Document ID: EPA-HQ-OPP-2007-1039-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-12-12T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

 OFFICE OF

                                                                        
                                    PREVENTION, PESTICIDES AND 

         TOXIC SUBSTANCES

November 27, 2007

MEMORANDUM

SUBJECT:	Summary of Product Chemistry, Environmental Fate and
Ecotoxicity Data for the Alkyl Amine Hydrochloride Registration Review
Decision Document.

	PC Code: 069152		Case No.: 3051

			CAS No.: 91745-52-7		DP Barcode: 342130

FROM:	Srinivas Gowda, Microbiologist/Chemist

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

TO:			Mark Hartman, Branch Chief

Diane Isbell, Team Leader

Heather Garvie, Chemical Review Manager

Regulatory Management Branch II

Antimicrobials Division (7510P)

THRU:	Siroos Mostaghimi, Team Leader, Team one

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Norman Cook, Branch Chief

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Attached is the summary of available Product Chemistry, Environmental
Fate and 

Ecotoxicity Data to support the registration review of the fungicide
Alkyl Amine Hydrochloride.

ALKYL AMINE HYDROCHLORIDE

REGISTRATION REVIEW DECISION

PRODUCT CHEMISTY, ENVIRONMENTAL FATE AND

 ECOLOGICAL EFFECTS SUMMARY

PC Code:  069152; Case No. 3051

Introduction

	The first product containing alkyl amine hydrochloride was registered
with EPA on September 1971.  Presently, there are two active products
under a single PC Code 069152, which are listed in Table 1.  There are
no inert products.  A RED was issued in August 1992.  Alkyl amine
hydrochloride is registered for use primarily as a bacteriostat and
fungicide in materials including; resins, paints, adhesives, printing
inks and dispersed colors, caulks, spackling, joint cements, sealants,
grouts, and wallboard compounds.

	There are no direct food or feed uses of Alkyl Amine Hydrochloride,
therefore, EPA has not established tolerances or exemptions from
tolerances in raw agricultural commodities or processed food and feed
products under the Federal Food, Drug and Cosmetic Act (FFDCA).

Table 1.  Registered Active Products of Alkyl Amine Hydrochloride

EPA Reg. No.	

Product Name	

Formulation Type	

Percent Active Ingredient	

Registrant

1529-29

	

NUOSEPT 635-W

PRESERVATIVE

	

MUP	

25%	

International Specialty Products

1529-30

	

FUNGITROL

158 FUNGICIDE

	

MUP	

21.22%	

International Specialty Products

Chemical Identification

Table 2 Chemical Identity 

Common Name 	Alkyl* amine hydrochloride *(as in fatty acids of coconut
oil)

Chemical Name	Amines, coco alkyl, hydrochlorides

Molecular Weight	221.82

PC Code 	069152

CAS Registry Number	91745-52-7

Empirical Formula	C12H27NHCl

Registration Review Case No.	3051 (Coco alkyl)amine salts

Chemical Structure:

Use Pattern

Bacteriostat, Fungicide

Materials Preservatives

Resins

Paints

Adhesives

Printing inks and dispersed colors

Caulks

Spackling

Ready mix joint cements

Sealants

Grouts

Ready-mix wallboard compounds

Science Findings

	The Agency has conducted a review of the available product chemistry,
environmental fate, and ecotoxicity data for alkyl amine hydrochloride. 
The findings are summarized below. 

Product Chemistry Summary

All product chemistry data requirements have been fulfilled for the
active ingredient Alkyl Amine Hydrochloride.  See Table 3.

Table 3.  Product Chemistry Data Summary for Alkyl Amine Hydrochloride

Guideline Number

	Requirement	Status1	Results

830.1550	Product identity and composition	A	Refer to Table 2

830.1600	Description of materials used to produce the product	A	CBI

830.1620	Description of production process	A	CBI

830.1650	Description of formulation process	A	CBI

830.1670	Discussion of formation of impurities	A	CBI

830.1700	Preliminary analysis	A	CBI

830.1750	Certified limits	A	CBI

830.1800	Enforcement analytical method	A	High Performance Liquid
Chromatography (HPLC)

830.1900	Submittal of samples	N/A

	830.6302	Color	A	Straw yellow (25% a.i.)

White solid (100% a.i.)

830.6303	Physical State	A	Clear, yellow liquid (25% a.i.)

White powder (100% a.i.)

830.6304	Odor	A	Mild, characteristic

830.6313	Stability to sunlight, normal and elevated temperature,
metals/metal ions	A	Stable (25%)

Stable (100% a.i.) when stored for 14 days under the following
conditions: ambient temperature (~23°C); elevated temperature (~54°C);
simulated sunlight; mixed with metals

(stainless steel, galvanized steel, copper, and

aluminum); and mixed with metal ions (iron,

zinc, and aluminum). Marginally stable when

stored for 14 days with copper ion. 

830.6314	Oxidation/Reduction: Chemical Incompatibility	N/A

	830.6315	Flammability	A	64.5 ± 3(d) °C (25% a.i.)

830.6316	Explodability	A	Not explodable

830.6317	Storage Stability	A	No loss of active ingredient after 31 days
of storage at 54°C (25% a.i.)

No loss of active ingredient during 12 month storage period at 21.9 ±
1.6°C (25% a.i.)

830.6320	Corrosion Characteristic	A	No signs of corrosion after 31 days
at elevated temperature of 54°C (25% a.i.)

No signs of corrosion were evident in the

container after 12 months at ~ 22°C (25% a.i.)

830.6321	Dielectric breakdown voltage	N/A

	830.7000	pH (1% aqueous solution)	A	6.31 (25% a.i.)

830.7050	UV/Visible absorption	N/A

	830.7100	Viscosity	A	14 ± 0.1 (d)cSt at 25°C

830.7200	Melting Point	A	N/A (25% a.i.)

164 - 170°C (100% a.i.)

830.7220	Boiling point	A	101.4 °C (25% a.i.)

830.7300	Density	A	0.975 g/cm3 (25% a.i.)

830.7370	Dissociation Constants in water (pKa)	A	2.3 ± 0.2 (pKa) (25%
a.i.)

830.7550	Octanol/water partition coefficient	A	log 1.05 ± 1.15 (25%
a.i.)

830.7840	Water solubility (25°C)(g/100ml)	A	Soluble in water (25% a.i.)

44.5 (100% a.i)

830-xxxx	Solubility in organic solvents (g/100mL)	A	Octanol: 4.67 ±
0.07(s) g/100 mL (100% a.i.)

Acetonitrile: 139 ± 5(s) ppm (100% a.i.)

Soluble in low molecular weight alcohols, esters, ketones, & glycol
derivatives (25% a.i.)

830.7950	Vapor pressure (20°C)	A	1 x 10-5 mm Hg (25% a.i.)

Other Physical/Chemical Properties

Classification of a.i.

Amine

Fatty acid salt

	Fatty acids of coconut oil

5.0% Caprylyl,

7.0% Capryl,

56.0% Lauryl,

18.0% Myristyl,

7.0% Palrnityl,

5.0% Stearyl,

2.0% Linoleyl (Source: Product Label)

	Henry's Law Constant 

1.59E-011 atm-m3/mole at 25°C (EPI Suite)

	Log Kow   

1.85 (Source: EPI Suite)

	Koc

1.5E+004 (Source: EPI Suite)

	Ready Biodegradability

Yes (Source: EPI Suite)

	Estimated Log BCF

1.850  (BCF = 70.79) (Source: EPI Suite)

1A = Acceptable; N/A = Not applicable.

 Environmental Fate Summary

The Agency has no environmental fate data on alkyl amine hydrochloride. 
The Agency did not perform an environmental risk assessment for alkyl
amine hydrochloride, since pesticide products containing this active
ingredient are used only indoors.  Alkyl amine hydrochloride is a
mixture of closely related compounds of the general class of quaternary
amines.  Diluted in water, it is expected to remain stable to hydrolysis
and degradation over the short term.  In time, the compound would be
expected to undergo microbial metabolism, yielding such metabolites as
ammonia, chloride, short(er) chain fatty acids, and finally CO2.  The
use is limited to the inside of buildings which restricts its presence
from exterior environments.  Virtually no exposure to nontarget
organisms or the environment is expected to result from use of the
registered alkyl amine hydrochloride products.  For this reason, the
Agency is not requiring any environmental fate studies or any additional
ecological effects studies at this time.  The only environmental fate
data the Agency would ordinarily ask for is hydrolysis, which is
required for all registered pesticides regardless of the use pattern.  
However, in this case, a thirty-day hydro1ysis study would not likely
yield any useful information, since little or no hydrolysis would be
expected to take place.

Ecological Effects Summary

No risk assessment was performed for alkyl amine hydrochloride.  The
Agency has reviewed four basic ecotoxicology studies for alkyl amine
hydrochloride.  The Agency's conclusions for the avian and aquatic
effects studies are as follows.

Terrestrial Studies

Alkyl amine hydrochloride is considered to be slightly toxic to upland
game birds (Colinus virginianus) with an acute oral LD50 value of 989
mg/kg.  Based on avian dietary exposure, alkyl amine hydrochloride would
be categorized as practically non-toxic to upland game birds (Colinus
virginianus) and waterfowl (Anas platyrhynchos) with LD50 values greater
than 5620 ppm.

Aquatic Studies

	Two studies were performed to assess aquatic toxicity.  Based on
rainbow trout and daphnia testing, alkyl amine hydrochloride is
classified as highly toxic to freshwater fish (Oncorhvnchus mvkiss &
Lepomis macrochirus) with LC50 values of 0.18 ppm and 0.48 ppm, and very
highly toxic to freshwater invertebrates (Daphnia magna) with a LC50 of
0.027 ppm.

	Ecological Effects risk Assessment

	Although some of the studies were deficient in their conduct, they were
adequate to provide the Agency with sufficient information to determine
appropriate label precautions.  No risk assessment was performed for
alkyl amine hydrochloride since there is no exterior exposure from its
indoor use.

Risk to Threatened and Endangered Species

Based on indoor use patterns, low exposure levels, and low toxicity
potential of alkyl amine hydrochloride, the Agency expects that the
registered uses of alkyl amine hydrochloride will have “no effect”
(NE) on endangered or threatened terrestrial or aquatic species, or
their designated critical habitats, as listed by the U.S. Fish and
Wildlife Service (USFWS) and the National Oceanic and Atmospheric
Administration (NOAA).  However, EPA will review any comments made by
the public on this document and will conduct another environmental risk
assessment, if new information warrants such action.

Environmental Fate and Ecotoxicity Data Gaps and Anticipated Work

	None.

Sign-off Date      :  11/27/07

DP Barcode No.  :  D342130

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