Document ID: EPA-HQ-OPP-2008-0879-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-12-19T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

 OFFICE OF

                                                                        
                                    PREVENTION, PESTICIDES AND 

         TOXIC SUBSTANCES

December 4, 2008

MEMORANDUM

SUBJECT:	Summary of Product Chemistry, Environmental Fate, and
Ecotoxicity Data for the 2-[(Hydroxymethyl)-amino]ethanol Registration
Review Decision Document.

	PC Code: 099001		Case No.: 3070

			CAS No.: 34375-28-5		DP Barcode: 358961

FROM:	Srinivas Gowda, Microbiologist/Chemist

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

TO:			Mark Hartman, Branch Chief

Diane Isbell, Team Leader

Lance Wormell, 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
industrial/material preservative, microbiocide, bactericide, fungicide,
fungistat, mildew inhibitor, 2-((Hydroxymethyl)amino)ethanol.

2-((Hydroxymethyl)amino)ethanol

REGISTRATION REVIEW DECISION

PRODUCT CHEMISTRY, ENVIRONMENTAL FATE AND

 ECOLOGICAL EFFECTS SUMMARY

PC Code:  099001; Case No. 3070

Introduction

2-((Hydroxymethyl)amino)ethanol (HMAE) is a formaldehyde releaser and
also known by the trade names, Troysan® 174 and Nuosept® 91.  It is
strongly alkaline solution and completely miscible in water.

The active ingredient 2-((Hydroxymethyl)amino)ethanol was first
registered in the United States on April 3, 1975, for use as an
industrial preservative against bacterial and fungal deterioration.  
Presently, there are four active products under a single PC Code 099001
which are listed in Table1.  A RED was completed in December 1993.

2-((Hydroxymethyl)amino)ethanol is a broad spectrum, non-metallic,
organic liquid industrial preservative/biocide registered for use in the
manufacture of water-based products such as caulks, sealants, lattices,
grouts, spackling, ready-mixed wallboard compounds, resin emulsions,
latex paint, adhesives, pigment dispersions, dispersed colors, pigment
slurries and ready-mix joint cements, cutting oils, and drilling
additives, to prevent bacterial and fungal deterioration.  It is used in
all products where water is a primary component.

2-((Hydroxymethyl)amino)ethanol must not be used in connection with
feed, food or drinking water.  2-((Hydroxymethyl)amino)ethanol is not
registered for agricultural uses.  There are no direct food or feed uses
of 2-((Hydroxymethyl)amino)ethanol, 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).

2-((Hydroxymethyl)amino)ethanol is not cleared by the Federal food, Drug
and cosmetic Act for use in food grade adhesives.

In June 2007, the Agency received an amended application from
International Specialty Products (ISP) to change the nomenclature of the
active ingredient from 2-((Hydroxymethyl)amino)ethanol (HMAE) to
Hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine (HHT) for the product
Nuosept® 91 Preservative (EPA Reg. No. 1529-31).  The amendment to
change the name of the active ingredient to HHT was accepted and the ISP
was asked to submit the revised CSF and label to reflect the proper name
of the active ingredient (HHT).  HHT is a formaldehyde releaser.

Also, on August 14, 2008, the Agency met with the registrant, Troy
Chemical Corp., at which Troy Chemical announced its intention to cancel
the product Troysan® 174 (EPA Reg. No. 5383-11) and transfer a number
of its uses to an already registered HHT product label/registration (EPA
Reg. No. 365-76; Troyshield B2).

Table 1.  Registered Active Products of 2-((Hydroxymethyl)amino)ethanol

Registration #	Registration Name	Company Name	Formulation Type	% of
Active Ingredient

1529-31	Nuosept® 91 Preservative	International Specialty Products 
Technical Chemical	100

5383-11	Troysan® 174	Troy Chemical Corp	Ready-to-Use Solution	98.9

5383-47	Troysan® 364 	Troy Chemical Corp	Soluble Concentrate	21

5383-68	Troysan® 174P	Troy Chemical Corp	Wettable Powder	50

Table 2. Chemical Identity 

Common Name	2-((Hydroxymethyl)amino)ethanol

Chemical Name	Ethanol, 2-(hydroxymethylamino)-

2-(Hydroxymethylamino) ethanol

2-Hmae

Ethanol, 2-((hydroxymethyl) amino)-

Ethanol, 2-(Hydroxymethylamino)-

Ethanol, 2-[(hydroxymethyl) amino]-

Trade Names	Troysan® 174, Nuosept® 91

Molecular Weight	91.11 g/mole

PC Code 	099001

CAS Registry Number	34375-28-5

Molecular Formula	C3H9NO2

Registration Review No.

Registration Review Case Name	3070

Ethanolamine, 2-

Classification	Alcohol

Amine

Active

Inert	Yes

No

Molecular Structures:

Parent:

2-((Hydroxymethyl)amino)ethanol

OH-CH2-NH-CH2-CH2-OH

Degradates:

Formaldehyde: H2C(OH)2

Ethanolamine: H2N(CH2)2OH	

2-((Hydroxymethyl)amino)ethanol

Degradates:

 

Formaldehyde monohydrate     Ethanolamine

Use Patterns

Bacteriostat, Mildew Inhibitor, Microbiocide (Deterioration/spoilage
bacteria)

Sold for industrial use only.

Materials Preservatives

Caulks

Sealants

Grouts

Spackling

Ready-mixed wallboard compounds

Joint cements

Resin emulsions

Latex paint

Adhesives (not intended for food contact)

Industrial adhesives (in-can use)

Lattices

Dispersed colors

Pigment dispersions

Pigment slurries

Ready-mix joint cements

Cutting oils

Drilling additives

Metalworking cutting fluids

Used as a preservative in aqueous cutting oil compositions

Used to provide in-can preservative properties for adhesives, caulks,
sealants, and lattices.

Used to control microbial growth at the air-water interface of paint
manufacturing latex storage tanks.  An aqueous solution should be
sprayed over the surface.

Used to prevent microbial growth at the air-film interface of latex
storage tanks in exterior paint manufacturing operations.

Used as a treatment for in-plant maintenance of non-food process
equipment.

Commercial/institutional/industrial indoor equipment (surface
treatment).

Science Findings

	The Agency has conducted a review of the available product chemistry,
environmental fate, and ecotoxicity data for
2-((hydroxymethyl)amino)ethanol.  The findings are summarized below.

Product Chemistry Summary

The data submitted pertaining to the physical and chemical
characteristics of the active ingredient,
2-((hydroxymethyl)amino)ethanol are adequate.

All product chemistry data requirements have been fulfilled for the
active ingredient 2-((hydroxymethyl)amino)ethanol.  Therefore, the
Agency does not anticipate needing additional product chemistry data for
2-((hydroxymethyl)amino)ethanol at this time.  See Table 3.

Table 3.  Product Chemistry Data Summary for
2-((hydroxymethyl)amino)ethanol (97% a.i. )

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	Gas Chromatography 

Supercritical Fluid Chromatography (SFC)

High Pressure Liquid chromatography

830.1900	Submittal of samples	N/A

	830.6302	Color	A	Clear amber liquid @ 20°C

830.6303	Physical State	A	Liquid @ 20°C

Clear amber liquid

830.6304	Odor	A	Mild odor

Sharp, amine odor

830.6313	Stability to sunlight, normal and elevated temperature,
metals/metal ions	A	Stable for 14 days under the following conditions: 
ambient temperature (~23°C);

simulated sunlight; mixed with aluminum, galvanized steel, and stainless
steel metals; and mixed with zinc ions.  An apparent effect was observed
with exposure to iron (III) ions, and a marginal loss was observed with
exposure to aluminum ions.

Slight loss @ 50°C after 2 weeks of storage.

Stable for one month at 4°C and 50°C and for 3 months at room
temperature.

It should not be exposed to temperatures exceeding 125°F (52°C) for
prolonged periods of time.

830.6314	Oxidation/Reduction: Chemical Incompatibility	A	This product
does not contain an oxidizing or reducing agent.  Waived.

Oxidizing/Reducing Reaction: Not Applicable.

830.6315	Flammability	A	Flash point is 230°F (110°C).

830.6316	Explodability	A	This product is not potentially explosive
Waived.

830.6317	Storage Stability	A	Stable for one month 4°C and 50°C and for
3 months at room temperature.

Stability (Shelf life): 2 years minimum.

Does not degrade when stored at ambient temperature over a one-year
period.

830.6319	Miscibility	A	This product is not an emulsifiable liquid and is
not to be diluted with petroleum solvents.  Waived.

830.6320	Corrosion Characteristic	A	Not Required 

830.6321	Dielectric breakdown voltage	N/A	This product will not be used
around electrical equipment Waived

830.7000	pH at 25°C	A	11 ± 0.5 – 100%

11 – 11.7

10.66 (1% solution)

Troysan® 174 is not suitable for use in systems with a pH below 7.

830.7050	UV/Visible absorption	N/A	Not Required

830.7100	Viscosity at 25°C	A	260 mm2/s (cST) @ 22°C

207.5 ± 0.1 (s) cST @ 25°C

830.7200	Melting Point	N/A	The product is not a solid, rather a liquid.
Waived

830.7220

	Boiling point	A	264-265°C at 739 mm Hg

110°C with decomposition

113.1°C at 760 mm Hg

830.7300	Density

Bulk Density	A	1.149 @ 25°C

1.1545 g/ml @ 25°C

9.4 – 9.7 pounds/gallon

9.5 – 9.6 lbs/gal at 80°F

	Specific Gravity	A	1.149 (25/25°C)

1.14 – 1.16

1.144 – 1.153 at 80°F

1.152 at 80°F

830.7370	Dissociation Constant

Dissociation Constants in water (pKa)	A	pKa: 8.5  + 0.2 (s) @ 25°C

830.7550	Octanol/water partition coefficient	A	Not Required

830.7840	Water solubility (g/100ml)	A	Completely miscible in water at
25.0 ± 0.5°C. 

830-xxxx	Solubility in organic solvents	A	Completely miscible in
isopropanol at 25 ± 0.5°C

23.6 ± 0.7 (sd) g/100 ml in octanol @ 25± 0.5°C

830.7950	Vapor pressure

	A	16.4 mmHg at 25°C

7.5 mmHg at 20°C

2082 Pa @ 24.6°C

2904 Pa @ 30.8°C

4453 Pa @ 38.8°C

6785 Pa @ 46.9°C

Other Physical/Chemical Properties

	Classification of a.i.

Alcohol

Amine

	Henry's Law Constant at 25ºC

4.496E-017 atm-m3/mole (Source: EPI Suite)

	Log Kow   

-1.53  (Source: EPI Suite)

	Koc (Estimated)

2.13  (Source: EPI Suite)

	Ready Biodegradability

Yes (Source: EPI Suite)

	Estimated Log BCF

0.500 (BCF=3.162) (Source: EPI Suite)

	Refractive index mD at 20ºC

1.480

1A = Acceptable; N/A = Not applicable; CBI = Confidential Business
Information.

Environmental Fate Summary

2-((Hydroxymethyl)amino)ethanol is a formaldehyde releaser.  A
hydrolysis study was conducted on the 2-((hydroxymethyl)amino)ethanol. 
2-((hydroxymethyl)amino) ethanol apparently hydrolyzed so rapidly in pH
5, 7, and 9 aqueous buffer solutions that no rate of hydrolysis or
half-life could be determined from the study.  The hydrolysis products
were ethanolamine and formaldehyde.  The primary degradates,
ethanolamine and formaldehyde, were approximately 100% of the applied
dose (parent compound) at day zero and they were stable for the length
of the study (30 days).  Hydrolysis study satisfied the OPP 161-1 data
requirement for the indoor use.

Hydrolysis is the only data the Agency has on this chemical.  Other
environmental fate studies were not required because of its indoor use
patterns.  Due to the indoor use pattern, the Agency did not conduct an
environmental fate assessment for 2-((hydroxymethyl)amino)ethanol. 
However, the Agency anticipates conducting an environmental fate
assessment for material preservatives that potentially pass through
wastewater treatment plants (WWTPs) and may be discharged into
terrestrial and aquatic environments.  For this assessment the Agency
anticipates needing those data [ready bio-degradability (835.3110),
activated sludge sorption isotherm (835.1110), activated sludge, and
respiration inhibition (850.6800)] outlined on page 12 of this document.

Ecological Effects Summary

No risk assessment was performed for 2-((hydroxymethyl)amino)ethanol. 
The Agency has reviewed four basic ecotoxicology studies for
2-((hydroxymethyl)amino)ethanol.  The four studies submitted on the 97%
active ingredient were all found to be acceptable for use in a hazard
assessment.  Ecotoxicity guideline studies and the results are
summarized in Table 4.  The Agency's conclusions for the avian and
aquatic effects studies are as follows.

a.	Terrestrial Studies

2-((hydroxymethyl)amino)ethanol is considered to be slightly toxic to
upland game birds (Colinus virginianus) with an acute oral LD50 value of
1743 mg/kg.  Based on avian dietary exposure,
2-((hydroxymethyl)amino)ethanol would be categorized as slightly toxic
to upland game birds (Colinus virginianus) with LC50 values greater than
3755 ppm.

b.	Aquatic Studies

Two studies were performed to assess aquatic toxicity.  Based on rainbow
trout and daphnia testing, 2-((hydroxymethyl)amino)ethanol is classified
as slightly toxic to freshwater fish (Oncorhynchus mykiss) with LC50
values of >60.3 ppm, and slightly toxic to freshwater invertebrates
(Daphnia magna) with EC50 = 25.2  ppm.

Table 4.  Ecotoxicity  Data Summary for 2-((hydroxymethyl)amino)ethanol

Guideline Number

	Test

Species	Percent

a.i.	Test

Type	Test

Results	Study

Status	Category of Toxicity

850.2100

71-1a	Bobwhite Quail

Colinus virginianus	97	Acute  Oral	14 D LD50= 1743 mg/kg

NOAEL: 292 mg/kg 	Core	Slightly toxic

850.2200

71-2a	Bobwhite Quail

Colinus virginianus	97	Avian Dietary	8 D LC50=

>3755 ppm

NOAEC = 1930 ppm	Supplemental	Slightly toxic

850.1075

72-1c	Rainbow Trout

Oncorhynchus mykiss	97	Fish 

Acute 	96-hr LC50=

>60.3 ppm

NOAEC: 30.7 ppm	Supplemental	Slightly toxic

850.1010

72-2a	Daphnia 

Daphnia magna	97	Aquatic Invertebrate	48-hr EC50=

25.2 ppm

NOAEC: 8.3 ppm	Core	Slightly toxic

2-((hydroxymethyl)amino)ethanol is slightly toxic to birds, fish and
aquatic invertebrates.

Ecological Effects Risk Assessment

An ecological risk assessment was not conducted on the
2-((hydroxymethyl)amino)ethanol use patterns described in this document.
 2-((hydroxymethyl)amino)ethanol uses that have potential for
environmental exposure are materials preservative discharges.  The
Agency anticipates conducting an ecological risk assessment for material
preservatives that potentially pass through wastewater treatment plants
(WWTPs) and may be discharged into terrestrial and aquatic environments.
 For this ecological risk assessment, including an endangered species
assessment for all uses, the Agency anticipates needing the algal
toxicity data outlined on page 12 of this document.

The planned ecological risk assessment will allow the Agency to
determine if use patterns will result in a “no effect” or “may
affect” determination for federally listed threatened or endangered
species (listed species), or their designated critical habitat.  If the
ecological risk assessment indicates that
2-((hydroxymethyl)amino)ethanol “may affect” a listed species or its
designated critical habitat, the assessment will be refined.  The
refined risk assessment will allow the Agency to determine whether use
of 2-((hydroxymethyl)amino)ethanol is “likely” or “not likely to
adversely affect” the species or critical habitat.  When an assessment
concludes “likely to adversely affect” further refinements to the
risk assessment or regulatory options may be pursued prior to a “may
affect” consultation with the U.S. Fish and Wildlife Service and/or
National Marine Fisheries Service (Services), as appropriate.

Environmental Fate and Ecotoxicity Data Gaps and Anticipated Work

Environmental fate and ecological risk assessments have not been
conducted for 2-((hydroxymethyl)amino)ethanol.  The Agency anticipates
conducting environmental fate and ecological risk assessments for
material preservatives that potentially pass through waste water
treatment plants (WWTPs) and may be discharged into terrestrial and
aquatic environments.  Therefore, the Agency anticipates needing the
proposed environmental fate and ecotoxicity data for
2-((hydroxymethyl)amino)ethanol and/or any of its major degradation
products that are of potential concern for all registered uses of
2-((hydroxymethyl)amino)ethanol.  The following environmental fate and
ecotoxicity data are needed to conduct an environmental fate and
ecological risk assessment:

The Agency anticipates needing the following data in order to conduct a
complete environmental fate assessment:

(GLN 850.6800) modified activated sludge respiration inhibition;

(GLN 835.1110) activated sludge sorption isotherm; and

(GLN 835.3110) ready biodegradability.

The Agency anticipates needing the following data in order to conduct a
complete ecological risk assessment, including an endangered species
assessment for all uses:

 (GLNs 850.4400 & 850.5400) algal toxicity (Tier II) using freshwater
green alga, Selenastrum capricornutum.

Additional Data/Clarifying Information Required to Support the
Nomenclature Change from HMAE to HHT

Revised Confidential Statement of Formula for Nuosept® 91 Preservative,
EPA Reg. No. 1529-31.

Revised label to reflect the new nomenclature (HHT) for Nuosept® 91
Preservative, EPA Reg. No. 1529-31.

Provide rationale, and data, including C-13 NMR to show that the linear
azine becomes a cyclic triazine.

Justifications to show that available product chemistry, environmental
fate, and ecotoxicity data developed on HMAE and HHT is adequate to
support the proposed nomenclature change.  Also, clarify if there are
any discrepancies between the available HMAE and HHT product chemistry,
environmental fate, and ecotoxicity data.  Click on links listed below
for the Agency’s product chemistry, environmental fate, and
ecotoxicity assessments done on
Hexahydro-1,3,5-tris(2-hydroxyethyl)-s-triazine (HHT).

  HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&o=0900006480509086" \o "View Document details"  HHT Preliminary
Product Chemistry Chapter.   Docket ID:   HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&
d=EPA-HQ-OPP-2008-0193" \o "View Docket details"  EPA-HQ-OPP-2008-0193  
Document ID:   HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&o=0900006480509086" \o "View Document details" 
EPA-HQ-OPP-2008-0193-0002.8 

  HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&o=0900006480509084" \o "View Document details"  HHT Preliminary
Environmental Fate Assessment.   Docket ID:   HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&
d=EPA-HQ-OPP-2008-0193" \o "View Docket details"  EPA-HQ-OPP-2008-0193  
Document ID:   HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&o=0900006480509084" \o "View Document details" 
EPA-HQ-OPP-2008-0193-0002.6 

  HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&o=090000648050907b" \o "View Document details"  HHT Preliminary
Ecological Hazards Assessment.   Docket ID:   HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&
d=EPA-HQ-OPP-2008-0193" \o "View Docket details"  EPA-HQ-OPP-2008-0193  
Document ID:   HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&o=090000648050907b" \o "View Document details" 
EPA-HQ-OPP-2008-0193-0002.5 

  HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&o=09000064805099df" \o "View Document details"  HHT Preliminary Human
Health and Ecological Risk Assessments.   Docket ID:   HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&
d=EPA-HQ-OPP-2008-0193" \o "View Docket details"  EPA-HQ-OPP-2008-0193  
Document ID:   HYPERLINK
"http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetai
l&o=09000064805099df" \o "View Document details" 
EPA-HQ-OPP-2008-0193-0002.1 



APPENDICESAppendix A. Environmental Fate Guideline Study Justifications

Guideline	Study Title	Practical Utility of the Data 

850.6800	Modified Activated Sludge, Respiration Inhibition	1) What is
the value of the study?

The modified activated sludge, respiration inhibition test would allow
EPA to identify antimicrobial pesticides which could harm microorganisms
found in biological wastewater treatment systems and would also help
establish correct concentrations for use in the ready biodegradability
test.

2) How would the data be used?

The data would be used to determine the potential of
2-((hydroxymethyl)amino)ethanol to directly harm the nontarget organisms
and/or to microbial treatment processes present in a WWTP and to
determine suitable noninhibitory concentrations of
2-((hydroxymethyl)amino)ethanol to be used in biodegradability tests.

3) How could the data affect the risk assessment?

If the data shows that 2-((hydroxymethyl)amino)ethanol is toxic to
nontarget organisms and/or to microbial process found in WWTPs then, the
Agency may need Tier II environmental fate data to evaluate potential
adverse effects on WWTPs.

4) What is triggering the need for this data?

Studies are needed to conduct environmental fate assessment and to
determine the potential exposure of 2-((hydroxymethyl)amino)ethanol to
waste water treatment plants (WWTPs) (via effects on WWTP microbes).

835.1110	Activated Sludge Sorption Isotherm	1) What is the value of the
study?

The results from activated sludge sorption study would allow EPA to
assess the distribution of the antimicrobial among the solid, aqueous,
and vapor phases of WWTPs.  Specifically, this study identifies those
chemicals which sorb to sludge biomass.

2) How would the data be used?

The data would be used to determine the sorption potential of
2-((hydroxymethyl)amino)ethanol to activated sludge biomass and in
biological wastewater treatment systems.

3) How could the data affect the risk assessment?

If 2-((hydroxymethyl)amino)ethanol is not sorbed or biodegraded then, it
would pass through a biological treatment system unaffected and it may
contaminate surface and drinking waters and also may have potential
adverse effects to nontarget organisms.

4) What is triggering the need for this data?

Studies are needed to conduct environmental fate assessment and to
determine the sorption potential of activated sludge for the removal of
specific chemical compounds in biological wastewater treatment systems.

835.3110

	Ready Biodegradability	1) What is the value of the study?

The ready biodegradability study would enable the Agency to determine
the likelihood that the antimicrobial pesticide of biodegrading in
aquatic environments under aerobic conditions.

2) How would the data be used?

The results from the data would be used to determine the rate and extent
of aerobic biodegradation of 2-((hydroxymethyl)amino)ethanol when it is
released into aquatic environments and would help establish if
2-((hydroxymethyl)amino)ethanol is stable or not stable under real
environmental conditions.

3) How could the data affect the risk assessment?

If the results show low biodegradability then,
2-((hydroxymethyl)amino)ethanol would occur in significant quantities in
WWTP effluents (water and biosolids) and in environmental compartments
(e.g., surface waters) such that potential adverse effects to nontarget
organisms, found in such environmental compartments, may occur.

4) What is triggering the need for this data?

Data are needed to conduct environmental fate assessment and to
determine the ready biodegradability of 2-((hydroxymethyl)amino)ethanol.



Appendix B: Ecological Guideline Study Justifications

Guideline	Study Title	Practical Utility of the Data:  

850.5400	Tier II green algae using

Selenastrum

capricornutum	1) What is the value of the study? 

As part of a Tier I risk assessment, one indicator plant species is
tested for phytotoxicity.  This study would allow the Agency to
categorize 2-((hydroxymethyl)amino)ethanol as toxic or non-toxic to
plants.  If toxic, additional higher tier plant tests would be needed. 
An endangered species assessment for endangered or threatened plants is
not possible without this study.

2) How would the data be used?

This study would be used to evaluate the toxicity of
2-((hydroxymethyl)amino)ethanol to non-target plants in terrestrial and
aquatic ecosystems.

3) How could the data affect the risk assessment? 

Adverse effects to non-target plants in terrestrial and aquatic
ecosystems may result in mitigation to protect species at risk. 
Mitigation might include reduced label dosages, neutralization of
effluents prior to discharge into water, restrictions on use in
sensitive ecosystems or where endangered species are present, or other
mitigation measures.

4) What is triggering the need for this data?

Increased concern from state regulators and the public to evaluate
impacts on WWTP operations, endangered species, and persistence in the
environment, since initial registration, have triggered the need for
this study.  Green algae are critical to ecosystem health and
productivity.

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