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.

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.

1: Final Report on the Safety Assessment of Hydroxyethylcellulose, Hydroxypropylcellulose, Methylcellulose, Hydroxypropyl Methylcellulose, and Cellulose Gum

1986 ◽  
Vol 5 (3) ◽  
pp. 1-59 ◽  
Keyword(s):  
Safety Assessment ◽  
Mutagenic Activity ◽  
Hydroxypropyl Methylcellulose ◽  
Laboratory Animals ◽  
Final Report ◽  
Cellulose Derivatives ◽  
Cosmetic Products ◽  
Rabbit Skin ◽  
Dermal Irritation ◽  
Reproductive Effects

Hydroxyethylcellulose, Hydroxypropylcellulose, Methylcellulose, Hydroxypropyl Methylcellulose, and Cellulose Gum are modified cellulose polymers that are used in cosmetic products at concentrations up to 10%. The cellulose derivatives pass essentially unchanged through the gastrointestinal tract following oral administration. They are practically nontoxic when administered by inhalation or by oral, intraperitoneal, subcutaneous, or dermal routes. Subchronic and chronic oral studies indicate that the cellulose derivatives are nontoxic when administered to laboratory animals. No significant teratogenic or reproductive effects have been demonstrated. Ocular and dermal irritation studies show that the cellulose derivatives are, at most, minimally irritating to rabbit eyes and nonirritating to slightly irritating to rabbit skin when tested at concentrations up to 100%. No mutagenic activity of theseingredients was demonstrated. The cellulose derivatives at concentrations up to 100% were nonirritating to mildly irritating, nonsensitizing, and nonphotosensitizing when evaluated in clinical studies. It is concluded that theingredients reviewed are safe as cosmeticingredients in the present practices of use and concentration.

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.

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.

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.

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.

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.

2 Final Report on the Safety Assessment of Dilauryl Thiodipropionate

1992 ◽  
Vol 11 (1) ◽  
pp. 25-41 ◽  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Lauryl Alcohol ◽  
Final Report ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Safety Test ◽  
Human Volunteers ◽  
Test Concentration ◽  
Rats And Mice

Dilauryl Thiodipropionate (DLTDP) is the diester of lauryl alcohol and 3,3′-thiodipro-pionic acid which is used as an antioxidant and sequestering agent in cosmetics at concentrations up to 1%. When administered orally to rats and mice, DLTDP was slightly toxic and was relatively nontoxic in subchronic oral studies with rats. No irritation was produced by a formulation containing 0.05% DLTDP when tested at 0.0025% on intact and abraded skin. DLTDP was nonmutagenic in four different assay systems. This cosmetic ingredient was not a teratogen or reproductive toxicant in oral studies in mice, rats, hamsters or rabbits. A formulation containing 0.05% DLTDP when tested at 0.05% was not a sensitizer in a guinea pig maximization test. DLTDP, at a concentration of 0.05% in a makeup foundation, was not an irritant, sensitizer, or phototoxin when tested on human volunteers. The maximum reported safety test concentration used in dermal toxicity of DLTDP was 0.05%. The report limits its safety conclusion by concluding that DLTDP is safe for use in cosmetic products at the maximum dermal tested concentration of 0.05%.

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