2 Final Report on the Safety Assessment of Propyl Gallate

1985 ◽  
Vol 4 (3) ◽  
pp. 23-64 ◽  
Keyword(s):  
Human Skin ◽  
Propyl Gallate ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Toxicity Studies ◽  
Animal Toxicity

Propyl Gallate acid is used as an antioxidant in cosmetic products at concentrations normally less than 0.1 percent. Propyl Gallate is absorbed when ingested, methylated, conjugated, and excreted in the urine. Acute animal toxicity studies indicate that Propyl Gallate is slightly toxic when ingested and practically nontoxic when applied to the skin. Numerous chronic oral toxicity studies indicate that Propyl Gallate at concentrations up to 5 percent is practically nontoxic to rats, mice, dogs, and guinea pigs. Propyl Gallate is nonirritating to human skin at concentrations up to 10 percent; however, it is sensitizing at this and higher concentrations. Propyl Gallate was nonphototoxic. It is concluded that Propyl Gallate is safe as a cosmetic ingredient at concentrations not exceeding 1 percent.

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.

Final Report on the Safety Assessment of Laneth-10 Acetate Group

1982 ◽  
Vol 1 (4) ◽  
pp. 1-24 ◽  
Keyword(s):  
Guinea Pig ◽  
Topical Application ◽  
Safety Assessment ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Toxicity Studies ◽  
Animal Data

The Laneths are ethoxylated lanolin alcohols that may be acetylated and used in a wide variety of cosmetic products. Acute oral toxicity studies indicate that Laneth-10 Acetate is relatively nontoxic to the rat; acute dermal toxicity studies indicate that it is relatively nontoxic to the guinea pig. Laneth-10 Acetate was found to be a mild, transient irritant to the rabbit's eye. Laneth-10 Acetate was shown to be nonirritating and nonsensitizing to SO subjects. Laneth-16 is slightly toxic when administered orally to the rat. Neither Laneth-16 nor Laneth-25 was a skin irritant or sensitizing agent in 50 subjects. On the basis of the available animal data and limited human experience presented in this report, it is concluded that the Laneths are safe for topical application to humans in the present practices of use and concentration.

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.

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.

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.

5 Final Report on the Safety Assessment of Potassium-Coco-Hydrolyzed Animal Protein and Triethanolamine-Coco-Hydrolyzed Animal Protein

1983 ◽  
Vol 2 (7) ◽  
pp. 75-86 ◽  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Condensation Product ◽  
Animal Protein ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Cosmetic Ingredients ◽  
Available Information

Potassium and TEA-Coco-Hydrolyzed Animal Proteins (PCHAP and TEA-CHAP) are salts of the condensation product of coconut acid and hydrolyzed animal protein. They are used in cosmetic products as detergents, foamers, and levelers. Acute oral toxicity studies showed that both PCHAP and TEA-CHAP were practically nontoxic when ingested. Both ingredients at concentrations of 10%-100% were practically nonirritating to moderately irritating when instilled in the eyes of rabbits. Both were nonirritating to mildly irritating when applied at concentrations of 10%-50% to the skin of rabbits. Guinea pig sensitization studies with both PCHAP and TEA-CHAP were negative. PCHAP and TEA-CHAP, at concentrations of 2% 10% were nonirritating to practically nonirritating in humans. In a repeated insult patch test, PCHAP gave a positive sensitization reaction in two of 168 subjects; two additional subjects showed cumulative irritation and one other was reported to have a nonspecific irritation. One subject out of 28 tested did not demonstrate significant irritation or sensitivity to either PCHAP or TEA-CHAP, but was photosensitized to both ingredients. On the basis of the available information, the Panel concludes that Potas-sium-Coco-Hydrolyzed Animal Protein and TEA-Coco-Hydrolyzed Animal Protein are safe as cosmetic ingredients in the present practices of use as recorded in this report.

Final Report on the Safety Assessment of Quaternium-22

1995 ◽  
Vol 14 (6) ◽  
pp. 485-497
Keyword(s):  
Safety Assessment ◽  
Adverse Reactions ◽  
Toxicity Study ◽  
Final Report ◽  
Test Substance ◽  
Cosmetic Products ◽  
Dermal Toxicity ◽  
Oral Toxicity ◽  
Ethylene Chlorohydrin ◽  
Ocular Exposure

The quaternary ammonium salt Quaternium-22 is used as a film former, hair conditioning agent, and antistatic agent in a wide variety of cosmetic products. This ingredient has reportedly also been used as an emollient and skin conditioner. It is supplied in water with 60% solids (Quaternium-22). Impurities include 3-dimethylaminopropylamine (DMAPA) at concentrations up to 2.45%, and ethylene chlorohydrin (ECH) up to 0.097%. The maximum concentration of Quaternium-22 in formulations is 5.0%. An acute oral toxicity study in rats using 6% Quaternium-22 failed to kill any of the animals. Exposure to 0.5% Quaternium-22 was a slight irritant in a 28-day dermal toxicity study in rabbits; no other adverse reactions related to the test substance were found. Ocular exposure to 8.5% Quaternium-22 produced minimal conjunctival irritation, but 6% did not. Intracutaneous injections of 6% Quaternium-22 did not produce irritation or sensitization in Guinea pigs. No evidence of mutagenesis was seen in the Ames test. Clinical data revealed no irritation or sensitization, nor was there any evidence of photosensitization. While there was some concern over the toxicity of the DMAPA and ECH impurities, the absence of any toxicologic or mutagenic findings on exposure to material containing these impurities suggested there were no adverse effects associated with either the ingredient or any impurities. In order that exposure to these impurities be kept low, however, it was recommended that the concentration of this ingredient in cosmetic products should be limited so that the concentration of DMAPA not exceed 0.2% and that of ECH not exceed 0.008%-this is consistent with the expected use of Quaternium-22 at ≥ 5% solids. Accordingly, it was concluded that the cosmetic ingredient Quaternium-22 is safe in the present practices of use.

1: Final Report on the Safety Assessment of Amyl Acetate and Isoamyl Acetate

1988 ◽  
Vol 7 (6) ◽  
pp. 705-719 ◽  
Keyword(s):  
Safety Assessment ◽  
Competitive Inhibitor ◽  
Isoamyl Acetate ◽  
Amyl Alcohol ◽  
Amyl Acetate ◽  
Contact Hypersensitivity ◽  
Final Report ◽  
Cosmetic Products ◽  
Oral Toxicity ◽  
Ascites Tumors

Amyl Acetate, as used in cosmetic products, is the ester of mixed isomers of amyl alcohol and acetic acid. In cosmetic products, it is used as a solvent in fingernail formulations at concentrations of up to 10%. Amyl Acetate can stimulate acetylcholine release in the nerve endings and act as a competitive inhibitor of acetylcholine in isolated nerves. Amyl Acetate was not cytotoxic to diploid ascites tumors and was not a mitotic arrestant in cytogenetic studies. Amyl Acetate and Isoamyl Acetate were nonmutagenic in a series of mutagenic assays. The acute oral toxicity of Amyl Acetate exceeds 5 g/kg. Only a low order of hepatotoxicity was reported following the intraperitoneal injection of 1.5 g/kg of Amyl Acetate in mature guinea pigs. No subchronic studies were available for Amyl Acetate; however, the results of subchronic studies of amyl alcohol in rats at concentrations up to 1 g/kg per day were unremarkable. Ocular studies of 100% Amyl Acetate in rabbits produced a conjunctival score of 6 (maximum 110) on day 1 that cleared by day 2. No evidence of delayed contact hypersensitivity, phototoxicity, or photoallergy due to Amyl Acetate or Isoamyl Acetate was observed in human repeat insult patch test studies. It is concluded that Amyl Acetate and Isoamyl Acetate are safe as presently used in cosmetic products.

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.

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.

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