3 Final Report on the Safety Assessment of Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Trioleate

1985 ◽  
Vol 4 (3) ◽  
pp. 65-121 ◽  
Keyword(s):  
Safety Assessment ◽  
Normal Skin ◽  
Mouse Skin ◽  
Tumor Promoter ◽  
Final Report ◽  
Low Concentrations ◽  
Cosmetic Ingredients ◽  
Sorbitan Esters ◽  
Sorbitan Tristearate ◽  
Skin Irritants

The Sorbitan esters, including Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Trioleate, are used in cosmetic products as emulsifiers and stabilizers at concentrations normally under 5 percent. Toxicity was reported in subchronic and chronic studies at concentrations above that normally used in cosmetics. They are generally mild skin irritants but nonsensitizers in animals. They have the potential to induce cutaneous irritation in humans but not sensitization to normal skin. Carcinogenic studies using Sorbitan Stearate and Laurate were negative. At concentrations of 10 percent or greater, Sorbitan Laurate is a tumor promoter in mouse skin. It is concluded that the latter is not relevant to the use of the Sorbitan esters at low concentrations in cosmetics and that the Sorbitan esters reviewed in the report are safe as cosmetic ingredients under present conditions of concentration and use.

3: Final Report on the Safety Assessment of Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine

1987 ◽  
Vol 6 (1) ◽  
pp. 53-76 ◽  
Keyword(s):  
Contact Dermatitis ◽  
Oral Administration ◽  
Safety Assessment ◽  
Animal Studies ◽  
Water Soluble ◽  
Final Report ◽  
Cosmetic Products ◽  
Cosmetic Ingredients ◽  
Allergic Contact ◽  
Skin Irritants

Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine are used as water-soluble emulsifiers and neutralizers in cosmetic products at concentrations up to 1%. In animal studies these ingredients were slightly toxic to practically nontoxic to rats and guinea pigs via acute oral administration. Triisopropanolamine was relatively nontoxic to rats in the two subchronic oral studies. These ingredients were moderate skin irritants for rabbits. All four ingredients, when tested at 100% concentrations, were severe ocular irritants in rabbits. Products containing small amounts (-1%) of Diisopropanolamine or Triisopropanolamine were not ocular irritants in rabbits. The Triisopropanolamine salt was not mutagenic in Aspergillus nidulans. Diisopropanolamine and Isopropanolamine at concentrations of 2% did not induce allergic contact dermatitis or photoallergic dermatitis in humans. Clinical studies on cosmetic products containing no more than 1% Diisopropanolamine or 1.1% Triisopropanolamine were minimal skin irritant and contact sensitizers. It is concluded that Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed Isopropanolamine are safe as cosmetic ingredients in the present practices of use and concentration. The Isopropanolamines should not be used in products containing N-nitrosating agents.

scholarly journals 10 Final Report on the Safety Assessment of Cholesterol

1986 ◽  
Vol 5 (5) ◽  
pp. 491-516 ◽  
Keyword(s):  
Clinical Studies ◽  
Safety Assessment ◽  
Final Report ◽  
Experimental Animals ◽  
Normal Metabolism ◽  
Hair Care ◽  
Uvb Exposure ◽  
High Doses ◽  
Skin Irritants

Cholesterol is used as an emulsifier in cosmetic skin and hair care products and eye and face makeup formulations at concentrations up to 5%. The normal metabolism and excretion of Cholesterol is well documented in man and experimental animals. Cholesterol is not a significant dermal or ocular irritant. Cholesterol does not appear to have any genotoxic activity in bacterial or mammalian cell in vitro mutagenic and transformation assays. High doses of Cholesterol were teratogenic in rats. Cholesterol has not been established as a promoter, cocarcinogen, or total carcinogen. Clinical studies to evaluate the safety of topically applied Cholesterol were restricted to products formulated with the ingredient. Most products were moisturizers containing 1.4% Cholesterol. The highest concentration of Cholesterol tested (6%) was evaluated in a modified prophetic test (110 subjects) and an RIPT (45 subjects); both assays had UVA and UVB exposure incorporated into the protocols. The Cholesterol-containing products were minimal to mild primary and cumulative skin irritants but not sensitizers or photosensitizers.

3 Final Report on the Safety Assessment of Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50

1983 ◽  
Vol 2 (7) ◽  
pp. 35-60 ◽  
Keyword(s):  
Clinical Studies ◽  
Ames Test ◽  
Safety Assessment ◽  
Animal Species ◽  
Skin Irritation ◽  
Final Report ◽  
Dermal Toxicity ◽  
Rabbit Eye ◽  
Toxicity Studies ◽  
Cosmetic Ingredients

Nonoxynols are chemically stable ethoxylated alkylphenols which are chemically foaming and solubilizing agents. Estimates of the acute oral LD50s of nine of the Nonoxynols (-2 to 15) range from 0.62 to 7.4 g/kg in several animal species. Acute dermal toxicity studies in rabbits produced an LD50 range of 1.8 ml/kg to 4.4 g/kg. Skin irritation tests on rabbits indicated that Nonoxynols are nonirritating to moderately irritating. Nonoxynol compounds with short ethoxylated chains are generally severe ocular irritants, whereas long-chained Nonoxynols are only slightly irritating to the rabbit eye. No evidence of carcinogenicity was observed when Nonoxynol-4 and 9 were fed to both dogs and rats. A mutagenicity study of these two compounds by the Ames test was negative. Undiluted Nonoxynol-4 and 9 were nonirritating and nonsensitizing in clinical studies. A 50% solution of Nonoxynol-15 and/or Nonoxynol-50 produced no irritation or sensitization when tested on 168 subjects, nor was there evidence of phototoxicity when tested on a subset of this population. It is concluded that Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50 are safe as cosmetic ingredients.

2 Final Report on the Safety Assessment of Fossil and Synthetic Waxes

1984 ◽  
Vol 3 (3) ◽  
pp. 43-99 ◽  
Keyword(s):  
Test Data ◽  
Safety Assessment ◽  
Clinical Test ◽  
Final Report ◽  
Cosmetic Ingredients ◽  
Toxicological Test

Toxicological test data on Ozokerite, Ceresin, Montan Wax, Paraffin, Microcrystalline Wax, Emulsifying Wax N.F., Synthetic Wax and Synthetic Beeswax are presented. Based on the documented animal and clinical test data, it is concluded that these waxes are safe for use as cosmetic ingredients in the present practices of concentration and use.

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.

Final Report on the Safety Assessment of Carbomers-934, -910, -934P, -940, -941, and -962

1990 ◽  
Vol 1 (2) ◽  
pp. 109-141 ◽  
Keyword(s):  
Molecular Weight ◽  
Acrylic Acid ◽  
Safety Assessment ◽  
Animal Studies ◽  
Skin Irritation ◽  
Final Report ◽  
Pathological Changes ◽  
Cosmetic Ingredients ◽  
Body Weights ◽  
Available Information

The Carbomers are synthetic, high molecular weight, nonlinear polymers of acrylic acid, cross-linked with a polyalkenyl polyether. The Carbomer polymers are used in cosmetics and emulsifying agents at concentrations up to 50%. Acute oral animal studies showed that Carbomers-910, -934, -934P, -940, and -941 have low toxicities when ingested. Rabbits showed minimal skin irritation and zero to moderate eye irritation when tested with Carbomers-910 and -934. Subchronic feeding of rats and dogs with Carbomer-934 in the diet resulted in lower than normal body weights, but no pathological changes were observed. Dogs chronically fed Carbomer-934P manifested gastrointestinal irritation and marked pigment deposition within Kupffer cells of the liver. Clinical studies with Carbomers showed that these polymers have low potential for skin irritation and sensitization at concentrations up to 100%. Carbomer-934 demonstrated low potential for phototoxicity and photo-contact allergenicity. On the basis of the available information presented and as qualified in the report, it is concluded that the Carbomers are safe as cosmetic ingredients.

5 Final Report on the Safety Assessment of Ethyl Acetate and Butyl Acetate

1989 ◽  
Vol 8 (4) ◽  
pp. 681-705 ◽  
Keyword(s):  
Ethyl Acetate ◽  
Guinea Pigs ◽  
Butyl Acetate ◽  
Chinese Hamster ◽  
Micronucleus Assay ◽  
Final Report ◽  
Nail Polish ◽  
Cosmetic Ingredients ◽  
Mild Irritant ◽  
Skin Irritants

Ethyl and Butyl Acetate are used as solvents in nail polish, nail polish removers, basecoats, and other manicuring preparations. Ethyl and Butyl Acetate were relatively nontoxic when administered orally, dermally, or by inhalation to rabbits, rats, mice, and guinea pigs. A nail polish containing 10% Ethyl Acetate and 25% Butyl Acetate was a moderate to severe irritant in unrinsed rabbit eyes and a mild irritant in rinsed rabbit eyes. Butyl Acetate was not a sensitizer in either mice or guinea pigs. Ethyl and Butyl Acetate were nonmutagenic when tested by the Ames procedure, Rec-assay, and micronucleus assay. Neither compound induces mitotic aneuploidy in yeast or chromosomal aberrations in Chinese hamster fibroblasts. Butyl Acetate was not teratogenic when inhaled. Ethyl Acetate and Butyl Acetate were mild skin irritants but not sensitizers to humans. Ethyl Acetate was neither phototoxic or photoallergenic in human tests. It is concluded that Ethyl Acetate and Butyl Acetate are safe as cosmetic ingredients in 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.

Final Report on the Safety Assessment of Malic Acid and Sodium Malate

2001 ◽  
Vol 20 (1_suppl) ◽  
pp. 47-55 ◽  
Keyword(s):  
Citric Acid ◽  
Malic Acid ◽  
Safety Assessment ◽  
Reproductive Toxicity ◽  
Feed Consumption ◽  
Final Report ◽  
Dermal Irritation ◽  
Low Concentrations ◽  
Cosmetic Formulations ◽  
Sodium Malate

Malic Acid functions in cosmetic formulations as a pH adjuster, and Sodium Malate functions as a skin conditioning agent-humectant. Malic Acid is reportedly used in almost 50 cosmetic formulations across a range of product types at low concentrations, whereas Sodium Malate is used in only one. As a pH adjuster, Malic Acid is used at low concentrations. One commercial method of preparing Malic Acid is hydration of fumaric acid or maleic acid, and then purified to limit the amount of the starting material present. Because Malic Acid is a component of the Kreb's cycle, another method is fermentation. Malic Acid was relatively nontoxic in acute toxicity studies using animals. In a chronic oral study, feeding Malic Acid to rats resulted only in weight gain changes and changes in feed consumption. Malic Acid did not cause reproductive toxicity in mice, rats, or rabbits. Malic Acid was a moderate to strong skin irritatant in animal tests, and was a strong ocular irritant. Malic Acid was not mutagenic across a range of genotoxicity tests. Malic Acid was irritating in clinical tests, with less irritation seen as pH of the applied material increased. Patients patch tested with Malic Acid, placed on a diet that avoided foods containing Malic or citric acid, and then challenged with a diet high in Malic and citric acid had both immediate urticarial and delayed contact dermatitis reactions. These data were considered sufficient to determine that Malic Acid and Sodium Malate would be safe at the low concentrations at which these ingredients would be used to adjust pH (even though Sodium Malate is not currently used for that purpose). The data, however, were insufficient to determine the safety of these ingredients when used in cosmetics as other than pH adjusters and specifically, the data are insufficient to determine the safety of Sodium Malate when used as a skin conditioning agent-humectant. The types of data required for the Expert Panel to determine the safety of Sodium Malate as a skin-conditioning agent are: concentration of use data; dermal irritation and sensitization data; and ocular irritation data, if available. The data needed to assess the safety of Malic Acid or Sodium Malate for some function other than as a skin-conditioning agent cannot be specified without knowing the intended function. Were these ingredients to be used as exfoliants, for example, data similar to that included in the Cosmetic Ingredient Review safety assessment of Glycolic Acid would be needed. Until these data are available, it is concluded that the available data are insufficient to support the safety of these ingredients in cosmetic formulations for functions other than use as a pH adjuster.

Amended Final Report On the Safety Assessment of Pyrocatechol

1997 ◽  
Vol 16 (1_suppl) ◽  
pp. 11-58 ◽  
Author(s):  
F. Alan Andersen
Keyword(s):  
Bone Marrow ◽  
Safety Assessment ◽  
Female Rats ◽  
Tumor Promoter ◽  
Oral Exposure ◽  
Final Report ◽  
Hair Dyes ◽  
Absorption Data ◽  
Male And Female Rats

Pyrocatechol is a phenol used primarily in hair dyes but has one reported use in skin care preparations. When this ingredient was first reviewed it was concluded that Pyrocatechol was safe for use in formulations designed for discontinuous, brief use followed by rinsing from the skin and hair at concentrations of up to 1.0%. This amendment to that report was prepared in order to incorporate the results from several studies, including those reporting immunologic, carcinogenic, and cocarcinogenic effects of Pyrocatechol. In vitro, Pyrocatechol has been shown to affect several immunologic and other properties of murine bone marrow cells, both alone and when combined with hydroquinone. Pyrocatechol, when produced as an hepatic metabolite of benzene, has been reported to concentrate in the bone marrow and to adversely affect hematopoietic precursor cells. These effects are somewhat species specific. In vivo, dermal exposure of mice to Pyrocatechol affects the number and distribution of Langerhans cells at the site of exposure but is not associated with a change in contact sensitivity. Oral exposure of pregnant rats to Pyrocatechol did result in an increase in teratogenic effects. The results of a micromass teratogen test in vitro were also positive. Pyrocatechol was tested in a number of bacterial and mammalian mutagenesis systems. Both negative and positive results were observed. Carcinogenicity studies were conducted in rats and mice. Pyrocatechol was provided in the feed. While adenomatous hyperplasia was noted in both species, adenocarcinomas were seen in male and female rats only. In cocarcinogenesis studies there is a similar pattern of hyperplasia and adenomas of the glandular stomach in the groups exposed to Pyrocatechol alone. When administered with several other carcinogens, Pyrocatechol had a cocarcinogenic effects. Pyrocatechol was not a tumor promoter in dermal studies. Based on these data and the significant potential for skin absorption of Pyrocatechol in leave-on preparations, it was concluded that Pyrocatechol is unsafe for use in leave-on cosmetic formulations. Pyrocatechol used in a rinse-off application such as hair dyes may not present a similar concern if Pyrocatechol is completely and rapidly oxidized. Because no data were available, it was concluded that there are insufficient data to support the safety of this ingredient. The data needed to complete the safety assessment include the extent and rate of oxidation when used in hair dyeing. If not rapidly and completely oxidized, then further chemical characterization of cosmetic grade Pyrocatechol is needed, along with cutaneous absorption data in aqueous and alcohol vehicles and ultraviolet absorption data (if positive, photosensitization studies may be needed).

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