United States
                  Environmental Protection
                       Prevention, Pesticides
                       And Toxic Substances
April 1995
                  R.E.D.   FACTS
    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

                    shellacked surfaces.  Used solution should not be poured back into the
Human Health
      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
      The case aliphatic alcohols contains three other active ingredients—
methanol, propyl alcohol, and tert-butyl  alcohol—which are not being
supported for reregistration.

      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

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

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.

                         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.
  Product Labeling
Changes Required
            For More
                   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
                   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.

     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-
     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.