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.

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 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 on the Safety Assessment of Carbomers-934, -910, -934P, -940, -941, and -962

1990 ◽  
Vol 1 (2) ◽  
pp. 109-141 ◽  
Keyword(s):  
Molecular Weight ◽  
Acrylic Acid ◽  
Safety Assessment ◽  
Animal Studies ◽  
Skin Irritation ◽  
Final Report ◽  
Pathological Changes ◽  
Cosmetic Ingredients ◽  
Body Weights ◽  
Available Information

The Carbomers are synthetic, high molecular weight, nonlinear polymers of acrylic acid, cross-linked with a polyalkenyl polyether. The Carbomer polymers are used in cosmetics and emulsifying agents at concentrations up to 50%. Acute oral animal studies showed that Carbomers-910, -934, -934P, -940, and -941 have low toxicities when ingested. Rabbits showed minimal skin irritation and zero to moderate eye irritation when tested with Carbomers-910 and -934. Subchronic feeding of rats and dogs with Carbomer-934 in the diet resulted in lower than normal body weights, but no pathological changes were observed. Dogs chronically fed Carbomer-934P manifested gastrointestinal irritation and marked pigment deposition within Kupffer cells of the liver. Clinical studies with Carbomers showed that these polymers have low potential for skin irritation and sensitization at concentrations up to 100%. Carbomer-934 demonstrated low potential for phototoxicity and photo-contact allergenicity. On the basis of the available information presented and as qualified in the report, it is concluded that the Carbomers are safe as cosmetic ingredients.

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.

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.

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.

3: Final Report on the Safety Assessment of Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine

1987 ◽  
Vol 6 (1) ◽  
pp. 53-76 ◽  
Keyword(s):  
Contact Dermatitis ◽  
Oral Administration ◽  
Safety Assessment ◽  
Animal Studies ◽  
Water Soluble ◽  
Final Report ◽  
Cosmetic Products ◽  
Cosmetic Ingredients ◽  
Allergic Contact ◽  
Skin Irritants

Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine are used as water-soluble emulsifiers and neutralizers in cosmetic products at concentrations up to 1%. In animal studies these ingredients were slightly toxic to practically nontoxic to rats and guinea pigs via acute oral administration. Triisopropanolamine was relatively nontoxic to rats in the two subchronic oral studies. These ingredients were moderate skin irritants for rabbits. All four ingredients, when tested at 100% concentrations, were severe ocular irritants in rabbits. Products containing small amounts (-1%) of Diisopropanolamine or Triisopropanolamine were not ocular irritants in rabbits. The Triisopropanolamine salt was not mutagenic in Aspergillus nidulans. Diisopropanolamine and Isopropanolamine at concentrations of 2% did not induce allergic contact dermatitis or photoallergic dermatitis in humans. Clinical studies on cosmetic products containing no more than 1% Diisopropanolamine or 1.1% Triisopropanolamine were minimal skin irritant and contact sensitizers. It is concluded that Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine are safe as cosmetic ingredients in the present practices of use and concentration. The Isopropanolamines should not be used in products containing N-nitrosating agents.

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.

4: Final Report on the Safety Assessment of Toluene

1987 ◽  
Vol 6 (1) ◽  
pp. 77-120 ◽  
Keyword(s):  
Human Skin ◽  
Safety Assessment ◽  
Animal Studies ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Skin Exposure

Toluene has a wide variety of noncosmetic applications. However, the cosmetic use is limited to nail products at concentrations up to 50%. Toluene was practically nontoxic when given orally to rats; acute oral LD50 values ranged from 2.6 g/kg to 7.5 g/kg. Results of animal studies indicated that undiluted Toluene is a skin irritant. No skin irritation or sensitization was observed in subjects treated with cosmetic products containing 31-33% Toluene. No phototoxic or photoallergic reactions were noted in subjects treated with 25% or 30% Toluene. The sole cosmetic use of Toluene is in products intended to be applied directly to the nail; therefore, human skin exposure to this ingredient will be minimal under conditions of cosmetic use. On the basis of the available data and the limited user skin exposure from cosmetic products containing Toluene, it is concluded that this ingredient is safe for cosmetic use at the present practices of use and concentration.

3 Final Report on the Safety Assessment of Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50

1983 ◽  
Vol 2 (7) ◽  
pp. 35-60 ◽  
Keyword(s):  
Clinical Studies ◽  
Ames Test ◽  
Safety Assessment ◽  
Animal Species ◽  
Skin Irritation ◽  
Final Report ◽  
Dermal Toxicity ◽  
Rabbit Eye ◽  
Toxicity Studies ◽  
Cosmetic Ingredients

Nonoxynols are chemically stable ethoxylated alkylphenols which are chemically foaming and solubilizing agents. Estimates of the acute oral LD50s of nine of the Nonoxynols (-2 to 15) range from 0.62 to 7.4 g/kg in several animal species. Acute dermal toxicity studies in rabbits produced an LD50 range of 1.8 ml/kg to 4.4 g/kg. Skin irritation tests on rabbits indicated that Nonoxynols are nonirritating to moderately irritating. Nonoxynol compounds with short ethoxylated chains are generally severe ocular irritants, whereas long-chained Nonoxynols are only slightly irritating to the rabbit eye. No evidence of carcinogenicity was observed when Nonoxynol-4 and 9 were fed to both dogs and rats. A mutagenicity study of these two compounds by the Ames test was negative. Undiluted Nonoxynol-4 and 9 were nonirritating and nonsensitizing in clinical studies. A 50% solution of Nonoxynol-15 and/or Nonoxynol-50 produced no irritation or sensitization when tested on 168 subjects, nor was there evidence of phototoxicity when tested on a subset of this population. It is concluded that Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50 are safe as cosmetic ingredients.

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