Alcohol Denat.
More safety information:
CIR Safety Review: The CIR Expert Panel reviewed the safety of Alcohol Denat., SD Alcohol 3 -A, SD Alcohol 30, SD Alcohol 39, SD Alcohol 39-B, SD Alcohol 39-C, SD Alcohol 40, SD Alcohol 40-B, SD Alcohol 40-C as well as the denaturants Denatonium Benzoate, Quassin, Brucine and Brucine Sulfate. Other denaturants were not reviewed in this report because they were previously reviewed by CIR or were not considered to be widely used in cosmetics and personal care products.
The review of Alcohol Denat. examined data on alcohol and the specific denatured alcohols, as well as the denaturants, Denatonium Benzoate, Quassin, Brucine and Brucine Sulfate. Alcohol and SD Alcohols did not result in dermal sensitization. The CIR Expert Panel was not concerned with the safety of Alcohol as used in cosmetics and personal care products because relative to intake of Alcohol in alcoholic beverages, dermal application or inhalation of cosmetic products containing Alcohol and Alcohol Denat. would not product significant systemic exposure to Alcohol.
Denatonium Benzoate is a bitter substance detectable at a concentration of 10 parts per billion (ppb), discernibly bitter at 50 ppb, and unpleasantly bitter at 10 parts per million (ppm). It has a similar structure to lidocaine a topical anesthetic.
A study of the distribution of topically applied lidocaine, demonstrated that virtually no lidocaine appears in the plasma, suggesting that the larger Denatonium Benzoate molecule would also have little or no systemic exposure. Denatonium Benzoate did not show adverse effects in an acute inhalation toxicity test. It was non-irritating to the eyes. In two chronic toxicity studies of Denatonium Benzoate, no compound-related toxicity was observed at doses much higher than expected from use of this ingredient as a denaturant.
Quassin, Brucine and Brucine Sulfate are bitter alkaloids obtained plants. Brucine has a similar structure to strychnine.
The available laboratory data on Quassin suggested that large oral doses result in reproductive effects in males. No genotoxicity data or dermal tests on Quassin were available.
Brucine was non-mutagenic in bacteria. In a repeated insult patch test, a hair care product containing Alcohol Denat. denatured with Brucine Sulfate was not a dermal irritant or sensitizer.
The CIR Expert Panel concluded that Alcohol Denat., SD Alcohol3 -A, SD Alcohol 30, SD Alcohol 39-B, SD Alcohol 39-C, SD Alcohol 40-B, and SD Alcohol 40-C denatured with t-Butyl Alcohol, Denatonium Benzoate, Diethyl Phthalate, or Methyl Alcohol were safe for use in cosmetic and personal care products. The data were also considered sufficient to support the safety of Denatonium Benzoate when used as a denaturant. The data were insufficient to support the safety Quassin, Brucine, and Brucine Sulfate as denaturants, and alcohol denatured with these denaturants. The data needed to support the safety of Quassin, Brucine and Brucine Sulfate included genotoxicity in a mammalian system, and dermal penetration data.
More information about the regulation of Alcohol Denat. by the Alcohol and Tobacco Tax and Trade Bureau (TTB) of the Department of Treasury.
http://www.ttb.gov/industrial/sda_regs_laws.shtml
FDA: Link to Code of Federal Regulations for ethanol
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
FDA: More information about the use of Alcohol in OTC antimicrobial drug products
http://www.fda.gov/cder/otcmonographs/Antimicrobial/antimicr...
In Europe, Alcohol Denat. is Alcohol denatured with one or more denaturing agents in accordance with the national legislation of each European Union (EU) country. All EU Member states recognize denaturing methods applied by any of the other EU nations.
Brucine is not permitted to be used in cosmetics and personal care products marketed in Europe (see Annex II).
Link to the EU Cosmetics Directive:
http://ec.europa.eu/consumers/sectors/cosmetics/documents/di...
In Canada, Brucine is permitted for use in cosmetics and personal care products at concentrations equal to or less than 0.1%.
Please check the Health Canada website at http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_... for more information.
The review of Alcohol Denat. examined data on alcohol and the specific denatured alcohols, as well as the denaturants, Denatonium Benzoate, Quassin, Brucine and Brucine Sulfate. Alcohol and SD Alcohols did not result in dermal sensitization. The CIR Expert Panel was not concerned with the safety of Alcohol as used in cosmetics and personal care products because relative to intake of Alcohol in alcoholic beverages, dermal application or inhalation of cosmetic products containing Alcohol and Alcohol Denat. would not product significant systemic exposure to Alcohol.
Denatonium Benzoate is a bitter substance detectable at a concentration of 10 parts per billion (ppb), discernibly bitter at 50 ppb, and unpleasantly bitter at 10 parts per million (ppm). It has a similar structure to lidocaine a topical anesthetic.
A study of the distribution of topically applied lidocaine, demonstrated that virtually no lidocaine appears in the plasma, suggesting that the larger Denatonium Benzoate molecule would also have little or no systemic exposure. Denatonium Benzoate did not show adverse effects in an acute inhalation toxicity test. It was non-irritating to the eyes. In two chronic toxicity studies of Denatonium Benzoate, no compound-related toxicity was observed at doses much higher than expected from use of this ingredient as a denaturant.
Quassin, Brucine and Brucine Sulfate are bitter alkaloids obtained plants. Brucine has a similar structure to strychnine.
The available laboratory data on Quassin suggested that large oral doses result in reproductive effects in males. No genotoxicity data or dermal tests on Quassin were available.
Brucine was non-mutagenic in bacteria. In a repeated insult patch test, a hair care product containing Alcohol Denat. denatured with Brucine Sulfate was not a dermal irritant or sensitizer.
The CIR Expert Panel concluded that Alcohol Denat., SD Alcohol
More information about the regulation of Alcohol Denat. by the Alcohol and Tobacco Tax and Trade Bureau (TTB) of the Department of Treasury.
http://www.ttb.gov/industrial/sda_regs_laws.shtml
FDA: Link to Code of Federal Regulations for ethanol
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
FDA: More information about the use of Alcohol in OTC antimicrobial drug products
http://www.fda.gov/cder/otcmonographs/Antimicrobial/antimicr...
In Europe, Alcohol Denat. is Alcohol denatured with one or more denaturing agents in accordance with the national legislation of each European Union (EU) country. All EU Member states recognize denaturing methods applied by any of the other EU nations.
Brucine is not permitted to be used in cosmetics and personal care products marketed in Europe (see Annex II).
Link to the EU Cosmetics Directive:
http://ec.europa.eu/consumers/sectors/cosmetics/documents/di...
In Canada, Brucine is permitted for use in cosmetics and personal care products at concentrations equal to or less than 0.1%.
Please check the Health Canada website at http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/_... for more information.
More scientific information:
Industrially, Alcohol is produced in several ways: by fermentation using glucose produced from sugar from the hydrolysis of starch, in the presence of yeast and temperature of less than 37°C; by direct hydration using ethene or other alkenes from cracking of fractions of distilled crude oil.
Alcohol Denat. is produced by mixing small amounts of one or more denaturants, generally bittering agents, with the alcohol to make it taste bad. The amount of denaturant needed and which denaturants can be used in alcohol used cosmetics and personal care products are specified by regulations. In the United States, formulas for Alcohol Denat. are specified by the Alcohol and Tobacco Tax and Trade Bureau of the Department of the Treasury.
Alcohol Denat. is produced by mixing small amounts of one or more denaturants, generally bittering agents, with the alcohol to make it taste bad. The amount of denaturant needed and which denaturants can be used in alcohol used cosmetics and personal care products are specified by regulations. In the United States, formulas for Alcohol Denat. are specified by the Alcohol and Tobacco Tax and Trade Bureau of the Department of the Treasury.
