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.

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.

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.

Sodium Lauryl Sulfate in Egg Whites

1967 ◽  
Vol 50 (4) ◽  
pp. 847-849
Author(s):  
John Wiskerchen
Keyword(s):  
Chloride Solution ◽  
Sodium Lauryl Sulfate ◽  
Collaborative Study ◽  
Egg White ◽  
Chloride Complex ◽  
Bromphenol Blue ◽  
Lauryl Sulfate ◽  
Benzethonium Chloride ◽  
Alkyl Sulfates

Abstract A method is given for the quantitative determination of sodium lauryl sulfate in liquid, frozen, powdered, or flake-dried egg white. The egg white is dissolved in water and the protein is precipitated with ethanol and filtered off. The filtrate is evaporated, the residue is dissolved in water, and the pH is adjusted to 5.0. Total alkyl sulfates are titrated with standard benzethonium chloride solution in the presence of chloroform with bromphenol blue indicator. Results are calculated as sodium lauryl sulfate. The formation of the bromphenol bluebenzethonium chloride complex, when excess benzethonium chloride is present, is taken as the end point. The blue-green complex is soluble in the chloroform. Overall recoveries of sodium lauryl sulfate from egg whites ranged from 94 to 100%. Collaborative study of the method is recommended.

Final Report of the Safety Assessment of Kojic Acid as Used in Cosmetics

2010 ◽  
Vol 29 (6_suppl) ◽  
pp. 244S-273S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Guinea Pig ◽  
Safety Assessment ◽  
Expert Panel ◽  
Kojic Acid ◽  
Tumor Promotion ◽  
Final Report ◽  
Cosmetic Products ◽  
Pig Skin ◽  
Animal Data ◽  
Skin Lightening

Kojic acid functions as an antioxidant in cosmetic products. Kojic acid was not a toxicant in acute, chronic, reproductive, and genotoxicity studies. While some animal data suggested tumor promotion and weak carcinogenicity, kojic acid is slowly absorbed into the circulation from human skin and likely would not reach the threshold at which these effects were seen. The available human sensitization data supported the safety of kojic acid at a use concentration of 2% in leave-on cosmetics. Kojic acid depigmented black guinea pig skin at a concentration of 4%, but this effect was not seen at 1%. The Cosmetic Ingredient Review (CIR) Expert Panel concluded that the 2 end points of concern, dermal sensitization and skin lightening, would not be seen at use concentrations below 1%; therefore, this ingredient is safe for use in cosmetic products up to that level.

scholarly journals Final Report of the Safety Assessment of Allantoin and Its Related Complexes

2010 ◽  
Vol 29 (3_suppl) ◽  
pp. 84S-97S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Curtis D. Klaassen ◽  
James G. Marks ◽  
...  
Keyword(s):  
Galacturonic Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
Glycyrrhetinic Acid ◽  
Final Report ◽  
Polygalacturonic Acid ◽  
Product Categories ◽  
Safety Test ◽  
Data Gaps ◽  
Safety Assessments

Allantoin is a heterocyclic organic compound. Allantoin ascorbate, allantoin biotin, allantoin galacturonic acid, allantoin glycyrrhetinic acid, allantoin panthenol, and allantoin polygalacturonic acid are complexes of allantoin. All of the ingredients in this review act as skin-conditioning agents. Allantoin was reported to be used in 1376 cosmetic products at concentrations up to 2%. There are data gaps regarding use and concentration of the remaining allantoin complexes. Ascorbic acid, biotin, glycyrrhetinic acid, and panthenol have been determined by the CIR Expert Panel to be safe. Galacturonic acid and polygalacturonic acid have not been reviewed by the CIR Expert Panel, and substantial data on these chemicals were not available. The safety test data in this safety assessment and in previous safety assessments were considered sufficient to support the safety of allantoin and the allantoin complexes in product categories and at concentrations reviewed in this safety assessment.

Safety Assessment of Pentaerythrityl Tetraesters as Used in Cosmetics

2015 ◽  
Vol 34 (2_suppl) ◽  
pp. 99S-112S ◽  
Author(s):  
Lillian C. Becker ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Fatty Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
The Other ◽  
Human Data ◽  
Safety Assessments

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of 16 pentaerythrityl tetraester compounds as used in cosmetics. These ingredients mostly function as hair-conditioning agents, skin-conditioning agents—miscellaneous and binders, skin-conditioning agents–occlusive, viscosity-increasing agents–nonaqueous, and skin-conditioning agents—emollient. The Panel reviewed the available animal and human data related to these ingredients and previous safety assessments of the fatty acid moieties. The Panel concluded that pentaerythrityl tetraisostearate and the other pentaerythrityl tetraester compounds were safe in the practices of use and concentration as given in this safety assessment.

Final Safety Assessment of Thiodipropionic Acid and Its Dialkyl Esters as Used in Cosmetics

2010 ◽  
Vol 29 (4_suppl) ◽  
pp. 137S-150S ◽  
Author(s):  
Catherine Diamante ◽  
Monice Zondlo Fiume ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Single Dose ◽  
Safety Assessment ◽  
Expert Panel ◽  
The Other ◽  
Repeated Dose ◽  
Clinical Testing ◽  
Cosmetic Products ◽  
Significant Toxicity ◽  
Dose Oral ◽  
Animal Skin

Dilauryl thiodipropionate (DLTDP), dicetyl thiodipropionate, dimyristyl thiodipropionate, distearyl thiodipropionate, and ditridecyl thiodipropionate are dialkyl esters of their respective alcohols and thiodipropionic acid (TDPA) used in cosmetics. Ingested DLTDP was excreted in the urine as TDPA. Single-dose acute oral and parenteral studies and subchronic and chronic repeated dose oral studies did not suggest significant toxicity. Neither DLTDP nor TDPA was irritating to animal skin or eyes and they were not sensitizers. TDPA was neither a teratogen nor a reproductive toxicant. Genotoxicity studies were negative for TDPA and DLTDP. Clinical testing demonstrated some evidence of irritation but no sensitization or photosensitization. The Cosmetic Ingredient Review Expert Panel considered that the data from DLTDP reasonably may be extrapolated to the other dialkyl esters and concluded that these ingredients were safe for use in cosmetic products that are formulated to be nonirritating.

4 Final Report on the Safety Assessment of o-Cymen-5-ol

1984 ◽  
Vol 3 (3) ◽  
pp. 131-138
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Safety Evaluation ◽  
Final Report ◽  
Cosmetic Products

The safety on o-Cymen-5-ol has not been documented and substantiated. The Cosmetic Ingredient Review Expert Panel cannot conclude that o-Cymen-5-ol is safe for use in cosmetic products until such time that the appropriate safety data have been obtained and evaluated. The data that were available are documented in the report as well as the types of data that are required before a safety evaluation may be undertaken.

Final Report of the Amended Safety Assessment of Sodium Laureth Sulfate and Related Salts of Sulfated Ethoxylated Alcohols

2010 ◽  
Vol 29 (4_suppl) ◽  
pp. 151S-161S ◽  
Author(s):  
Valerie C. Robinson ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Final Report ◽  
Data Gaps ◽  
Ethoxylated Alcohols ◽  
Toxicological Testing

Sodium laureth sulfate is a member of a group of salts of sulfated ethoxylated alcohols, the safety of which was evaluated by the Cosmetic Ingredient Review (CIR) Expert Panel for use in cosmetics. Sodium and ammonium laureth sulfate have not evoked adverse responses in any toxicological testing. Sodium laureth sulfate was demonstrated to be a dermal and ocular irritant but not a sensitizer. The Expert Panel recognized that there are data gaps regarding use and concentration of these ingredients. However, the overall information available on the types of products in which these ingredients are used and at what concentrations indicates a pattern of use. The potential to produce irritation exists with these salts of sulfated ethoxylated alcohols, but in practice they are not regularly seen to be irritating because of the formulations in which they are used. These ingredients should be used only when they can be formulated to be nonirritating.

3 Final Report on the Safety Assessment of t-Butyl Alcohol

1989 ◽  
Vol 8 (4) ◽  
pp. 627-641 ◽  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Safety Evaluation ◽  
Butyl Alcohol ◽  
Final Report ◽  
Cosmetic Products

The safety of this ingredient has not been documented and substantiated. The Cosmetic Ingredient Review Expert Panel cannot conclude that t-Butyl Alcohol is safe for use in cosmetic products until such time that the appropriate safety data have been obtained and evaluated. The data that were available are documented in the report as well as the types of data that are required before a safety evaluation may be undertaken.

Sign in / Sign up

Export Citation Format

Share Document