United States Prevention, Pesticides EPA 738-F-07-004
Environmental Protection and Toxic Substances June 2007
Agency (7508P)
&EPA Aliphatic Alcohols Facts
Pesticide Registration
All pesticides sold or distributed in the Unites States must be registered by the
Environmental Protection Agency (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 before November 1, 1984 be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregi strati on, EPA obtains and reviews a complete set
of studies from pesticide producers, describing the human health and environmental
effects of each pesticide. The Agency develops any mitigation measures or regulatory
controls needed to effectively reduce each pesticide's risks. EPA then reregisters
pesticide products that can be used without posing unreasonable risks to human health or
the environment.
When a pesticide is eligible for reregi strati on, EPA explains the basis for its
decision in a Reregi strati on Eligibility Decision (RED) document. This fact sheet
summarizes the information in the RED document for the aliphatic alcohols of case 4004.
Regulatory History and Uses
Reregi strati on case number 4004 consists of straight chain aliphatic alcohols with
6 to 16 carbon atoms in the chain, which has been abbreviated in previous documents as
aliphatic alcohols (Cx-Cxx) or (C6-C16). Currently, case 4004 consists of four active
ingredients. Three of these active ingredients are used as plant growth regulators on
tobacco. These are described as fatty alcohol blend (PC code 079029), 1-octanol
(079037) and 1-decanol (079038). The fatty alcohol blend under PC code 079029 is
predominantly a mixture of 1-octanol and 1-decanol, although some labels list 0.5% 1-
hexanol (C6) and 1.5 % dodecanol (C12) among the active ingredients. The single
product listed under PC code 079037, although listed as 1-octanol, is also in fact a
mixture of 1-octanol and 1-decanol. The earliest registered label for use of aliphatic
alcohols for tobacco sucker control included in the Agency's Pesticide Product Label
System (PPLS) was issued to Uniroyal in 1964.
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The fourth active ingredient in case 4004, 1-dodecanol (PC code 001509), was
first registered for use as a Lepidopteran pheromone/sex attractant in 1993. The potential
human health risks from 1-dodecanol were reassessed in 2002 by the Agency's
Biopesticides and Pollution Prevention Division (BPPD), as described in the document,
Tolerance Reassessment Decision Regarding Tolerance Exemption for the Biochemical
Lepidopteran Pheromones. July 26, 2002. The RED document describes the potential
ecological effects of the use of 1-dodecanol.
Other aliphatic alcohols are not assessed in the RED. The fatty alcohol product
included under PC code 079059 is not being supported, and will be voluntarily cancelled.
In April 1995, the Agency completed a RED for case number 4003 (Cl - C5), which
consists of aliphatic alcohols with only one to five carbons. The active ingredients
addressed in that assessment included ethanol (PC code 001501) and isopropanol (PC
code 047501).
Health Effects
The human health risk assessment incorporates potential exposure and risk from
all sources, which for aliphatic alcohols are limited. The uses of the aliphatic alcohols of
case 4004 do not involve use on food commodities.
The data base of submitted toxicity studies and published literature is sufficient to
assess the uses of the aliphatic alcohols. Currently, there is no known mode of
toxicological action for the aliphatic alcohols. Based on the low hazard concern via the
oral, dermal, and inhalation routes of exposure, toxicity endpoints were not established,
and a qualitative risk assessment was performed for the aliphatic alcohols.
The greatest potential for adverse effects from use of the aliphatic alcohols is the
potential for severe and sometimes non-reversible eye irritation, which was observed in
some eye-irritation studies. One of these primary eye irritation studies indicated that
aliphatic alcohols are characterized as Toxicity Category I for eye irritation.
Risks and Risk Mitigation
Human Health
There are no human health risks of concern for aliphatic alcohols. However, the
Agency is updating the Restricted Entry Interval (REI) and Personal Protective
Equipment (PPE) requirements for aliphatic alcohols. 1-Decanol, which is a component
of all the tobacco sucker control products in this case, is an acute Toxicity Category I eye
irritant; therefore, pursuant to the Worker Protection Standard (WPS) and according to
the OPPTS Label Review Manual 3rd Edition, products with agricultural uses must
require a 48 hour REI and the following PPE for early entry: coveralls, chemical-resistant
gloves made of any water proof material, shoes plus socks, and protective eyewear.
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Ecological
The risk assessment identified no exposure scenarios with aliphatic alcohols that
pose ecological risks of concern to the Agency. A number of guideline studies had not
been submitted for the aliphatic alcohols, but sufficient information was available to
allow the Agency to reach this conclusion. For instance, because environmental fate data
are not available, physical and chemical properties for the aliphatic alcohols were
estimated by Quantitative Structure-Activity Relationships (QSAR) using EPISuite v3.21
(Estimation Programs Interface for Windows (EPIWIN)). The main route of dissipation
for the aliphatic alcohols was determined to be volatilization; half-lives for volatility from
soil for 1-octanol and 1-decanol were estimated to be 3.5 minutes and 1 minute,
respectively. The volatility of the aliphatic alcohols was taken into consideration for
estimates of potential ecological concentrations which were compared to endpoints from
available ecotoxicity studies. Risk quotients calculated in this manner did not exceed the
Agency's levels-of-concern for non-endangered or endangered and threatened (listed)
species.
Some ecotoxicity data, such as chronic studies for estuarine fish and
invertebrates, and chronic toxicity to birds, were neither submitted to the Agency nor
available in the ECOTOX database. However, the volatility of the aliphatic alcohols
makes it unlikely that they would be available for transport in runoff if a significant rain
event did not occur within a few hours of application. The Agency does not expect a
chronic risk to birds because 1) the aliphatic alcohols are not acutely toxic to birds at
doses many times higher than expected exposure, 2) the volatility of the aliphatic
alcohols makes chronic exposure unlikely, with estimated environmental concentrations
dropping more than an order of magnitude within 30 minutes, 3) the aliphatic alcohols
assessed are listed as food additives and are "Generally Recognized as Safe" (GRAS) by
the U.S. Food and Drug Administration1, and 4) a mammalian chronic toxicity study
indicates the aliphatic alcohols are not chronically toxic to mammals. Based on these
conclusions, the Agency will not require missing chronic toxicity data at this time.
However, because the toxicity data are not available, the Agency cannot
completely preclude risk to listed birds and estuarine/marine animals at this time.
Similarly, since a no-effect level was not determined for aquatic plants, the Agency
cannot preclude direct effects on these organisms, although exposure is expected to be
negligible.
Data Requirements
The generic data base supporting the reregi strati on of aliphatic alcohols has been
reviewed and determined to be substantially complete. However, one data gap, the
UV/VIS Absorption study (Guideline 830.7050), remains. This study will be included in
the generic DCI for this RED, which the Agency intends to issue at a future date. In
addition, updated Confidential Statements of Formula (CSFs) are required.
1 http://vm.cfsan.fda.gov/~dms/ca.fiis.himl
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Regulatory Conclusion
The Agency has determined that products containing the aliphatic alcohols of case
4004 as active ingredients are eligible for reregi strati on provided that the risk mitigation
measures are adopted and labels are amended to reflect these measures.
For More Information
Electronic copies of the Aliphatic Alcohols RED and all supporting documents
are available in the public docket EPA-HQ-OPP-2007-0134 located on-line in the Federal
Docket management System (FDMC) at http://www.regulations.gov.
For more information about EPA's pesticide reregi strati on program, the Aliphatic
Alcohols RED, or reregi strati on of individual products containing aliphatic alcohols,
please contact the Special Review and Reregi strati on Division (7508P), Office of
Pesticide Programs, U.S. EPA, Washington, D.C. 20460, telephone 703-308-8000.
For information about the health affects of pesticides, of for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the National
Pesticide Information Center (NPIC). Call toll-free 1-800-858-7378, from 6:30 am to
4:30 pm Pacific Time, or 9:30 am to 7:30 pm Eastern Standard Time, seven days a week.
The NPIC internet address is httniZ/nEJ^orstedu.
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