SD Alcohol 40

The Food and Drug Administration (FDA) includes Alcohol (ethanol) on its list of direct food substances considered Generally Recognized as Safe (GRAS). Alcohol may also be used as an indirect food additive. For example, it may be used as a component of adhesives in contact with food. The FDA has also approved Alcohol for use in Over-the-Counter (OTC) antimicrobial drug products.

The safety of Alcohol Denat., 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 has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The safety of other denaturants such as t-Butyl Alcohol, Diethyl Phthalate and Methyl Alcohol were reviewed by the CIR Expert Panel in other reports and found safe for use. The CIR Expert Panel evaluated the scientific data and concluded that Alcohol Denat., SD Alcohol 3-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 products. The data were also considered sufficient to support the safety of Denatonium Benzoate when used as a denaturant. The CIR Expert Panel also concluded that the data were insufficient to support the safety Quassin, Brucine and Brucine Sulfate as denaturants, and Alcohol denatured with these denaturants.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 Alcohol 3-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/enterprise/cosmetics/html/consolidated_d...

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/hotlist-liste_e... for more information.