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.

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.

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.

Amended Safety Assessment of Isethionate Salts as Used in Cosmetics

2017 ◽  
Vol 36 (1_suppl) ◽  
pp. 5S-16S
Author(s):  
Christina L. Burnett ◽  
Bart Heldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Physicochemical Properties ◽  
Clinical Data ◽  
Safety Assessment ◽  
Expert Panel ◽  
Core Structure ◽  
Cosmetic Products ◽  
Toxicological Data ◽  
Data Gaps

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) rereviewed the safety of 12 isethionate salts as used in cosmetics and concluded that these ingredients are safe in the present practices of use and concentration, when formulated to be nonirritating. These isethionate salts are reported to function mostly as surfactants and cleansing agents in cosmetic products. The Panel reviewed the available animal and clinical data as well as information from previous CIR reports. Although there are data gaps, the shared chemical core structure, expected similarities in physicochemical properties, and similar functions and concentrations in cosmetics enabled grouping these ingredients and reading across the available toxicological data to support the safety assessment of each ingredient.

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.

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.

Final Report of the Cosmetic Ingredient Review Expert Panel on the Safety Assessment of Cocamidopropyl betaine (CAPB)

2012 ◽  
Vol 31 (4_suppl) ◽  
pp. 77S-111S ◽  
Author(s):  
Christina L. Burnett ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
Curtis D. Klaassen ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Fatty Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
Quantitative Risk Assessment ◽  
Final Report ◽  
Significant Toxicity ◽  
Cosmetic Ingredients ◽  
Cocamidopropyl Betaine

Cocamidopropyl betaine (CAPB) and related amidopropyl betaines are zwitterions used mainly as surfactants in cosmetics. These cosmetic ingredients are similar in their chemistry, in particular with respect to the presence of 3,3-dimethylamino-propylamine (DMAPA) and fatty acid amidopropyl dimethylamine (amidoamine) impurities, which are known as sensitizers. The CIR Expert Panel concluded that because these ingredients present no other significant toxicity, when formulated to be nonsensitizing (which may be based on a quantitative risk assessment), these ingredients are safe for use as cosmetic ingredients in the practices of use and concentration of this safety assessment.

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.

scholarly journals Final Report of the Cosmetic Ingredient Review Expert Panel on the Safety Assessment of Dicarboxylic Acids, Salts, and Esters

2012 ◽  
Vol 31 (4_suppl) ◽  
pp. 5S-76S ◽  
Author(s):  
Monice M. Fiume ◽  
HBart eldreth ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Dicarboxylic Acid ◽  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Dicarboxylic Acids ◽  
Entire Group ◽  
Final Report ◽  
Product Usage ◽  
Cosmetic Product

The CIR Expert Panel assessed the safety of dicarboxylic acids and their salts and esters as used in cosmetics. Most dicarboxylic acids function in cosmetics as pH adjusters or fragrance ingredients, but the functions of most of the salts in cosmetics are not reported. Some of the esters function as skin conditioning or fragrance ingredients, plasticizers, solvents, or emollients. The Expert Panel noted gaps in the available safety data for some of the dicarboxylic acid and their salts and esters in this safety assessment. The available data on many of the ingredients are sufficient, however, and similar structural activity relationships, biologic functions, and cosmetic product usage suggest that the available data may be extrapolated to support the safety of the entire group. The Panel concluded that the ingredients named in this report are safe in the present practices of use and concentration.

3 Final Report on the Safety Assessment of Tallow, Tallow Glyceride, Tallow Glycerides, Hydrogenated Tallow Glyceride, and Hydrogenated Tallow Glycerides

1990 ◽  
Vol 9 (2) ◽  
pp. 153-164 ◽  
Keyword(s):  
Fatty Acid ◽  
Drug Administration ◽  
Safety Assessment ◽  
Expert Panel ◽  
Food And Drug Administration ◽  
Consumer Products ◽  
Skin Care ◽  
Final Report ◽  
Cosmetic Ingredients ◽  
The Individual

Tallow, Tallow Glyceride, Tallow Glycerides, Hydrogenated Tallow Glyceride, and Hydrogenated Tallow Glycerides are used in eye and face makeup preparations and in skin care preparations. Concentrations of use range from ≤0.1 % to > 50%. The fatty acid constituents of Tallow, and some of the corresponding fatty acid alcohols have been evaluated for safety by the Federation of American Societies of Experimental Biology, the Food and Drug Administration, and by an Expert Panel of the Cosmetic Ingredient Review. In all cases, the ingredients were found safe in present practices of use. None of these constituents of Tallow were toxic through oral and dermal exposure, they were not ocular or dermal irritants, and they were neither dermal sensitizers nor photosensitizers. The same was true for other oils which contain varying concentrations of the constituents of Tallow. Based on the CIR safety evaluations of the individual constituents of Tallow and of cosmetic ingredients containing the constituents of Tallow, and on the approval of Tallow for use in foods and other consumer products, it is concluded that Tallow, Tallow Glyceride, Tallow Glycerides, Hydrogenated Tallow Glyceride, and Hydrogenated Tallow Glycerides are safe as cosmetic ingredients in the present practices of use.

scholarly journals 1 Final Report on the Safety Assessment of Benzylparaben

1986 ◽  
Vol 5 (5) ◽  
pp. 301-307 ◽  
Keyword(s):  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Safety Evaluation ◽  
Final Report ◽  
Cosmetic Products

The safety of this ingredient has not been documented and substantiated. The Cosmetic Ingredient Review Expert Panel cannot conclude that Benzylparaben 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.

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