scholarly journals Final Report on the Safety Assessment of Biotin

2001 ◽  
Vol 20 (4_suppl) ◽  
pp. 1-12

Biotin is a water-soluble vitamin used as a hair-conditioning agent and a skin-conditioning agent in many cosmetic products at concentrations ranging from 0.0001% to 0.6%. Although Biotin does absorb some ultraviolet (UV) radiation, the absorption shows no peaks in the UVA or UVB region. Biotin is rapidly metabolized and excreted in urine. Little acute oral toxicity is seen in animal tests. Short-term and subchronic toxicity studies likewise found no evidence of toxicity. Although intradermal injection of a small quantity of Biotin (0.1 ml) into guinea pig skin did not produce skin irritation, Biotin (0.1% at pH 7.3) did produce slight, transient ocular irritation in rabbit eyes. Biotin was not mutagenic in bacterial tests, but positive results were found in a Tradescantia micronucleus test. There was evidence of an increase in the number of resorptions in rats receiving Biotin by subcutaneous injection, with concomitant decreases in fetal, uterine, and placental weights. Another study of mice receiving Biotin orally or by subcutaneous injection found no differences between control and treatment groups. Although there is one case study reporting an urticarial reaction in the literature, there are a very large number of individuals exposed to Biotin on a daily basis, and there is not a parallel appearance of irritation, sensitization, or other adverse reactions. Based on these available data, it was concluded that Biotin is safe as used in cosmetic formulations.

1991 ◽  
Vol 10 (1) ◽  
pp. 205-213 ◽  

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.


1995 ◽  
Vol 14 (6) ◽  
pp. 498-510 ◽  

The ester Stearyl Heptanoate, a waxy solid that is insoluble in water, is used as a skin conditioning agent-occlusive in a wide variety of cosmetic formulations at varying concentrations (e.g., up to 25% in lip balms, up to 5% in ointments). Studies report a high oral LD50, ≥ 5 g/kg, for rats. Animal data indicate potential for mild skin irritation, but none for sensitization. Undiluted Stearyl Heptanoate did produce some ocular irritation in rabbits, but a 1.5% solution produced no effects. Mutagenesis assays (Ames and micronucleus test) were negative. Clinical data showed no evidence of irritation or sensitization or comedogenicity. Although animal and clinical sensitization studies were done at a low concentration compared with expected use concentrations, the data suggest that it would not be a sensitizer even at higher concentrations. Data on ocular irritation show only mild reactions to undiluted Stearyl Heptanoate, suggesting that expected use concentrations should not produce significant ocular irritation. On the basis of the available animal and clinical data, it is concluded that Stearyl Heptanoate is safe for use as a cosmetic ingredient in the present practice of use.


1985 ◽  
Vol 4 (5) ◽  
pp. 223-248 ◽  

Butylene Glycol, Hexylene Glycol, Ethoxydiglycol, and Dipropylene Glycol are viscous liquids used in the cosmetic industry as humectants, emulsifiers, plasticizers, and solvents. The results of acute, subchronic, and chronic oral toxicity studies using a variety of animal species indicate a low order of toxicity for the Glycols. Results of parenteral injection, inhalation, and acute and subchronic cutaneous toxicity studies likewise support a low order of toxicity. Butylene Glycol, Ethoxydiglycol, and Dipropylene Glycol caused minimal to mild irritation of rabbit skin, whereas Hexylene Glycol was moderately irritating. The Glycols produced mild to severe ocular irritation when tested in rabbits, with Hexylene Glycol producing the most severe irritation. Although undiluted Hexylene Glycol produced severe ocular irritation, a 25 percent aqueous solution produced no signs of irritation. Undiluted Butylene Glycol was not an eye irritant to rabbits but was to humans. Human skin patch tests on undiluted Butylene Glycol and undiluted Hexylene Glycol produced a very low order of primary skin irritation. A repeated insult patch test on Butylene Glycol produced no evidence of skin sensitization. Based on the available data it is concluded the Butylene Glycol, Hexylene Glycol, Ethoxydiglycol, and Dipropylene Glycol are safe as presently used in cosmetics.


1983 ◽  
Vol 2 (5) ◽  
pp. 141-159 ◽  

Polyvinylpyrrolidone/Vinyl Acetate Copolymer (PVP/VA Copolymer) is the copolymer of vinyl pyrrolidone (VP) and vinyl acetate (VA) monomers. The ingredient is used primarily in hair care products and secondly in skin and nail products. Acute oral toxicity studies on mice and rats showed low to no toxicity. Chronic oral and inhalation studies produced no effects. The acute ocular irritation of PVP/VA Copolymer at concentrations ranging from 25% to 50% in alcohol produced no reaction to severe irritation. Acute skin irritation studies of 50% PVP/VA Copolymer in alcohol on abraded and intact skin produced mild skin irritation. PVP/VA Copolymer was not a sensitizer to guinea pigs after intracutaneous injections. Formulations containing 1.75%, 4.0%, and 5.0% PVP/VA Copolymer produced no irritation in 24-hour clinical patch tests nor any evidence of sensitization in a repeated insult patch test at a concentration of 5.0%. On the basis of the available information, it is concluded that Polyvinylpyrrolidone/Vinyl Acetate Copolymer is safe as a cosmetic ingredient under present conditions of concentration and use.


1985 ◽  
Vol 4 (5) ◽  
pp. 1-29 ◽  

Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol are long-chain saturated or unsaturated (Oleyl) fatty alcohols. They are used in numerous cosmetic product categories at concentrations of less than 0.1 percent to greater than 50 percent. The metabolism of Stearyl Alcohol and Oleyl Alcohol in rats is described. The results of acute oral toxicity studies indicate a very low order of toxicity. In rabbit irritation tests, these alcohols produced minimal ocular irritation and minimal to mild cutaneous irritation. Stearyl Alcohol produced no evidence of contact sensitization or comedogenicity. Clinical patch testing indicates a very low order of skin irritation potential and sensitization. Photoreactivity studies on products containing these ingredients were negative for phototoxicity or photosensitization. Based on the available data, it is concluded that Stearyl Alcohol, Oleyl Alcohol, and Octyl Dodecanol are safe as currently used in cosmetics.


1996 ◽  
Vol 15 (4) ◽  
pp. 337-347

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.


1988 ◽  
Vol 7 (6) ◽  
pp. 721-739 ◽  

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).


1998 ◽  
Vol 17 (4_suppl) ◽  
pp. 95-130 ◽  
Author(s):  
Bindu Nair

Polyvinylpyrrolidone (PVP) is a linear polymer of 1-vinyl-2-pyrrolidone monomers used as a binder, emulsion stabilizer, film former, hair fixative, and suspending agent-nonsurfactant. The molecular weight of the polymer ranges from 10,000 to 700,000. PVP K-30, with an average molecular weight of 40,000, is typically used in cosmetic formulations. The highest concentration reported to be used is 35%. There was no significant absorption of PVP K-30 given orally to rats, and the acute oral LD50 was >100 g/kg for rats and guinea pigs. Neither toxic effects nor gross lesions were found in rats maintained for two years on a diet containing 10% PVP K-30. Short-term PVP inhalation studies produced mild lymphoid hyperplasia and fibroplasia in rats, but no inflammatory response. In animal studies, no evidence of significant ocular irritation, skin irritation, or skin sensitization was found at PVP-iodine solution concentrations of 10%. While PVP-iodine is not a cosmetic ingredient, these negative findings were considered to support the safety of the PVP component. Undiluted PVP K-30 was not a dermal irritant or sensitizer in clinical tests. No developmental toxicity was seen in vehicle controls where PVP was used as a vehicle for another agent. In certain assay systems, PVP was genotoxic, but was negative in the majority of studies. Orally administered PVP significantly decreased the rate of bladder tumors in mice exposed to bracken fern. Several studies tested the carcinogenicity of subcutaneous implants of particulate PVP in rats, mice, and rabbits. Although the majority of these studies conducted in rats were positive, tumors (sarcomas) were localized to the site of implantation. Based on the available data, it was concluded that PVP is safe as used in cosmetics.


2005 ◽  
Vol 24 (3_suppl) ◽  
pp. 65-74

Octyldodecyl Stearoyl stearate is an ester that functions as a skin-conditioning agent and viscosity-increasing agent. It is reported to be used in 105 cosmetic products at concentrations from 2% to 15%. In an isolated human skin permeation and penetration study, 0.005% of the applied dose permeated the skin, around 3% was found in the epidermis, around 1.5% was in tape stripped skin layers, and around 95% stayed in the material applied to the skin. A formulation having 20.6 % Octyldodecyl Stearoyl stearate was classified as minimally to mildly irritating in an in vitro ocular irritation assay. Several tests of products containing from 7.5% to 12.7% Octyldodecyl Stearoyl stearate using rabbits produced minimal to mild ocular irritation. One test of 100% Octyldodecyl Stearoyl stearate (a trade compound) and another of 10% Octyldodecyl Stearoyl stearate in corn oil using rabbits produced no ocular irritation. Tests using rabbits demonstrated that Octyldodecyl Stearoyl stearate at use concentrations was non- to mildly irritating to skin; only one study reported moderate irritation. Octyldodecyl Stearoyl stearate was not mutagenic, with or without S-9 activation, in an Ames test and did not produce a significant increase in micronucleated cells in a mouse in vivo study. In clinical single-insult patch tests at use concentrations, Octyldodecyl Stearoyl stearate was nonirritating to mildly irritating; in a cumulative irritation study, it caused mild irritation. Octyldodecyl Stearoyl stearate was nonsensitizing in clinical tests. Because few toxicity data were available on Octyldodecyl Stearoyl Stearate, summaries of data from existing safety assessments of related ingredients (Octyl Dodecanol, Stearic Acid, and Octyl Stearate) were included. Undiluted Octyl Dodecanol was nontoxic during acute oral and dermal studies using rats and guinea pigs. Stearic Acid was nontoxic to rats during acute oral studies, but caused toxicity during subchronic studies. Rabbits treated topically with the acid were not affected adversely, and mild erythema and slight induration were observed when Stearic Acid was administered intradermally to guinea pigs and rabbits. Octyl stearate had very low acute oral toxicity in rats and mice. Octyl Dodecanol produced only transient mild ocular irritation in rabbits when administered at concentrations up to 100%. Octyl Dodecanol (30% and 100%) was nonirritating to skin in one study using rabbits. In another study using multiple species, 100% Octyl Dodecanol (described as technical grade) caused severe skin irritation in rabbits, moderate irritation in guinea pigs and rats, and no irritation in swine. Stearic Acid was non- to moderately irritating in animal studies, and did not cause photosensitization. In studies using rabbits, undiluted Octyl stearate caused slight, transient ocular irritation, and minimal skin irritation. Stearic Acid did not induce mitotic crossovers and aneuploidy in Saccharomyces cerevisiae, and was nonmutagenic in the Ames test. In a feeding study using mice, Stearic Acid was noncarcinogenic at doses up to 50 g/kg/day. Mice given subcutaneous injections of the acid had low incidences of carcinomas, sarcomas, and lymphomas. In clinical studies, concentrations of up to 100% Octyl Dodecanol were non- to mildly irritating, nonsensitizing, nonphototoxic, and non-photosensitizing. Stearic Acid was nonirritating at concentrations up to 100%, and at concentrations up to 13% it was nonsensitizing and nonphotosensitizing. Octyl stearate (7.6%) in formulation was nonirritating, nonsensitizing, and nonphotosensitizing. Based on skin permeation and penetration data, the Panel does not expect any significant amount of Octyldodecyl Stearoyl stearate to be systemically available. There is no evidence of systemic toxicity associated with any of the related chemicals reviewed in previous safety assessments. None of the available toxicology or clinical data suggest a concern about adverse skin reactions to Octyldodecyl Stearoyl Stearate, or to any of the related chemicals. There is no evidence of ocular toxicity, except for a mild, transient ocular irritation associated with Octyldodecyl Stearoyl stearate and the related chemicals. Overall, Octyldodecyl Stearoyl stearate was considered safe as used in cosmetics.


1982 ◽  
Vol 1 (4) ◽  
pp. 103-118 ◽  

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.


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