Final Report on the Safety Assessment of TEA-Lauryl Sulfate

1982 ◽  
Vol 1 (4) ◽  
pp. 143-167 ◽  
Keyword(s):  
Sulfuric Acid ◽  
Human Skin ◽  
Safety Assessment ◽  
Animal Studies ◽  
Skin Irritation ◽  
Final Concentration ◽  
Final Report ◽  
Lauryl Sulfate ◽  
Skin Sensitization ◽  
Skin Reactions

TEA-Lauryl Sulfate is the triethanolamine salt of lauryl sulfuric acid. It is used in cosmetics as a detergent, a stabilizer and a solubilizer. The ingredient was moderately to slightly toxic in acute oral studies with rats; reported LD50s ranged from 0.27 to > 1.95 g/kg. Animal studies showed that the surfactant is a significant skin and eye irritant. In clinical studies, shampoos containing 10.5% TEA-Lauryl Sulfate caused no irritation under semioccluded conditions. Diluted shampoos containing 0.15-7.5% of the surfactant caused human skin reactions ranging from no irritation to moderate irritation. This skin irritation phenomenon is observed with most detergents. Undiluted shampoos containing 10.5% TEA-Lauryl Sulfate showed low potential for eliciting human skin sensitization. No evidence of photosensitization was observed in subjects exposed to solutions containing up to 0.42% TEA-Lauryl Sulfate. On the basis of the available animal and human data, the Panel concludes that TEA-Lauryl Sulfate can be used without significant irritation at a final concentration not exceeding 10.5%. Greater concentrations may cause irritation, especially if allowed to contact the skin for significant periods of time.

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.

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 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 Glutaral

1996 ◽  
Vol 15 (2) ◽  
pp. 98-139 ◽  
Keyword(s):  
Drinking Water ◽  
Safety Assessment ◽  
Animal Studies ◽  
Skin Irritation ◽  
Blood Chemistry ◽  
Lymphocytic Leukemia ◽  
Final Report ◽  
Carcinogenicity Study ◽  
Animal Skin

The dialdehyde Glutaral (also commonly called glutaraldehyde) is used in a wide variety of cosmetics as a preservative. In vitro dermal penetration studies of Glutaral indicate low penetration through animal skin and even less through human skin. The oral LD50 of Glutaral for rats ranged from 66 mg/kg up to 733 mg/kg. A 28-day dermal toxicity study of Glutaral produced skin irritation and slight effects on weight and blood chemistry with concentrations as low as 50 mg/kg/day. Animal skin irritation was dose-dependant, with a no-effect concentration of 1%. Ocular exposure to Glutaral caused severe irritation in rabbits at concentrations 1%, with a no-effect level of 0.1%. Glutaral was not embryotoxic, fetotoxic, or teratogenic at concentrations that did not cause severe maternal toxicity. The no observable adverse effects level for reproduction toxicity was > 1,000 ppm. Bacterial mutagenesis tests produced mixed results, as would be expected for a preservative. In most mammalian system mutagenesis tests, Glutaral was not genotoxic. In a 2-year drinking water study in rats, there was an increase in large granular lymphocytic leukemia (LGLL), but only in females administered 50–1,000 ppm Glutaral. The response was not dose dependent. Clinical studies report some evidence of dermal irritation and sensitization, but no photosensitization. Occupational data and animal studies indicate that inhalation of Glutaral can cause respiratory irritation, in addition to skin effects. Evaluation of the increased incidence of LGLL in the 2-year drinking water study indicated that the incidence was within the historical control levels for this spontaneously occurring neoplasm. These data, however, were not considered sufficient to base a finding of safety of Glutaral in products intended for prolonged use. It was concluded that a 2-year dermal carcinogenicity study following National Toxicology Program (NTP) procedures was needed to complete the safety assessment of Glutaral for use in leave-on products. For rinse-off products, it was concluded that the ocular and dermal irritancy of Glutaral could be substantially avoided if the concentration did not exceed 0.5% and exposure was only brief and discontinuous. Because it can cause respiratory irritation, it was concluded that Glutaral should not be used in aerosolized cosmetic products.

2 Final Report on the Safety Assessment of p-Hydroxyanisole

1985 ◽  
Vol 4 (5) ◽  
pp. 31-63 ◽  
Keyword(s):  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Tumor Promoter ◽  
Final Report ◽  
Skin Sensitization ◽  
Cosmetic Products ◽  
Rabbit Skin ◽  
Ames Assay

p-Hydroxyanisole is used as an antioxidant in cosmetic products at concentrations of up to 1.0 percent. The acute oral LD50 of p-Hydroxyanisole in rats was estimated as 1630 mg/kg. Undiluted p-Hydroxyanisole is a severe skin and ocular irritant in rabbits but produced minimal eye irritation at 0.1 percent and minimal rabbit skin irritation at 5 percent. Skin sensitization to p-Hydroxyanisole occurred when guinea pigs were treated at 0.5 M. p-Hydroxyanisole is a skin-depigmenting agent at concentrations approximating those used in cosmetic products. p-Hydroxyanisole was nonmutagenic in the Ames assay. No local toxic changes or tumors were observed following long-term application of 5 and 10 percent p-Hydroxyanisole. The antioxidant was inactive as a tumor promoter. Solutions of p-Hydroxyanisole produced embryotoxicity but not teratogenicity. The function of p-Hydroxyanisole in cosmetics is that of an antioxidant; it is not intended for use as a skin lightener or skin-depigmenting agent. Because of the depigmenting action of p-Hydroxyanisole in black guinea pigs at reported concentrations approaching those used in cosmetics, it is concluded that p-Hydroxyanisole is unsafe for use as a cosmetic ingredient.

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.

scholarly journals 7: Final Report on the Safety Assessment of Petroleum Distillate

1986 ◽  
Vol 5 (3) ◽  
pp. 225-248
Keyword(s):  
Human Skin ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Petroleum Distillate ◽  
Final Report ◽  
Cosmetic Products ◽  
Single Exposure ◽  
Eye Irritation ◽  
Cosmetic Formulations ◽  
Animal Tests

Cosmetic grade Petroleum Distillate consists predominantly of C10-C16 paraffinic, naphthenic, and isoparaffinic hydrocarbons. The Distillate is used in a variety of cosmetic products at concentrations up to 50%. Undiluted Petroleum Distillate had an acute oral LD50 in rats of >25 ml/kg. Subchronic animal tests on a formulation containing 41.75% Petroleum Distillate were uneventful. Moderate skin irritation and mild, transient eye irritation were observed in rabbits following a single exposure to undiluted Petroleum Distillate. Cosmetic formulations containing 29.2–55% Petroleum Distillate were generally nonirritating, nonsensitizing, and nonphotosensitizing to human skin. It is concluded that Petroleum Distillate, as characterized in the report, is safe as a cosmeticingredient at the current concentrations of use.

Final Report on the Safety Assessment of Choleth-24

1982 ◽  
Vol 1 (4) ◽  
pp. 119-126 ◽  
Keyword(s):  
Human Skin ◽  
Topical Application ◽  
Clinical Studies ◽  
Safety Assessment ◽  
Animal Studies ◽  
Final Report ◽  
Polyoxyethylene Ether ◽  
Cholesterol Fraction

Choleth-24 is the polyoxyethylene ether of the cholesterol fraction of lanolins, and is used in cosmetics as a surfactant, dispersant, stabilizer, and emulsifier at concentrations up to 5%. Acute animal studies have shown Choleth-24 to be slightly toxic when ingested, nonirritating to mildly irritating when applied by the Draize method to skin at concentrations of 0.5-100%, and practically nonirritating when instilled in the eyes of rabbits at concentrations up to 100%. Clinical studies have determined Choleth-24 to be only slightly irritating and nonsensitizing when applied to human skin in concentrations up to 50%. Choleth-24 at 0.5% concentration was neither phototoxic nor photoallergenic when tested in 201 subjects. It is concluded that Choleth-24 is safe for topical application to humans in the present practices of use and concentration.

Final Report on the Safety Assessment of Azulene

1999 ◽  
Vol 18 (3_suppl) ◽  
pp. 27-32 ◽  
Author(s):  
F. Alan Andersen
Keyword(s):  
Safety Assessment ◽  
Animal Studies ◽  
Skin Irritation ◽  
Skin Penetration ◽  
Toxicity Study ◽  
Final Report ◽  
Ciliary Activity ◽  
Oral Toxicity ◽  
Wide Range ◽  
Cosmetic Formulations

Azulene is an extract from the volatile oil of several perennial herbs and is detected in tobacco smoke. It functions as a skin conditioning agent in cosmetic formulations, including hair dyes. Azulene is reported to be used in a wide range of cosmetic formulations, but these reported uses are likely to be uses of guaiazulene, a chemically related colorant, because there are currently no suppliers of Azulene to the cosmetics industry. The anti-inflammatory action of Azulene has been demonstrated in several animal studies. Effects at the cellular level are reported to include inhibition of respiration and growth, but no effect on ciliary activity or membrane permeability. Relatively low oral toxicity was seen in acute animal studies. Azulene was not mutagenic in an Ames test, with and without metabolic acfivation. An allergic response to Azulene was noted in one case report. These data were clearly insufficient to support the safety of Azulene in cosmetics. Additional data needed to make a safety assessment include: methods of manufacture and impurities, especially naphthalenes; 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; one genotoxicity study in a mammalian system, if positive, then a 2-year dermal carcinogenesis study using National Toxicology Program methods is needed; skin irritation and sensitization in animals or humans; and ocular toxicity.

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).

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