scholarly journals 7 Final Report on the Safety Assessment of Hydrolyzed Collagen

1985 ◽  
Vol 4 (5) ◽  
pp. 199-221 ◽  
Keyword(s):  
Clinical Studies ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Full Strength ◽  
Hydrolyzed Collagen ◽  
Cosmetic Formulations ◽  
Animal Toxicity

Hydrolyzed Collagen is a hydrolysate derived from animal byproducts. It is used in cosmetic products as a conditioner or moisturizer at concentrations less than 5 percent. Hydrolyzed Collagen was practically nontoxic when administered orally or dermally in acute animal toxicity studies. This ingredient was minimally irritating to rabbit eyes when tested full-strength. Primary skin irritation tests in rabbits indicated that Hydrolyzed Collagen was nonirritating or minimally irritating when tested full-strength. Subchronic dermal studies on 2 cosmetic formulations containing 2 percent Hydrolyzed Collagen were negative for systemic toxicity. Hydrolyzed Collagen was nonsensitizing in guinea pigs. In clinical studies, Hydrolyzed Collagen produced no skin irritation, sensitization, or indication of phototoxicity. On the basis of the available animal and clinical data, it is concluded that Hydrolyzed Collagen is safe as a cosmetic ingredient in the present practices of use and concentration.

1: Final Report on the Safety Assessment of Sodium Lauryl Sulfoacetate

1987 ◽  
Vol 6 (3) ◽  
pp. 261-277 ◽  
Keyword(s):  
Clinical Studies ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Sodium Lauryl Sulfate ◽  
Skin Irritation ◽  
Final Report ◽  
Lauryl Sulfate ◽  
Cosmetic Products ◽  
Cosmetic Product ◽  
Ocular Irritation

Sodium Lauryl Sulfoacetate is a detergent used in cosmetic products. A 12% solution of the ingredient was slightly toxic to rats in an acute oral study. No treatment-related effects of significance were noted in rats in a subchronic study at a dose of 75 mg/kg/day. Some effects were observed at 250 and 750 mg/kg/day. Minimal to slight ocular irritation occurred in rabbits when tested with 3.0% Sodium Lauryl Sulfoacetate. A diluted product tested at 1% Sodium Lauryl Sulfate was nonirritating to the genital mucosa of rabbits. No skin irritation, sensitization, or phototoxicity was noted in guinea pigs exposed to a cosmetic product containing 2% Sodium Lauryl Sulfoacetate. Cosmetic products containing up to 16% Sodium Lauryl Sulfoacetate were nonmutagenic in the Ames Salmonella/microsome assay, both with and without activation. In clinical studies, Sodium Lauryl Sulfoacetate was a mild to strong skin irritant but not a sensitizer at concentrations up to 2.0%. The irritant effects are similar to those produced by other detergents, and the severity of the irritation appears to increase directly with concentration. It is concluded that Sodium Lauryl Sulfoacetate is safe for use in cosmetic products in the present practices of use and concentration.

Final Report on the Safety Assessment of Acetamide MEA

1993 ◽  
Vol 12 (3) ◽  
pp. 225-236 ◽  
Keyword(s):  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Nitroso Compounds ◽  
Final Report ◽  
Skin Exposure ◽  
Ocular Irritation ◽  
Cosmetic Formulations ◽  
A Minor ◽  
Primary Irritation

Acetamide MEA is used in cosmetics as a skin conditioning agent-humectant and hair conditioning agent. Oral LD50s of 27 g/kg were reported for Acetamide MEA in rats. No rabbits died following an acute dermal exposure of 20 ml/kg Acetamide MEA. In ocular irritation studies, 70% Acetamide MEA and cosmetic formulations containing 1.3% Acetamide MEA were classified as nonocular irritants in rabbits. Only mild skin irritation occurred following a 24-h skin exposure to undiluted Acetamide MEA. In the maximization test, Acetamide MEA was classified as a nonsensitizer in guinea pigs when tested at a concentration of 5.0%. Neither primary irritation nor sensitization reactions to 7.5% Acetamide MEA were observed in a human repeated insult patch test. Acetamide MEA was not nonmutagenic in the Ames assay. In the presence of nitrosating agents, Acetamide MEA may form N-nitroso compounds; acetamide may be a minor impurity in Acetamide MEA. On the basis of the data presented in this report, it is concluded that Acetamide MEA is safe as a cosmetic ingredient at concentrations not to exceed 7.5% in leave-on products and is safe in the present practice of use in rinse-off products. Cosmetic formulations containing Acetamide MEA should not contain nitrosating agents or significant amounts of free acetamide.

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.

2: Final Report on the Safety Assessment of Propylene Carbonate

1987 ◽  
Vol 6 (1) ◽  
pp. 23-51 ◽  
Keyword(s):  
Aqueous Solution ◽  
Dna Repair ◽  
Propylene Carbonate ◽  
Clinical Studies ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Clear Liquid ◽  
Cosmetic Products ◽  
Ocular Irritation

Propylene Carbonate is a nonviscous, clear liquid that is used in cosmetic products at concentrations ranging from 0.1% to 5%. Undiluted Propylene Carbonate produced minimal to moderate ocular irritation and slight erythema in rabbits. The dermal LD50 in rabbits of the undiluted ingredient was >20 ml/kg. Undiluted Propylene Carbonate was nontoxic by inhalation to dogs and guinea pigs in a 21-day study. Propylene Carbonate was negative for mutagenicity in the Ames Assay, and negative for genotoxicity in the Rat He-patocyte Primary Culture/DNA Repair Test. In clinical studies, undiluted Propylene Carbonate caused moderate skin irritation, whereas 5 and 10% Propylene Carbonate in aqueous solution produced no skin irritation or sensitization. Cosmetic products containing up to 20% Propylene Carbonate were essentially nonsensitizing and, at most, moderately irritating to human skin, nonphototoxic, and nonphotosensitizing. It is concluded that Propylene Carbonate is safe as a cosmetic ingredient in the present practices of use and concentration.

2 Final Report on the Safety Assessment of Propyl Gallate

1985 ◽  
Vol 4 (3) ◽  
pp. 23-64 ◽  
Keyword(s):  
Human Skin ◽  
Propyl Gallate ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Toxicity Studies ◽  
Animal Toxicity

Propyl Gallate acid is used as an antioxidant in cosmetic products at concentrations normally less than 0.1 percent. Propyl Gallate is absorbed when ingested, methylated, conjugated, and excreted in the urine. Acute animal toxicity studies indicate that Propyl Gallate is slightly toxic when ingested and practically nontoxic when applied to the skin. Numerous chronic oral toxicity studies indicate that Propyl Gallate at concentrations up to 5 percent is practically nontoxic to rats, mice, dogs, and guinea pigs. Propyl Gallate is nonirritating to human skin at concentrations up to 10 percent; however, it is sensitizing at this and higher concentrations. Propyl Gallate was nonphototoxic. It is concluded that Propyl Gallate is safe as a cosmetic ingredient at concentrations not exceeding 1 percent.

Final Report on the Safety Assessment of Diisopropylamine

1995 ◽  
Vol 14 (3) ◽  
pp. 182-192 ◽  
Keyword(s):  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Short Term ◽  
Negative Results ◽  
Cosmetic Formulations ◽  
Actual Use ◽  
Mean Concentration ◽  
Dermal Application

Diisopropylamine is a strongly alkaline, aliphatic amine used to adjust the p H of cosmetic formulations. In 1993, it was reported to be used in only one formulation. In acute and short-term inhalation studies, toxic effects were observed in the respiratory system and eyes of rats and guinea pigs. Dermal application of diluted and undiluted Diisopropylamine in rats and guinea pigs showed irritation but not sensitization. This ingredient is considered an ocular irritant. Mixed results were obtained in evaluating the mutagenicity of this ingredient by the Ames test, but there were negative results in the rat hepato-cyte primary culture/DNA repair assay. Occupational exposure to Diisopropylamine vapor (5–10 min, two or three times per day, mean concentration 0.1–0.2 mg/l) was associated with dimness of vision, nausea, and headaches. Because the skin irritation results were interpreted as attributable to the alkaline p H of this ingredient, and it is recognized that it is likely neutralized in cosmetic formulations, the irritation potential in actual use was not a concern. In the presence of N-nitrosating agents, Diisopropylamine has the potential to form nitrosamines. Based on the data presented in this report, it is concluded that Diisopropylamine is safe as a cosmetic ingredient in the present practices of use, except it should not be used in products containing N-nitrosating agents.

Final Report of the Safety Assessment for PEG-75 Lanolin, PEG-20 Lanolin, PEG-27 Lanolin, PEG-30 Lanolin, PEG-40 Lanolin, PEG-50 Lanolin, PEG-60 Lanolin, and PEG-85 Lanolin

1982 ◽  
Vol 1 (4) ◽  
pp. 91-102 ◽  
Keyword(s):  
Polyethylene Glycol ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Glycol Ethers ◽  
Eye Irritation ◽  
Oil Water ◽  
Available Information

PEG Lanolins are the polyethylene glycol ethers of whole lanolin. They are widely used in cosmetics as auxiliary oil/water emulsifiers at concentrations of up to 25%. PEG Lanolins were found to be nontoxic in acute oral, dermal, and inhalation studies at varying concentrations. They caused little or no eye irritation in rabbits at concentrations of 50-100%. PEG Lanolins at 10-100% caused mild or negligible skin irritation and were reported to be nonsensitizing in guinea pigs. PEG Lanolins were reported to be nonirritating and nonsensitizing in patients at concentrations from 10-60%. On the basis of the available information, it is concluded that the PEG-75 Lanolin Group is safe as presently used in cosmetic products.

2 Final Report on the Safety Assessment of p-Hydroxyanisole

1985 ◽  
Vol 4 (5) ◽  
pp. 31-63 ◽  
Keyword(s):  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Tumor Promoter ◽  
Final Report ◽  
Skin Sensitization ◽  
Cosmetic Products ◽  
Rabbit Skin ◽  
Ames Assay

p-Hydroxyanisole is used as an antioxidant in cosmetic products at concentrations of up to 1.0 percent. The acute oral LD50 of p-Hydroxyanisole in rats was estimated as 1630 mg/kg. Undiluted p-Hydroxyanisole is a severe skin and ocular irritant in rabbits but produced minimal eye irritation at 0.1 percent and minimal rabbit skin irritation at 5 percent. Skin sensitization to p-Hydroxyanisole occurred when guinea pigs were treated at 0.5 M. p-Hydroxyanisole is a skin-depigmenting agent at concentrations approximating those used in cosmetic products. p-Hydroxyanisole was nonmutagenic in the Ames assay. No local toxic changes or tumors were observed following long-term application of 5 and 10 percent p-Hydroxyanisole. The antioxidant was inactive as a tumor promoter. Solutions of p-Hydroxyanisole produced embryotoxicity but not teratogenicity. The function of p-Hydroxyanisole in cosmetics is that of an antioxidant; it is not intended for use as a skin lightener or skin-depigmenting agent. Because of the depigmenting action of p-Hydroxyanisole in black guinea pigs at reported concentrations approaching those used in cosmetics, it is concluded that p-Hydroxyanisole is unsafe for use as a cosmetic ingredient.

scholarly journals 7: Final Report on the Safety Assessment of Petroleum Distillate

1986 ◽  
Vol 5 (3) ◽  
pp. 225-248
Keyword(s):  
Human Skin ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Petroleum Distillate ◽  
Final Report ◽  
Cosmetic Products ◽  
Single Exposure ◽  
Eye Irritation ◽  
Cosmetic Formulations ◽  
Animal Tests

Cosmetic grade Petroleum Distillate consists predominantly of C10-C16 paraffinic, naphthenic, and isoparaffinic hydrocarbons. The Distillate is used in a variety of cosmetic products at concentrations up to 50%. Undiluted Petroleum Distillate had an acute oral LD50 in rats of >25 ml/kg. Subchronic animal tests on a formulation containing 41.75% Petroleum Distillate were uneventful. Moderate skin irritation and mild, transient eye irritation were observed in rabbits following a single exposure to undiluted Petroleum Distillate. Cosmetic formulations containing 29.2–55% Petroleum Distillate were generally nonirritating, nonsensitizing, and nonphotosensitizing to human skin. It is concluded that Petroleum Distillate, as characterized in the report, is safe as a cosmeticingredient at the current concentrations of use.

1 Final Report on the Safety Assessment of Isostearyl Neopentanoate

1985 ◽  
Vol 4 (3) ◽  
pp. 1-22 ◽  
Keyword(s):  
Test Data ◽  
Clinical Studies ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Short And Long Term ◽  
Cosmetic Formulation

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.

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