United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-012
April 1995
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
Aliphatic Alcohols
All pesticides sold or distributed in the United States must be
registered by EPA, based on scientific studies showing that they can be used
without posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for
reregistration case 4003, aliphatic alcohols, which contains the active
ingredients ethanol and isopropanol.
Aliphatic alcohols are registered for uses which include hard surface
treatment disinfectants, sanitizers, a sterilant, virucides, fungicides, and
mildewcides. Ethanol also is registered for use as a plant growth regulator
(a ripener), and is used with quaternary ammonium compounds in
swimming pool water systems. Isopropanol also is used in combination with
other pesticide active ingredients to kill fleas, ticks, and other household
insects. Both ethanol and isopropanol are well known substances and have a
wide range of human uses. For example, ethanol is contained in some
beverages, and isopropanol is the major ingredient in rubbing alcohol.
Aliphatic alcohols are applied as surface wipes, sprays, mop-on,
sponge-on, wipe-on or pour-on treatments, by immersion, and through
closed systems (for commercial/industrial water cooling systems).
Use practice limitations for ethanol include cautions not to use the
product on polished wood furniture or rayon fabrics, and not to get the
product on foods, drinks, feeds, or surfaces they may contact. Isopropanol
is not recommended for use on aluminum, should not be used on polished
wood furniture or rayon fabrics, and should not be sprayed on lacquered or
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shellacked surfaces. Used solution should not be poured back into the
bottle.
Regulatory
History
Human Health
Assessment
Aliphatic alcohols were first registered as indoor disinfectants in the
U.S. as early as 1948. Currently, 73 ethanol and 67 isopropanol pesticide
products are registered. Ethanol and isopropanol are considered inert
ingredients in some pesticide formulations; a determination is made on a
case-by-case basis.
Historically, aliphatic alcohols have been regulated both as pesticides
under EPA's jurisdiction and as devices under the Food and Drug
Administration (FDA)'s purview. This regulatory burden has been reduced
by a 1993/94 Memorandum of Understanding (MOU) which divides liquid
chemical germicides into two categories: sterilants (which FDA will
regulate) and general purpose disinfectants (which EPA will regulate). Both
Agencies will continue to have jurisdiction over all liquid chemical
germicides until rulemaking has been completed, but product performance
and efficacy data need only be reviewed by the Agency with primary
jurisdiction.
The case aliphatic alcohols contains three other active ingredients—
methanol, propyl alcohol, and tert-butyl alcohol—which are not being
supported for reregistration.
Toxicity
In studies using laboratory animals, aliphatic alcohols have been
shown to be of low acute toxicity. Ethanol has been placed in Toxicity
Category IV (indicating the lowest degree of acute toxicity) for all effects
tested including acute oral and inhalation toxicity, and primary eye and skin
irritation. Isopropanol also has been placed in Toxicity Category IV for all
effects except acute oral toxicity, for which it is placed in Toxicity Category
III. In an acute neurotoxicity study using rats, isopropanol vapors caused
decreased motor activity and effects on nervous system functions at the
higher dose levels.
In a subchronic toxicity study using rats, ethanol caused decreased
body weights and fatty degeneration in the livers of treated animals. In a
study using human volunteers, ethanol-saturated patches caused skin
irritation at 19-21 days of exposure. An inhalation study using rats, guinea
pigs, rabbits, monkeys, and dogs resulted in no signs of toxicity.
In a subchronic inhalation study using rats and mice, isopropanol
caused some clinical signs including ataxia, narcosis, hypoactivity, and lack
of startle response, as well as kidney lesions. In a subchronic inhalation
study using rats, no treatment-related changes were noted but motor activity
was increased at the highest dose level.
In a chronic toxicity study using rats, ethanol caused decreased mean
body weights, decreased activity, and impaired maze learning ability. In a
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Environmental
Assessment
chronic dermal toxicity study, no treatment-related effects were noted. Two
similar studies with isopropanol caused similar results.
EPA's review of the scientific literature indicates that carcinogenic
effects are not expected from the uses of ethanol. In a carcinogenicity study
using rats, isopropanol caused an increased incidence of granular kidneys,
thickened stomachs, and kidney lesions. A second study using mice also
caused increased incidence of stomach and kidney lesions, which were
determined not to be of biological significance.
Ethanol is generally recognized as a human developmental
neurotoxicant, causing Fetal Alcohol Syndrome in the offspring of mothers
who chronically consume high amounts of ethyl alcohol. However, the risk
in an industrial environment appears to be minimal.
Developmental toxicity studies using rats and rabbits show that
isopropanol causes reduced fetal body weights, decreased maternal body
weights, and increases in liver or kidney weights.
Ethanol was negative for mutagenicity effects in six out of seven
studies, while isopropanol was negative in all three studies available.
Dietary Exposure
Dietary exposure is not expected to result from the approved uses of
ethanol and isopropanol, including the plant regulator (ripener) use.
Occupational and Residential Exposure
Use of aliphatic alcohols may result in high dermal and inhalation
exposure of mixers, loaders and applicators, especially when power sprays
are used. However, the risk from exposure to these active ingredients is
considered to be incidental, considering the frequent intentional human
exposures to these substances.
Human Risk Assessment
Aliphatic alcohols are of low acute toxicity. No dietary exposure is
expected from their use as pesticides. EPA does not expect developmental
or reproductive effects to occur from the potential dermal and inhalation
exposures that may result from the registered pesticidal uses of ethanol and
isopropanol.
Environmental Fate
Aliphatic alcohols are organic chemical compounds. They are
flammable liquids and are highly soluble in water and many organic
solvents. Highly volatile liquids, they are stable in water under typical use
conditions. EPA does not anticipate significant exposure to the environment
from their uses.
Ecological Effects
Ethanol and isopropanol are practically non-toxic to mammals, fish,
and aquatic invertebrates.
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Ecological Effects Risk Assessment
Aliphatic alcohols are practically non-toxic to all species tested. They
are used primarily indoors. Both are highly volatile. Exposure to
terrestrial organisms would be extremely minimal.
Additional Data EPA is requiring product-specific data including product chemistry,
acute toxicity, and efficacy studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregistration.
Required
Product Labeling
Changes Required
Regulatory
Conclusion
For More
Information
All aliphatic alcohol end-use products must comply with EPA's
current pesticide product labeling requirements. In addition, the following
statement must be added to the label of each product, except sterilant
products, that is registered for treatment of any medical device or medical
equipment surface:
"This product is not to be used as a terminal sterilant/high level
disinfectant on any surface or instrument that (1) is introduced directly
into the human body, either into or in contact with the bloodstream or
normally sterile areas of the body, or (2) contacts intact mucous
membranes but which does not ordinarily penetrate the blood barrier
or otherwise enter normally sterile areas of the body. This product
may be used to preclean or decontaminate critical or semi-critical
medical devices prior to sterilization or high level disinfection."
The use of currently registered products containing aliphatic alcohols
(ethanol and isopropanol) in accordance with approved labeling will not
pose unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration.
Aliphatic alcohol products will be reregistered once the required
product-specific data, revised Confidential Statements of Formula, and
revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for aliphatic alcohols during a 60-day time
period, as announced in a Notice of Availability published in the Federal
Register. To obtain a copy of the RED document or to submit written
comments, please contact the Pesticide Docket, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System at
703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
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Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the aliphatic alcohols RED document
also will be available from the National Technical Information Service
(NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-
4650.
For more information about EPA's pesticide reregistration program,
the aliphatic alcohols RED, or reregistration of individual products
containing aliphatic alcohols, please contact the Special Review and
Reregistration Division (7508W), OPP, US EPA, Washington, DC 20460,
telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 8:00 am and 8:00 pm Eastern Standard
Time, Monday through Friday.
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