2: Final Report on the Safety Assessment of Retinyl Palmitate and Retinol

1987 ◽  
Vol 6 (3) ◽  
pp. 279-320 ◽  
Keyword(s):  
Vitamin A ◽  
Safety Assessment ◽  
Retinyl Palmitate ◽  
In Vitro Tests ◽  
Final Report ◽  
Cosmetic Products ◽  
High Intake ◽  
Naturally Occurring ◽  
Cosmetic Ingredients

Retinol is the naturally occurring form of vitamin A; Retinyl Palmitate is the ester of Retinol and Palmitic Acid. In acute oral studies, Retinol was slightly toxic to mice, and Retinyl Palmitate was practically nontoxic in mice and rats. Large single doses can be lethal. It is recognized that Retinol is essential for reproduction; however, high intake of Retinol has produced adverse effects on several reproductive functions. Vitamin A was nonmutagenic in several in vitro tests. There is no evidence that vitamin A is carcinogenic. However, the vitamin has both enhanced and inhibited responses to viral or chemical carcinogens. Cosmetic products containing 0.1-1% Retinyl Palmitate were, at most, slightly irritating and nonsensitizing when tested on a total of 607 subjects. Results of cumulative irritation tests of two products containing 0.1% Retinyl Palmitate indicated that the products were nonirritating and non-sensitizing. On the basis of the available animal and clinical data presented in this report, it is concluded that Retinyl Palmitate and Retinol are safe as cosmetic ingredients in 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.

scholarly journals Contact Allergy to Fragrances: In Vitro Opportunities for Safety Assessment

Cosmetics ◽  
2019 ◽  
Vol 6 (1) ◽  
pp. 3 ◽  
Author(s):  
Emanuela Corsini ◽  
Valentina Galbiati
Keyword(s):  
Safety Assessment ◽  
Contact Allergy ◽  
Hazard Identification ◽  
Quantitative Risk Assessment ◽  
Cosmetic Products ◽  
Animal Testing ◽  
Cosmetic Ingredients ◽  
Substantial Progress ◽  
Allergic Contact

The majority of cosmetic products contain fragrances to make products more pleasant to the consumer, as we all like goods that smell nice. Unfortunately, contact allergy to fragrance compounds is among the most frequent findings in patients with suspected allergic contact dermatitis. In order to revert this and to reduce contact allergy to cosmetics, it is imperative to improve safety assessment of cosmetic products for skin sensitization. In the era of animal ban for cosmetic ingredients, this represents a challenge. Luckily, in the last decades, substantial progress has been made in the understanding of the mechanism of chemical-induced contact allergy and several in vitro methods are available for hazard identification. The purpose of this manuscript is to explore the possibility of non-animal testing for quantitative risk assessment of fragrance-induced contact allergy, essential for cosmetic products, which cannot be tested on animals.

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.

Final Report on the Safety Assessment of Cocoyl Sarcosine, Lauroyl Sarcosine, Myristoyl Sarcosine, Oleoyl Sarcosine, Stearoyl Sarcosine, Sodium Cocoyl Sarcosinate, Sodium Lauroyl Sarcosinate, Sodium Myristoyl Sarcosinate, Ammonium Cocoyl Sarcosinate, and Ammonium Lauroyl Sarcosinate

2001 ◽  
Vol 20 (1_suppl) ◽  
pp. 1-14 ◽  
Keyword(s):  
Fatty Acids ◽  
Fatty Acid ◽  
Safety Assessment ◽  
Final Report ◽  
Inhalation Toxicity ◽  
Cosmetic Products ◽  
Cells In Culture ◽  
Cosmetic Ingredients ◽  
Cosmetic Formulations ◽  
Lauroyl Sarcosinate

This safety assessment addresses cosmetic ingredients that are N-acyl derivatives of sarcosine and are generally referred to as acyl sarcosines, and those that are salts, known generally as acyl sar-cosinates. Previous assessments have addressed the safety of each of the fatty acids that appear in these acyl sarcosines and sarcosinates (Coconut Acid, Oleic Acid, Lauric Acid, and Myristic Acid). In each case the fatty acid was either safe for use or safe as used in cosmetic formulations. Acyl sarcosines are considered modified fatty acids with greater solubility and increased acidity of the carboxylic acid group compared to the parent fatty acid. They are used in a large number of cosmetic formulations as hair-conditioning agents and surfactant-cleansing agents. In soaps, concentrations are reported to be as high as 12.9%. These ingredients have low oral toxicity in rats. Although cytotoxic to Chinese hamster cells in culture, acyl sarcosines and sarcosinates are not mutagenic in those cells, nor in bacterial cells in culture. Carcinogenicity data were not available. These ingredients are nonirritating and nonsen-sitizing to animal and human skin, although they can enhance the penetration of other ingredients through the skin. For that reason, caution should be exhibited in formulating cosmetic products that contain these ingredients in combination with other ingredients whose safety is based on their lack of absorption or where dermal absorption is a concern (e.g., HC Yellow No. 4, Disperse Yellow 3). Because sarcosine can be nitrosated to form N-nitrososarcosine, a known animal carcinogen, these ingredients should not be used in cosmetic products in which N-nitroso compounds may be formed. With the above caveat, and based on the available data, it was concluded that these acyl sarcosines and sarcosinates are safe as used in rinse-off products. They may be safely used in leave-on products at concentrations up to 5%, the highest concentration tested in clinical irritation and sensitization studies. Oleoyl Sarcosine is used as a corrosion inhibitor in some aerosol products, at extremely low concentrations. In this circumstance, the ingredient is not being used as a cosmetic ingredient and this report is not intended to limit that use. Because of the absence of data on inhalation toxicity, however, it was concluded that the available data were not sufficient to support the safety of acyl sarcosines and sarcosinates as cosmetic ingredients in products where they are likely to be inhaled.

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 of the Amended Safety Assessment of Glyceryl Lau rate, Glyceryl Lau rate SE, Glyceryl Laurate/Oleate, Glyceryl Adipate, Glyceryl Alginate, Glyceryl Arachidate, Glyceryl Arachidonate, Glyceryl Behenate, Glyceryl Caprate, Glyceryl Caprylate, Glyceryl Caprylate/Caprate, Glyceryl Citrate/Lactate/Linoleate/Oleate, Glyceryl Cocoate, Glyceryl Collagenate, Glyceryl Erucate, Glyceryl Hydrogenated Rosinate, Glyceryl Hydrogenated Soyate, Glyceryl Hydroxystearate, Glyceryl Isopalmitate, Glyceryl Isostearate, Glyceryl Isostearate/Myristate, Glyceryl Isostearates, Glyceryl Lanolate, Glyceryl Linoleate, Glyceryl Linolenate, Glyceryl Montanate, Glyceryl Myristate, Glyceryl Isotridecanoate/Stearate/Adipate, Glyceryl Oleate SE, Glyceryl Oleate/Elaidate, Glyceryl Palmitate, Glyceryl Palmitate/Stearate, Glyceryl Palmitoleate, Glyceryl Pentadecanoate, Glyceryl Polyacrylate, Glyceryl Rosinate, Glyceryl Sesquioleate, Glyceryl/Sorbitol Oleate/Hydroxystearate, Glyceryl Stearate/Acetate, Glyceryl Stearate/Maleate, Glyceryl Tallowate, Glyceryl Thiopropionate, and Glyceryl Undecylenate1

2004 ◽  
Vol 23 (2_suppl) ◽  
pp. 55-94 ◽  
Keyword(s):  
Safety Assessment ◽  
Skin Irritation ◽  
Test System ◽  
Dermal Absorption ◽  
Final Report ◽  
Low Grade ◽  
Vitro Assay ◽  
Cosmetic Ingredients ◽  
Glyceryl Behenate

The safety of 43 glyceryl monoesters listed as cosmetic ingredients was reviewed in a safety assessment completed in 2000. Additional safety test data pertaining to Glyceryl Rosinate and Glyceryl Hydrogenated Rosinate were received and served as the basis for this amended report. Glyceryl monoesters are used mostly as skin-conditioning agents—emollients and/or surfactant—emulsifying agents in cosmetics. The following 20 glyceryl monoesters are currently reported to be used in cosmetics: Glyceryl Laurate, Glyceryl Alginate, Glyceryl Arachidonate, Glyceryl Behenate, Glyceryl Caprylate, Glyceryl Caprylate/Caprate, Glyceryl Cocoate, Glyceryl Erucate, Glyceryl Hydroxystearate, Glyceryl Isostearate, Glyceryl Lanolate, Glyceryl Linoleate, Glyceryl Linolenate, Glyceryl Myristate, Glyceryl Oleate/Elaidate, Glyceryl Palmitate, Glyceryl Polyacrylate, Glyceryl Rosinate, Glyceryl Stearate/Acetate, and Glyceryl Undecylenate. Concentration of use data received from the cosmetics industry in 1999 indicate that Glyceryl Monoesters are used at concentrations up to 12 % in cosmetic products. Glyceryl Monoesters are not pure monoesters, but are mostly mixtures with mono-, di-, and tri-esters. The purity of commercial and conventional Monoglyceride (Glyceryl Monoester) is a minimum of 90%. Glyceryl Monoesters (monoglycerides) are metabolized to free fatty acids and glycerol, both of which are available for the resynthesis of triglycerides. Glyceryl Laurate enhanced the penetration of drugs through cadaverous skin and hairless rat skin in vitro and has been described as having a wide spectrum of antimicrobial activity. A low-grade irritant response was observed following inhalation of an aerosol containing 10% Glyceryl Laurate by test animals. Glyceryl monoesters have little acute or short-term toxicity in animals, and no toxicity was noted following chronic administration of a mixture consisting mostly of glyceryl di- and mono- esters. Glyceryl Laurate did have strong hemolytic activity in an in vitro assay using sheep erythrocytes. Glyceryl Laurate, Glyceryl Isostearate, or Glyceryl Citrate/Lactate/Linoleate/Oleate were not classified as ocular irritants in rabbits. Undiluted glyceryl monoesters may produce minor skin irritation, especially in abraded skin, but in general these ingredients are not irritating at concentrations used in cosmetics. Glyceryl monoesters are not sensitizers, except that Glyceryl Rosinate and Hydrogenated Glyceryl Rosinate may contain residual rosin, which can cause allergic reactions. These ingredients are not photosensitizers. Glyceryl Citrate/Lactate/Linoleate/Oleate was not mutagenic in the Ames test system. Glyceryl Laurate exhibited antitumor activity and Glyceryl Stearate was negative in a tumor promotion assay. At concentrations higher than used in cosmetics, Glyceryl Laurate did cause moderate erythema in human repeat-insult patch test (RIPT) studies, but the other glyceryl monoesters tested failed to produce any significant positive reactions. Glyceryl Rosinate was irritating to animal skin at 50%, but did not produce sensitization in clinical tests at concentrations up to 10% and covered with semioccluded patches. There is reported use of Glyceryl Rosinate at 12% in mascara, which is somewhat higher than the concentration in the clinical testing. It was reasoned that the available data do support the safety of this use because there would be minimal contact with the skin and no occlusion. The safety of Arachidonic Acid was not documented and substantiated for cosmetic product use in an earlier safety assessment and those same safety questions apply to Glyceryl Arachidonate. Based on these data, the Cosmetic Ingredient Review (CIR) Expert Panel found that these glyceryl monoesters are safe as cosmetic ingredients in the present practices of use and concentration: except that the available data are insufficient to support the safety of Glyceryl Arachidonate. Additional data needed to support the safety of Glyceryl Arachidonate include (1) dermal absorption data; and, based on the results of the absorption studies, there may be a need for (2) immunomodula-tory data; (3) carcinogenicity and photocarcinogenicity data; and (4) human irritation, sensitization, and photosensitization data.

2 Final Report on the Safety Assessment of PEG-2, 6, 8,-12, 20, 32, 40, 50, 100, and 150 Stearates

1983 ◽  
Vol 2 (7) ◽  
pp. 17-34 ◽  
Keyword(s):  
Polyethylene Glycol ◽  
Safety Assessment ◽  
Nonionic Surfactants ◽  
Skin Irritation ◽  
Mortality Rates ◽  
Final Report ◽  
Cosmetic Products ◽  
Carcinogenic Effect ◽  
Cosmetic Ingredients

The PEG Stearates are the polyethylene glycol esters of stearic acid. These nonionic surfactants are used mainly in cosmetic products as surfactants and emollients at concentrations up to 25%. The PEG Stearates, whose average number of ethylene oxide monomers range from 2 to 150, were nonlethal to test animals up to 10 g/kg. They gave evidence of only low-level skin irritation and minimal eye irritation when tested at 100% concentrations in test animals. PEG-8, 40, and 100 Stearates produced no significant changes in growth mortality rates, histopathologic observations or hematologic values in long-term feeding studies. Multiple generation studies of PEG-8 and 40 Stearates were negative for effects on reproduction; the presence or absence of a carcinogenic effect was not reported. Clinical studies on the PEG Stearates indicated that these ingredients are neither irritants nor sensitizers at concentrations of ≥ 25%. There was no evidence of phototoxicity or photosensitization of PEG-2 or 8 Stearates. It is concluded that PEG-2, 6, 8, 12, 20, 32, 40, 50, 100, and 150 Stearates are safe as cosmetic ingredients in the present practices of concentration and use.

Final Report on the Safety Assessment of Methenamine

1992 ◽  
Vol 11 (4) ◽  
pp. 531-558 ◽  
Keyword(s):  
Drinking Water ◽  
Drosophila Melanogaster ◽  
Safety Assessment ◽  
Intestinal Tract ◽  
Final Report ◽  
Formaldehyde Concentration ◽  
Cosmetic Products ◽  
Teratogenic Effects ◽  
Carcinogenic Activity

Methenamine is a biocide that is used in cosmetic eye make-up preparations at concentrations of less than 1%. Methenamine, following oral administration, undergoes hydrolysis and generates formaldehyde. Methenamine is rapidly absorbed from the intestinal tract and excreted mostly unchanged in the urine. A single oral dose of 20 g/kg Methenamine did not cause mortality in rats. No untoward signs of toxicity were observed in either subchronic or chronic studies. Methenamine was slightly irritating to the skin of rabbits. In ocular studies it was mildy irritating. In animal assays, Methenamine was a sensitizer when tested at a concentration of 25%, but not at 0.2%. It was neither an irritant nor a sensitizer to humans at 0.1%. In a number of teratologic and reproductive studies, no teratogenic effects attributable to Methenamine were observed. Methenamine was a mutagen in Drosophila melanogaster but not in other in vitro mutagenicity assays. Methenamine did not show any carcinogenic activity, either alone or when nitrite was included in the drinking water of the test animals. Methenamine is judged to be safe for non-aerosolized cosmetic products at a concentration not to exceed 0.16%. At this concentration, the released formaldehyde concentration will not exceed 0.2%.

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.

4 Final Report on the Safety Assessment of Captan

1989 ◽  
Vol 8 (4) ◽  
pp. 643-680 ◽  
Keyword(s):  
Adverse Effects ◽  
Oral Administration ◽  
Safety Assessment ◽  
Final Report ◽  
Cosmetic Products ◽  
Intestinal Neoplasms

Captan is used in cosmetic products as a bacteriostat. Captan is not appreciably absorbed through the skin of mice. When administered orally to rats and absorbed, it is eliminated in the urine and feces. The compound is considered to be practically nontoxic to rats when orally administered. It is considered to be both a human irritant and sensitizer. Although teratogenic and reproductive studies indicated that Captan produced adverse effects in rats, mice, rabbits, and dogs, the ingredient was not teratogenic. Captan in the diet increased the incidence of intestinal neoplasms in mice. Because Captan is mutagenic in vitro, produces intestinal neoplasms in mice following oral administration, and upon degradation becomes an elec-trophile, it is concluded that an 18-month skin carcinogenicity bioassay in mice must be conducted before a conclusion on the safety of Captan can be reached.

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