United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-92-005
August 1992
R.E.D. FACTS
Pesticide
Registration
Use Profile
Alkyl Amine
Hydrochloride
All pesticides sold or used 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 undue hazards 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 Document, or RED. This fact
sheet summarizes the information in the RED for alkyl amine
hydrochloride.
Alkyl amine hydrochloride is an antimicrobial pesticide registered for
use as a self-sanitizer for floors and equipment and as a preservative in
paints and coatings. As a constituent of liquid floor wax, it inhibits the
further growth of bacteria when used in hospitals, laboratories, nursing
homes, commercial buildings and households. As an industrial
preservative, it prevents the growth of bacteria in paints, adhesives and
coatings. The pesticide products containing this active ingredient are used
only indoors.
Regulatory
History
Pesticide products containing alkyl amine hydrochloride were first
registered in September 1971. At present, three such products are
registered: one liquid floor wax containing only 0.063 percent of the active
ingredient, and two industrial preservatives used in paints and coatings
containing 21 . 2 and 25 percent of the active ingredient, respectively. Two
of these products contain alkyl amine hydrochloride as their only active
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ingredient; the third (an industrial preservative product) also contains
another active ingredient.
Human Health
Assessment
EPA has determined that only a minimal set of studies are needed to
assess the potential risks of alkyl amine hydrochloride because of its very
limited use as a pesticide, and since none of the uses result in residues in the
food supply.
Toxicity
Alkyl amine hydrochloride, per se, is corrosive to the eyes, skin and
lungs. It has been placed in Toxicity Category I (indicating the highest
degree of toxicity) for these effects.
In a subchronic dermal toxicity study in rats, inflammation of the skin
and increased adrenal weights were observed, but only at the highest dose
level. In a developmental toxicity study also in rats, no developmental
malformations or variations were observed. Some early fetal loss and
decreased fetal body weights were observed, however EPA does not
consider these effects to be of significant toxicological concern because the
Agency believes they were caused by toxicity to the mother.
Occupational Exposure
Workers may be exposed to alkyl amine hydrochloride when applying
the liquid floor wax product. However, since this product contains only
0.063 percent of the antimicrobial and is applied using a hand mop, only
low exposure is expected from this use. The current product labeling bears
the signal word "CAUTION," and notes that the product is harmful if
swallowed and may cause skin irritation. It does not recommend any
measures to reduce applicator exposure.
Workers may be exposed to greater amounts of alkyl amine
hydrochloride when handling or applying either of the two industrial
preservative products. These products contain relatively high concentrations
of alkyl amine hydrochloride (21.2 and 25 percent, respectively), and are
added during the formulation of paints and coatings. Product labeling
currently bears the signal word "DANGER," and the precautions:
"Concentrated solutions are corrosive and cause severe eye and skin
damage. Do not get in eyes, on skin or clothing. MAY BE FATAL
OR HARMFUL IF SWALLOWED. Precautions should include the
use of eye shields, long rubber gloves and a vapor respirator. Do not
breathe spray mist. Use with adequate ventilation. Wash thoroughly
after handling."
EPA believes that these label precautions are necessary to protect
mixers, loaders and applicators in the coatings industry, and is continuing
and strengthening them.
The concentration of alkyl amine hydrochloride in finished,
formulated paints and coatings is only about 0.038 to 0.16 percent. Thus,
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people applying these finished paints and coatings are exposed to only low
levels of the active ingredient.
Human Risk Assessment
EPA has reviewed data adequate to assess the potential human health
risks from the pesticide uses of alkyl amine hydrochloride. The Agency
believes that these uses should not result in any unreasonable risks to
workers, provided that the directions and precautions on product labels are
followed.
Environmental
Assessment
Environmental Risk Assessment
EPA did not perform an environmental risk assessment for alkyl
amine hydrochloride, since pesticide products containing this active
ingredient are used only indoors. Virtually no exposure to nontarget
organisms or the environment is expected to result from use of the
registered alkyl amine hydrochloride products. EPA is not requiring any
environmental fate studies or any additional ecological effects studies at this
time.
Product Labeling
Changes Required
Additional Data No additional generic data are required to support the reregi strati on of
Red UJ red alkyl amine hydrochloride. However, product-specific acute toxicity and
product chemistry studies are required.
The labels of the alkyl amine hydrochloride products must comply
with EPA's current pesticide labeling requirements. In addition, the
Precautionary Statements on all labels must include the warning, "Prolonged
or frequently repeated skin contact may cause allergic reactions in some
individuals."
Floor Wax Product
Directions for Use must include the statement, "Avoid contamination
of foods."
Industrial Preservative Products
Labels must carry the skull and crossbones along with the signal word,
"POISON."
Labels must continue to warn that, "Concentrated solutions are
corrosive and cause severe eye and skin damage," and must require the use
of eye shields, rubber gloves, a pesticide respirator and protective clothing.
In the Directions for Use, products labeled "For manufacturing use
only as a preservative" must delete the word "manufacturing."
Labels must include the following Environmental Hazards warning:
"This pesticide is toxic to fish and aquatic invertebrates. Do not
discharge effluent containing this product into lakes, streams, ponds,
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Regulatory
Conclusion
For More
Information
estuaries, oceans or public waters unless this product is specifically
identified and addressed in an NPDES permit. Do not discharge this
product into sewer systems without previously notifying the sewage
treatment plant authority. For guidance, contact your State Water
Board or Regional Office of U. S. EPA."
• The registered floor wax and industrial coatings uses of alkyl
amine hydrochloride are not likely to cause unreasonable adverse effects in
people or the environment, and are eligible for reregi strati on.
• The two registered products containing alkyl amine hydrochloride
as the sole active ingredient will be reregistered once product-specific data
and amended labeling are received and accepted by EPA.
• The third registered alkyl amine hydrochloride product will be
reregistered when such data and labeling are received and accepted by EPA,
and when its other active ingredient also is eligible for reregi strati on.
EPA is requesting public comments on the Reregi strati on Eligibility
Document (RED) for alkyl amine hydrochloride 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 or to submit written comments,
please contact the Public Response and Program Resources Branch, Field
Operations Division (7506C), Office of Pesticide Programs (OPP), US
EPA, Washington, DC 20460, telephone 703-305-5805.
In the future, the alkyl amine hydrochloride RED 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 alkyl amine hydrochloride or about
EPA's pesticide reregi strati on program, please contact the Special Review
and Reregistration Division (7508W), OPP, US EPA, Washington, DC
20460, telephone 703-308-8000. For information about reregi strati on of
individual alkyl amine hydrochloride products, please contact the
Registration Division (7505C), OPP, US EPA, Washington, DC 20460,
telephone 703-305-5447.
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, 24 hours a day, seven days a week, or Fax your
inquiry to 806-743-3094.
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