4 Final Report on the Safety Assessment of Captan

1989 ◽  
Vol 8 (4) ◽  
pp. 643-680 ◽  
Keyword(s):  
Adverse Effects ◽  
Oral Administration ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Intestinal Neoplasms

Captan is used in cosmetic products as a bacteriostat. Captan is not appreciably absorbed through the skin of mice. When administered orally to rats and absorbed, it is eliminated in the urine and feces. The compound is considered to be practically nontoxic to rats when orally administered. It is considered to be both a human irritant and sensitizer. Although teratogenic and reproductive studies indicated that Captan produced adverse effects in rats, mice, rabbits, and dogs, the ingredient was not teratogenic. Captan in the diet increased the incidence of intestinal neoplasms in mice. Because Captan is mutagenic in vitro, produces intestinal neoplasms in mice following oral administration, and upon degradation becomes an elec-trophile, it is concluded that an 18-month skin carcinogenicity bioassay in mice must be conducted before a conclusion on the safety of Captan can be reached.

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 Methenamine

1992 ◽  
Vol 11 (4) ◽  
pp. 531-558 ◽  
Keyword(s):  
Drinking Water ◽  
Drosophila Melanogaster ◽  
Safety Assessment ◽  
Intestinal Tract ◽  
Final Report ◽  
Formaldehyde Concentration ◽  
Cosmetic Products ◽  
Teratogenic Effects ◽  
Carcinogenic Activity

Methenamine is a biocide that is used in cosmetic eye make-up preparations at concentrations of less than 1%. Methenamine, following oral administration, undergoes hydrolysis and generates formaldehyde. Methenamine is rapidly absorbed from the intestinal tract and excreted mostly unchanged in the urine. A single oral dose of 20 g/kg Methenamine did not cause mortality in rats. No untoward signs of toxicity were observed in either subchronic or chronic studies. Methenamine was slightly irritating to the skin of rabbits. In ocular studies it was mildy irritating. In animal assays, Methenamine was a sensitizer when tested at a concentration of 25%, but not at 0.2%. It was neither an irritant nor a sensitizer to humans at 0.1%. In a number of teratologic and reproductive studies, no teratogenic effects attributable to Methenamine were observed. Methenamine was a mutagen in Drosophila melanogaster but not in other in vitro mutagenicity assays. Methenamine did not show any carcinogenic activity, either alone or when nitrite was included in the drinking water of the test animals. Methenamine is judged to be safe for non-aerosolized cosmetic products at a concentration not to exceed 0.16%. At this concentration, the released formaldehyde concentration will not exceed 0.2%.

4 Final Report on the Safety Assessment of Sweet Almond Oil and Almond Meal

1983 ◽  
Vol 2 (5) ◽  
pp. 85-99 ◽  
Keyword(s):  
Oral Administration ◽  
Clinical Studies ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Intact Skin ◽  
Rabbit Skin ◽  
Almond Oil ◽  
Pharmacological Studies ◽  
Sweet Almond

Sweet Almond Oil is used as an emollient and emulsifier in cosmetic products. Almond Meal is used as a skin cleanser and in medicated soaps. Pharmacological studies reveal that Sweet Almond Oil is absorbed slowly through intact skin, whereas it is easily absorbed and digested following oral administration. It is nontoxic when ingested, and products containing up to 25% Sweet Almond Oil are practically nonirritating to rabbit skin and only minimally irritating to rabbit eyes. In subchronic studies, Sweet Almond Oil at 100% concentrations was only slightly irritating to rabbit skin. In clinical studies, undiluted Sweet Almond Oil and products containing up to 25% Sweet Almond were practically nonirritating and nonsensitizing. Formulations containing up to 2% Sweet Almond Meal were practically nonirritating and nonsensitizing when tested in a repeated insult patch test. On the basis of the available data and clinical experience, it is concluded that Sweet Almond Oil and Almond Meal are safe for topical application to humans in the present practices of use and concentration.

2: Final Report on the Safety Assessment of Retinyl Palmitate and Retinol

1987 ◽  
Vol 6 (3) ◽  
pp. 279-320 ◽  
Keyword(s):  
Vitamin A ◽  
Safety Assessment ◽  
Retinyl Palmitate ◽  
In Vitro Tests ◽  
Final Report ◽  
Cosmetic Products ◽  
High Intake ◽  
Naturally Occurring ◽  
Cosmetic Ingredients

Retinol is the naturally occurring form of vitamin A; Retinyl Palmitate is the ester of Retinol and Palmitic Acid. In acute oral studies, Retinol was slightly toxic to mice, and Retinyl Palmitate was practically nontoxic in mice and rats. Large single doses can be lethal. It is recognized that Retinol is essential for reproduction; however, high intake of Retinol has produced adverse effects on several reproductive functions. Vitamin A was nonmutagenic in several in vitro tests. There is no evidence that vitamin A is carcinogenic. However, the vitamin has both enhanced and inhibited responses to viral or chemical carcinogens. Cosmetic products containing 0.1-1% Retinyl Palmitate were, at most, slightly irritating and nonsensitizing when tested on a total of 607 subjects. Results of cumulative irritation tests of two products containing 0.1% Retinyl Palmitate indicated that the products were nonirritating and non-sensitizing. On the basis of the available animal and clinical data presented in this report, it is concluded that Retinyl Palmitate and Retinol are safe as cosmetic ingredients in the present practices of use and concentration.

3: Final Report on the Safety Assessment of Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine

1987 ◽  
Vol 6 (1) ◽  
pp. 53-76 ◽  
Keyword(s):  
Contact Dermatitis ◽  
Oral Administration ◽  
Safety Assessment ◽  
Animal Studies ◽  
Water Soluble ◽  
Final Report ◽  
Cosmetic Products ◽  
Cosmetic Ingredients ◽  
Allergic Contact ◽  
Skin Irritants

Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine are used as water-soluble emulsifiers and neutralizers in cosmetic products at concentrations up to 1%. In animal studies these ingredients were slightly toxic to practically nontoxic to rats and guinea pigs via acute oral administration. Triisopropanolamine was relatively nontoxic to rats in the two subchronic oral studies. These ingredients were moderate skin irritants for rabbits. All four ingredients, when tested at 100% concentrations, were severe ocular irritants in rabbits. Products containing small amounts (-1%) of Diisopropanolamine or Triisopropanolamine were not ocular irritants in rabbits. The Triisopropanolamine salt was not mutagenic in Aspergillus nidulans. Diisopropanolamine and Isopropanolamine at concentrations of 2% did not induce allergic contact dermatitis or photoallergic dermatitis in humans. Clinical studies on cosmetic products containing no more than 1% Diisopropanolamine or 1.1% Triisopropanolamine were minimal skin irritant and contact sensitizers. It is concluded that Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine are safe as cosmetic ingredients in the present practices of use and concentration. The Isopropanolamines should not be used in products containing N-nitrosating agents.

1 Final Report on the Safety Assessment of Isostearyl Neopentanoate

1985 ◽  
Vol 4 (3) ◽  
pp. 1-22 ◽  
Keyword(s):  
Test Data ◽  
Clinical Studies ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Short And Long Term ◽  
Cosmetic Formulation

Isostearyl Neopentanoate, the ester of Isostearyl Alcohol and Neopentanoic Acid, is used in cosmetic products as an emollient at concentrations up to 50 percent. The undiluted ingredient at doses up to 4 ml/kg was shown to be relatively non-toxic in short-and long-term feeding studies. Test data from animal and clinical studies indicate the undiluted ingredient is neither an irritant nor a sensitizer. A cosmetic formulation containing 16 percent Isostearyl Neopentanoate produced no phototoxicity and no photoallergenicity. Mutagenicity, carcinogenicity, and teratogenicity data were not available. Isostearyl Neopentanoate was not considered to be a significant comedogenic agent. On the basis of available data, it is concluded that this ingredient is safe as a cosmetic ingredient in its present practices of use.

Final Report of the Safety Assessment of Kojic Acid as Used in Cosmetics

2010 ◽  
Vol 29 (6_suppl) ◽  
pp. 244S-273S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Expert Panel ◽  
Kojic Acid ◽  
Tumor Promotion ◽  
Final Report ◽  
Cosmetic Products ◽  
Pig Skin ◽  
Animal Data ◽  
Skin Lightening

Kojic acid functions as an antioxidant in cosmetic products. Kojic acid was not a toxicant in acute, chronic, reproductive, and genotoxicity studies. While some animal data suggested tumor promotion and weak carcinogenicity, kojic acid is slowly absorbed into the circulation from human skin and likely would not reach the threshold at which these effects were seen. The available human sensitization data supported the safety of kojic acid at a use concentration of 2% in leave-on cosmetics. Kojic acid depigmented black guinea pig skin at a concentration of 4%, but this effect was not seen at 1%. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that the 2 end points of concern, dermal sensitization and skin lightening, would not be seen at use concentrations below 1%; therefore, this ingredient is safe for use in cosmetic products up to that level.

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.

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 10 Final Report on the Safety Assessment of Cholesterol

1986 ◽  
Vol 5 (5) ◽  
pp. 491-516 ◽  
Keyword(s):  
Clinical Studies ◽  
Safety Assessment ◽  
Final Report ◽  
Experimental Animals ◽  
Normal Metabolism ◽  
Hair Care ◽  
Uvb Exposure ◽  
High Doses ◽  
Skin Irritants

Cholesterol is used as an emulsifier in cosmetic skin and hair care products and eye and face makeup formulations at concentrations up to 5%. The normal metabolism and excretion of Cholesterol is well documented in man and experimental animals. Cholesterol is not a significant dermal or ocular irritant. Cholesterol does not appear to have any genotoxic activity in bacterial or mammalian cell in vitro mutagenic and transformation assays. High doses of Cholesterol were teratogenic in rats. Cholesterol has not been established as a promoter, cocarcinogen, or total carcinogen. Clinical studies to evaluate the safety of topically applied Cholesterol were restricted to products formulated with the ingredient. Most products were moisturizers containing 1.4% Cholesterol. The highest concentration of Cholesterol tested (6%) was evaluated in a modified prophetic test (110 subjects) and an RIPT (45 subjects); both assays had UVA and UVB exposure incorporated into the protocols. The Cholesterol-containing products were minimal to mild primary and cumulative skin irritants but not sensitizers or photosensitizers.

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