scholarly journals 5 Final Report on the Safety Assessment of Zinc Phenolsulfonate

1986 ◽  
Vol 5 (5) ◽  
pp. 373-390
Keyword(s):  
Growth Inhibition ◽  
Patch Test ◽  
Clinical Assessment ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Products ◽  
Feeding Study ◽  
Significant Toxicity

Zinc Phenolsulfonate is a substituted phenol used in cosmetic products as an antimicrobial and astringent at concentrations up to 5%. This compound was moderately toxic when administered orally. No deaths or growth inhibition were reported in a 91-day rat feeding study. No significant toxicity was reported when Zinc Phenolsulfonate was applied dermally in acute and sub-chronic studies. A single insult patch test of a 5% aqueous Zinc Phenolsulfonate solution was negative for skin irritation in rabbits. Minimal skin irritation was reported when 100% Zinc Phenolsulfonate was tested. The Buehler test for delayed sensitization was negative. No eye irritation was observed in rabbits exposed to 5% aqueous Zinc Phenolsulfonate and only moderate irritation at 100%. No mutagenicity was observed when Zinc Phenolsulfonate was tested with and without metabolic activation in five Salmonella strains. Clinical assessment of Zinc Phenolsulfonate with product formulations indicated that Zinc Phenolsulfonate was at most a mild skin irritant in normal use, but not a sensitizer. It is concluded that Zinc Phenolsulfonate is safe as a cosmetic ingredient in the present practices of use and concentration.

scholarly journals 3: Final Report on the Safety Assessment of Coconut Oil, Coconut Acid, Hydrogenated Coconut Acid, and Hydrogenated Coconut Oil

1986 ◽  
Vol 5 (3) ◽  
pp. 103-121
Keyword(s):  
Clinical Assessment ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Coconut Oil ◽  
Laboratory Animals ◽  
Final Report ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Eye Irritation ◽  
Foaming Agent

In cosmetic products, Coconut Oil is used as a cleanser, foaming agent, or stabilizer at concentrations up to 50%. Acute, chronic, and subchronic oral toxicity studies indicate that Coconut Oil and Hydrogenated Coconut Oil are relatively nontoxic byingestion. Neither compound produced significant skin or eye irritation in laboratory animals. No sensitization was reported. Clinical assessment of cosmetic products containing Coconut Oil produced very minimal skin irritation reactions. There was no indication that theseingredients were primary irritants, sensitizers, or phototoxic compounds following human testing. It is concluded that Coconut Oil, Coconut Acid, Hydrogenated Coconut Oil, and Hydrogenated Coconut Acid are safe for use as cosmeticingredients.

Final Report on the Safety Assessment of Aldioxa

1993 ◽  
Vol 12 (3) ◽  
pp. 237-242
Keyword(s):  
Organic Compound ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Safety Data ◽  
Control Group ◽  
Final Report ◽  
Cosmetic Products ◽  
Feeding Study ◽  
Human Volunteers

Aldioxa is a heterocyclic organic compound used in cosmetic products as an astringent and skin conditioning agent. The oral LD50 for mice exceeds 23 mg/kg, and 8 g/kg for rats. All of the toxicologic parameters investigated in a 94-day subchronic feeding study in rats were similar in the test and the control group. No significant macroscopic adverse results were obtained in a three generation study in which rats were fed diets containing 10% Aldioxa. A suspension containing 25% Aldioxa was not a sensitizer when applied to the shaved backs of 3 male guinea pigs, nor when 10 animals were given intradermal injections of a 2% Aldioxa suspension on alternating days for a total of 10 applications and challenged after a 10-day nontreatment period. A hydrophilic unguent containing 4% Aldioxa was neither an irritant nor a sensitizer when evaluated on 200 human volunteers. The safety of Aldioxa has not been completely documented and substantiated. It cannot be concluded that this ingredient is safe for use in cosmetic products until the appropriate needed safety data cited in the report have been obtained and evaluated.

scholarly journals 2 Final Report on the Safety Assessment of Shellac

1986 ◽  
Vol 5 (5) ◽  
pp. 309-327 ◽  
Keyword(s):  
Adverse Effects ◽  
Respiratory Tract ◽  
Clinical Assessment ◽  
Maximum Concentration ◽  
Safety Assessment ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Formulations ◽  
Animal Toxicity ◽  
Spray Formulation

Cosmetic-grade Shellac is a mixture of hydroxyaliphatic and alicyclic acids and their polyesters. It is used in cosmetic formulations at concentrations up to 25%. Shellac had an LD50 of greater than 5 g/kg in rats. Results of acute animal toxicity studies using cosmetic formulations containing up to 6% Shellac indicated no adverse effects upon oral (rats), dermal (rabbits), ocular (rabbits), and respiratory tract (rabbits) exposure. Chronic inhalation of a Shellac hair spray formulation by rabbits produced no observable toxicity. No treatment-related toxic or pathologic effects were observed when concentrations of Shellac up to 10,000 ppm were fed to rats in a subchronic study. Ames' mutagenicity assays, with and without metabolic activation, were negative. Clinical assessment of safety of cosmetic formulations containing up to 6% Shellac indicated no measurable irritation and absence of sensitization and photosensitization. It is concluded that cosmetic-grade Shellac is safe for use in cosmetic formulations at concentrations up to 6%, the maximum concentration tested.

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.

3 Final Report on the Safety Assessment of Polyquaternium-10

1988 ◽  
Vol 7 (3) ◽  
pp. 335-351 ◽  
Keyword(s):  
Stratum Corneum ◽  
Quaternary Ammonium ◽  
Safety Assessment ◽  
Metabolic Activation ◽  
Hydroxyethyl Cellulose ◽  
Final Report ◽  
Cosmetic Products ◽  
Ammonium Derivative ◽  
Quaternary Ammonium Derivative ◽  
Low Degree

Polyquaternium-10 is a polymeric quaternary ammonium derivative of hydroxyethyl cellulose that is used in cosmetics as a conditioner, thickener, and emollient at concentrations of ≤0.1%–5%. Polyquaternium-10 has, at most, only a low potential to penetrate the stratum corneum but is adsorbed by keratinous surfaces. The oral LD50 of Polyquaternium-10 was not obtained at 16 g/kg in rats. Inhalation, dermal, and ocular animal test data indicated, at most, only a low degree of toxicity at test concentrations of Polyquaternium-10 greater than that used in cosmetic products. Polyquaternium-10 with and without metabolic activation was not a mutagen in three separate assay systems. Polyquaternium-10 was neither an irritant nor a human sensitizer when tested at 2.0%. Cosmetic products containing up to 1% Polyquaternium-10 were not human irritants, sensitizers, or photosensitizers. On the basis of the information presented, it is concluded that Polyquaternium-10 is safe as a cosmetic ingredient in the present practices of use.

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.

Final Report on the Safety Assessment of Stearalkonium Chloride

1990 ◽  
Vol 1 (2) ◽  
pp. 57-69 ◽  
Keyword(s):  
Aqueous Solution ◽  
Patch Test ◽  
Quaternary Ammonium ◽  
Safety Assessment ◽  
Antimicrobial Properties ◽  
Final Report ◽  
Cosmetic Products ◽  
Single Application ◽  
Rabbit Eye ◽  
Ld50 Value

Stearalkonium Chloride is a cationic quaternary ammonium salt used in cosmetic products at concentrations of ≤0.1 to 5%. It is used in cosmetics predominantly for its surfactant and antimicrobial properties. Studies have failed to establish with certainty the oral LD50 in rats of Stearalkonium Chloride, the value falling between 0.5 and 1.25 g/kg. In mice, an LD50 value of 0.760-0.113 g/kg was reported in a seven-day oral study. Single application dermal studies with concentrations of up to 25% have shown Stearalkonium Chloride to produce minor irritation in rabbits. Acute eye studies in rabbits have shown a 25% solution of the material to be a severe irritant. Concentrations of 1.25% and less are slightly and transiently irritating to the rabbit eye. A repeated insult patch test with a 1% aqueous solution of Stearalkonium Chloride on 50 subjects showed the material to be neither a primary irritant nor a sensitizer. A single 48-hour patch test with challenge two weeks later indicated that 20% Stearalkonium Chloride is not a sensitizer. On the basis of the evidence at hand, it is concluded that Stearalkonium Chloride is safe when incorporated in cosmetic products in concentrations similar to those presently marketed.

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.

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.

Final Report On the Safety Assessment of Benzoxiquine1

1997 ◽  
Vol 16 (1_suppl) ◽  
pp. 117-122
Author(s):  
F. Alan Andersen
Keyword(s):  
Safety Assessment ◽  
Safety Data ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Products ◽  
Over The Counter ◽  
Drug Products ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Mammalian System

Benzoxiquine is described as a biocide for use in cosmetic products. It is currently reported to be used in only one product. In a separate finding, the Food and Drug Administration determined that Benzoxiquine is not generally recognized as safe and effective in over-the-counter topical antifungal drug products. The only data available on the toxicity of Benzoxiquine indicates that it is mutagenic in the Ames test without metabolic activation. Because of the lack of data, the safety of Benzoxiquine could not be substantiated. The data needed to make a safety assessment include purity/impurities, ultraviolet absorption (if there is absorption, then photosensitization data will be needed), 28-day dermal toxicity, dermal teratogenicity, ocular irritation (if already available only), dermal irritation and sensitization, and two different genotoxicity studies (one using a mammalian system). If the latter data are positive, dermal carcinogenesis data using the methods of the National Toxicology Program will be needed. It cannot be concluded that Benzoxiquine is safe for use in cosmetic products until these safety data have been obtained and evaluated.

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