United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-93-009
September 1993
R.E.D. FACTS
Pesticide
Reregistration
Lauryl Sulfate Salts
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 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 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 reregistration, EPA announces this and
explains why in a Reregistration Eligibility Decision (RED) document. This
fact sheet summarizes the information in the RED document for the case
Lauryl Sulfate Salts, which contains the active ingredient sodium lauryl
sulfate.
Use Profile
Regulatory
History
Sodium lauryl sulfate is used as a flea and tick repellant in one
registered pesticide product—a flea and tick shampoo for cats and dogs.
Sodium lauryl sulfate also is a widely used component of many non-
pesticidal consumer products currently marketed in the United States,
including shampoos and fruit juices.
The reregistration case Lauryl Sulfate Salts originally included four
active ingredients (sodium lauryl sulfate, magnesium lauryl sulfate,
ammonium lauryl sulfate, and triethanolamine lauryl sulfate). In May 1988,
EPA announced that these four active ingredients have no independent
pesticidal activity when included in antimicrobial products, and thus are
properly classified as inert ingredients in those products (please see 40 CFR
153.139). Therefore, the antimicrobial products that contain these active
ingredients are not subject to this RED.
Currently, only sodium lauryl sulfate has an active (end-use) pesticide
product registration, for a ready-to-use liquid pet shampoo called "Dr.
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Human Health and
Environmental
Assessment
Dogkatz Critter Chaser." EPA has not issued a Data Call-in (DCI)
requesting generic data on sodium lauryl sulfate prior to this RED.
The Food and Drug Administration (FDA) lists sodium lauryl sulfate
as a food additive, has exempted it from the requirement of a food additive
tolerance, and considers it Generally Recognized as Safe or GRAS (please
see 21 CFR 172.822). Its non-pesticidal uses far outnumber its one
pesticide use.
Sodium lauryl sulfate is among those pesticides for which EPA
believes a broadly reduced set of generic data requirements is appropriate
for reregistration. The Agency therefore has waived most generic data
requirements with the exception of studies that are considered essential,
including additional information about chemical purity and product
chemistry studies. In evaluating sodium lauryl sulfate's potential risks to
human health and the environment, EPA relied on information commonly
available in scientific literature.
Sodium lauryl sulfate is a detergent-like substance that employs a non-
toxic mode of action in controlling fleas and ticks on household pets. The
potential for dermal and/or inhalation exposure exists to people applying the
registered pet shampoo product. However, this exposure is not considered
significant and does not create a health risk concern. Published reports
suggest that sodium lauryl sulfate has low acute mammalian toxicity and no
known chronic effects. EPA has no reports of adverse effects resulting
from its use. Both exposure and health risks to people using the product are
expected to be low.
EPA also believes that since the pesticide is used only on pets,
negligible exposure to the environment and to nontarget organisms will
result. The Agency concludes that the registered product and use of sodium
lauryl sulfate should not result in unreasonable adverse effects to human
health or the environment.
Additional Data
Required
Although EPA has waived most generic studies, the Agency is
requiring additional details about the chemical characterization of the
sodium lauryl sulfate used in the formulated product. EPA also is requiring
product-specific data, including product chemistry, acute toxicity and
efficacy studies, as well as revised Confidential Statements of Formula and
revised labeling, for reregistration.
Product Labeling The label of the registered end-use pesticide product containing
Changes Required sodium lauryl sulfate must comply with EPA's current pesticide labeling
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Regulatory
Conclusion
For More
Information
requirements. In addition, labeling must specify which pets/animals may be
treated with the product.
Use of the registered pesticide product containing sodium lauryl
sulfate in accordance with approved labeling will not pose unreasonable
risks or adverse effects to humans or the environment. Therefore, all
current uses of the product are eligible for reregistration. This product will
be reregistered once the required physical chemistry data, product-specific
data, revised Confidential Statement of Formula and revised labeling are
received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for Lauryl Sulfate Salts 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.
Following the comment period, the Lauryl Sulfate Salts 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 reregistration program,
the Lauryl Sulfate Salts RED, or reregistration of the product containing
sodium lauryl sulfate, please contact the Special Review and Reregistration
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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