The Expert Panel for Cosmetic Ingredient Safety (Panel) assessed the safety of Diacetone Alcohol as used in cosmetic formulations. This ingredient is reported to function as a fragrance ingredient and solvent. The Panel considered the available data and concluded that Diacetone Alcohol is safe in cosmetics in the present practices of use and concentration described in this safety assessment.
NikitakisJKowczA, eds. wINCI: International Cosmetic Ingredient Dictionary and Handbook. https://webdictionary.personalcarecouncil.org/jsp/Home.jsp. Washington, DC: Personal Care Products Council. Last Updated 2019. Accessed October 30, 2019.
The National Institute for Occupational Safety and Health (NIOSH). NIOSH pocket guide to chemical hazards: diacetone alcohol. https://www.cdc.gov/niosh/npg/npgd0178.html. Last Updated 2019. Accessed October 30, 2019.
6.
O'NeilMJHeckelmanPEDobbelaarPHRomanKJKennyCMKaraffaLS, eds. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals. 15th ed.New Jersey: The Royal Society of Chemistry; 2013.
ThotlaSAgarwalVMahajaniSM. Simultaneous production of diacetone alcohol and mesityl oxide from acetone using reactive distillation. Chem Eng Sci. 2007;62(18-20):5567-5574.
US Food and Drug Administration (FDA) Center for Food Safety & Applied Nutrition (CFSAN). Voluntary cosmetic registration program - frequency of use of cosmetic ingredients. Obtained under the Freedom of Information Act from CFSAN; requested as “Frequency of Use Data” January 4, 2021; recveid January 21, 2021; 2021.
11.
Personal Care Products Council. Concentration of use by FDA product category: diacetone alcohol. Unpublished data submitted to Personal Care Products Council on January 16, 2020; 2020.
SheftelVO. Indirect Food Additives and Polymers: Migration and Toxicology. 1st ed.Boca Raton, London: Lewis Publishers; 2000.
15.
FasanoWJMcDougalJN. In vitro dermal absorption rate testing of certain chemicals of interest to the Occupational Safety and Health Administration: summary and evaluation of USEPA's mandated testing. Regul Toxicol Pharmacol. 2008;51(2):181-194.
16.
SuttoT. Prioritization of the Oral (Ingestive) Hazard of Industrial Chemicals. Washington, DC: Naval Research Laboratory; 2011.
17.
World Health Organization and Food and Agriculture Organization of the United Nations. Safety Evaluation of Certain Food Additives and Contaminants Prepared by the Seventy-Third Meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Geneva, Switzerland; 2011. https://www.inchem.org/documents/jecfa/jecmono/v64je01.pdf. Accessed November 13, 2019.
18.
ButterworthSTGClarkDGRoderickHR. The Inhalation Toxicity of Diacetone Alcohol Following Six Week's Exposure to Rats. Group Research Report TLGR.80.029. London: Shell Research Limited; 1980.
19.
U.S. National library of medicine, TOXNET toxicology data network. CCRIS: 4-hydroxy-4-methyl-2-pentanone. https://toxnet.nlm.nih.gov/.Bethesda,Maryland. Last Updated 2009. Accessed November 13, 2019.
20.
BrooksTMMeyerALHutsonDH. The genetic toxicology of some hydrocarbon and oxygenated solvents. Mutagenesis. 1988;3(3):227-232.
21.
SeifriedHESeifriedRMClarkeJJJunghansTBSanRHC. A compilation of two decades of mutagenicity test results with the ames Salmonella typhimurium and L5178Y mouse lymphoma cell mutation assays. Chem Res Toxicol. 2006;19(5):627-644.
22.
BASF Corporation. Letter from BASF corp to US EPA RE: reporting of Health and safety information on dimethylacetamide, dimethylaniline, cyclohexanol, and diacetone alcohol with attachments, Dated 12/14/1995.
23.
ELF Atochem North America Inc., Centre International de Toxicologie. Skin sensitization test in Guinea pigs (maximization method of Magnusson, B. and Kligman, A.M.) of diacetone alcohol, with cover letter dated 1/27/1998. Submission to the U.S. Environmental Protection Agency.
24.
CarpenterCPSmythHF. Chemical burns of the rabbit cornea. Am J Ophthalmol. 1946;29(11):1363-1372.
25.
SilvermanLSchulteHFFirstWW. Further studies on sensory response to certain industrial solvent vapors. J Ind Hyg Toxicol. 1946;28(1):262-266.
26.
Occupational Safety and Health Administration (OSHA). OSHA occupational chemical database. Diacetone Alcohol (4-Hydroxy-4-Methyl-2-Pentanone). https://www.osha.gov/chemicaldata/chemResult.html?RecNo=176. Last Updated 2019. Accessed October 30, 2019.