8 Final Report on the Safety Assessment of Sodium Cetearyl Sulfate

1992 ◽  
Vol 11 (1) ◽  
pp. 145-155 ◽  
Keyword(s):  
Test Data ◽  
Safety Assessment ◽  
Sodium Lauryl Sulfate ◽  
Safety Evaluation ◽  
Final Report ◽  
Lauryl Sulfate ◽  
Chemical Similarity ◽  
Ocular Irritation ◽  
Safety Test ◽  
Cosmetic Ingredients

Sodium Cetearyl Sulfate is the sodium salt of a mixture of cetyl and stearyl sulfate which is used as a surfactant and cleansing agent in cosmetics at concentrations ranging from ≥ 0.1 to 25.0%. The LD50 was not achieved in two studies in which rats received a single oral dose of 5.0 ml/kg. In ocular irritation tests, 20.0% aqueous Sodium Cetearyl Sulfate was not irritating to the eyes of rabbits. Twenty percent Sodium Cetearyl Sulfate was not irritating to the skin of rabbits. In a guinea pig sensitization study, Sodium Cetearyl Sulfate was not a sensitizer. Sodium Cetearyl Sulfate is less irritating to the skin than Sodium Lauryl Sulfate, whose safety test data are summarized in the report. Due to the chemical similarity of these two cosmetic ingredients, the safety test data on Sodium Lauryl Sulfate was considered to be applicable to the safety evaluation of this ingredient. On the basis of the animal and clinical data on Sodium Cetearyl Sulfate and Sodium Lauryl Sulfate as presented in the report, it is concluded that Sodium Cetearyl Sulfate is safe as a cosmetic ingredient in the present practices of use and concentration.

Final Report on the Safety Assessment of Steapyrium Chloride and Lapyrium Chloride

1991 ◽  
Vol 10 (1) ◽  
pp. 87-97 ◽  
Keyword(s):  
Test Data ◽  
Structural Characteristics ◽  
Safety Evaluation ◽  
Final Report ◽  
Rabbit Skin ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Safety Test ◽  
Cosmetic Ingredients ◽  
Intact Rabbit

Steapyrium Chloride and Lapyrium Chloride are quaternary ammonium salts used in cosmetic products as biocides or as antistatic agents at concentrations equal to or less than 5.0%. The oral LD50 of Steapyrium Chloride was estimated to be 8.2 g/kg. Subchronic studies in rats established a no-effect dose of 100 mg/kg. Only a very slight dermal irritation was produced on abraded or intact rabbit skin by 1.0% Steapyrium Chloride. A 50% solution of Lapyrium Chloride produced slight to moderate erythema under occluded conditions. Very slight ocular irritation was produced in the eye of the rabbit by a solution containing 1.0% Steapyrium Chloride. Steapyrium Chloride was nonmutagenic when tested in a Salmonella/microsome assay, both with and without activation. Steapyrium Chloride was neither an irritant nor sensitizer when tested at 100% concentration in a repeat insult occluded patch test on 164 individuals. Steapyrium Chloride does not absorb light in the UVA or UVB range and, therefore, would not be expected to be a phototoxic agent. Only limited formulation safety test data were available for Lapyrium Chloride. However, the structural characteristics of Lapyrium Chloride and Steapyrium Chloride are very similar. Therefore, the safety test data on Steapyrium Chloride were used for the safety evaluation of both compounds. On the basis of the available data in this report, it is concluded that Steapyrium Chloride and Lapyrium Chloride are safe as cosmetic ingredients.

1: Final Report on the Safety Assessment of Sodium Lauryl Sulfoacetate

1987 ◽  
Vol 6 (3) ◽  
pp. 261-277 ◽  
Keyword(s):  
Clinical Studies ◽  
Guinea Pigs ◽  
Safety Assessment ◽  
Sodium Lauryl Sulfate ◽  
Skin Irritation ◽  
Final Report ◽  
Lauryl Sulfate ◽  
Cosmetic Products ◽  
Cosmetic Product ◽  
Ocular Irritation

Sodium Lauryl Sulfoacetate is a detergent used in cosmetic products. A 12% solution of the ingredient was slightly toxic to rats in an acute oral study. No treatment-related effects of significance were noted in rats in a subchronic study at a dose of 75 mg/kg/day. Some effects were observed at 250 and 750 mg/kg/day. Minimal to slight ocular irritation occurred in rabbits when tested with 3.0% Sodium Lauryl Sulfoacetate. A diluted product tested at 1% Sodium Lauryl Sulfate was nonirritating to the genital mucosa of rabbits. No skin irritation, sensitization, or phototoxicity was noted in guinea pigs exposed to a cosmetic product containing 2% Sodium Lauryl Sulfoacetate. Cosmetic products containing up to 16% Sodium Lauryl Sulfoacetate were nonmutagenic in the Ames Salmonella/microsome assay, both with and without activation. In clinical studies, Sodium Lauryl Sulfoacetate was a mild to strong skin irritant but not a sensitizer at concentrations up to 2.0%. The irritant effects are similar to those produced by other detergents, and the severity of the irritation appears to increase directly with concentration. It is concluded that Sodium Lauryl Sulfoacetate is safe for use in cosmetic products in the present practices of use and concentration.

9 Final Report on the Safety Assessment of Sodium Myreth Sulfate

1992 ◽  
Vol 11 (1) ◽  
pp. 157-163 ◽  
Keyword(s):  
Test Data ◽  
Sodium Salt ◽  
Safety Assessment ◽  
Final Report ◽  
Similar Compound ◽  
Experimental Animals ◽  
Safety Test ◽  
Myristyl Alcohol ◽  
Cosmetic Ingredients ◽  
Combined Data

Sodium Myreth Sulfate is the sodium salt of sulfated, ethoxylated myristyl alcohol which is used as a surfactant and cleansing agent in cosmetics at concentrations ranging from > 1.0–5.0% to > 50.0%. A formulation containing 7.0% Sodium Myreth Sulfate was shown to be an ocular irritant in experimental animals and in some human test subjects. These irritant effects were similar to those previously reported for the chemically similar compound Sodium Laureth Sulfate which was shown to be safe for use in cosmetics. The report summarizes the safety test data on Sodium Laureth Sulfate. Based upon the combined data cited in the report on both cosmetic ingredients, it is concluded that Sodium Myreth Sulfate is safe as a cosmetic ingredient in the present practices of use and concentration.

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.

Final Report on the Safety Assessment of Dimethyl Stearamine

1995 ◽  
Vol 14 (6) ◽  
pp. 428-432
Keyword(s):  
Safety Assessment ◽  
Developmental Toxicity ◽  
Final Report ◽  
Inhalation Toxicity ◽  
Dermal Toxicity ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Safety Test ◽  
Mammalian System ◽  
Additional Safety

Dimethyl Stearamine is a tertiary aliphatic amine that is used as an antistatic agent in cosmetics at concentrations up to 5%. Bacterial studies suggest antibacterial action at concentrations as low as 3.6 moles per 106. Mutagenicity testing was negative, even though the ingredient can act as a biocide. Additional safety test data are needed, including concentration of use, impurities, inhalation toxicity (or information on particle size), ocular irritation, dermal irritation and sensitization, and a 28-day dermal toxicity study (possibly followed by absorption, distribution, and metabolism studies). Additionally, if significantly absorbed, reproduction and developmental toxicity (including teratogenicity) data and two genotoxicity assays, one using a mammalian system, are needed. If the mutagenesis data are positive, then a dermal carcinogenesis study may be needed. In the absence of this further information, the available data are insufficient to support the safety of Dimethyl Stearamine in cosmetics.

Final Report on the Safety Assessment of Adipic Acid Dihydrazide

1994 ◽  
Vol 13 (3) ◽  
pp. 154-156 ◽  
Keyword(s):  
Test Data ◽  
Adipic Acid ◽  
Final Report ◽  
Cosmetic Products ◽  
Uv Spectrum ◽  
Ocular Irritation ◽  
Dermal Irritation ◽  
Safety Test ◽  
Cosmetic Formulations

Adipic Acid Dihydrazide has been used as a chemical additive in a variety of cosmetic products. The ingredient was previously reported to be used; however, there are no reported uses of Adipic Acid Dihydrazide during 1992. The available safety test data were insufficient to judge the safety of use of Adipic Acid Dihydrazide in cosmetic products. The types of data required before an evaluation on the safety of use of this cosmetic ingredient include: metabolism (stability of compound in vivo, with respect to hydrolysis to hydrazine); stability and impurities (specifically, data on hydrazine content is necessary); concentration of use in cosmetic formulations. If the interpretation of the preceding requested data indicates that this ingredient could be safely used in cosmetic formulations, the following additional safety test data must be available and evaluated before it can be determined whether this compound may be safely used in cosmetic products. The needed data include: chemistry (including pH, method of manufacture, and UV spectrum); ocular irritation; dermal irritation; dermal sensitization; dermal photosensitization (only if the compound absorbs in the UV spectrum); 28-day dermal toxicity; genotoxicity (at least two assays); carcinogenicity may be requested if genotoxicity assays are positive.

scholarly journals Final Report on the Safety Assessment of Octyl Palmitate, Cetyl Palmitate and Isopropyl Palmitate

1990 ◽  
Vol 1 (2) ◽  
pp. 13-35 ◽  
Keyword(s):  
Safety Assessment ◽  
Isopropyl Alcohol ◽  
Skin Tests ◽  
Final Report ◽  
Dermal Toxicity ◽  
Rabbit Skin ◽  
Ocular Irritation ◽  
Cosmetic Ingredients ◽  
Cetyl Palmitate ◽  
Available Information

The Palmitates used in cosmetic products are esters of palmitic acid and octyl, cetyl, or isopropyl alcohol. The acute oral LD50 is estimated from studies with rats to be greater than 14.4 g/kg for Cetyl Palmitate and greater than 64.0 g/kg for Octyl and Isopropyl Palmitates. Acute studies with rabbits showed no evidence of dermal toxicity for any of the Palmitates. Isopropyl Palmitate was “well tolerated” and Octyl Palmitate was nontoxic in separate subchronic dermal studies. Rabbit skin tests with the Palmitates showed that they are nonirritating and nonsensitizing. Also, Draize rabbit eye irritation tests on the Palmitates produced either no or only very slight ocular irritation. One of three formulations containing Octyl Palmitate at concentrations between 40% and 50% produced mild irritation. Formulations containing Cetyl Palmitate at concentration of 2.7% were minimally irritating and produced no signs of sensitization, phototoxicity, or photo contact allergenicity. A formulation containing 45.6% Isopropyl Palmitate produced no signs of irritation, sensitization, phototoxicity, or photo contact allergenicity. From the available information, it is concluded that Octyl Palmitate, Cetyl Palmitate, and Isopropyl Palmitate are safe as cosmetic ingredients in the present practices of use and concentration.

3 Final Report on the Safety Assessment of Isopropyl Isostearate

1992 ◽  
Vol 11 (1) ◽  
pp. 43-49 ◽  
Keyword(s):  
Test Data ◽  
Safety Assessment ◽  
Isopropyl Alcohol ◽  
Aqueous Suspension ◽  
Final Report ◽  
Cosmetic Products ◽  
Isopropyl Esters ◽  
Isostearic Acid ◽  
Safety Test ◽  
Repeated Applications

Isopropyl Isostearate, the ester of isopropyl alcohol and isostearic acid, is used as a skin conditioning agent-emollient in cosmetic products. Undiluted Isopropyl Isostearate was classified as a slight ocular irritant. Repeated applications of a 10.0% aqueous suspension of Isopropyl Isostearate to the skin of albino rabbits was well-tolerated. Based upon the safety test data on chemically similar isopropyl esters that is summarized in the report, it is concluded that Isopropyl Isostearate is safe as a cosmetic ingredient in the present practices of use and concentration.

scholarly journals 1 Final Report on the Safety Assessment of Cocoamphoacetate, Cocoamphopropionate, Cocoamphodiacetate, and Cocoamphodipropionate

1990 ◽  
Vol 9 (2) ◽  
pp. 121-142 ◽  
Keyword(s):  
Patch Test ◽  
Organic Compounds ◽  
Safety Assessment ◽  
Metabolic Activation ◽  
Final Report ◽  
Acute Oral Toxicity ◽  
Oral Toxicity ◽  
Ocular Irritation ◽  
Cosmetic Ingredients ◽  
Rats And Mice

Cocoamphoacetate (CAA), Cocoamphopropionate (CAP), Cocoamphodiacetate (CADA), and Cocoamphodipropionate (CADP) are imidazoline-derived amphoteric organic compounds. These amphoteric compounds are used in cosmetics as surfactants, mild foaming and cleansing agents, detoxifying agents, and conditioners at concentrations ranging from ≤ 0.1 to 50 percent. In acute oral toxicity studies, CADA and CAA were nontoxic in rats and mice, CADP was nontoxic in rats, and CAP was nontoxic in mice. An oral LD50 of 7.8 ml/kg was reported for mice dosed with 70% CADP. The results of ocular irritation studies of these compounds, as commercially supplied, varied widely. CADA was moderately to severely irritating when eyes were not rinsed and practically nonirritating to mildly irritating when rinsed. CADP was practically nonirritating under unrinsed conditions. CAA was minimally to severely irritating and CAP was practically nonirritating to minimally irritating under unrinsed conditions. In a clinical ocular study, 1,3, and 10% dilutions of a shampoo containing 28.1% CADA were nonirritating to the human eye. CAP, CADA, and CADP were nonmutagenic in the Ames assay, both with and without metabolic activation. CAA and CAP, at a concentration of 10%, were neither irritants nor sensitizers in a repeated insult patch test on 141 subjects. Based upon the available data, it is concluded that CAA, CAP, CADA, and CADP are safe for use as cosmetic ingredients.

scholarly journals Final Report on the Safety Assessment of Sodium Cetearyl Sulfate and Related Alkyl Sulfates as Used in Cosmetics

2010 ◽  
Vol 29 (3_suppl) ◽  
pp. 115S-132S ◽  
Author(s):  
Monice Fiume ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Curtis D. Klaassen ◽  
James G. Marks ◽  
...  
Keyword(s):  
Sodium Salt ◽  
Safety Assessment ◽  
Sodium Lauryl Sulfate ◽  
Expert Panel ◽  
The Other ◽  
Final Report ◽  
Lauryl Sulfate ◽  
Alkyl Sulfates ◽  
Sodium Decyl Sulfate

Sodium cetearyl sulfate is the sodium salt of a mixture of cetyl and stearyl sulfate. The other ingredients in this safety assessment are also alkyl salts, including ammonium coco-sulfate, ammonium myristyl sulfate, magnesium coco-sulfate, sodium cetyl sulfate, sodium coco/hydrogenated tallow sulfate, sodium coco-sulfate, sodium decyl sulfate, sodium ethylhexyl sulfate, sodium myristyl sulfate, sodium oleyl sulfate, sodium stearyl sulfate, sodium tallow sulfate, sodium tridecyl sulfate, and zinc coco-sulfate. These ingredients are surfactants used at concentrations from 0.1% to 29%, primarily in soaps and shampoos. Many of these ingredients are not in current use. The Cosmetic Ingredient Review (CIR) Expert Panel previously completed a safety assessment of sodium and ammonium lauryl sulfate. The data available for sodium lauryl sulfate and ammonium lauryl sulfate provide sufficient basis for concluding that sodium cetearyl sulfate and related alkyl sulfates are safe in the practices of use and concentration described in the safety assessment.

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