lanolin Wax are safe for use in cosmetic formulations under the present practices of use.

Final Report of the Cosmetic Ingredient Review Expert Panel Amended Safety Assessment of Calendula officinalis—Derived Cosmetic Ingredients

2010 ◽  
Vol 29 (6_suppl) ◽  
pp. 221S-243S ◽  
Author(s):  
F. Alan Andersen ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Seed Oil ◽  
Expert Panel ◽  
Developmental Toxicity ◽  
Final Report ◽  
Repeat Dose ◽  
Clinical Tests ◽  
Calendula Officinalis ◽  
Cosmetic Ingredients ◽  
Dose Oral

Calendula officinalis extract, C officinalis flower, C officinalis flower extract, C officinalis flower oil, and C officinalis seed oil are cosmetic ingredients derived from C officinalis. These ingredients may contain minerals, carbohydrates, lipids, phenolic acids, flavonoids, tannins, coumarins, sterols and steroids, monoterpenes, sesquiterpenes, triterpenes, tocopherols, quinones, amino acids, and resins. These ingredients were not significantly toxic in single-dose oral studies using animals. The absence of reproductive/developmental toxicity was inferred from repeat-dose studies of coriander oil, with a similar composition. Overall, these ingredients were not genotoxic. They also were not irritating, sensitizing, or photosensitizing in animal or clinical tests but may be mild ocular irritants. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that these ingredients are safe for use in cosmetics in the practices of use and concentration given in this amended safety assessment.

scholarly journals 2 Final Report on the Safety Assessment of Shellac

1986 ◽  
Vol 5 (5) ◽  
pp. 309-327 ◽  
Keyword(s):  
Adverse Effects ◽  
Respiratory Tract ◽  
Clinical Assessment ◽  
Maximum Concentration ◽  
Safety Assessment ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Formulations ◽  
Animal Toxicity ◽  
Spray Formulation

Cosmetic-grade Shellac is a mixture of hydroxyaliphatic and alicyclic acids and their polyesters. It is used in cosmetic formulations at concentrations up to 25%. Shellac had an LD50 of greater than 5 g/kg in rats. Results of acute animal toxicity studies using cosmetic formulations containing up to 6% Shellac indicated no adverse effects upon oral (rats), dermal (rabbits), ocular (rabbits), and respiratory tract (rabbits) exposure. Chronic inhalation of a Shellac hair spray formulation by rabbits produced no observable toxicity. No treatment-related toxic or pathologic effects were observed when concentrations of Shellac up to 10,000 ppm were fed to rats in a subchronic study. Ames' mutagenicity assays, with and without metabolic activation, were negative. Clinical assessment of safety of cosmetic formulations containing up to 6% Shellac indicated no measurable irritation and absence of sensitization and photosensitization. It is concluded that cosmetic-grade Shellac is safe for use in cosmetic formulations at concentrations up to 6%, the maximum concentration tested.

Final Report on the Safety Assessment of Cyclomethicone

1991 ◽  
Vol 10 (1) ◽  
pp. 9-19 ◽  
Keyword(s):  
Ames Test ◽  
Safety Assessment ◽  
Oral Feeding ◽  
Final Report ◽  
Histopathological Changes ◽  
Short Term ◽  
Local Skin ◽  
Reproductive Effects ◽  
Cosmetic Formulations ◽  
Gross Lesions

Cyclomethicone is a mixture of cyclic dimethylpolysiloxane compounds used primarily as an emollient and solvent in cosmetic formulations at concentrations from <0.1%to>50%. Cyclomethicone is not significantly absorbed through the skin. Small amounts of Cyclomethicone were absorbed by both humans and monkeys in oral feeding studies. The absorbed Cyclomethicone was detected in both the urine and expired air. Acute oral dose of Cyclomethicone to rats produced no deaths nor any gross lesions. Short-term dermal studies produced no behavioral, local skin, gross, nor histopathological changes. In subchronic inhalation studies in monkeys, no significant differences were found between exposed and unexposed animals. Undiluted Cyclomethicone applied to the intact and abraded skin of rabbits produced little or no irritation in two studies. Ocular studies indicated that Cyclomethicone produced only slight transient conjunctival irritation in washed and unwashed eyes. Cyclomethicone did not produce reproductive effects in rats. Cyclomethicone was not a mutagen when assayed in the Ames test. Cyclomethicone was neither irritating nor sensitizing to human skin in two clinical studies. On the basis of the available data, it is concluded that Cyclomethicone is safe as a cosmetic ingredient in present practices of use.

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