Final Report on the Safety Assessment of Juniperus Communis Extract, Juniperus Oxycedrus Extract, Juniperus Oxycedrus Tar, Juniperus Phoenicea Extract, and Juniperus Virginiana Extract

2001 ◽  
Vol 20 (2) ◽  
pp. 41-56 ◽  
Keyword(s):  
Safety Assessment ◽  
Juniperus Virginiana ◽  
Final Report ◽  
Juniperus Communis ◽  
Juniperus Oxycedrus ◽  
Juniperus Phoenicea

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.

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.

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.

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.

Final Report on the Safety Assessment of Cyclomethicone

1991 ◽  
Vol 10 (1) ◽  
pp. 9-19 ◽  
Keyword(s):  
Ames Test ◽  
Safety Assessment ◽  
Oral Feeding ◽  
Final Report ◽  
Histopathological Changes ◽  
Short Term ◽  
Local Skin ◽  
Reproductive Effects ◽  
Cosmetic Formulations ◽  
Gross Lesions

Cyclomethicone is a mixture of cyclic dimethylpolysiloxane compounds used primarily as an emollient and solvent in cosmetic formulations at concentrations from <0.1%to>50%. Cyclomethicone is not significantly absorbed through the skin. Small amounts of Cyclomethicone were absorbed by both humans and monkeys in oral feeding studies. The absorbed Cyclomethicone was detected in both the urine and expired air. Acute oral dose of Cyclomethicone to rats produced no deaths nor any gross lesions. Short-term dermal studies produced no behavioral, local skin, gross, nor histopathological changes. In subchronic inhalation studies in monkeys, no significant differences were found between exposed and unexposed animals. Undiluted Cyclomethicone applied to the intact and abraded skin of rabbits produced little or no irritation in two studies. Ocular studies indicated that Cyclomethicone produced only slight transient conjunctival irritation in washed and unwashed eyes. Cyclomethicone did not produce reproductive effects in rats. Cyclomethicone was not a mutagen when assayed in the Ames test. Cyclomethicone was neither irritating nor sensitizing to human skin in two clinical studies. On the basis of the available data, it is concluded that Cyclomethicone is safe as a cosmetic ingredient in present practices of use.

Final Report on the Safety Assessment of Cetethyl Morpholinium Ethosulfate

2001 ◽  
Vol 20 (3_suppl) ◽  
pp. 99-102 ◽  
Keyword(s):  
Safety Assessment ◽  
Developmental Toxicity ◽  
Quaternary Salt ◽  
Skin Penetration ◽  
Toxicity Study ◽  
Final Report ◽  
Inhalation Toxicity ◽  
Absorption Data ◽  
Dermal Irritation ◽  
Safety Test

Cetethyl Morpholinium Ethosulfate is a quaternary salt used as an antistatic agent and as a surfactant in several hair care products. The concentration at which this ingredient is used is unknown, although data reported in 1984 indicated a maximum concentration of 1%. In an inhalation toxicity study, the approximate lethal concentration of Cetethyl Morpholinium Ethosulfate was 0.403 mg/mm3. This ingredient was shown to be a severe ocular irritant in an animal study. No other safety test data on this ingredient were available. These data were clearly insufficient to support the safety of Cetethyl Morpholinium Ethosulfate in cosmetics. Data available on Morpholine were summarized, but these data themselves were insufficient to support safety. The data needed in order to complete the safety assessment of Cetethyl Morpholinium Ethosulfate include: methods of manufacture and impurities, especially nitrosamines; current concentration of use; skin penetration; if there is significant skin penetration, then both a 28-day dermal toxicity study to assess general skin and systemic toxicity and a reproductive and developmental toxicity study are needed; two genotoxicity studies, at least one in a mammalian system, if positive, then a 2-year dermal carcinogenisis study using National Toxicology Program (NTP) methods may be needed; ultraviolet (UV) absorption data, if significantly absorbed, then photosensitization data are needed; dermal irritation and sensitization; and ocular toxicity, if available.

Final Report on the Safety Assessment of Polyvinyl Acetate

1992 ◽  
Vol 11 (4) ◽  
pp. 465-473 ◽  
Keyword(s):  
Safety Assessment ◽  
Polyvinyl Acetate ◽  
Chinese Hamster ◽  
Safety Evaluation ◽  
Fibroblast Cell ◽  
Final Report ◽  
Cosmetic Products ◽  
Ames Assay ◽  
Negative Results ◽  
Chinese Hamster Fibroblast

Polyvinyl Acetate, as used in cosmetic products, is a latex emulsion known as the homopolymer of ethenyl acetate. It is used as a binder, emulsion stabilizer, and hair fixative at concentrations less than 25%. Polyvinyl Acetate was nonmutagenic in the Ames assay, with and without activation, and in the Chinese Hamster fibroblast cell assay. Carcinogenic implantation studies using mice gave negative results. It is concluded that the data available are insufficient to support the safety of Polyvinyl Acetate as currently used in cosmetic products. The types of data needed to complete the safety evaluation are listed in the report.

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