United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-7-96-007
February 1996
R.E.D. FACTS
Pesticide
Reregistration
4,4-
Dimethyloxazolidine
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 reregistration, 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 reregistration, 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 the
chemical 4,4-dimethyloxazolidine, found in reregistration case 3095.
Use Profile
Regulatory
History
4,4-Dimethyloxazolidine is used as an antimicrobial to control
bacteria and fungi in oil recovery drilling muds, packer fluids, secondary oil
recovery injection water, adhesives, metal working cutting fluids, latex
paints, resin emulsions, wet-end additives and industrial processing
chemicals or in specialty industrial products. Formulations include soluble
concentrated solids and ready-to-use liquids. Products containing 4,4-
dimethyloxazolidine are added to systems and industrial products using
pouring and pumping methods. Product labeling restrictions include
National Pollutant Discharge Elimination System (NPDES) permit
requirements.
4,4-Dimethyloxazolidine was first registered as a pesticide in the U.S.
in 1982. In 1987 the Agency issued the Antimicrobial Data Call-In Notice
imposing subchronic toxicity and occupational exposure data requirements
for this and other antimicrobial chemicals. Another Data Call-In Notice
was issued in September 1992 for 4,4-dimethyloxazolidine requiring
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additional data in support of reregi strati on. Currently, there are six products
containing 4,4-dimethyloxazolidine that are eligible for reregi strati on.
Human Health Toxicity
Assessment In acute toxicity studies using laboratory animals, 4,4-
dimethyloxazolidine has been shown to be slightly toxic by the acute oral,
dermal and inhalation routes and has been placed in Toxicity Category III
(the second lowest of four categories) for these effects. 4,4-
Dimethyloxazolidine has been placed in Toxicity Category I (the highest of
four categories) for its effects as a severe eye irritant. 4,4-
Dimethyloxazolidine is not a skin sensitizer. The overall results of
mutagenicity studies with 4,4-dimethyloxazolidine suggest that
mutagenicity health hazards from its expected usage are minimal. 4,4-
Dimethyloxazolidine does not cause developmental effects.
Reproductive toxicity, metabolism, chronic toxicity, and
carcinogenicity studies are not required because there are no expected
chronic occupational/residential exposures, and the current use pattern
scenarios of 4,4-dimethyloxazolidine will not result in significant human
exposure over a significant portion of the human life span.
Dietary Exposure
Current uses of 4,4-dimethyloxazolidine do not include any food or
feed uses. Exposure through the diet therefore is not anticipated and a
dietary exposure and risk assessment is not necessary.
Occupational and Residential Exposure
While there are potential application and post-application exposures
from the use of 4,4-dimethyloxazolidine in commercial, industrial, and
residential settings, the Agency has decided that an occupational/residential
mixer/loader/applicator exposure analysis is not warranted at this time due
to the absence of toxicological endpoints of concern.
Human Risk Assessment
4,4-Dimethyloxazolidine is a severe eye irritant but otherwise is of
relatively low acute toxicity. This particular effect is most appropriately
addressed at the individual product level where formulation and dilution
affect the degree of irritation and necessity for eye protection. Long term
exposure effects are not of concern because use of 4,4-dimethyloxazolidine
does not result in significant exposure over the course of people's lives and
subchronic toxicological endpoints are not of concern. EPA has also
considered the potential hazard of exposure to formaldehyde as a degradate
of 4,4-dimethyloxazolidine. Post-application settings are addressed for
formaldehyde by the Occupational Safety and Health Administration.
OSHA has a comprehensive workplace standard for formaldehyde for the
protection of workers in the industrial setting due to formaldehyde-release
in the workplace.
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Environmental
Assessment
Environmental Fate
EPA requires only a hydrolysis study to characterize the
environmental fate of 4,4-dimethyloxazolidine, due to its current use
patterns. From the results of this study, 4,4-dimethyloxazolidine was found
to dissipate so rapidly that no degradation rate or half-life could be
determined. Only minor amounts of the parent 4,4-dimethyloxazolidine
were present soon after solution preparation. The hydrolysis products were
formaldehyde and 2-amino-2-methyl-l-propanol(AMP); AMP remained
stable throughout the length of the study (30 days).
Ecological Effects
4,4-Dimethyloxazolidine is slightly to moderately toxic to birds on an
acute basis and slightly toxic on a subacute basis. It demonstrates slight
toxicity to both cold and warm freshwater fish, and is slightly toxic to
freshwater invertebrates on an acute basis. Acute toxicity testing with
estuarine and marine organisms resulted in practically non-toxic effects on
estuarine fish and shrimp species, while moderate toxicity was observed
among eastern oysters.
Ecological Effects Risk Assessment
EPA requires only a limited set of ecotoxicology and environmental
fate studies for microbiocides. While the hazard to aquatic organisms from
4,4-dimethyloxazolidine has been characterized, a quantitative risk
assessment has not been conducted. The risks to aquatic environments from
these uses are regulated under the National Pollution Discharge Elimination
System (NPDES) permitting program of EPA's Office of Water. EPA does
not anticipate any exposure of concern to fish or wildlife, providing that all
4,4-dimethyloxazolidine products are handled and applied as specified in
the product labeling and discharges to the environment comply with all
federal disposal laws and the NPDES program.
Risk Mitigation
To protect handlers of 4,4-dimethyloxazolidine from potential eye
irritation hazards, end use products in Toxicity Categories I or II for eye
irritation potential must require use of protective eyewear on their labeling.
Other minimum work attire or personal protective equipment (PPE),
including use of a long-sleeved shirt, long pants, and socks and shoes
during application, is also required for all handlers of products containing
4,4-dimethyloxazolidine. General user safety requirements and
recommendations, application restrictions, and use directions must be
included on product labeling. NPDES statements also are required to
address potential environmental risks.
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Additional Data The Agency is requiring product-specific data including product
Required chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregi strati on.
Product Labeling
Changes Required
All 4,4-dimethyloxazolidine end-use products must comply with
EPA's current pesticide product labeling requirements and with the
following.
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain 4,4-
dimethyloxazolidine, 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 4,4-
dimethyloxazolidine, 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.
Minimum (Baseline) PPE/Engineering Control Requirements
Because of the lack of special toxicity endpoints of concern, EPA is
not requiring any active-ingredient-based PPE/engineering control beyond
the minimum (baseline) PPE/engineering control requirements for 4,4-
dimethyloxazolidine end-use products that are intended primarily for
occupational use. Any additional PPE for each 4,4-dimethyloxazolidine
occupational end-use product will be established on the basis of the end-use
product's acute toxicity. NOTE: All end-use products will be required to
specify a long-sleeved shirt, long pants, socks and shoes as minimum work
attire for all handlers. If the end-use product is classified as toxicity
Category I or II for eye irritation potential, protective eyewear is also
required.
Placement in Labeling
The personal protective equipment requirements must be placed on
the end-use product labeling in the location specified in PR Notice 93-7,
and the format and language of the PPE requirements must be the same as is
specified in PR Notice 93-7.
Other Labeling Requirements
The Agency is requiring the following precautionary labeling
statements to be located on all end-use products containing 4,4-
dimethyloxazolidine.
Application Restrictions
"Do not use this product in a way that will contact workers or other
persons."
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User safety requirements
If gloves and/or protective eyewear are required PPE for the use of the end-
use product, add:
"Follow manufacturers' instructions for cleaning/maintaining personal
protective equipment. If no such instructions for washables, use detergent
and hot water. Keep and wash personal protective equipment 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."
If gloves are required PPE for the use of the end-use product, add:
"Users should remove personal protective equipment
immediately after handling this product. Wash the outside of
gloves before removing. As soon as possible wash thoroughly."
Directions for Use
Registrants must specify on labeling the complete directions for use for
each use pattern: site of application, type of application, timing of
application, equipment used for application, and the rate of application
(dosage).
Effluent Discharge Labeling Statements
To reduce environmental risk from 4,4-dimethyloxazolidine discharge
and disposal, product labels must continue to have the statements pertaining
to effluent discharge under the National Pollutant Discharge Elimination
System (NPDES) permitting system (refer to PR Notice 93-10 or 40 CFR
152.46(a)(l)) and disposal under any applicable federal laws.
Regulatory
Conclusion
The use of currently registered products containing 4,4-
dimethyloxazolidine in accordance with labeling as required herein 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.
Products containing 4,4-dimethyloxazolidine will be reregistered once
EPA receives and accepts the required product-specific data, revised
Confidential Statements of Formula, and revised labeling.
For More
Information
EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for 4,4-dimethyloxazolidine 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
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of Pesticide Programs (OPP), US EPA, Washington, D.C. 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, GOPHEREPAGOV, or using ftp on FTP.EPAGOV, or using
WWW (World Wide Web) on WWW.EPAGOV.
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 4,4-dimethyloxazolidine 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 4,4-dimethyloxazolidine RED, or reregi strati on of individual products
containing 4,4-dimethyloxazolidine, please contact the Special Review and
Reregistration Division (7508W), OPP, US EPA, Washington, D.C. 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 a.m. and 7:30 p.m. Eastern Standard
Time, Monday through Friday.
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