7 Final Report on the Safety Assessment of Polyvinylpyrrolidone/Vinyl Acetate Copolymer

1983 ◽  
Vol 2 (5) ◽  
pp. 141-159 ◽  
Keyword(s):  
Vinyl Acetate ◽  
Skin Irritation ◽  
Vinyl Pyrrolidone ◽  
Final Report ◽  
Oral Toxicity ◽  
Intact Skin ◽  
Patch Tests ◽  
Ocular Irritation ◽  
Available Information ◽  
Acetate Copolymer

Polyvinylpyrrolidone/Vinyl Acetate Copolymer (PVP/VA Copolymer) is the copolymer of vinyl pyrrolidone (VP) and vinyl acetate (VA) monomers. The ingredient is used primarily in hair care products and secondly in skin and nail products. Acute oral toxicity studies on mice and rats showed low to no toxicity. Chronic oral and inhalation studies produced no effects. The acute ocular irritation of PVP/VA Copolymer at concentrations ranging from 25% to 50% in alcohol produced no reaction to severe irritation. Acute skin irritation studies of 50% PVP/VA Copolymer in alcohol on abraded and intact skin produced mild skin irritation. PVP/VA Copolymer was not a sensitizer to guinea pigs after intracutaneous injections. Formulations containing 1.75%, 4.0%, and 5.0% PVP/VA Copolymer produced no irritation in 24-hour clinical patch tests nor any evidence of sensitization in a repeated insult patch test at a concentration of 5.0%. On the basis of the available information, it is concluded that Polyvinylpyrrolidone/Vinyl Acetate Copolymer is safe as a cosmetic ingredient under present conditions of concentration and use.

8 Final Report on the Safety Assessment of Butylene Glycol, Hexylene Glycol, Ethoxydiglycol, and Dipropylene Glycol

1985 ◽  
Vol 4 (5) ◽  
pp. 223-248 ◽  
Keyword(s):  
Skin Irritation ◽  
Final Report ◽  
Oral Toxicity ◽  
Cutaneous Toxicity ◽  
Patch Tests ◽  
Ocular Irritation ◽  
Toxicity Studies ◽  
Hexylene Glycol ◽  
Dipropylene Glycol ◽  
Low Order

Butylene Glycol, Hexylene Glycol, Ethoxydiglycol, and Dipropylene Glycol are viscous liquids used in the cosmetic industry as humectants, emulsifiers, plasticizers, and solvents. The results of acute, subchronic, and chronic oral toxicity studies using a variety of animal species indicate a low order of toxicity for the Glycols. Results of parenteral injection, inhalation, and acute and subchronic cutaneous toxicity studies likewise support a low order of toxicity. Butylene Glycol, Ethoxydiglycol, and Dipropylene Glycol caused minimal to mild irritation of rabbit skin, whereas Hexylene Glycol was moderately irritating. The Glycols produced mild to severe ocular irritation when tested in rabbits, with Hexylene Glycol producing the most severe irritation. Although undiluted Hexylene Glycol produced severe ocular irritation, a 25 percent aqueous solution produced no signs of irritation. Undiluted Butylene Glycol was not an eye irritant to rabbits but was to humans. Human skin patch tests on undiluted Butylene Glycol and undiluted Hexylene Glycol produced a very low order of primary skin irritation. A repeated insult patch test on Butylene Glycol produced no evidence of skin sensitization. Based on the available data it is concluded the Butylene Glycol, Hexylene Glycol, Ethoxydiglycol, and Dipropylene Glycol are safe as presently used in cosmetics.

scholarly journals 2: Final Report on the Safety Assessment of Glyceryl Ricinoleate

1988 ◽  
Vol 7 (6) ◽  
pp. 721-739 ◽  
Keyword(s):  
Ricinoleic Acid ◽  
Castor Oil ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Ultraviolet Spectrum ◽  
Toxicity Tests ◽  
Final Report ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Patch Tests

Glyceryl Ricinoleate is the monoester of glycerol and ricinoleic acid. Castor oil contains 87–90% Glycerol Ricinoleate. Ricinoleic acid is metabolized by both β-oxidation and α-oxidation. Acute oral toxicity tests in mice indicated that Glyceryl Ricinoleate has an LD50 greater than 25.0 ml/kg and is, at most, mildly irritating to unrinsed rabbit eyes. This ingredient was not a primary skin irritant. Castor oil was nonmutagenic by the Ames test. Ricinoleic acid was not a carcinogen when tested in mice. In human single-insult occlusive patch tests, no indication of skin irritation potential was observed in the two products containing 5.6% Glyceryl Ricinoleate. The available data on Glyceryl Ricinoleate were insufficient to determine whether this ingredient, under each relevant condition of use, was either safe or not safe. The types of data required before a decision can be made include: (1) 28 day chronic dermal toxicity in guinea pigs, and (2) clinical sensitization and photosensitization studies (or an appropriate ultraviolet spectrum instead of the photosensitization data).

8 Final Report on the Safety Assessment of Polyquaternium-11

1983 ◽  
Vol 2 (5) ◽  
pp. 161-178 ◽  
Keyword(s):  
Molecular Weight ◽  
High Molecular Weight ◽  
Skin Irritation ◽  
Low Molecular Weight ◽  
Final Report ◽  
Dermal Toxicity ◽  
Molecular Weight Polymer ◽  
Patch Tests ◽  
Skin Patch ◽  
Available Information

Polyquaternium-11 is a quaternized copolymer of vinylpyrrolidone and di-methylamine ethylmethacrylate, and is used at concentrations up to 50% in a variety of hair care preparations. The acute oral LD50 in test animals of high molecular weight Polyqua-ternium-11 is estimated to be greater than 12.8 g/kg; the LD50 for the low molecular weight polymer is calculated to be 6.2 g/kg. At concentrations of up to 50% in water, the raw ingredient produced no signs of skin or eye irritation. There was no evidence of dermal toxicity in subchronic tests nor in a maximization test for sensitization. In clinical studies, 1 of 19 subjects showed slight skin irritation after a 24-hour single insult skin patch with 9.5% Polyquaternium-11 in water. Repeated insult patch tests at concentrations up to 50% produced no instances of skin sensitization and only isolated instances of transient skin irritation. Clinical photoreactivity studies on both low and high molecular weight polymers showed no evidence of phototoxicity or photoallergenicity. From the available information, it is concluded that Polyquaternium-11 is safe as a cosmetic ingredient in the present practices of use.

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 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.

8 Final Report on the Safety Assessment of Triethanolamine, Diethanolamine, and Monoethanolamine

1983 ◽  
Vol 2 (7) ◽  
pp. 183-235 ◽  
Keyword(s):  
Skin Testing ◽  
Skin Irritation ◽  
Laboratory Animals ◽  
Final Report ◽  
Oral Toxicity ◽  
Rabbit Skin ◽  
Patch Tests ◽  
Prolonged Contact ◽  
Cosmetic Formulations

Triethanolamine (TEA), Diethanolamine (DEA), and Monoethanolamine (MEA) are amino alcohols used in cosmetic formulations as emulsifiers, thickeners, wetting agents, detergents, and alkalizing agents. The nitrosation of the etha-nolamines may result in the formation of N-nitrosodiethanolamine (NDELA) which is carcinogenic in laboratory animals. In single-dose oral toxicity for rats, TEA was practically nontoxic to slightly toxic, and DEA and MEA were slightly toxic. Long-term oral ingestion of the ethanolamines by rats and guinea pigs produced lesions limited mainly to the liver and kidney. Long-term cutaneous applications to animals of the ethanolamines also produced evidence of hepatic and renal damage. TEA and DEA showed little potential for rabbit skin irritation in acute and subchronic skin irritation tests. MEA was corrosive to rabbit skin at a 30% concentration in a single semioccluded patch application and at a >10% concentration in 10 open applications over a period of 14 days. The ethanolamines were nonmutagenic in the Ames test and TEA is also nonmutagenic to Bacillus subtilis. TEA did not cause DNA-damage inducible repair in an unscheduled DNA synthesis test. TEA had no carcinogenic or cocarcinogenic activity when dermally applied to mice for 18 months. Clinical skin testing of TEA and cosmetic products containing TEA and DEA showed mild skin irritation in concentrations above 5%. There was very little skin sensitization. There was no phototoxicity or photosensitization reactions with products containing up to 20.04% TEA. A formulation containing 11.47% MEA and a formulation containing 1.6% DEA and 5.9% MEA were irritating to human skin in patch tests. The Panel concludes that TEA, DEA, and MEA are safe for use in cosmetic formulations designed for discontinuous, brief use followed by thorough rinsing from the surface of the skin. In products intended for prolonged contact with the skin, the concentration of ethanolamines should not exceed 5%. MEA should be used only in rinse-off products. TEA and DEA should not be used in products containing N-nitrosating agents.

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 Report on the Safety Assessment of Biotin

2001 ◽  
Vol 20 (4_suppl) ◽  
pp. 1-12
Keyword(s):  
Subcutaneous Injection ◽  
Micronucleus Test ◽  
Skin Irritation ◽  
Daily Basis ◽  
Intradermal Injection ◽  
Water Soluble ◽  
Final Report ◽  
Oral Toxicity ◽  
Treatment Groups ◽  
Ocular Irritation

Biotin is a water-soluble vitamin used as a hair-conditioning agent and a skin-conditioning agent in many cosmetic products at concentrations ranging from 0.0001% to 0.6%. Although Biotin does absorb some ultraviolet (UV) radiation, the absorption shows no peaks in the UVA or UVB region. Biotin is rapidly metabolized and excreted in urine. Little acute oral toxicity is seen in animal tests. Short-term and subchronic toxicity studies likewise found no evidence of toxicity. Although intradermal injection of a small quantity of Biotin (0.1 ml) into guinea pig skin did not produce skin irritation, Biotin (0.1% at pH 7.3) did produce slight, transient ocular irritation in rabbit eyes. Biotin was not mutagenic in bacterial tests, but positive results were found in a Tradescantia micronucleus test. There was evidence of an increase in the number of resorptions in rats receiving Biotin by subcutaneous injection, with concomitant decreases in fetal, uterine, and placental weights. Another study of mice receiving Biotin orally or by subcutaneous injection found no differences between control and treatment groups. Although there is one case study reporting an urticarial reaction in the literature, there are a very large number of individuals exposed to Biotin on a daily basis, and there is not a parallel appearance of irritation, sensitization, or other adverse reactions. Based on these available data, it was concluded that Biotin is safe as used in cosmetic formulations.

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.

1 Final Report on the Safety Assessment of Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol

1985 ◽  
Vol 4 (5) ◽  
pp. 1-29 ◽  
Keyword(s):  
Safety Assessment ◽  
Oleyl Alcohol ◽  
Skin Irritation ◽  
Final Report ◽  
Stearyl Alcohol ◽  
Contact Sensitization ◽  
Oral Toxicity ◽  
Product Categories ◽  
Ocular Irritation ◽  
Low Order

Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol are long-chain saturated or unsaturated (Oleyl) fatty alcohols. They are used in numerous cosmetic product categories at concentrations of less than 0.1 percent to greater than 50 percent. The metabolism of Stearyl Alcohol and Oleyl Alcohol in rats is described. The results of acute oral toxicity studies indicate a very low order of toxicity. In rabbit irritation tests, these alcohols produced minimal ocular irritation and minimal to mild cutaneous irritation. Stearyl Alcohol produced no evidence of contact sensitization or comedogenicity. Clinical patch testing indicates a very low order of skin irritation potential and sensitization. Photoreactivity studies on products containing these ingredients were negative for phototoxicity or photosensitization. Based on the available data, it is concluded that Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol are safe as currently used in cosmetics.

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