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 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.

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 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.

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.

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 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.

Final Report on the Safety Assessment of Cetyl Lactate and Myristyl Lactate

1990 ◽  
Vol 1 (2) ◽  
pp. 97-107 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Rabbit Skin ◽  
Ocular Irritation ◽  
Myristyl Alcohol ◽  
Irritation Test ◽  
Skin Irritation Test ◽  
Available Information

Cetyl Lactate and Myristyl Lactate are the esters of lactic acid and either cetyl or myristyl alcohol. They are used in a wide variety of cosmetic products up to a maximum concentration of 25%. The acute oral LD50 of Cetyl Lactate is estimated from studies with rats to be greater than 20 g/kg. Cetyl Lactate was shown to be minimally irritating to rabbit skin and nonirritating or only slightly irritating to rabbit eyes in Draize irritation tests. At 25%, Cetyl Lactate produced no signs of toxicity or irritation in a 30-day rabbit-skin irritation study. Cetyl Lactate was found to be minimally irritating and nonsensitizing to human skin at concentrations up to 5%. The acute oral LD50 of Myristyl Lactate is estimated from studies with rats to be greater than 20 g/kg. Myristyl Lactate was shown to be minimally irritating in Draize primary skin irritation tests, but one contradictory study concluded that undiluted Myristyl Lactate produced moderate irritation. It produced no signs of ocular irritation in Draize rabbit eye irritation tests. Mild irritation was elicited by a formulation in a modified Draize rabbit skin irritation test. The same formulation was found to be nonirritating and nonsensitizing in a human repeated insult patch study. Based on the available information, it is concluded that Cetyl Lactate and Myristyl Lactate are safe in the present practices of use.

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.

6 Final Report on the Safety Assessment of Vinyl Acetate/Crotonic Acid Copolymer

1983 ◽  
Vol 2 (5) ◽  
pp. 125-140 ◽  
Keyword(s):  
Vinyl Acetate ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Crotonic Acid ◽  
Final Report ◽  
Hair Spray ◽  
Acid Copolymer ◽  
Film Forming ◽  
Available Information ◽  
Oral Doses

Vinyl Acetate/Crotonic Acid (VA/CA) Copolymer is a polymer formed from vinyl acetate and crotonic acid monomers. VA/CA Copolymer is primarily used as a film forming agent in aerosol hair sprays and other hair preparations. An aqueous solution containing 3.7% VA/CA Copolymer and a hair spray containing 13.75% of the ingredient were relatively harmless when administered to rats in single oral doses of up to 50 ml/kg and 5 g/kg, respectively. These same test materials elicited no skin irritation in rabbits and minimal, transient eye irritation. Hair spray formulations containing 0.86% of the copolymer caused no skin irritation or sensitization when tested in a repeated insult patch test on humans. On the basis of the available information, Vinyl Acetate/Crotonic Acid Copolymer is considered safe as a cosmetic ingredient under present practices of product and concentration use.

scholarly journals Safety Assessment of Polyquaternium-22 and Polyquarternium-39 as Used in Cosmetics

2016 ◽  
Vol 35 (3_suppl) ◽  
pp. 47S-53S ◽  
Author(s):  
Wilbur Johnson ◽  
Bart Heldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Developmental Toxicity ◽  
Skin Irritation ◽  
Cosmetic Products ◽  
Limited Data ◽  
Local Effects ◽  
Cosmetic Formulations ◽  
Monomer Content ◽  
Unreacted Monomer

Polyquaternium-22 and polyquaternium-39 are polymers that function as antistatic agents, film formers, and hair fixatives in cosmetic products. These ingredients are being used at concentrations up to 2% (polyquaternium-22, in a rinse-off product) and up to 3% (polyquaternium-39, in rinse-off and leave-on products). The unreacted monomer content of these ingredients was considered low and of no toxicological concern. Limited data showed no skin irritation/sensitization. Although these ingredients were nongenotoxic in bacterial assays, mammalian genotoxicity, carcinogenicity, and reproductive and developmental toxicity data were not available. These polymers, however, are large, highly polar molecules that would likely not be absorbed, and neither local effects in the respiratory tract nor systemic toxicity are expected following product application/exposure. The Expert Panel concluded that polyquaternium-22 and polyquaternium-39 are safe in the present practices of use and concentration in cosmetic formulations.

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