United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-96-027
December 1995
R.E.D. FACTS
ORTHO-BENZYL-P-
CHLOROPHENOL
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. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
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 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 2045, Ortho-benzyl-para-chlorophenol.
Ortho-benzyl-para-chlorophenol and its salts are used as
disinfectants/antimicrobials for controlling variety of bacteria, fungi, algae,
and viruses. The use sites include swimming pool water related surfaces
such as decks, and other hard surface areas surrounding swimming pools
refuse/solid waste sites, air washer water systems, evaporative condenser
water systems and industrial processing water, and commercial/industrial
water cooling systems.
Ortho-benzyl-para-chlorophenol and its salts are also used as
disinfectants for farm premises, poultry houses, food processing plants,
eating establishments, and federally inspected meat and poultry processing
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Regulatory
History
Human Health
Assessment
plants. Labeling for disinfectants registered for use in federally inspected
meat, poultry, and egg processing plants, as well as for phenolic-based
products used as disinfectants in food preparation, storage, and serving
establishments/areas, requires that food products and packaging materials
are removed or carefully covered prior to application and that a potable
water rinse is employed after treatment. Phenolic-based products
recommended for use as disinfectants on food contact surfaces in eating
establishments and homes are limited to sites such as counter tops, stoves,
and refrigerators, which followed by a potable water rinse would allow their
classification as a nonfood use. Application of these products as
disinfectants on eating utensils, glassware, and similar items would be
considered a food use and would require a tolerance or an exemption from
the requirements of a tolerance prior to approval, however specific label
directions are provided in Section V, of the RED document which result in
the classification of farm premise and poultry house disinfectants as non-
food use products.
Ortho-benzyl-para-chlorophenol, potassium and sodium 2-benzyl-4-
chlorophenate salts were first registered in the United States in 1948 as
disinfectants. They are currently registered as disinfectants, bacteriostats,
sanitizers and microbiocides. Additionally, the salts are currently registered
for use as tuberculocides, virucides and fungicides.
There are currently 143 products registered by the Environmental
Protection Agency containing ortho-benzyl-para-chlorophenol active
ingredients.
Toxicity
Ortho-benzyl-para-chlorophenol is Category III for acute oral and
dermal toxicity, and Category IV for acute inhalation toxicity. Ortho-
benzyl-para-chlorophenol is severely irritating to the eye (Category I), and
is corrosive with repeated contact to the skin. The requirement for a dermal
sensitization study was waived due to the corrosive nature of ortho-benzyl-
para-chlorophenol. In chronic studies, ortho-benzyl-para-chlorophenol
induces increases in kidney nephropathy and has been classified as a Group
C, possible human carcinogen. This was based on increases in renal tubule
combined adenomas/carcinomas in male B6C3F1 mouse and in renal
transitional cell carcinomas in female F344/N rat. However, renal tubular
carcinomas in the mouse and renal transitional cell tumors in the rat are
rare.
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Dietary Exposure
No dietary exposure is expected from the pesticide uses of ortho-
benzyl-para-chlorophenol since no food or feed uses are registered.
Ortho-benzyl-para-chlorophenol and its salts when registered for use
as sanitizers on food-processing equipment and utensils, and on other food-
contact articles are under the purview of FDA (21 CFR Part 178.1010 (20)).
EPA accepts FDA's approval and acceptance of the chemical(s) use pattern.
Occupational and Residential Exposure
The Agency has determined that regulatory action regarding the
establishment of active ingredient-based minimum PPE requirements for
occupational handlers must be taken for ortho-benzyl-para-chlorophenol.
The Chemical Manufacturers Association (CMA) exposure data used to
assess the risk resulting from three of the use-scenarios were based on the
handlers in these use-scenarios wearing chemical-resistant gloves.
Therefore, chemical-resistant gloves shall be required for occupational
handlers of ortho-benzyl-para-chlorophenol for the following use-scenarios:
mixing and pouring a soluble liquid, transferring (pumping) liquid, and
pouring powdered or flaked solid product. Since the chronic MOE for
hand-wiping (ungloved) was less than 300, chemical resistant gloves are
required to reduce/mitigate the potential risk to applicators. For exposures
related to indoor fogging applications, EPA is requiring the use of a full-
face canister-style respirator to mitigate ocular and inhalation concerns.
The high-pressure spray application use-scenario, which is an
intermediate exposure scenario, had an MOE of less than 100. The CMA
exposure data used to assess the risk from this use-scenario was based, in
some replicates, on the handlers wearing chemical-resistant gloves and
rainsuits, there are no additional PPE options available that would
adequately mitigate the risk. Furthermore, there are no practicable
engineering controls for this use-scenario. Due to uncertainties in the data
used to calculate exposure, the Agency will consider the high pressure
spray scenario conditionally acceptable until new exposure data are
available.
Human Risk Assessment
Since ortho-benzyl-para-chlorophenol has no food or feed uses,
dietary risk is not expected.
Environmental Fate
The Agency expects that the registered uses of ortho-benzyl-para-
chlorophenol should not result in significant exposure to the environment.
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Additional Data
Required
Product Labeling
Changes
Required
The environmental fate data indicated that the two salts rapidly degrade into
the acid in the environment. Therefore, the data supporting the acid also
can be used to support the potassium and sodium salts.
Ecological Effects Risk Assessment
The Agency requires only a limited set of ecotoxicology and
environmental fate studies for microbiocides. The chemical, ortho-benzyl-
para-chlorophenol, is nontoxic to birds and highly toxic to freshwater fish
and aquatic invertebrates. While the hazard to aquatic organisms from
ortho-benzyl-para-chlorophenol has been characterized, a quantitative risk
assessment has not been conducted. The risks to aquatic environments
from the uses of ortho-benzyl-para-chlorophenol are regulated under the
NPDES permitting program of the Office of Water. The Agency currently
requires that labels for all ortho-benzyl-para-chlorophenol products require
that discharges to aquatic environments comply with a NPDES permit.
Because terrestrial use of ortho-benzyl- para-chlorophenol and its
potassium and sodium salts is limited to refuse/solid waste sites, exposure
to wildlife is not expected to be significant.
EPA is requiring product-specific data including product chemistry
and information to upgrade the acute toxicity studies, and data to satisfy the
mammalian cells in culture forward gene mutation assay ( specifically a
mouse lymphoma assay, revised Confidential Statements of Formula
(CSFs), and revised labeling for reregi strati on of products containing
Ortho-benzyl-para-chlorophenol and its salts.
All end use products containing ortho-benzyl-para-chlorophenol and
it salts must comply with EPA's current pesticide product labeling
requirements.
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain ortho-
benzyl-para-chlorophenol, the product labeling must be revised to adopt the
handler personal protective equipment/engineering control requirements set
forth in this section. Any conflicting PPE requirements on the current
labeling must be removed.
For multiple-active-ingredient end-use products that contain ortho-
benzyl-para-chlorophenol, the handler personal protective
equipment/engineering control requirements set forth in this section must be
compared to the requirements on the current labeling and the more
protective must be retained. For guidance on which requirements are
considered more protective, see PR Notice 93-7.
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Minimum (Baseline) PPE/Engineering Control Requirements
EPA is establishing active-ingredient-based minimum (baseline)
PPE/engineering control requirements for ortho-benzyl-para-
chlorophenol end-use products that are intended primarily for
occupational use for the following use-scenarios: (1) mixing and
pouring soluble liquids, (2) transferring (pumping) liquids, (6) hand-
wiping, (7) pouring powdered or flaked formulations, and (8) applying
fogs to enclosed areas. The minimum (baseline) PPE for such
occupational uses of ortho-benzyl-para-chlorophenol end-use products
are:
"Applicators and other handlers must wear:
—long-sleeve shirt and long pants,
—socks plus shoes, and
—chemical-resistant gloves*.
"In addition, for applicators and other handlers exposed to the
fog during fogging applications and until the fog has dissipated
and the enclosed area has been thoroughly ventilated must wear:
—a full-face respirator with a canister approved for pesticides
(MSHA/NIOSH approval number prefix TC-14G)"
*For the glove statement, use the statement established for
ortho-benzyl-para-chlorophenol through the instructions in
Supplement Three of PR Notice 93-7.
EPA is not establishing active-ingredient-based minimum (baseline)
PPE for occupational handlers in the following use-scenarios: (4) low-
pressure spray, and (5) mopping (ungloved).
Regulatory
Conclusion
In addition, for a comprehensive list of labeling requirements, please
see the ortho-benzyl-para-chlorophenol RED document.
The use of currently registered products containing ortho-benzyl-para-
chlorophenol 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 reregi strati on.
Ortho-benzyl-para-chlorophenol products will be reregistered once
the required product-specific data, revised Confidential Statements of
Formula, and revised labeling are received and accepted by EPA.
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For More
Information
EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for ortho-benzyl-para-chlorophenol 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. 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 ortho-benzyl-para-chlorophenol
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 ortho-benzyl-para-chlorophenol RED, or reregi strati on of individual
products containing ortho-benzyl-para-chlorophenol and its salts, 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 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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