United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-94-028
September 1994
R.E.D. FACTS
Pesticide
Reregistration
Chloroxylenol
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 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 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 reregi strati on, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for reregi strati on
case 3045, chloroxylenol or chloro-m-xylenol.
Use Profile
Regulatory
History
Chloroxylenol is an antimicrobial used to control bacteria, algae and
fungi in adhesives, emulsions, paints and wash tanks. It also is used to
sanitize bathroom premises, diaper pails, laundry equipment, human bedding
and pet living quarters in households, hospitals and other institutions.
Formulations include a soluble concentrate/liquid (applied using a squirt
bottle) and a pressurized liquid (aerosol), as well as a technical formulation
and a formulation intermediate.
Use practice limitations include a prohibition against discharging
effluent containing the pesticide into lakes, streams, ponds, estuaries, oceans
or public waters unless specifically addressed in an NPDES permit, and a
warning not to discharge the pesticide to sewer systems without previously
notifying the sewage treatment plant authority.
Chloroxylenol was first registered as a pesticide in the U.S. in 1959, for
use as a fungicide. Products used as disinfectants and sanitizers have
subsequently been registered. EPA issued an antimicrobial Data Call-In
Notice in March 1987 to obtain chronic and subchronic toxicity data for the
chloroxylenol manufacturing use product. Technical chemistry data were
obtained through a Dioxin/Furan Data Call-In issued in 1988. Currently, two
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Physical
Chemistry
Assessment
Human Health
Assessment
manufacturing use products and five end use products containing this active
ingredient are registered.
EPA was concerned with the potential formation of dioxins and
chlorinated dioxin impurities during the manufacture of chloroxylenol, and
with the effect of these impurities on human health and the environment. The
Agency has required the registrant to fully satisfy technical chemistry data
requirements addressing this concern. These data have been submitted and do
not suggest that dioxins or chlorinated dioxin impurities are present in
technical chloroxylenol.
Toxicity
Chloroxylenol generally is of moderate to low acute toxicity, but causes
severe eye irritation and has been placed in Toxicity Category I (indicating
the greatest degree of acute toxicity) for eye irritation effects. Chloroxylenol
is of low acute toxicity via the inhalation route and causes only slight skin
irritation, so it has been placed in Toxicity Category IV (the lowest of four
categories) for these effects. It is slightly toxic by the oral and dermal routes,
and has been placed in Toxicity Category III for acute oral and dermal effects.
In a subchronic dermal study using rabbits, chloroxylenol caused
redness, toughness and cracking of the skin at the highest dose level. In a
developmental toxicity study using rats, chloroxylenol caused maternal effects
including decreased weight gain and food consumption. Deaths occurred at
the highest dose. The No Observed Effect Level was the highest dose
administered. Chloroxylenol is not mutagenic.
Dietary Exposure
Since no food or feed uses are registered, the Agency anticipates no
dietary exposure to chloroxylenol. A food additive tolerance has been
established by the Food and Drug Administration (FDA) allowing use of
chloroxylenol as a preservative in food packaging adhesives (please see 21
CFR 175.105(c)(5)). However the safety of that use is under FDA's
regulatory purview.
Occupational and Residential Exposure
Based on current use patterns, the potential dermal and inhalation
exposures to applicators, mixers and loaders may be significant when
chloroxylenol is applied as a medical disinfectant using spray application
methods, or as a preservative using the open pouring application method.
Secondary exposure of residents and others to chloroxylenol after application
of end-use products is significantly less than workers' exposure.
Human Risk Assessment
Since chloroxylenol is not applied to food or feed crops and is not used
in food handling establishments, no dietary risk is expected. FDA regulates
the use of this pesticide as a food packaging adhesive.
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Environmental
Assessment
Additional Data
Required
No toxicological endpoints of concern have been identified for
chloroxylenol except eye irritation. Personal protective equipment (PPE) may
be required for some end-use products on a case-by-case basis, but is not
required for all chloroxylenol products at this time.
Environmental Fate and Assessment
Chloroxylenol is hydrologically stable and is a weak acid. EPA does
not anticipate significant environmental exposure to this pesticide since it has
only one limited outdoor use, on pet living quarters.
Ecological Effects
Chloroxylenol's toxic effects range from low to high, depending on the
species. The pesticide is practically non-toxic to bobwhite quail on an acute
oral basis and to birds on a dietary basis. However, it is highly toxic to
freshwater fish and moderately toxic to aquatic invertebrates on an acute
basis. Plants and non-target insects are not expected to be exposed to
chloroxylenol since it is used mostly indoors.
Ecological Effects Risk Assessment
Chloroxylenol is practically non-toxic to birds, moderately toxic to
freshwater invertebrates and highly toxic to fish. However, exposure to
terrestrial and aquatic organisms is extremely minimal since chloroxylenol
has almost all indoor uses. The sole outdoor use, on pet living quarters, will
not result in significant environmental exposure. Therefore, when used
according to label directions, chloroxylenol poses only a minimal risk to
terrestrial and aquatic organisms.
No additional generic data for chloroxylenol is required at this time.
The Agency is requiring product-specific data including product chemistry
and acute toxicity studies, revised Confidential Statements of Formula (CSFs)
and revised labeling for reregi strati on.
Product Labeling
Changes Required
All chloroxylenol end-use products must comply with EPA's current
pesticide product labeling requirements, and with the following:
Products with the Outdoor Use - Products with the pet living quarters use
on their labeling must bear the following statement:
"This pesticide is toxic to fish. Do not apply directly to water. Do not
contaminate water when disposing of equipment wash waters or
rinsate."
Non-Residential Products with Indoor Nonfood and/or Medical Uses -
Must bear the following statement:
"This pesticide is toxic to fish. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans or other water
unless in accordance with the requirements of a National Pollutant
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Discharge Elimination System (NPDES) permit and the permitting
authority has been notified in writing prior to discharge. Do not
discharge this product to sewer systems without previously notifying the
local sewage treatment plant authority. For guidance contact your State
Water Board or Regional Office of the EPA."
Regulatory
Conclusion
All end-use products must specify their formulaton type and percent of active
ingredient on their labels.
The use of currently registered pesticide products containing
chloroxylenol in accordance with approved labeling is not expected to pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregi strati on.
For More
Information
Products containing chloroxylenol will be reregistered once the product-
specific data, revised Confidential Statements of Formula and revised labeling
are received and accepted by EPA. Products containing chloroxylenol and
other active ingredients will be reregistered only after the other active
ingredients also are eligible for reregi strati on.
EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for chloroxylenol 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 Reregi strati on Information System at
703-308-7224, and also can be reached on the Internet via FEDWORLD.GOV
and EPA's gopher sener, EARTHl.EPA.GOV.
Following the comment period, the chloroxylenol RED document 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
chloroxylenol RED, or reregi strati on of individual products containing
chloroxylenol, please contact the Special Review and Reregi strati on 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 6:00 pm Central Time, Monday
through Friday.
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