3 Final Report on the Safety Assessment of Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50

1983 ◽  
Vol 2 (7) ◽  
pp. 35-60 ◽  
Keyword(s):  
Clinical Studies ◽  
Ames Test ◽  
Safety Assessment ◽  
Animal Species ◽  
Skin Irritation ◽  
Final Report ◽  
Dermal Toxicity ◽  
Rabbit Eye ◽  
Toxicity Studies ◽  
Cosmetic Ingredients

Nonoxynols are chemically stable ethoxylated alkylphenols which are chemically foaming and solubilizing agents. Estimates of the acute oral LD50s of nine of the Nonoxynols (-2 to 15) range from 0.62 to 7.4 g/kg in several animal species. Acute dermal toxicity studies in rabbits produced an LD50 range of 1.8 ml/kg to 4.4 g/kg. Skin irritation tests on rabbits indicated that Nonoxynols are nonirritating to moderately irritating. Nonoxynol compounds with short ethoxylated chains are generally severe ocular irritants, whereas long-chained Nonoxynols are only slightly irritating to the rabbit eye. No evidence of carcinogenicity was observed when Nonoxynol-4 and 9 were fed to both dogs and rats. A mutagenicity study of these two compounds by the Ames test was negative. Undiluted Nonoxynol-4 and 9 were nonirritating and nonsensitizing in clinical studies. A 50% solution of Nonoxynol-15 and/or Nonoxynol-50 produced no irritation or sensitization when tested on 168 subjects, nor was there evidence of phototoxicity when tested on a subset of this population. It is concluded that Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50 are safe as cosmetic ingredients.

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.

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 Carbomers-934, -910, -934P, -940, -941, and -962

1990 ◽  
Vol 1 (2) ◽  
pp. 109-141 ◽  
Keyword(s):  
Molecular Weight ◽  
Acrylic Acid ◽  
Safety Assessment ◽  
Animal Studies ◽  
Skin Irritation ◽  
Final Report ◽  
Pathological Changes ◽  
Cosmetic Ingredients ◽  
Body Weights ◽  
Available Information

The Carbomers are synthetic, high molecular weight, nonlinear polymers of acrylic acid, cross-linked with a polyalkenyl polyether. The Carbomer polymers are used in cosmetics and emulsifying agents at concentrations up to 50%. Acute oral animal studies showed that Carbomers-910, -934, -934P, -940, and -941 have low toxicities when ingested. Rabbits showed minimal skin irritation and zero to moderate eye irritation when tested with Carbomers-910 and -934. Subchronic feeding of rats and dogs with Carbomer-934 in the diet resulted in lower than normal body weights, but no pathological changes were observed. Dogs chronically fed Carbomer-934P manifested gastrointestinal irritation and marked pigment deposition within Kupffer cells of the liver. Clinical studies with Carbomers showed that these polymers have low potential for skin irritation and sensitization at concentrations up to 100%. Carbomer-934 demonstrated low potential for phototoxicity and photo-contact allergenicity. On the basis of the available information presented and as qualified in the report, it is concluded that the Carbomers are safe as cosmetic ingredients.

Final Report on the Safety Assessment of Hydroxybenzomorpholine

1991 ◽  
Vol 10 (1) ◽  
pp. 205-213 ◽  
Keyword(s):  
Safety Assessment ◽  
Micronucleus Test ◽  
Coal Tar ◽  
Skin Irritation ◽  
High Dose ◽  
Final Report ◽  
Oral Toxicity ◽  
Hair Dyes ◽  
Hair Dye ◽  
Rabbit Eye

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.

scholarly journals Final Report on the Safety Assessment of Octyl Palmitate, Cetyl Palmitate and Isopropyl Palmitate

1990 ◽  
Vol 1 (2) ◽  
pp. 13-35 ◽  
Keyword(s):  
Safety Assessment ◽  
Isopropyl Alcohol ◽  
Skin Tests ◽  
Final Report ◽  
Dermal Toxicity ◽  
Rabbit Skin ◽  
Ocular Irritation ◽  
Cosmetic Ingredients ◽  
Cetyl Palmitate ◽  
Available Information

The Palmitates used in cosmetic products are esters of palmitic acid and octyl, cetyl, or isopropyl alcohol. The acute oral LD50 is estimated from studies with rats to be greater than 14.4 g/kg for Cetyl Palmitate and greater than 64.0 g/kg for Octyl and Isopropyl Palmitates. Acute studies with rabbits showed no evidence of dermal toxicity for any of the Palmitates. Isopropyl Palmitate was “well tolerated” and Octyl Palmitate was nontoxic in separate subchronic dermal studies. Rabbit skin tests with the Palmitates showed that they are nonirritating and nonsensitizing. Also, Draize rabbit eye irritation tests on the Palmitates produced either no or only very slight ocular irritation. One of three formulations containing Octyl Palmitate at concentrations between 40% and 50% produced mild irritation. Formulations containing Cetyl Palmitate at concentration of 2.7% were minimally irritating and produced no signs of sensitization, phototoxicity, or photo contact allergenicity. A formulation containing 45.6% Isopropyl Palmitate produced no signs of irritation, sensitization, phototoxicity, or photo contact allergenicity. From the available information, it is concluded that Octyl Palmitate, Cetyl Palmitate, and Isopropyl Palmitate are safe as cosmetic ingredients in the present practices of use and concentration.

2: Final Report on the Safety Assessment of Propylene Carbonate

1987 ◽  
Vol 6 (1) ◽  
pp. 23-51 ◽  
Keyword(s):  
Aqueous Solution ◽  
Dna Repair ◽  
Propylene Carbonate ◽  
Clinical Studies ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Clear Liquid ◽  
Cosmetic Products ◽  
Ocular Irritation

Propylene Carbonate is a nonviscous, clear liquid that is used in cosmetic products at concentrations ranging from 0.1% to 5%. Undiluted Propylene Carbonate produced minimal to moderate ocular irritation and slight erythema in rabbits. The dermal LD50 in rabbits of the undiluted ingredient was >20 ml/kg. Undiluted Propylene Carbonate was nontoxic by inhalation to dogs and guinea pigs in a 21-day study. Propylene Carbonate was negative for mutagenicity in the Ames Assay, and negative for genotoxicity in the Rat He-patocyte Primary Culture/DNA Repair Test. In clinical studies, undiluted Propylene Carbonate caused moderate skin irritation, whereas 5 and 10% Propylene Carbonate in aqueous solution produced no skin irritation or sensitization. Cosmetic products containing up to 20% Propylene Carbonate were essentially nonsensitizing and, at most, moderately irritating to human skin, nonphototoxic, and nonphotosensitizing. It is concluded that Propylene Carbonate is safe as a cosmetic ingredient in the present practices of use and concentration.

Final Report of the Amended Safety Assessment of Glyceryl Lau rate, Glyceryl Lau rate SE, Glyceryl Laurate/Oleate, Glyceryl Adipate, Glyceryl Alginate, Glyceryl Arachidate, Glyceryl Arachidonate, Glyceryl Behenate, Glyceryl Caprate, Glyceryl Caprylate, Glyceryl Caprylate/Caprate, Glyceryl Citrate/Lactate/Linoleate/Oleate, Glyceryl Cocoate, Glyceryl Collagenate, Glyceryl Erucate, Glyceryl Hydrogenated Rosinate, Glyceryl Hydrogenated Soyate, Glyceryl Hydroxystearate, Glyceryl Isopalmitate, Glyceryl Isostearate, Glyceryl Isostearate/Myristate, Glyceryl Isostearates, Glyceryl Lanolate, Glyceryl Linoleate, Glyceryl Linolenate, Glyceryl Montanate, Glyceryl Myristate, Glyceryl Isotridecanoate/Stearate/Adipate, Glyceryl Oleate SE, Glyceryl Oleate/Elaidate, Glyceryl Palmitate, Glyceryl Palmitate/Stearate, Glyceryl Palmitoleate, Glyceryl Pentadecanoate, Glyceryl Polyacrylate, Glyceryl Rosinate, Glyceryl Sesquioleate, Glyceryl/Sorbitol Oleate/Hydroxystearate, Glyceryl Stearate/Acetate, Glyceryl Stearate/Maleate, Glyceryl Tallowate, Glyceryl Thiopropionate, and Glyceryl Undecylenate1

2004 ◽  
Vol 23 (2_suppl) ◽  
pp. 55-94 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Test System ◽  
Dermal Absorption ◽  
Final Report ◽  
Low Grade ◽  
Vitro Assay ◽  
Cosmetic Ingredients ◽  
Glyceryl Behenate

The safety of 43 glyceryl monoesters listed as cosmetic ingredients was reviewed in a safety assessment completed in 2000. Additional safety test data pertaining to Glyceryl Rosinate and Glyceryl Hydrogenated Rosinate were received and served as the basis for this amended report. Glyceryl monoesters are used mostly as skin-conditioning agents—emollients and/or surfactant—emulsifying agents in cosmetics. The following 20 glyceryl monoesters are currently reported to be used in cosmetics: Glyceryl Laurate, Glyceryl Alginate, Glyceryl Arachidonate, Glyceryl Behenate, Glyceryl Caprylate, Glyceryl Caprylate/Caprate, Glyceryl Cocoate, Glyceryl Erucate, Glyceryl Hydroxystearate, Glyceryl Isostearate, Glyceryl Lanolate, Glyceryl Linoleate, Glyceryl Linolenate, Glyceryl Myristate, Glyceryl Oleate/Elaidate, Glyceryl Palmitate, Glyceryl Polyacrylate, Glyceryl Rosinate, Glyceryl Stearate/Acetate, and Glyceryl Undecylenate. Concentration of use data received from the cosmetics industry in 1999 indicate that Glyceryl Monoesters are used at concentrations up to 12 % in cosmetic products. Glyceryl Monoesters are not pure monoesters, but are mostly mixtures with mono-, di-, and tri-esters. The purity of commercial and conventional Monoglyceride (Glyceryl Monoester) is a minimum of 90%. Glyceryl Monoesters (monoglycerides) are metabolized to free fatty acids and glycerol, both of which are available for the resynthesis of triglycerides. Glyceryl Laurate enhanced the penetration of drugs through cadaverous skin and hairless rat skin in vitro and has been described as having a wide spectrum of antimicrobial activity. A low-grade irritant response was observed following inhalation of an aerosol containing 10% Glyceryl Laurate by test animals. Glyceryl monoesters have little acute or short-term toxicity in animals, and no toxicity was noted following chronic administration of a mixture consisting mostly of glyceryl di- and mono- esters. Glyceryl Laurate did have strong hemolytic activity in an in vitro assay using sheep erythrocytes. Glyceryl Laurate, Glyceryl Isostearate, or Glyceryl Citrate/Lactate/Linoleate/Oleate were not classified as ocular irritants in rabbits. Undiluted glyceryl monoesters may produce minor skin irritation, especially in abraded skin, but in general these ingredients are not irritating at concentrations used in cosmetics. Glyceryl monoesters are not sensitizers, except that Glyceryl Rosinate and Hydrogenated Glyceryl Rosinate may contain residual rosin, which can cause allergic reactions. These ingredients are not photosensitizers. Glyceryl Citrate/Lactate/Linoleate/Oleate was not mutagenic in the Ames test system. Glyceryl Laurate exhibited antitumor activity and Glyceryl Stearate was negative in a tumor promotion assay. At concentrations higher than used in cosmetics, Glyceryl Laurate did cause moderate erythema in human repeat-insult patch test (RIPT) studies, but the other glyceryl monoesters tested failed to produce any significant positive reactions. Glyceryl Rosinate was irritating to animal skin at 50%, but did not produce sensitization in clinical tests at concentrations up to 10% and covered with semioccluded patches. There is reported use of Glyceryl Rosinate at 12% in mascara, which is somewhat higher than the concentration in the clinical testing. It was reasoned that the available data do support the safety of this use because there would be minimal contact with the skin and no occlusion. The safety of Arachidonic Acid was not documented and substantiated for cosmetic product use in an earlier safety assessment and those same safety questions apply to Glyceryl Arachidonate. Based on these data, the Cosmetic Ingredient Review (CIR) Expert Panel found that these glyceryl monoesters are safe as cosmetic ingredients in the present practices of use and concentration: except that the available data are insufficient to support the safety of Glyceryl Arachidonate. Additional data needed to support the safety of Glyceryl Arachidonate include (1) dermal absorption data; and, based on the results of the absorption studies, there may be a need for (2) immunomodula-tory data; (3) carcinogenicity and photocarcinogenicity data; and (4) human irritation, sensitization, and photosensitization data.

2 Final Report on the Safety Assessment of PEG-2, 6, 8,-12, 20, 32, 40, 50, 100, and 150 Stearates

1983 ◽  
Vol 2 (7) ◽  
pp. 17-34 ◽  
Keyword(s):  
Polyethylene Glycol ◽  
Safety Assessment ◽  
Nonionic Surfactants ◽  
Skin Irritation ◽  
Mortality Rates ◽  
Final Report ◽  
Cosmetic Products ◽  
Carcinogenic Effect ◽  
Cosmetic Ingredients

The PEG Stearates are the polyethylene glycol esters of stearic acid. These nonionic surfactants are used mainly in cosmetic products as surfactants and emollients at concentrations up to 25%. The PEG Stearates, whose average number of ethylene oxide monomers range from 2 to 150, were nonlethal to test animals up to 10 g/kg. They gave evidence of only low-level skin irritation and minimal eye irritation when tested at 100% concentrations in test animals. PEG-8, 40, and 100 Stearates produced no significant changes in growth mortality rates, histopathologic observations or hematologic values in long-term feeding studies. Multiple generation studies of PEG-8 and 40 Stearates were negative for effects on reproduction; the presence or absence of a carcinogenic effect was not reported. Clinical studies on the PEG Stearates indicated that these ingredients are neither irritants nor sensitizers at concentrations of ≥ 25%. There was no evidence of phototoxicity or photosensitization of PEG-2 or 8 Stearates. It is concluded that PEG-2, 6, 8, 12, 20, 32, 40, 50, 100, and 150 Stearates are safe as cosmetic ingredients in the present practices of concentration and use.

scholarly journals 7 Final Report on the Safety Assessment of Hydrolyzed Collagen

1985 ◽  
Vol 4 (5) ◽  
pp. 199-221 ◽  
Keyword(s):  
Clinical Studies ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Full Strength ◽  
Hydrolyzed Collagen ◽  
Cosmetic Formulations ◽  
Animal Toxicity

Hydrolyzed Collagen is a hydrolysate derived from animal byproducts. It is used in cosmetic products as a conditioner or moisturizer at concentrations less than 5 percent. Hydrolyzed Collagen was practically nontoxic when administered orally or dermally in acute animal toxicity studies. This ingredient was minimally irritating to rabbit eyes when tested full-strength. Primary skin irritation tests in rabbits indicated that Hydrolyzed Collagen was nonirritating or minimally irritating when tested full-strength. Subchronic dermal studies on 2 cosmetic formulations containing 2 percent Hydrolyzed Collagen were negative for systemic toxicity. Hydrolyzed Collagen was nonsensitizing in guinea pigs. In clinical studies, Hydrolyzed Collagen produced no skin irritation, sensitization, or indication of phototoxicity. On the basis of the available animal and clinical data, it is concluded that Hydrolyzed Collagen is safe as a cosmetic ingredient in the present practices of use and concentration.

1: Final Report on the Safety Assessment of Sodium Lauryl Sulfoacetate

1987 ◽  
Vol 6 (3) ◽  
pp. 261-277 ◽  
Keyword(s):  
Clinical Studies ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Sodium Lauryl Sulfate ◽  
Skin Irritation ◽  
Final Report ◽  
Lauryl Sulfate ◽  
Cosmetic Products ◽  
Cosmetic Product ◽  
Ocular Irritation

Sodium Lauryl Sulfoacetate is a detergent used in cosmetic products. A 12% solution of the ingredient was slightly toxic to rats in an acute oral study. No treatment-related effects of significance were noted in rats in a subchronic study at a dose of 75 mg/kg/day. Some effects were observed at 250 and 750 mg/kg/day. Minimal to slight ocular irritation occurred in rabbits when tested with 3.0% Sodium Lauryl Sulfoacetate. A diluted product tested at 1% Sodium Lauryl Sulfate was nonirritating to the genital mucosa of rabbits. No skin irritation, sensitization, or phototoxicity was noted in guinea pigs exposed to a cosmetic product containing 2% Sodium Lauryl Sulfoacetate. Cosmetic products containing up to 16% Sodium Lauryl Sulfoacetate were nonmutagenic in the Ames Salmonella/microsome assay, both with and without activation. In clinical studies, Sodium Lauryl Sulfoacetate was a mild to strong skin irritant but not a sensitizer at concentrations up to 2.0%. The irritant effects are similar to those produced by other detergents, and the severity of the irritation appears to increase directly with concentration. It is concluded that Sodium Lauryl Sulfoacetate is safe for use in cosmetic products in the present practices of use and concentration.

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