Final Report on the Safety Assessment of Quaternium-22

1995 ◽  
Vol 14 (6) ◽  
pp. 485-497
Keyword(s):  
Safety Assessment ◽  
Adverse Reactions ◽  
Toxicity Study ◽  
Final Report ◽  
Test Substance ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Ethylene Chlorohydrin ◽  
Ocular Exposure

The quaternary ammonium salt Quaternium-22 is used as a film former, hair conditioning agent, and antistatic agent in a wide variety of cosmetic products. This ingredient has reportedly also been used as an emollient and skin conditioner. It is supplied in water with 60% solids (Quaternium-22). Impurities include 3-dimethylaminopropylamine (DMAPA) at concentrations up to 2.45%, and ethylene chlorohydrin (ECH) up to 0.097%. The maximum concentration of Quaternium-22 in formulations is 5.0%. An acute oral toxicity study in rats using 6% Quaternium-22 failed to kill any of the animals. Exposure to 0.5% Quaternium-22 was a slight irritant in a 28-day dermal toxicity study in rabbits; no other adverse reactions related to the test substance were found. Ocular exposure to 8.5% Quaternium-22 produced minimal conjunctival irritation, but 6% did not. Intracutaneous injections of 6% Quaternium-22 did not produce irritation or sensitization in Guinea pigs. No evidence of mutagenesis was seen in the Ames test. Clinical data revealed no irritation or sensitization, nor was there any evidence of photosensitization. While there was some concern over the toxicity of the DMAPA and ECH impurities, the absence of any toxicologic or mutagenic findings on exposure to material containing these impurities suggested there were no adverse effects associated with either the ingredient or any impurities. In order that exposure to these impurities be kept low, however, it was recommended that the concentration of this ingredient in cosmetic products should be limited so that the concentration of DMAPA not exceed 0.2% and that of ECH not exceed 0.008%-this is consistent with the expected use of Quaternium-22 at ≥ 5% solids. Accordingly, it was concluded that the cosmetic ingredient Quaternium-22 is safe in the present practices of use.

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.

Final Report on the Safety Assessment of Sodium m-Nitrobenzenesulfonate

1996 ◽  
Vol 15 (4) ◽  
pp. 337-347
Keyword(s):  
Lethal Dose ◽  
Water Soluble ◽  
Toxicity Study ◽  
Final Report ◽  
Test Substance ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Hair Dyes ◽  
Hair Dye ◽  
Ocular Irritation

Sodium m-Nitrobenzenesulfonateis a water-soluble ingredient that is used as a chemical additive in hair dyes and colors and has been used as a base component in semipermanent hair coloring products. Product formulation data submitted to the Food and Drug Administration in 1994 indicated that this ingredient was used in 25 products, all of which were hair dyes and colors. In an acute oral toxicity study involving rats, the median lethal dose was not achieved at a dose of 5,000 mg/kg Sodium m-Nitrobenzenesulfonate. The results of a chronic oral toxicity study of a composite hair dye formulation containing 2.25% Sodium m-Nitrobenzenesulfonate indicated neither gross nor microscopic changes in beagle dogs that were related to test substance administration. The same hair dye formulation (administered in the diet at concentrations of 0.005% and 0.02%) was not classified as a reproductive toxicant in studies involving rats and rabbits. Moderate ocular irritation and mild skin irritation reactions to Sodium m-Nitrobenzenesulfonate were observed in rabbits. Based on these data, however, the safety of use of Sodium m-Nitrobenzenesulfonate in cosmetic products cannot be documented and substantiated. Additional safety test data are needed, including (1) purity and impurity data; (2) a 28-day dermal toxicity study and, if positive, then dermal absorption and distribution data in animals; (3) significantly absorbed, two different genotoxicity assays (one using a mammalian system) and, if positive, a dermal carcinogenicity study using National Toxicology Program methods; and (4) ocular irritation data in animals (if available). The currently available data are insufficient to support the safety of Sodium m-Nitrobenzenesulfonate as used in cosmetic products.

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).

Final Report on the Safety Assessment of Polyacrylamide

1991 ◽  
Vol 10 (1) ◽  
pp. 193-203 ◽  
Keyword(s):  
Body Weight ◽  
Adverse Effects ◽  
Safety Assessment ◽  
Maximum Dose ◽  
Toxicity Study ◽  
Final Report ◽  
Oral Toxicity ◽  
Monomer Content ◽  
Acrylamide Monomers ◽  
Reproductive Study

Polyacrylamide is a polymer of controllable molecular weight formed from the polymerization of acrylamide monomers. Average concentrations of the monomer were reported as less than 0.01% by several manufacturers. Polyacrylamide is used as a foam builder and stabilizer in shampoo products and as a vehicle in sunscreen preparations. An acute oral toxicity study of Polyacrylamide in rats reported that a single maximum oral dose of 4.0 g/kg body weight was tolerated. In a subchronic oral toxicity study in both rats and dogs, animals were given a maximum dose of 464 mg/kg body weight, with no signs of toxicity in any animals. Two separate studies in rats reported no absorption when the compound was administered by gavage. In a 2-year chronic oral toxicity study, rats fed between 500 and 10,000 ppm in their diet had no significant adverse effects. Similar results were obtained in dogs. A 2-year feeding study in rats fed up to 5.0% Polyacrylamide reported no significant adverse effects. Cutaneous tolerance tests performed to evaluate the irritation of Polyacrylamide indicated that the compound was relatively well tolerated. Undiluted Polyacrylamide applied to the conjunctival sac of the rabbit caused a very slight response. No compound-related lesions were noted in a three-generation reproductive study in which rats were fed either 500 or 2000 ppm Polyacrylamide. On the basis of data presented in this report, it is concluded that Polyacrylamide, with less than 0.01% acrylamide monomer content, is safe as a cosmetic ingredient as currently used.

2 Final Report on the Safety Assessment of Dilauryl Thiodipropionate

1992 ◽  
Vol 11 (1) ◽  
pp. 25-41 ◽  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Lauryl Alcohol ◽  
Final Report ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Safety Test ◽  
Human Volunteers ◽  
Test Concentration ◽  
Rats And Mice

Dilauryl Thiodipropionate (DLTDP) is the diester of lauryl alcohol and 3,3′-thiodipro-pionic acid which is used as an antioxidant and sequestering agent in cosmetics at concentrations up to 1%. When administered orally to rats and mice, DLTDP was slightly toxic and was relatively nontoxic in subchronic oral studies with rats. No irritation was produced by a formulation containing 0.05% DLTDP when tested at 0.0025% on intact and abraded skin. DLTDP was nonmutagenic in four different assay systems. This cosmetic ingredient was not a teratogen or reproductive toxicant in oral studies in mice, rats, hamsters or rabbits. A formulation containing 0.05% DLTDP when tested at 0.05% was not a sensitizer in a guinea pig maximization test. DLTDP, at a concentration of 0.05% in a makeup foundation, was not an irritant, sensitizer, or phototoxin when tested on human volunteers. The maximum reported safety test concentration used in dermal toxicity of DLTDP was 0.05%. The report limits its safety conclusion by concluding that DLTDP is safe for use in cosmetic products at the maximum dermal tested concentration of 0.05%.

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.

4 Final Report on the Safety Assessment of Butyl Stearate, Cetyl Stearate, Isobutyl Stearate, Isocetyl Stearate, Isopropyl Stearate, Myristyl Stearate, and Octyl Stearate

1985 ◽  
Vol 4 (5) ◽  
pp. 107-146 ◽  
Keyword(s):  
Safety Assessment ◽  
Animal Studies ◽  
Health Effect ◽  
Final Report ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Potential Health ◽  
Rabbit Skin ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations

The 7 Stearates described in this report are either oily liquids or waxy solids that are primarily used in cosmetics as skin emollients at concentrations up to 25 percent. The toxicology of the Stearates has been assessed in a number of animal studies. They have low acute oral toxicity and are essentially nonirritating to the rabbit eye when tested at and above use concentration. At cosmetic use concentrations the Stearates are, at most, minimally irritating to rabbit skin. In clinical studies the Stearates and cosmetic products containing them were at most minimally to mildly irritating to the human skin, essentially nonsensitizing, nonphototoxic and nonphotosensitizing. Comedogenicity is a potential health effect that should be considered when the Stearate ingredients are used in cosmetic formulations. On the basis of the information in this report, it is concluded that Butyl, Cetyl, Isobutyl, Isocetyl, Isopropyl, Myristyl, and Octyl Stearate are safe as cosmetic ingredients in the present practices of use.

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.

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.

Sign in / Sign up

Export Citation Format

Share Document