United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-97-016
January 1998
R.E.D. FACTS
Paranitrophenol
Pesticide
Reregistration
Use Profile
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 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. To implement
provisions of the Food Quality Protection Act of 1996, EPA considers the
special sensitivity of infants and children to pesticides, as well as aggregate
exposure of the public to pesticide residues from all sources, and the
cumulative effects of pesticides and other compounds with common
mechanisms of toxicity. The Agency develops any mitigation measures or
regulatory controls needed to effectively reduce each pesticide's risks. EPA
then reregisters pesticides that meet the safety standard of the FQPA and
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 Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregi strati on case 2465, Paranitrophenol.
Paranitrophenol, a nitrated benzene, is a nonfood use chemical that is
registered for use as a fungicide to control fungal mold on leather and
specialty industrial products used by the military. The treatment process is
for protection of military leather shoes, leather combat boots, and other
leather items while in storage in the field, and for specified cork insulations
on Air Force equipment. Paranitrophenol-treated cork is used in missile
silo construction. A single product containing 99.5% paranitrophenol,
formulated as a flaked solid, is registered.
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Regulatory
History
Human Health
Assessment
Paranitrophenol was first registered in the United States in 1963 as a
fungicide incorporated into leather products and hides as a preservative. A
second fungicidal product was registered in 1967. Both products contained
a second active ingredient, salicylanilide. However, the registrations for all
registered products containing salicylanilide as an active ingredient have
been canceled.
Currently, one pesticide product is registered containing
paranitrophenol as an active ingredient. This registration, granted in 1980,
is for use of paranitrophenol as a fungicide incorporated into leather for
military use, at a concentration not to exceed 0.7% on the basis of dry
finished leather weight. In 1983, this registration was amended to add use
of the product for incorporation into cork insulation for military use.
Toxicity
Paranitrophenol is a corrosive eye irritant (Toxicity Category I,
indicating the greatest degree of acute toxicity) and a potential dermal
irritant. Paranitrophenol is acutely toxic (Toxicity Category II) via the oral
route and moderately toxic (Toxicity Category III) via the dermal route.
A subchronic oral toxicity study in rats showed an increased
incidence of acute mortality, while a dermal study in mice resulted in
dermal irritation and mortality. Chronic toxicity has not been conclusively
evaluated. Paranitrophenol has been classified as Group D for
carcinogenicity, indicating that there is inadequate information to determine
its cancer potential.
Paranitrophenol is not believed to cause reproductive or
developmental toxicity, but additional studies are needed to confirm these
tentative findings. The data available on mutagenicity are not complete.
Additional toxicity studies or information are needed to support
reregi strati on of paranitrophenol. Required studies using the technical
active ingredient include: rat acute inhalation toxicity study (81-3); primary
dermal irritation study in rabbits (81-5); dermal sensitization potential study
in guinea pigs (81-6); rabbit developmental toxicity study (83-3b)
(exposure via dermal route is required); and in vivo bone marrow
cytogenetics assay (84-4). In addition, an acute inhalation toxicity study in
rats using the formulated end-use product at the minimum dilution specified
on product labels is required.
Dietary Exposure
No dietary exposure is expected from the pesticide uses of
paranitrophenol since no food or feed uses are registered.
Occupational and Residential Exposure
There is a potential for dermal and inhalation exposure to handlers
during usual paranitrophenol use patterns, that is, while treating leather or
cork for military use, or handling dry hides or cork to which
paranitrophenol has been added. Post-application exposure also may occur,
when working near a vat where paranitrophenol was added or while
wearing treated military boots or shoes.
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Environmental
Assessment
Risk Mitigation
and Regulatory
Conclusion
At this time, EPA lacks information about probable dermal and
inhalation exposures to primary and post-application handlers, and is unable
to assess worst-case risks to these workers. Exposure data for primary
handlers are required, as are acute inhalation toxicity data. Since
paranitrophenol is classified as Toxicity Category I for eye irritation
potential and since data on skin irritation potential are not available, the
Agency is imposing risk reduction measures including use of personal
protective equipment (chemical-resistant gloves and apron, and protective
eyewear) as well as a long sleeved shirt, long pants, shoes, and socks.
EPA believes that inhalation and ocular exposures for secondary
handlers are minimal, and that the risk from secondary post-application
exposure, wearing treated footwear, is not significant.
Human Risk Assessment
Paranitrophenol is corrosive to the eyes, is a potential skin irritant,
and its inhalation toxicity is not known. It is of relatively high acute
toxicity by the oral route. No food uses are registered so dietary risk is not
anticipated. However, based on reviews of the generic data, EPA has some
concerns about potential handler dermal and inhalation exposure during
treatment of leather and cork products for use by the military. Lacking
adequate exposure and toxicity data, the Agency is unable to conduct a
quantitative risk assessment. In order to assess the risk and support the
continued registration of paranitrophenol, additional acute toxicity,
developmental toxicity, and mutagenicity studies would be required. EPA
is requiring use of personal protective equipment to reduce possible eye and
skin exposures and risks to primary handlers of paranitrophenol.
FQPA Considerations
Paranitrophenol is not registered for food uses, nor is it available for
use by homeowners in residential settings. However, military personnel
could be exposed from wearing paranitrophenol-treated leather shoes or
boots. Developmental and reproduction studies do not indicate any pre-
natal effects, but these findings should be confirmed by an new rabbit
developmental study.
Paranitrophenol is slightly to moderately toxic to birds and aquatic
animals. Wild animals or plants are not likely to be exposed to
paranitrophenol, however, since it is not applied outside of a factory.
Paranitrophenol thus is not expected to pose a risk to nontarget organisms.
EPA's reregi strati on eligibility decision for paranitrophenol is to
accept its voluntary cancellation. All uses of the sole registered pesticide
product containing paranitrophenol will be voluntarily canceled as of
May 30, 2002.
A number of studies are needed to more fully assess the risks and
support the reregi strati on of paranitrophenol. EPA contacted the sole
registrant, the U.S. Department of the Army, about obtaining the necessary
data. Subsequently, EPA received a request from the Army to cancel the
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Product Labeling
Changes
Required
registration of the sole product containing paranitrophenol, effective May
30, 2002. In requesting cancellation, the registrant noted that there are no
supplies of paranitrophenol in stock; that the product would be used only in
a national security emergency situation; and that they would rely on
available alternative fungicides registered for use in treating leather and
cork products and would pursue efficacy testing of these alternative
products.
EPA has decided to accept the voluntary cancellation request because:
• The weight of evidence from all available toxicological data does not
suggest a potent threat to handlers and others from dermal and
inhalation exposure.
• Exposure to paranitrophenol is believed to be very limited. Its uses
are confined to leather and cork treatments applied by military
contractors to a few products used by the military. The worker
population exposed during treatment is likely to be small. The only
large population potentially exposed is military personnel wearing
treated footwear. EPA was able to quantitatively estimate their risk
and found it to be acceptably low, even using protective assumptions.
• During the five year phase-out period, workers using and handling
paranitrophenol solutions and freshly treated products are required to
wear chemical-resistant aprons and gloves.
Revised product label language is required to reflect the phase out
date, personal protective equipment requirements, and additional handler
safety requirements, as set forth in the RED document and summarized
below.
The paranitrophenol end-use product must comply with EPA's current
pesticide product labeling requirements and with the following. For a
comprehensive list of labeling requirements, please see Section V of the
paranitrophenol RED document.
H Personal Protective Equipment (PPE) Requirements
"Mixers, loaders, applicators and other handlers must wear:
— Long-sleeve shirt and long pants,
— Shoes plus socks,
— Protective eyewear,
— Chemical-resistant full front apron, with attached full
sleeve chemical resistant gloves."
Since this product is toxicity category II for acute inhalation toxicity,
a respirator requirement also must be added, based on the product's vapor
pressure.
In addition to the minimum PPE specified above, the following
specific PPE requirement must be added to labels:
"Handlers participating in hands-on operations, including introduction of
materials to and removal from the dip and handling leather or cork still wet
with the treatment, must wear chemical-resistant full-front aprons with
attached full-sleeve gloves."
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© Application Restrictions
"Do not use this product in a way that will contact workers or other
persons."
H Restrictions For Use Statement
"This product can not be used after May 30, 2002."
© User Safety Requirements
"Follow manufacturer" s instructions for cleaning/maintaining PPE. If no
such instructions for washables, use detergent and hot water. Keep and
wash PPE separately from other laundry."
© User Safety Recommendations
- "Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
- "Users should remove clothing immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing."
- "Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible wash
thoroughly."
For More EPA is requesting public comments on the Reregi strati on Eligibility
Information Decision (RED) document for paranitrophenol during a 60-day time period,
as announced in a Notice of Availability published in the Federal Register.
A notice announcing receipt of the voluntary cancellation request for the
only registered paranitrophenol product also will be published, and
comments may be submitted for a 30-day period. To obtain a copy of the
RED document or to submit written comments, please contact the Pesticide
Docket, Public Information and Records Integrity Branch, Information
Resources and Services Division (7502C), Office of Pesticide Programs
(OPP), EPA, Washington, DC 20460, telephone 703-305-5805.
Electronic copies of the RED and this fact sheet are available on the
Internet. See http://www.epa.gov/REDs.
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 1-
800-490-9198; fax 513-489-8695.
Following the comment period, the paranitrophenol 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 reregi strati on program,
the paranitrophenol RED, or reregi strati on of individual products containing
paranitrophenol, please contact the Special Review and Reregi strati on
Division (7508W), OPP, 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
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the National Pesticides Telecommunications Network (NPTN). 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.
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