U.S. Environmental Protection Agency
Hazard Characterization Document
December, 2009
Acetone (CASRN 67-64-1)
The High Production Volume (HPV) Challenge Program1 was conceived as a voluntary
initiative aimed at developing and making publicly available screening-level health and
environmental effects information on chemicals manufactured in or imported into the United
States in quantities greater than one million pounds per year. In the Challenge Program,
producers and importers of HPV chemicals voluntarily sponsored chemicals; sponsorship
entailed the identification and initial assessment of the adequacy of existing toxicity
data/information, conducting new testing if adequate data did not exist, and making both new
and existing data and information available to the public. Each complete data submission
contains data on 18 internationally agreed to "SIDS" (Screening Information Data Set1'2)
endpoints that are screening-level indicators of potential hazards (toxicity) for humans or the
The Environmental Protection Agency's Office of Pollution Prevention and Toxics (OPPT) is
evaluating the data submitted in the HPV Challenge Program on approximately 1400 sponsored
chemicals by developing hazard characterizations (HCs). These HCs consist of an evaluation of
the quality and completeness of the data set provided in the Challenge Program submissions.
They are not intended to be definitive statements regarding the possibility of unreasonable risk of
injury to health or the environment.
The evaluation is performed according to established EPA guidance2'3 and is based primarily on
hazard data provided by sponsors; however, in preparing the hazard characterization, EPA
considered its own comments and public comments on the original submission as well as the
sponsor's responses to comments and revisions made to the submission. In order to determine
whether any new hazard information was developed since the time of the HPV submission, a
search of the following databases was made from one year prior to the date of the HPV
Challenge or OECD HPV submission to the present: (ChemID to locate available data sources
including Medline/PubMed, Toxline, HSDB, IRIS, NTP, AT SDR, IARC, EXTOXNET, EPA
SRS, etc.), STN/CAS online databases (Registry file for locators, ChemAbs for toxicology data,
RTECS, Merck, etc.) and Science Direct. OPPT's focus on these specific sources is based on
their being of high quality, highly relevant to hazard characterization, and publicly available.
OPPT does not develop HCs for those HPV chemicals which have already been assessed
internationally through the HPV program of the Organization for Economic Cooperation and
Development (OECD) and for which Screening Initial Data Set (SIDS) Initial Assessment
Reports (SIAR) and SIDS Initial Assessment Profiles (SIAP) are available. These documents are
presented in an international forum that involves review and endorsement by governmental
authorities around the world. OPPT is an active participant in these meetings and accepts these
documents as reliable screening-level hazard assessments.
1	U.S. EPA. High Production Volume (HPV) Challenge Program; http://www.epa.gov/chemrtk/index.htm.
2	U.S. EPA. HPV Challenge Program - Information Sources; http://www.epa.gov/chemrtk/pubs/general/guidocs.htm.
3	U.S. EPA. Risk Assessment Guidelines; http://cfpub.epa.gov/ncea/raf/rafguid.cfm.

U.S. Environmental Protection Agency
Hazard Characterization Document
December, 2009
These hazard characterizations are technical documents intended to inform subsequent decisions
and actions by OPPT. Accordingly, the documents are not written with the goal of informing the
general public. However, they do provide a vehicle for public access to a concise assessment of
the raw technical data on HPV chemicals and provide information previously not readily
available to the public.

U.S. Environmental Protection Agency
Hazard Characterization Document
December, 2009
Chemical Abstract Service
Registry Number
Chemical Abstract Index
Structural Formula
Acetone (CASRN 67-64-1) is a liquid with high water solubility and high vapor pressure. It is
expected to possess high mobility in soil. CASRN 67-64-1 is readily biodegradable. The rate of
volatilization is considered moderate. The rate of hydrolysis is considered negligible. The rate of
atmospheric photooxidation is negligible. Bioconcentration factors (BCF) of 0.65 is low. CASRN
67-64-1 is expected to have low persistence (PI) and low bioaccumulation potential (Bl).
The acute toxicity of CASRN 67-64-1 in rats by the oral and inhalation routes is low. CASRN
67-64-1 is not a skin irritant in rabbits or a skin sensitizer in mice, but it is a severe eye irritant in
rabbits. Thirteen week repeated-dose oral toxicity studies have been conducted in mice and rats.
Male rats appeared to be the most sensitive species, with the kidney, hematological system, and
testes identified as target organs. The LOAEL for systemic toxicity is 1,700 mg/kg-day based on
mild nephropathy in males; the NOAEL is 900 mg/kg-day. No studies specifically addressing
reproductive toxicity were available, however, data from a repeated-dose toxicity study
conducted in rats via drinking water showed increases in relative testicular weight, reduced
sperm motility, decreases in caudal and epididymal weights, and increases in abnormal sperm at
3,400 mg/kg-day. There are no prenatal developmental toxicity studies following oral exposures
to CASRN 67-64-1. Prenatal developmental toxicity studies via the inhalation route in rats and
mice indicated that reduced fetal body weight is the most consistent effect observed at 6,600 ppm
(approximately 15 mg/L) in mice and 11,000 ppm (approximately 26 mg/L) in rats. The
NOAEC for developmental toxicity in both rats and mice is 2,200 ppm (approximately 5mg/L).
No signs of maternal toxicity were reported in rats. The NOAEC for maternal toxicity in rats is
11,000 ppm (approximately 26 mg/L). Signs of maternal toxicity in mice observed at 6,600 ppm
(approximately 15 mg/L) consisted of statistically significant increases in absolute and relative
liver weights, which may be indicative of enzyme induction. The NOAEC for maternal toxicity
in mice is 2,200 ppm (approximately 5 mg/L). CASRN 67-64-1 did not induce gene mutations
or chromosomal aberrations when tested in vitro. Although a chronic bioassay has not been
conducted for oral or inhalation exposure routes, CASRN 67-64-1 has frequently been used as a
solvent or vehicle control to dissolve test chemicals in dermal animal studies with no evidence of
increased tumor incidence. Human data on CASRN 67-64-1 are available, however, according
to the 2003 IRIS assessment, human data by the oral and inhalation routes were considered
inadequate for use in generation of an RfC or RfD.
The acute 96-hour LC50 for CASRN 67-64-1 to fish ranges from 6,070 mg/L to 15,000 mg/L and
the EC50 for aquatic invertebrates ranges from 2,100 mg/L to 16,700 mg/L. The NOECs for
CASRN 67-64-1 to aquatic plants range from 5,400 to 7,500 mg/L.
No data gaps were identified for SIPS endpoints.	

U.S. Environmental Protection Agency
Hazard Characterization Document
December, 2009
The sponsor country, the USA, presented the SIDS documents at the OECD SIAM 7 during June
29-30, 1999. The SIAR, SIAP and Dossier were finalized by OECD and published by the UNEP
in July 1999 (http://www.chem.unep.ch/irptc/sids/oecdsids/67641.pdf). This hazard
characterization includes the May 2003 IRIS assessment
(http://www.epa.gov/ncea/iris/toxreviews/0128-tr.pdf). SIDS documents, and any relevant
studies obtained through EPA's literature search.
1.	Chemical Identity
1.1	Identification and Purity
See identification and purity information at:
1.2	Physical-Chemical Properties
See physical-chemical properties at:
2.	General Information on Exposure
2.1	Production Volume and Use Pattern
CASRN 67-64-1 had an aggregated production and/or import volume in the United States of 1
billion pounds and greater during calendar year 2005.
Non-confidential information in the IUR indicated that the industrial processing and uses of the
chemical include intermediates, solvents (for cleaning or degreasing), solvents (which become
part of product formulation or mixture), solvents (for chemical manufacture and processing and
are not part of product at greater than 1% by weight), and other. Non-confidential commercial
and consumer uses of this chemical include artists supplies, paints and coatings, photographic
supplies, rubber and plastic products, and other.
2.2	Environmental Exposure and Fate
See environmental exposure and fate data at:
3.	Human Health Hazard
See human health hazard data at http://www.chem.unep.ch/irptc/sids/oecdsids/67641 .pdf. The
U.S. EPA evaluated acetone in 2003 for the IRIS program and the assessment is available at:

U.S. Environmental Protection Agency
Hazard Characterization Document
December, 2009
4. Hazard to the Environment
See environmental hazard data at: