6 Final Report on the Safety Assessment of Aminomethylpropanol and Aminomethylpropanediol

1990 ◽  
Vol 9 (2) ◽  
pp. 203-228 ◽  
Keyword(s):  
Salmonella Typhimurium ◽  
Safety Assessment ◽  
Adverse Reactions ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Products ◽  
Rabbit Skin ◽  
Cosmetic Formulations ◽  
Rats And Mice ◽  
Primary Irritation

AMP and AMPD are substituted aliphatic alcohols. AMP is used in cosmetic products at concentrations up to 10%, AMPD is used at concentrations up to 5%. AMP and AMPD when buffered, and orally administered, are practically nontoxic to rats and mice. In primary irritation studies, AMP and formulations containing AMP were, at most, minimally irritating to abraded and nonabraded rabbit skin. Cosmetic formulations containing AMPD were only minimally irritating to rabbit skin. AMP was not an intradermal sensitizer in guinea pigs. Cosmetic formulations containing AMPD and/or AMP were minimal to moderate ocular irritants. AMP and AMPD were nonmutagenic, both with and without metabolic activation, in Salmonella typhimurium strains. In clinical studies, AMP was neither a primary dermal irritant nor a contact sensitizer. AMPD was neither a primary irritant, fatiguing agent, nor sensitizer when tested in humans. AMP and AMPD are highly alkaline in pure form, they are buffered in cosmetic formulations, and, therefore, the adverse reactions seen with the undiluted chemical would not be expected with the cosmetic product. The highest level of both AMP and AMPD for which test data were available was 1.0%, therefore the safe use of these two compounds should be limited to this test value. Neither ingredient should be used in cosmetic products containing nitrosating agents.

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 Chloroxylenol

1985 ◽  
Vol 4 (5) ◽  
pp. 147-169 ◽  
Keyword(s):  
Safety Assessment ◽  
Metabolic Activation ◽  
Final Report ◽  
Skin Sensitization ◽  
Cosmetic Products ◽  
Oral Ingestion ◽  
Rabbit Skin ◽  
Rabbit Eye ◽  
Percent Concentration ◽  
Available Information

Chloroxylenol is used in cosmetic products as an antimicrobial at concentrations up to 5.0 percent. It is absorbed through the human skin and gastrointestinal tract. Following oral ingestion by a human of a product formulated with Chloroxylenol, both free and conjugated Chloroxylenol were detected in the urine. Chloroxylenol at 100 percent concentration was a moderate irritant to the rabbit eye, whereas a 0.1 percent aqueous Chloroxylenol solution was a nonirritant to rabbit skin. Chloroxylenol was nonmutagenic in the Salmonella mutagenesis assay, both with and without metabolic activation. No carcinogenicity or adequate teratogenicity studies have been reported. In clinical studies, formulations containing up to 1.0 percent Chloroxylenol were nonsensitizing and essentially nonirritating to the skin. The incidence of skin sensitization among 1752 dermatitis patients exposed to 1.0 percent Chloroxylenol was less than 1.0 percent. On the basis of the available information included in this report, it is concluded that Chloroxylenol is safe as a cosmetic ingredient in the present practices of use.

scholarly journals 2 Final Report on the Safety Assessment of Shellac

1986 ◽  
Vol 5 (5) ◽  
pp. 309-327 ◽  
Keyword(s):  
Adverse Effects ◽  
Respiratory Tract ◽  
Clinical Assessment ◽  
Maximum Concentration ◽  
Safety Assessment ◽  
Metabolic Activation ◽  
Final Report ◽  
Cosmetic Formulations ◽  
Animal Toxicity ◽  
Spray Formulation

Cosmetic-grade Shellac is a mixture of hydroxyaliphatic and alicyclic acids and their polyesters. It is used in cosmetic formulations at concentrations up to 25%. Shellac had an LD50 of greater than 5 g/kg in rats. Results of acute animal toxicity studies using cosmetic formulations containing up to 6% Shellac indicated no adverse effects upon oral (rats), dermal (rabbits), ocular (rabbits), and respiratory tract (rabbits) exposure. Chronic inhalation of a Shellac hair spray formulation by rabbits produced no observable toxicity. No treatment-related toxic or pathologic effects were observed when concentrations of Shellac up to 10,000 ppm were fed to rats in a subchronic study. Ames' mutagenicity assays, with and without metabolic activation, were negative. Clinical assessment of safety of cosmetic formulations containing up to 6% Shellac indicated no measurable irritation and absence of sensitization and photosensitization. It is concluded that cosmetic-grade Shellac is safe for use in cosmetic formulations at concentrations up to 6%, the maximum concentration tested.

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%.

Final Report on the Safety Assessment of Isostearamidopropyl Morpholine Lactate

1999 ◽  
Vol 18 (3_suppl) ◽  
pp. 51-56 ◽  
Author(s):  
F. Alan Andersen
Keyword(s):  
Developmental Toxicity ◽  
Metabolic Activation ◽  
Skin Penetration ◽  
Toxicity Study ◽  
Final Report ◽  
Inhalation Toxicity ◽  
Oral Toxicity ◽  
Rabbit Skin ◽  
Cosmetic Formulations ◽  
Mammalian System

Isostearamidopropyl Morpholine Lactate is the lactic acid salt of isostearamidopropyl morpholine used as an antistatic agent in 20 cosmetic formulations, mostly hair preparations. The concentration of use in hair preparations is in the 1-5% range- Isostearamidopropyl Morpholine Lactate was nontoxic in acute oral toxicity studies in rats. Although Morpholine is considered a cutaneous, ocular, and mucous membrane irritant, and a sensitizer, Isostearamidopropyl Morpholine Lactate exhibits none of the sensitization and irritant reactions observed with Morpholine. Isostearamidopropyl Morpholine Lactate was minimally irritating to rabbit eyes, and mildly irritating to intact and abraded rabbit skin. Although sensitization was not seen in clinical tests, some irritancy was noted. Isostearamidopropyl Morpholine Lactate was not mutagenic in the Ames test, with or without metabolic activation, although cell killing was seen at most test concentrations. Although Morpholine is readily nitrosated to form carcinogenic nitrosamines, N-nitroso impurities were not detected in Isostearamidopropyl Morpholine Lactate. Mutagenicity data on Isostearamidopropyl Morpholine Lactate in a mammalian system were not available, nor were data available on skin penetration or toxicity associated with inhalation exposures. Accordingly, the safety of this ingredient in leave-on cosmetic formulations could not be determined. Based on the available data, this ingredient was considered safe for use in rinse-off cosmetic products. Additional data needed for assessing the safety of leave-on uses include: (i) 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; (ii) one genotoxicity study in a mammalian system; if positive, then a 2-year dermal carcinogenesis study using National Toxicology Program (NTP) methods may be needed; and (iii) inhalation toxicity data.

3 Final Report on the Safety Assessment of Polyquaternium-10

1988 ◽  
Vol 7 (3) ◽  
pp. 335-351 ◽  
Keyword(s):  
Stratum Corneum ◽  
Quaternary Ammonium ◽  
Safety Assessment ◽  
Metabolic Activation ◽  
Hydroxyethyl Cellulose ◽  
Final Report ◽  
Cosmetic Products ◽  
Ammonium Derivative ◽  
Quaternary Ammonium Derivative ◽  
Low Degree

Polyquaternium-10 is a polymeric quaternary ammonium derivative of hydroxyethyl cellulose that is used in cosmetics as a conditioner, thickener, and emollient at concentrations of ≤0.1%–5%. Polyquaternium-10 has, at most, only a low potential to penetrate the stratum corneum but is adsorbed by keratinous surfaces. The oral LD50 of Polyquaternium-10 was not obtained at 16 g/kg in rats. Inhalation, dermal, and ocular animal test data indicated, at most, only a low degree of toxicity at test concentrations of Polyquaternium-10 greater than that used in cosmetic products. Polyquaternium-10 with and without metabolic activation was not a mutagen in three separate assay systems. Polyquaternium-10 was neither an irritant nor a human sensitizer when tested at 2.0%. Cosmetic products containing up to 1% Polyquaternium-10 were not human irritants, sensitizers, or photosensitizers. On the basis of the information presented, it is concluded that Polyquaternium-10 is safe as a cosmetic ingredient in the present practices of use.

Final Report on the Safety Assessment of Benzaldehyde1

2006 ◽  
Vol 25 (1_suppl) ◽  
pp. 11-27 ◽  
Keyword(s):  
Benzoic Acid ◽  
Adverse Reactions ◽  
Chinese Hamster ◽  
The United States ◽  
Tissue Type ◽  
Final Report ◽  
Cosmetic Products ◽  
Dermal Irritation ◽  
White Rats ◽  
Rats And Mice

Benzaldehyde is an aromatic aldehyde used in cosmetics as a denaturant, a flavoring agent, and as a fragrance. Currently used in only seven cosmetic products, its highest reported concentration of use was 0.5% in perfumes. Benzaldehyde is a generally regarded as safe (GRAS) food additive in the United States and is accepted as a flavoring substance in the European Union. Because Benzaldehyde rapidly metabolizes to Benzoic Acid in the skin, the available dermal irritation and sensitization data demonstrating no adverse reactions to Benzoic Acid were considered supportive of the safety of Benzaldehyde. Benzaldehyde is absorbed through skin and by the lungs, distributes to all well-perfused organs, but does not accumulate in any specific tissue type. After being metabolized to benzoic acid, conjugates are formed with glycine or glucuronic acid, and excreted in the urine. Little acute toxicity was seen. The oral LD50 of Benzaldehyde in rats and mice ranged from 800 to 2850 mg/kg. The intraperitoneal LD50 in white rats was 3265 mg/kg. In short-term oral studies, the no observed adverse effect level (NOAEL) was 400 mg/kg in rats and mice. In subchronic oral studies, the NOAEL was 400 mg/kg in rats and 600 mg/kg in mice. In a 16-week feeding study, rats given up to 10,000 ppm showed no signs of toxicity. Repeated inhalation of volatilized Benzaldehyde produced ocular and nasal irritation at 500 ppm and death in rabbits at 750 ppm. Undiluted Benzaldehyde was irritating to rabbit eyes, causing edema, erythema, and pain. Benzaldehyde was determined not to be a contact sensitizer, but did produce allergic reactions in a maximization test. Clinical reports of allergy to Benzaldehyde are rare. Benzoic Acid did not produce irritation or sensitization reactions in human clinical studies. Benzoic Acid also failed to produce reactions in phototoxicity and photosensitization tests. Neither Benzaldehyde, Benzoic Acid, nor Sodium Benzoate are reproductive or developmental toxicants at doses that are non-toxic to the mother. In a behavioral study, blood levels of 0.12 ng/ml Benzaldehyde produced a 44% reduction in motor activity in mice. Benzaldehyde did not produce mutations in bacterial assays, but did produce chromosomal abnormalities in Chinese hamster cells and increased mutations in a mouse lymphoma forward mutation assay. Benzaldehyde was evaluated by the National Toxicology Program, which found no evidence of carcinogenicity in rats, and some evidence of carcinogenicity in mice. Several studies have suggested that Benzaldehyde can have carcinostatic or antitumor properties. Overall, at the concentrations used in cosmetics, Benzaldehyde was not considered a carcinogenic risk to humans. Although there are limited irritation and sensitization data available for Benzaldehyde, the available dermal irritation and sensitization data and ultraviolet (UV) absorption and phototoxicity data demonstrating no adverse reactions to Benzoic Acid support the safety of Benzaldehyde as currently used in cosmetic products.

Final Report on the Safety Assessment of 4-Methoxy-m-Phenylenediamine, 4-Methoxy-m-Phenylenediamine Sulfate, and 4-Methoxy-m-Phenylenediamine-HCl

1992 ◽  
Vol 11 (4) ◽  
pp. 381-422 ◽  
Keyword(s):  
Safety Assessment ◽  
The United States ◽  
Final Report ◽  
Cosmetic Products ◽  
Hair Dyes ◽  
Teratogenic Effects ◽  
Hair Dye ◽  
Tissue Abnormalities ◽  
Rats And Mice ◽  
Dermal Application

The hair dye ingredient 4-Methoxy-m-Phenylenediamine Sulfate (4-MMPDS) prior to 1978 was used extensively used in the United States. Concerns raised because of studies which showed the hair dye to be an animal carcinogen prompted the voluntary reformulation and deletion of 4-MMPD in hair dyes containing this ingredient. No reports were made on the use of this ingredient until 1989 when 17 uses were reported. Assays on volunteers indicate that less than 0.2% of the dye penetrates the scalp and that about 3.9% is absorbed through the skin of the forearm. The dye is metabolized and excreted in the urine; a major metabolic product was 4-acetylamino-2-aminoanisole. The LD50 range in rats of aqueous solutions of 4-MMPD was 400–500 mg/kg. No gross tissue abnormalities were reported in subchronic feeding or dermal studies. 4-MMPD was not an ocular irritant when tested at 2.5%, but was a mild skin irritant when tested at the same concentration. The dermal application of hair dye formulations containing up to 4.0% 4-MMPD were negative for both embryotonic toxicity and teratogenic effects. The results of numerous mutagenic studies vary between the assay system used. 4-MMPD was noncarcinogenic in four dermal carcinogenic studies, but was carcinogenic to both rats and mice in feeding studies. On the basis of the information included in this report, it is concluded that 4-Methoxy-m-Phenylenediamine, 4-Methoxy-m-Phenylenediamine Sulfate, and 4-Methoxy-m-Phenylenediamine HCl are unsafe for use in cosmetic products.

Final Report on the Safety Assessment of Acetamide MEA

1993 ◽  
Vol 12 (3) ◽  
pp. 225-236 ◽  
Keyword(s):  
Guinea Pigs ◽  
Safety Assessment ◽  
Skin Irritation ◽  
Nitroso Compounds ◽  
Final Report ◽  
Skin Exposure ◽  
Ocular Irritation ◽  
Cosmetic Formulations ◽  
A Minor ◽  
Primary Irritation

Acetamide MEA is used in cosmetics as a skin conditioning agent-humectant and hair conditioning agent. Oral LD50s of 27 g/kg were reported for Acetamide MEA in rats. No rabbits died following an acute dermal exposure of 20 ml/kg Acetamide MEA. In ocular irritation studies, 70% Acetamide MEA and cosmetic formulations containing 1.3% Acetamide MEA were classified as nonocular irritants in rabbits. Only mild skin irritation occurred following a 24-h skin exposure to undiluted Acetamide MEA. In the maximization test, Acetamide MEA was classified as a nonsensitizer in guinea pigs when tested at a concentration of 5.0%. Neither primary irritation nor sensitization reactions to 7.5% Acetamide MEA were observed in a human repeated insult patch test. Acetamide MEA was not nonmutagenic in the Ames assay. In the presence of nitrosating agents, Acetamide MEA may form N-nitroso compounds; acetamide may be a minor impurity in Acetamide MEA. On the basis of the data presented in this report, it is concluded that Acetamide MEA is safe as a cosmetic ingredient at concentrations not to exceed 7.5% in leave-on products and is safe in the present practice of use in rinse-off products. Cosmetic formulations containing Acetamide MEA should not contain nitrosating agents or significant amounts of free acetamide.

1 Final Report on the Safety Assessment of Sodium Laureth Sulfate and Ammonium Laureth Sulfate

1983 ◽  
Vol 2 (5) ◽  
pp. 1-34 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Final Report ◽  
Cosmetic Products ◽  
Experimental Animals ◽  
Cosmetic Formulations ◽  
Available Information ◽  
Toxicological Testing

Sodium Laureth Sulfate and Ammonium Laureth Sulfate are used in cosmetic products as cleansing agents, emulsifiers, stabilizers, and solubilizers. The ingredients have been shown to produce eye and/or skin irritation in experimental animals and in some human test subjects; irritation may occur in some users of cosmetic formulations containing the ingredients under consideration. The irritant effects are similar to those produced by other detergents, and the severity of the irritation appears to increase directly with concentration. However, Sodium and Ammonium Laureth Sulfate have not evoked adverse responses in any other toxicological testing. On the basis of available information, the Panel concludes that Sodium Laureth Sulfate and Ammonium Laureth Sulfate are safe as presently used in cosmetic products.

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