United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-95-026
January 1996
R.E.D. FACTS
Pesticide
Reregistration
Sodium Omadine
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 Reregi strati on Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregi strati on case 209, sodium omadine.
Use Profile
Sodium omadine is a broad spectrum antimicrobial compound used as
a preservative in certain manufacturing materials and as additive in process
fluids which may otherwise be subject to deterioration through bacterial
and/or fungal growth. Sodium omadine may be used as a biocide in:
aqueous metalworking, cutting, cooling and lubricating fluids; latex
emulsions used in adhesives, caulks, patching compounds, sealants, pastes
and grouts; latex emulsions; aqueous fiber lubricants and inks; laundry rinse
additives and detergents; carpet cleaners and analytical and diagnostic
reagents. This RED did not address the use of sodium omadine as an in can
preservative of water based chemical or mineral add mixtures used in
concrete preparation, registered by the Agency on March 23, 1995.
Currently there are 5 registered products that contain from 3.6 to 40 percent
sodium omadine. All of these end-use products are formulated as liquid
soluble concentrates. There are no registered food uses.
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Regulatory
History
Human Health
Assessment
Sodium omadine was first registered in the United States in 1968 for
use as a biocide. The Registration Standard on sodium omadine (NTIS #
PB86-173929) was issued in July 1985, and required submission of product
chemistry, toxicology, ecotoxicity and environmental fate data. The 1987
Antimicrobial Data Call-In (DCI) required the submission of a variety of
subchronic and chronic toxicology and occupational exposure studies.
Toxicity
Sodium omadine caused slight erythema and edema in a dermal
irritation study using rabbits. Sodium omadine was found to be moderately
toxic by the dermal route (Toxicity Category II), slightly toxic by the oral
and inhalation routes (Toxicity Category III) and did not cause skin
sensitization in animals studies.
In a 90-day rat dermal toxicity study, there was no evidence of dose-
related dermal irritation. Dose related clinical signs seen in females
included emaciation, hunched posture, stiff hindlimbs, incoordination and
tremors. In a subchronic oral toxicity/neurotoxicity study, high dose rats
exhibited treatment related neurotoxic signs.
In a chronic toxicity study, clinical signs of toxicity noted in monkeys
administered sodium omadine by gavage included prostration, decreased
activity, emesis, thinness, weakness and cold extremities. Slight
hematologic changes were observed and were considered of minor
toxicologic importance.
In a rat oral carcinogenicity study, an increase in neoplasms was not
observed at any site. In a mouse dermal carcinogenicity study, application
of sodium omadine did not induce any benign or malignant neoplasms.
Although this study was found to be inadequate because the chemical was
not tested at a sufficiently high dose level, the Agency concluded that a new
study will not be required as long as the use patterns do not dramatically
change and the potential for human exposure remains low. Sodium
omadine has been classified as a Group D carcinogen based on the
insufficient weight of evidence regarding its cancer-causing potential.
In a developmental toxicity study in rabbits, there was no evidence of
maternal or fetal toxicity at any dose. In a two-generation reproduction
study, rats showed parental (skeletal muscle atrophy and decreased body
weight) and reproductive effects (slightly decreased number of pups per
litter, delayed development, decreased pup body weight and weight gain).
Sodium omadine was negative in three mutagenicity studies. Metabolism
studies indicated that it was rapidly absorbed, metabolized, and excreted at
all dosing levels tested.
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Dietary Exposure
No dietary exposure is expected from the pesticide uses of sodium
omadine since no food or feed uses are registered.
Occupational and Residential Exposure
Based on current use patterns, handlers may be exposed to sodium
omadine through dermal or inhalation routes from pouring and pumping of
sodium omadine in metal working fluids.
EPA has conducted exposure and risk assessments for workers
exposed to sodium omadine during pouring and pumping operations and
finds that margins of exposure (MOEs) for workers are greater than 100.
Thus, minimal risks are posed to workers during the pouring and pumping
of liquids that contain sodium omadine. The Agency has not evaluated
occupational risk to machinists because these worker's exposure is
regulated by the Occupational Safety Administration (OSHA). Available
information indicates that the amount of active ingredient (0.005 to 0.5%)
present in the oil used by machinists would most likely be even lower than
the amount to which handlers would be exposed. Therefore, exposure to
sodium omadine treated fluids would represent a lesser hazard to the
machinist than to handlers involved in pumping and pouring operations.
Sodium omadine is not registered for homeowner uses; therefore, risk
characterization of residential exposure is not required. The Agency,
however, believes that the amount of sodium omadine in products that may
enter the home or occupational setting such as laundry rinse additives,
detergents, carpet cleaners, emulsions and jet printer inks would be very
low due to dilution. For this reason, health risks to consumers from
exposure to products containing sodium omadine are also expected to be
very low.
Human Risk Assessment
Because sodium omadine is slightly to moderately acutely toxic, the
Agency is establishing active-ingredient-based minimum (baseline)
personal protective equipment (PPE) and engineering control requirements
(chemical resistant gloves) for end-use products that are intended primarily
for occupational use. All end-use product labels must also require, at a
minimum, that applicators and other mixer/loader handlers a wear long-
sleeve shirt, long pants and socks plus shoes. If the required eye irritation
study indicates that the end-use product is classified as toxicity category I
or II for eye irritation potential, protective eyewear is also required.
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Environmental
Assessment
Environmental Fate
Under normal environmental conditions, the hydrolytic half-life of
sodium omadine will likely be 23 days or longer. Photolysis is probably a
more important route of dissipation than hydrolysis. Photolytic half-lives of
40-126 minutes have been reported with irradiation by natural sunlight.
Ecological Effects
An acute oral toxicity study shows that sodium omadine is moderately
toxic to bobwhite quail. On a subacute dietary basis, sodium omadine has
been characterized as slightly toxic to mallard ducks and bobwhite quails.
Sodium omadine was found to be very highly toxic to rainbow trout,
bluegill sunfish and freshwater invertebrates.
Ecological Effects Risk Assessment
While the hazard to aquatic organisms from exposure to sodium
omadine has been characterized, a quantitative risk assessment has not been
conducted. The Office of Pesticide Programs has established a policy that
risks to aquatic environments from use of biocides such as sodium omadine
are best characterized and regulated under the NPDES permitting program
of EPA's Office of Water. All sodium omadine products are required to
state on their labels that discharges to aquatic environments must comply
with an NPDES permit.
Additional Data All generic data requirements have been satisfied for sodium
Required omadine. 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 sodium omadine end-use products must comply with EPA's
current pesticide product labeling requirements, and with the additional
requirements summarized below. Please see the RED document for the
complete text of these labeling requirements.
Effluent Discharge and Aquatic Hazard Labeling Statements:
"This pesticide is toxic to fish and aquatic invertebrates. Do not
discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or public waters unless in accordance with the
requirements of a National Pollutant Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment
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plant authority. For guidance contact your State Water Board or Regional
Office of the EPA."
"This pesticide is a chelating agent and should not be used with other
chelating agents or with chlorine."
Worker Protection Labeling Statements
•Minimum (Baseline) PPE/Engineering Control Requirements
For sole-active-ingredient end-use products that contain sodium
omadine, revise the product labeling to adopt these handler
PPE/engineering control requirements and remove any conflicting PPE
requirements.
For multiple-active-ingredient end-use products, compare these
handler PPE/engineering control requirements to those on current labeling
and retain the more protective. To determine which requirements are
considered more protective, see PR Notice 93-7.
The minimum (baseline) PPE for occupational uses of sodium
omadine end-use products is chemical-resistant gloves. (For the glove
statement, use the statement established for sodium omadine through the
instructions in Supplement Three of PR Notice 93-7). Please note: All
end-use product labels must also require, at a minimum, that applicators and
other mixer/loader handlers wear a long-sleeve shirt, long pants, and socks
plus shoes. If the end-use product is classified as toxicity category I or II
for eye irritation potential, protective eyewear is also required.
• Other Labeling Requirements for Occupational Use Products
Application Restrictions
"Do not apply this product in a way that will contact workers or other
persons."
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If
no such instructions exist 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."
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Regulatory
Conclusion
For More
Information
• "Users should remove PPE immediately after handling
this product. Wash the outside of gloves before
removing."
Application Method Timing and Equipment
All labeling must contain instructions stating when (i.e., as needed,
during manufacture, etc.) and how (i.e., pour from container, applied
through a closed delivery system, etc.) the preservative is added.
The use of currently registered products containing sodium omadine
in accordance with approved labeling will not pose unreasonable risks or
adverse effects to humans or the environment. Therefore, all uses of
sodium omadine registered prior to March 23, 1995, are eligible for
reregi strati on. (Uses registered on or after that date not included in this
RED).
Sodium omadine 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 Reregi strati on Eligibility
Decision (RED) document for sodium omadine 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 sodium omadine RED document
also will be available from the National Technical Information Service
(NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-
4650.
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For more information about EPA's pesticide reregi strati on program,
the sodium omadine RED, or reregi strati on of individual products
containing sodium omadine, 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 8:00 pm Eastern Standard
Time, Monday through Friday.
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