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.

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).

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.

Final Report on the Safety Assessment of Hydroxybenzomorpholine

1991 ◽  
Vol 10 (1) ◽  
pp. 205-213 ◽  
Keyword(s):  
Safety Assessment ◽  
Micronucleus Test ◽  
Coal Tar ◽  
Skin Irritation ◽  
High Dose ◽  
Final Report ◽  
Oral Toxicity ◽  
Hair Dyes ◽  
Hair Dye ◽  
Rabbit Eye

Hydroxybenzomorpholine (HBM) is a heterocyclic compound that is used in cosmetics as a coupler in coal tar hair dyes. No deaths were reported in a subchronic oral toxicity study in rats. Some degenerative changes in the cortical tubules of the kidneys were observed in the mid and high-dose groups. HBM was considered to be practically nonirritating to the rabbit eye and produced only slight skin irritation. HBM was neither a sensitizer nor a photoallergen. HBM was not mutagenic in either the Ames assay or in the mouse micronucleus test. On the basis of the data included in the report, Hydroxybenzomorpholine is considered to be safe as a hair dye ingredient at the current concentrations of use.

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.

6: Final Report on the Safety Assessment of Panthenol and Pantothenic Acid

1987 ◽  
Vol 6 (1) ◽  
pp. 139-162 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Allergic Sensitization ◽  
Pantothenic Acid ◽  
Final Report ◽  
Test Substance ◽  
Cosmetic Products ◽  
Toxicological Effects ◽  
Ocular Irritation ◽  
Low Concentrations

Panthenol is the alcohol analogue of Pantothenic Acid (vitamin B3). The LD50for D-Panthenol administered orally to mice was 15 g/kg. No toxicological effects were associated with the subchronic and/or chronic oral administration of Panthenol to rats. Minimal cutaneous hyperkeratosis was noted in rats in a subchronic dermal study of creams containing 0.2% Panthenol. In ocular irritation studies involving rabbits, concentrations up to 2% produced, at most, slight conjunctival redness and chemosis. Panthenol (100%) and products containing Panthenol (0.5% and 2%) administered to rabbits during skin irritation studies caused reactions ranging from no skin irritation to moderate-to-severe erythema and well-defined edema. Neither teratogenic nor fetotoxic effects were noted in the offspring when rats were fed calcium pantothenate prior to mating and throughout gestation. Skin irritation and sensitization studies of cosmetic products at concentrations up to 0.5% indicated that they were, at most, mild irritants but did not induce allergic sensitization. No test substance-related observations of eye irritation were reported for 23 subjects receiving instillations of products containing 0.1% Panthenol. Mutagenicity and carcinogenicity data were not available for the safety assessment of Panthenol. It is noted that the level of this ingredient required by humans exceeds the amount that could be absorbed from the low concentrations used in cosmetic products. The human metabolic requirement would preclude the likelihood of genotoxicity. It is concluded that Panthenol and Pantothenic Acid are safe as presently used in cosmetics.

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.

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.

scholarly journals 1 Final Report on the Safety Assessment of Cocoamphoacetate, Cocoamphopropionate, Cocoamphodiacetate, and Cocoamphodipropionate

1990 ◽  
Vol 9 (2) ◽  
pp. 121-142 ◽  
Keyword(s):  
Patch Test ◽  
Organic Compounds ◽  
Safety Assessment ◽  
Metabolic Activation ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
Ocular Irritation ◽  
Cosmetic Ingredients ◽  
Rats And Mice

Cocoamphoacetate (CAA), Cocoamphopropionate (CAP), Cocoamphodiacetate (CADA), and Cocoamphodipropionate (CADP) are imidazoline-derived amphoteric organic compounds. These amphoteric compounds are used in cosmetics as surfactants, mild foaming and cleansing agents, detoxifying agents, and conditioners at concentrations ranging from ≤ 0.1 to 50 percent. In acute oral toxicity studies, CADA and CAA were nontoxic in rats and mice, CADP was nontoxic in rats, and CAP was nontoxic in mice. An oral LD50 of 7.8 ml/kg was reported for mice dosed with 70% CADP. The results of ocular irritation studies of these compounds, as commercially supplied, varied widely. CADA was moderately to severely irritating when eyes were not rinsed and practically nonirritating to mildly irritating when rinsed. CADP was practically nonirritating under unrinsed conditions. CAA was minimally to severely irritating and CAP was practically nonirritating to minimally irritating under unrinsed conditions. In a clinical ocular study, 1,3, and 10% dilutions of a shampoo containing 28.1% CADA were nonirritating to the human eye. CAP, CADA, and CADP were nonmutagenic in the Ames assay, both with and without metabolic activation. CAA and CAP, at a concentration of 10%, were neither irritants nor sensitizers in a repeated insult patch test on 141 subjects. Based upon the available data, it is concluded that CAA, CAP, CADA, and CADP are safe for use as cosmetic ingredients.

Final Report of the Safety Assessment of Polyamino Sugar Condensate

1982 ◽  
Vol 1 (4) ◽  
pp. 25-32 ◽  
Keyword(s):  
Amino Acids ◽  
Safety Assessment ◽  
Condensation Reaction ◽  
Skin Irritation ◽  
Safety Data ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
Animal Data ◽  
Mild Irritant

Polyamino Sugar Condensate (PSC) is the product of a condensation reaction between amino acids and sugars. It appears in over 100 cosmetic preparations at concentrations up to 1%. PSC has an acute oral toxicity greater than 5 g/kg in rats. In tests on rabbits, undiluted PSC was not a primary irritant and produced only mild irritation in some animals. Subacute skin irritation was not observed in rabbits when PSC (undiluted) was applied. Human safety data indicate that PSC is nonsensitizing and, at worst, a mild irritant. PSC is also nonphototoxic. On the basis of the available animal data and limited human experience, it is concluded that Polyamino Sugar Condensate is safe for topical application to humans.

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