scholarly journals 3: Final Report on the Safety Assessment of Coconut Oil, Coconut Acid, Hydrogenated Coconut Acid, and Hydrogenated Coconut Oil

1986 ◽  
Vol 5 (3) ◽  
pp. 103-121
Keyword(s):  
Clinical Assessment ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Coconut Oil ◽  
Laboratory Animals ◽  
Final Report ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Eye Irritation ◽  
Foaming Agent

In cosmetic products, Coconut Oil is used as a cleanser, foaming agent, or stabilizer at concentrations up to 50%. Acute, chronic, and subchronic oral toxicity studies indicate that Coconut Oil and Hydrogenated Coconut Oil are relatively nontoxic byingestion. Neither compound produced significant skin or eye irritation in laboratory animals. No sensitization was reported. Clinical assessment of cosmetic products containing Coconut Oil produced very minimal skin irritation reactions. There was no indication that theseingredients were primary irritants, sensitizers, or phototoxic compounds following human testing. It is concluded that Coconut Oil, Coconut Acid, Hydrogenated Coconut Oil, and Hydrogenated Coconut Acid are safe for use as cosmeticingredients.

Final Report on the Safety Assessment of Glycol Stearate, Glycol Stearate SE, and Glycol Distearate

1990 ◽  
Vol 1 (2) ◽  
pp. 1-11 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Laboratory Animals ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Animal Data ◽  
Cosmetic Ingredients ◽  
Available Information

Glycol Stearate, Glycol Stearate SE, and Glycol Distearate consist primarily of the mono- and diesters of triple-pressed stearic acid. They are used in numerous categories of cosmetic products at concentrations ranging from less than 0.1 to 10%. Animal data for acute oral toxicity, skin and eye irritation, and sensitization show that these ingredients have low acute toxicity. A repeated insult patch test with 50% Glycol Distearate on 125 subjects presented no evidence of skin irritation or hypersensitivity. Human studies using formulations containing Glycol Stearate at levels of 2-5% reported no skin irritation or sensitization. Subchronic testing has not been adequately investigated in laboratory animals. Human test data for formulations containing > 4% Glycol Stearate or Glycol Distearate should be considered. Based on the available information presented herein, it is concluded that Glycol Stearate, Glycol Stearate SE, and Glycol Distearate are safe as cosmetic ingredients in the present practices of use and concentration.

Final Report of the Safety Assessment for PEG-75 Lanolin, PEG-20 Lanolin, PEG-27 Lanolin, PEG-30 Lanolin, PEG-40 Lanolin, PEG-50 Lanolin, PEG-60 Lanolin, and PEG-85 Lanolin

1982 ◽  
Vol 1 (4) ◽  
pp. 91-102 ◽  
Keyword(s):  
Polyethylene Glycol ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Glycol Ethers ◽  
Eye Irritation ◽  
Oil Water ◽  
Available Information

PEG Lanolins are the polyethylene glycol ethers of whole lanolin. They are widely used in cosmetics as auxiliary oil/water emulsifiers at concentrations of up to 25%. PEG Lanolins were found to be nontoxic in acute oral, dermal, and inhalation studies at varying concentrations. They caused little or no eye irritation in rabbits at concentrations of 50-100%. PEG Lanolins at 10-100% caused mild or negligible skin irritation and were reported to be nonsensitizing in guinea pigs. PEG Lanolins were reported to be nonirritating and nonsensitizing in patients at concentrations from 10-60%. On the basis of the available information, it is concluded that the PEG-75 Lanolin Group is safe as presently used in cosmetic products.

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.

scholarly journals 5 Final Report on the Safety Assessment of Zinc Phenolsulfonate

1986 ◽  
Vol 5 (5) ◽  
pp. 373-390
Keyword(s):  
Growth Inhibition ◽  
Patch Test ◽  
Clinical Assessment ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Products ◽  
Feeding Study ◽  
Significant Toxicity

Zinc Phenolsulfonate is a substituted phenol used in cosmetic products as an antimicrobial and astringent at concentrations up to 5%. This compound was moderately toxic when administered orally. No deaths or growth inhibition were reported in a 91-day rat feeding study. No significant toxicity was reported when Zinc Phenolsulfonate was applied dermally in acute and sub-chronic studies. A single insult patch test of a 5% aqueous Zinc Phenolsulfonate solution was negative for skin irritation in rabbits. Minimal skin irritation was reported when 100% Zinc Phenolsulfonate was tested. The Buehler test for delayed sensitization was negative. No eye irritation was observed in rabbits exposed to 5% aqueous Zinc Phenolsulfonate and only moderate irritation at 100%. No mutagenicity was observed when Zinc Phenolsulfonate was tested with and without metabolic activation in five Salmonella strains. Clinical assessment of Zinc Phenolsulfonate with product formulations indicated that Zinc Phenolsulfonate was at most a mild skin irritant in normal use, but not a sensitizer. It is concluded that Zinc Phenolsulfonate is safe as a cosmetic ingredient in the present practices of use and concentration.

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).

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.

5: Final Report on the Safety Assessment of Sodium Sesquicarbonate, Sodium Bicarbonate, and Sodium Carbonate

1987 ◽  
Vol 6 (1) ◽  
pp. 121-138 ◽  
Keyword(s):  
Sodium Bicarbonate ◽  
Cell Cultures ◽  
Sodium Carbonate ◽  
Safety Assessment ◽  
Laboratory Animals ◽  
Final Report ◽  
Cosmetic Products ◽  
High Concentrations

Sodium Sesquicarbonate, Sodium Carbonate, and Sodium Bicarbonate are used in cosmetic products at concentrations ranging up to 50%. The LD50 in rats for Sodium Bicarbonate ranged from 7.6 g/kg to 8.9 g/kg. Sodium Sesquicarbonate, Sodium Carbonate, and Sodium Bicarbonate caused conjunctivitis. Sodium Bicarbonate was not an ocular irritant to laboratory animals. Neither Sodium Bicarbonate nor Sodium Carbonate was a teratogen to laboratory animals. Sodium Sesquicarbonate and Sodium Bicarbonate were not mutagenic to two different cell cultures. Dermatitis, but not sensitization, was observed in employees of a Trona (Sodium Sesquicarbonate) mining facility. Sodium Carbonate, but not Sodium Bicarbonate, is a skin and eye irritant due to the alkaline nature of its solutions, The cosmetic use of Sodium Carbonate at high concentrations is mainly limited to products designed to be diluted before use and in products where pH is buffered to near neutrality. It is concluded that Sodium Sesquicarbonate, Sodium Bicarbonate, and Sodium Carbonate are safe as presently used in cosmetics.

4 Final Report on the Safety Assessment of Butyl Stearate, Cetyl Stearate, Isobutyl Stearate, Isocetyl Stearate, Isopropyl Stearate, Myristyl Stearate, and Octyl Stearate

1985 ◽  
Vol 4 (5) ◽  
pp. 107-146 ◽  
Keyword(s):  
Safety Assessment ◽  
Animal Studies ◽  
Health Effect ◽  
Final Report ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Potential Health ◽  
Rabbit Skin ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations

The 7 Stearates described in this report are either oily liquids or waxy solids that are primarily used in cosmetics as skin emollients at concentrations up to 25 percent. The toxicology of the Stearates has been assessed in a number of animal studies. They have low acute oral toxicity and are essentially nonirritating to the rabbit eye when tested at and above use concentration. At cosmetic use concentrations the Stearates are, at most, minimally irritating to rabbit skin. In clinical studies the Stearates and cosmetic products containing them were at most minimally to mildly irritating to the human skin, essentially nonsensitizing, nonphototoxic and nonphotosensitizing. Comedogenicity is a potential health effect that should be considered when the Stearate ingredients are used in cosmetic formulations. On the basis of the information in this report, it is concluded that Butyl, Cetyl, Isobutyl, Isocetyl, Isopropyl, Myristyl, and Octyl Stearate are safe as cosmetic ingredients in the present practices of use.

scholarly journals Final Report on the Safety Assessment of Polybutene

1982 ◽  
Vol 1 (4) ◽  
pp. 103-118 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Skin Tests ◽  
Toxicity Tests ◽  
Final Report ◽  
Test Results ◽  
Oral Toxicity ◽  
Cosmetic Formulations ◽  
Successive Generations ◽  
Available Information

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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