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.

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.

Final Report on the Safety Assessment of Laneth-10 Acetate Group

1982 ◽  
Vol 1 (4) ◽  
pp. 1-24 ◽  
Keyword(s):  
Guinea Pig ◽  
Topical Application ◽  
Safety Assessment ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Toxicity Studies ◽  
Animal Data

The Laneths are ethoxylated lanolin alcohols that may be acetylated and used in a wide variety of cosmetic products. Acute oral toxicity studies indicate that Laneth-10 Acetate is relatively nontoxic to the rat; acute dermal toxicity studies indicate that it is relatively nontoxic to the guinea pig. Laneth-10 Acetate was found to be a mild, transient irritant to the rabbit's eye. Laneth-10 Acetate was shown to be nonirritating and nonsensitizing to SO subjects. Laneth-16 is slightly toxic when administered orally to the rat. Neither Laneth-16 nor Laneth-25 was a skin irritant or sensitizing agent in 50 subjects. On the basis of the available animal data and limited human experience presented in this report, it is concluded that the Laneths are safe for topical application to humans in the present practices of use and concentration.

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.

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.

scholarly journals Final Report on the Safety Assessment of 4-Nitro-m-Phenylenediamine

1992 ◽  
Vol 11 (4) ◽  
pp. 489-495
Keyword(s):  
Coal Tar ◽  
Skin Irritation ◽  
Safety Data ◽  
Ultraviolet Absorption Spectrum ◽  
Final Report ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Absorption Data ◽  
Safety Test

4-Nitro-m-Phenylenediamine is a coal tar cosmetic used at concentrations of ≤0.1 %. In an acute oral toxicity study involving mice, the LD50 was 0.5 g/kg. 4-Nitro-m-Phenylenediamine was mutagenic in the chromosome aberrations assay and in the preincubation assay, using strains TA97, TA98, and TA 1537 of Salmonella typhimurium. The safety of use of 4-Nitro-m-Phenylenediamine in cosmetic products has not been documented and substantiated. The needed safety test data include: methods of production, ultraviolet absorption spectrum, impurities, skin absorption data, adequately performed skin irritation and sensitization studies, and dermal toxicity. It cannot be concluded that this ingredient is safe for use in cosmetic products until the cited safety data have been obtained and evaluated.

scholarly journals Final Report on the Safety Assessment of Glyceryl Stearate and Glyceryl Stearate/SE

1982 ◽  
Vol 1 (4) ◽  
pp. 169-192 ◽  
Keyword(s):  
Adverse Effects ◽  
Safety Assessment ◽  
Mouse Skin ◽  
Toxicity Tests ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Patch Tests ◽  
Cosmetic Formulations

Glyceryl Stearate and Glyceryl Stearate/SE are the esterification products of glycerine and stearic acid, and are used in cosmetic formulations as emollients, emulsifiers, and stabilizers. In acute oral toxicity studies in rats, both ingredients were slightly toxic. Glyceryl Stearate in the diet of rats for three consecutive generations had no adverse effects. Five percent Glyceryl Stearate did not promote the carcinogenicity of DMBA in mouse skin. In subchronic and chronic dermal toxicity tests, Glyceryl Stearate was nontoxic to rabbits but did cause moderate irritation. Primary eye irritation studies, at concentrations up to 100%, were mildly irritating or nonirritating to rabbits. Single and Repeated Insult Patch Tests showed both ingredients to be nonsensitizing and nonirritating. Products containing 2% Glyceryl Stearate were nonphototoxic and nonphotoallergenic. On the basis of the available data, it is concluded that Glyceryl Stearate and Glyceryl Stearate/SE are safe for topical application to humans in the present practices of use and concentration.

2 Final Report on the Safety Assessment of Benzophenones-1, 3, 4, 5, 9, and 11

1983 ◽  
Vol 2 (5) ◽  
pp. 35-77 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Metabolic Activation ◽  
Final Report ◽  
Oral Ingestion ◽  
Rabbit Skin ◽  
Animal Data ◽  
Irritation Test ◽  
Skin Irritation Test ◽  
Derivatives Of

Benzophenones-1 to 12 are substituted derivatives of 2-hydroxybenzophe-none. They are used as photostabilizers in cosmetics and have a photoprotective effect on the skin. When ingested and absorbed, Benzophenones were primarily conjugated and excreted in the urine. Benzophenones were practically nontoxic when chronically administered orally to rats, and Benzophenones-3 and 4 were nontoxic when applied to the skin of rabbits at doses of > 5 g/kg. Subchronic oral ingestion of Benzophenone-3 at 1 % was nontoxic to rats; however, another study showed Benzophenone-3 at 0.5% was toxic. Benzophenone-1 elicited toxic effects in rats at 0.6 g/kg. Benzophenones were nonirritating or mildly irritating to rabbit skin at concentrations of up to 100% and practically nonirritating to the eyes of rabbits. A subchronic skin irritation test indicated that Benzophenone-4 was capable of causing minimal irritation in rabbits at a concentration of 10%. Benzophenone-3 was reported to be nonsensitizing and nonphototoxic in guinea pigs and rabbits. Benzophenones-1, 3, 4, 5, and 9 were nonmutagenic both with and without metabolic activation in the Ames test. Skin irritation and sensitization in humans indicated that Benzophenones were mildly irritating and sensitizing at concentrations greater than those used in cosmetics. On the basis of the available animal data and clinical human experience, it is concluded that Benzophenone-1, 3, 4, 5, 9, and 11 are safe for topical application to humans in the present practices of use and concentration in cosmetics.

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.

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