United States Prevention, Pesticides September 2008
Environmental Protection And Toxic Substances
Agency (7508P)
Reregistration Eligibility
Decision
Acrolein
-------
Reregistration Eligibility Decision (RED) Document
for Acrolein
ListB
Case No. 2005
Approved by:
Steven Bradbury, Ph.D.
Director,
Special Review and Reregistration Division
Date:
-------
Table of Contents
I. Introduction 7
II. Chemical Overview 7
A. Regulatory History 8
B. Chemical Identification 8
C. Acrolein Use Profile 9
D. Estimated Usage 10
III. Summary of Acrolein Risk Assessments 10
A. Human Health Risk Assessment 11
1. Toxicity of Acrolein 12
2. Endpoint Selection 14
3. Dietary Exposure and Risk (All Populations) 15
4. Residential (Non-Occupational) Exposure and Risk 16
5. Aggregate Exposure and Risk 18
6. Occupational Exposure and Risk 18
a. Occupational Handler/Application Assessment 19
b. Occupational Post-Application Exposures 21
7. Endocrine Disruption 21
8. Incident Reports 21
B. Environmental Fate and Ecological Risk Assessment 22
1. Environmental Fate and Transport 22
2. Ecological Exposure and Risk 23
a. Terrestrial Organisms Exposure and Risk 25
1) Bird and Mammal Toxicity 25
2) Bird and Mammal Exposure 27
3) Bird and Mammal Risk 28
4) Non-target Terrestrial Plants 30
5) Non-target Insects 31
b. Aquatic Organism Exposure and Risk 31
1) Fish, Invertebrate, and Aquatic Plant Toxicity 31
2) Fish, Invertebrate, and Aquatic Plant Exposure 34
3) Fish, Invertebrate, and Aquatic Plant Risk 34
c. Listed Species Risk 35
3. Risk Characterization 36
a. Endangered Species 37
4. Ecological Incidents 38
IV. Risk Management and Reregistration Decision 39
A. Determination of Reregistration Eligibility 39
B. Public Comments and Responses 40
C. Risk Mitigation and Regulatory Position 41
1. Human Health Risk Management 41
2. Ecological Risk Management 43
V. What Registrants Need to Do 43
-------
A. Manufacturing Use Products 46
1. Additional Generic Data Requirements 46
2. Labeling for Technical and Manufacturing Use Products 46
B. End-Use Products 47
1. Additional Product-Specific Data Requirements 47
2. Labeling for End-Use Products 47
C. Labeling Changes Summary Table 48
VI. Appendices
Appendix A. Acrolein Use Patterns Eligible for Reregistration 52
Appendix B. Data Supporting Guideline Requirements for Acrolein 53
Appendix C. Technical Support Documents 55
Appendix D. Bibliography 56
-------
Acrolein Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Health Effects Division
Rebecca Daiss
Thurston Morton
Abdallah Khasawinah
Environmental Fate and Effects Division
David Jones
Kristina Garber
Thomas Steeger
Marietta Echeverria
Registration Division
Joanne Miller
Biological and Economic Analysis Division
Bill Phillips
Derek Berwald
Special Review and Reregistration Division
Amaris Johnson
John W. Pates, Jr.
Laura Parsons
-------
Glossary of Terms and Abbreviations
ai
CFR
CSF
DCI
EC
EEC
EPA
EUP
FDA
FIFRA
FFDCA
FQPA
G
GLN
LOC
LOD
LOAEL
^g/g
ug/L
mg/kg/day
mg/L
MOE
MRID
MUP
NA
NPDES
NR
NOAEL
OPP
OPPTS
PHED
PHI
ppb
PPE
ppm
RED
REI
RfD
RQ
SAP
SF
SLC
SLN
TGAI
USDA
USGS
UF
UV
WPS
Active Ingredient
Code of Federal Regulations
Confidential Statement of Formula
Data Call-In
Emulsifiable Concentrate Formulation
Estimated Environmental Concentration
Environmental Protection Agency
End-Use Product
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Granular Formulation
Guideline Number
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Micrograms Per Gram
Micrograms Per Liter
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
Manufacturing-Use Product
Not Applicable
National Pollutant Discharge Elimination System
Not Required
No Observed Adverse Effect Level
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Science Advisory Panel
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c) of FIFRA)
Technical Grade Active Ingredient
United States Department of Agriculture
United States Geological Survey
Uncertainty Factor
Ultraviolet
Worker Protection Standard
-------
I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in
1988 to accelerate the reregi strati on of products with active ingredients registered prior to
November 1, 1984, and amended again by the Food Quality Protection Act of 1996 (FQPA).
FIFRA calls for the development and submission of data to support the reregi strati on of an
active ingredient, as well as a review of all data submitted to the U.S. Environmental
Protection Agency. Reregi strati on involves a thorough review of the scientific database
underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential risks arising from the currently registered uses of a pesticide, to determine the need
for additional data on health and environmental effects, and to determine whether or not the
pesticide meets the "no unreasonable adverse effects" criteria of FIFRA.
This document summarizes EPA's human health and ecological risk assessments and
reregi strati on eligibility decision (RED) for acrolein. The document consists of six sections.
Section I contains the regulatory framework for reregistration; Section II provides an overview
of the chemical and a profile of its use and usage; Section III gives an overview of the human
health and environmental effects risk assessments; Section IV presents the Agency's decision
on reregistration eligibility and risk management; and Section V summarizes the label changes
necessary to implement the risk mitigation measures outlined in Section IV. Finally, the
Appendices (Section VI) list related information, supporting documents, and studies evaluated
for the reregistration decision. The risk assessments for acrolein and all other supporting
documents are available in the Office of Pesticides Program (OPP) public docket at
www.regulations.gov under docket number EPA-HQ-OPP-2007-0588.
II. Chemical Overview
There are 8 active acrolein registrations: two registered under section 3 of FIFRA, and
six Special Local Need (SLN or 24c) registrations registered under section 24(c) of FIFRA.
Acrolein has two use patterns: as an herbicide and biocide. The herbicidal use (EPA Reg#
10707-9) is for direct applications to water irrigation canal systems in the western U.S. Water
from the irrigation system may be used on cropland immediately after application of the
herbicide, but a specific "holding time" is required before irrigation water can be discharged to
natural water systems. All six SLNs are associated with the herbicide registration. Three of
these SLNs (WA0400017, ID900005, and NE030003) reduce the holding time specified on the
Section 3 label for treated water. The other three SLNs (UT030001, OR910018 and
CA780039) are for reservoir use. The reservoirs are irrigation water use only and are not used
to store drinking water. The Section 3 registration (EPA Reg# 10707-10) is for application as
a biocide for oil well drilling equipment. All registrations for use of acrolein in rodent burrows
and burrow entrances have been cancelled. See Table 1 for a current product listing.
Table 1. Summary Report of Supported Registered Products
Reg#
10707-9
10707-10
CA780039
Name
MAGNACIDE H HERBICIDE
MAGNACIDE B MICROBIOCIDE
MAGNACIDE H HERBICIDE
Company Name
Baker Petrolite
Corporation
%Active
Ingredient
95
95
95
-------
Table 1. Summary Report of Supported Registered Products
Reg#
ID900005
NE030003
OR910018
UT030001
WA040017
Name
MAGNACIDE H HERBICIDE
MAGNACIDE H HERBICIDE
MAGNACIDE H HERBICIDE
MAGNACIDE H HERBICIDE
MAGNACIDE H HERBICIDE
Company Name
%Active
Ingredient
95
95
95
95
95
A. Regulatory History
The acrolein reregi strati on case (2005) contains only one active ingredient, acrolein,
which was first registered as an herbicide by Baker Petrolite Corporation (BPC) in November
1975. Baker Petrolite Corporation is the sole technical registrant for both Magnicide H
Herbicide and Magnicide B Microbicide. Prior to its registered use as an herbicide, acrolein
was registered in 1959 as a biocide. Several Data Call-In (DCI) notices were previously issued
in the late 1980s and early 1990s identifying outstanding data needs for acrolein. The DCIs
included requests for plant and animal metabolism studies in order to determine the need for
crop tolerances.
B. Chemical Identification
Acrolein is registered as a restricted use pesticide for control of submerged and floating
aquatic weeds and algae in irrigation canals as well as irrigation reservoirs in some states. In
addition, acrolein is used as a biocide to kill bacteria that accumulate within the pipes of
petroleum producing systems. Acrolein forms several degradates (acrylic acid, allyl alcohol,
propanol, propionic acid, oxalic acid, and ultimately carbon dioxide) in the environment. In
addition, glycidol, a metabolite of acrolein, is considered a probable human carcinogen by the
International Agency for Research on Cancer (part of the World Health Organization). The
National Toxicology Program Annual Report concludes that glycidol is reasonably anticipated
to be a human carcinogen based on sufficient evidence of carcinogenicity in experimental
animals. The chemical structures and properties of acrolein and its metabolite (glycidol) are
presented in Tables 2-4.
Table 2: Acrolein Nomenclature
Chemical Structure
Common Name
Synonyms
Molecular Formula
PC Code
^IHM
Acrolein
2-propenal, acrylaldehyde, acrylic aldehyde, allyl aldehyde, propenal, trans
acrolein, acquinite, aqualin, biocide, crolean, ethylene aldehyde, Magnicide,
Magnicide H, NSC 8819, prop-2-en-l-al, 2-propene-l-one, slimicide, prop-2-
enal
C3H4O
000701
-------
Table 2: Acrolein Nomenclature
IUPAC Name
CAS Registry Number
2-propenal; Acrylaldehyde
107-02-8
Table 3: Physiochemical Properties of Acrolein
Melting Point/Range
Boiling Point
Molecular Weight
Specific Gravity
Vapor Density
Solubility
Vapor Pressure
Flashpoint
Octanol Water Partition
Coefficient (Log k)
Description
-88 °C (-126 °F)
53 °C (127 °F)
56. 1 g/mol
0.0839
1.94(air=l)
208 g/L at 20 °C soluble in water, alcohol, ether, and acetone
220 torr at 20 °C
-15°F(-26.1°C)
0.98-1.10
Clear, colorless to yellow liquid
Table 4: Nomenclature and Physiochemical Properties of Glycidol
Chemical Structure
Molecular Formula
IUPAC Name
CAS Registry Number
Melting Point/Range
Boiling Point
Molecular Weight
Specific Gravity
Vapor Density
Solubility
Vapor Pressure
Flashpoint
Octanol Water Partition
Coefficient (Log p)
Description
?XX/OH
C3H602
Oxiranylmethanol
556-52-5
-54 °C
167 °C (decomposes)
74.1 g/mol
0.0839
2. 15 (air = 1)
Miscible
120 Pa at 20 °C
72 °C
-0.95
Clear, colorless liquid
C. Acrolein Use Profile
Type of Pesticide:
Summary of Use:
Acrolein is an aquatic herbicide and biocide.
Acrolein has two use patterns: as an herbicide for the control of
vegetation in irrigation canals and as a biocide in water pumped into
injection wells associated with petroleum production.
-------
Mode of Action: Acrolein binds to organic material and degrades cellular structure by
cross-linking proteins.
Formulation Type: Both section 3 acrolein products: Magnicide H (aquatic herbicide, EPA
Registration #: 10707-9) and Magnicide B (biocide, EPA Registration #:
10707-10) are packaged as liquids and stored under an inert gas blanket.
Each contains 95% acrolein as the active ingredient.
Application Methods: As an herbicide, acrolein is injected directly below the surface of moving
water and moves with the flow of water killing weeds on contact in
irrigation canals and holding ponds. Acrolein is also used as a biocide in
water pumped into injection wells associated with petroleum production.
Acrolein is not directly applied to any crops. Both the herbicide and
biocide products are applied through a closed system.
Application Rates: For herbicidal use in irrigation canals, the maximum single application
concentration of acrolein is 15 ppm. The typical application rate is 8
ppm. For the biocide use, the maximum single application rate is 15
ppm. No maximum number of applications or minimum re-application
intervals are specified on the labels.
Application Timing: Magnacide H and Magnacide B applications can occur multiple times
during a year. Magnacide H may be applied up to 26 times per year in
some irrigation systems with an application interval as short as every 7
days, but 6 applications per year is the most common, with a two to
three week interval between applications. In some irrigation systems
applications are more frequent but at lower concentrations to control the
lower weed density. Detailed application information for Magnacide B
is not currently available.
Registrant: Baker Petrolite Corporation
D. Estimated Usage
Based on available data, approximately one million pounds of acrolein is sold annually.
Acrolein is a restricted use pesticide subject to strict use limitations. It can only be sold to and
applied by trained and certified applicators or persons under their direct supervision, and can
only be used for a use covered by the applicator's certification. There are no products
available for residential application.
III. Summary of Acrolein Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features and
findings of the human health and environmental risk assessments, and to help the reader better
understand the conclusions reached in the assessments. The assessments and supporting
documents referenced in Appendix C were used to formulate the safety finding and regulatory
decision for the pesticidal use of acrolein.
10
-------
While the risk assessments and related addenda are not included in this document, they
are available in the OPP Public Docket at www.regulations.gov, docket number EPA-HQ-
OPP-2007-0588. In addition, the documents may be accessed through the Agency's website at
http://www.epa.gov/pesticides.
• Acrolein HED Risk Assessment for Reregistration Eligibility Decision (RED)
Document (PC Code No. 000701) (B. Daiss.; 3/25/08, D348777).
• Environmental Fate and Ecological Risk Assessment Chapter in Support of Phase V
of the Reregistration Eligibility Decision of Acrolein (Jones, R.D., Ph.D., Garber,
K. and Steeger, T., Ph.D.; 7/23/08, D354775).
A. Human Health Risk Assessment
Acrolein is a pesticide with two registered uses in the U.S. In agriculture, acrolein is
registered for application in irrigation systems only in the western U.S. In petroleum
production industries, acrolein is applied to injection wells to control slime-producing
organisms in drilling muds. The human health risk assessment addresses potential exposure
risks from all registered sources; however, exposures to acrolein from the biocide use in
petroleum production (Magnicide B) are not expected since the current use pattern consists of
application through closed systems and with no release of the fluids to the above ground
environment. Therefore, only potential occupational and residential bystander exposures
resulting from the use of the herbicide (Magnicide H) were assessed.
Acrolein exposure to handlers can occur in occupational environments. There are no
registered food/feed uses for acrolein and thus no food-related dietary risk assessments were
conducted based on the use pattern and available data on plant metabolism. Risks from
drinking water exposures were not assessed because applications are made to irrigation canals
and holding ponds. The Agency does not anticipate that the water released from these canal
systems would contain acrolein residues that would reach drinking water sources.
Since there are no residential uses of acrolein, an assessment of residential handler and
post-application exposure scenarios was not required. However, residential bystanders may be
exposed due to the volatilization of acrolein from irrigation canals. For this reason, potential
inhalation exposure for bystanders was assessed using available air monitoring data collected
during and after the application of acrolein to canals.
In addition to the parent compound, acrolein, compounds of potential concern include
glycidol, a metabolite of acrolein that has been found in fish, and 3-hydroxypropanal, a
metabolite of acrolein that has been found in acrolein-treated water. While acrolein forms 3-
hydroxypropanal spontaneously in solution, it is an equilibrium process and acrolein will be
reformed from 3-hydroxypropanal as acrolein is dissipated by other processes. Therefore, 3-
hydroxypropanal is not considered a metabolite of concern for risk assessment purposes.
An assessment of the dietary exposure of subsistence fishermen to glycidol was
conducted because glycidol is a potential human carcinogen. Based on available data on
acrolein concentrations in fishable waters, and EPA data on the location and fishing habits of
11
-------
tribes living in areas proximate to treated canals, the Agency believes exposures to subsistence
fishermen are possible. Therefore, the Agency conducted a cancer dietary risk assessment for
glycidol and this assessment of dietary exposure of subsistence fishermen to glycidol indicates
cancer risks do not exceed the Agency's level of concern. For the complete human health risk
assessment, refer to the Acrolein HED Risk Assessment for Reregistration Eligibility Decision
(RED) Document, dated March 25, 2008, which is available in the public docket.
1. Toxicity of Acrolein
The human health risk assessment utilized animal toxicity studies to estimate risk to
humans exposed to acrolein. The toxicological database for acrolein is considered adequate for
evaluating and characterizing acrolein toxicity and selecting endpoints for the purpose of a risk
assessment.
Acrolein is acutely toxic by inhalation, oral, and dermal exposures (Toxicity Category I
for all routes). It is a potent irritant to the mucous membranes. Direct contact with liquid
acrolein causes rapid and severe eye and skin irritation or burns. Dermal exposure to acrolein
liquids or vapors may cause stinging of the eyes, lacrimation, and reddening, ulceration, or
necrosis of the skin. Table 5 describes the acute toxicity profile of acrolein.
Table 5: Acrolein Acute Toxicity Profile
Guideline No.
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute oral [rat]
Acute dermal [rabbit]
Acute inhalation [rat]
Primary eye irritation [rabbit]
Acute dermal irritation [rabbit]
Skin sensitization
MRID(s)
41257001
00141028
40945404
00141025
00141026
Sustin and
Breienstein, 1990
Results
LD50=llmg/kg
LD50 = 231mg/kg
LC50 = 0.019mg/L
Severely irritating
Severely irritating
Suggestive/limited
data
Toxicity
Category
I
I
I
I
I
N/A
Chronic Toxicity
Apart from rare cases of sensitization, no adverse effects in humans chronically
exposed to low concentrations of acrolein have been reported. Animal studies indicate that the
respiratory system is the major target organ for acrolein inhalation toxicity. Oral acrolein
exposure may result in gastrointestinal discomfort, vomiting, and stomach ulceration and/or
hemorrhage. Also, changes in body and organ weights, hematology, and serum biochemistry
have been observed in animals exposed orally to acrolein, although some of these effects are
believed to be secondary effects of gastrointestinal and/or respiratory tract irritation. In
addition, the central nervous system does not appear to be a target of acrolein toxicity based on
an Agency for Toxic Substances Disease Registry (ATSDR) 2005 review.
12
-------
Developmental Toxicity
In a rat developmental toxicity study, the LOAEL was 10 mg/kg/day based on
decreased fetal weights and litter weights and on incomplete ossification of the skeleton and
general retarded development of the fetuses. The developmental NOAEL was 6 mg/kg/day. In
a rabbit developmental toxicity study, the LOAEL was > 2 mg/kg/day and the developmental
NOAEL was 2 mg/kg/day (the highest dose tested).
In a two-generation reproduction toxicity study for rats, the LOAEL for parental
toxicity was 6 mg/kg/day, based on decreased body weights, body weight gains, and food
consumption in both sexes and both generations during pre-mating and on gross and
microscopic findings in the stomach. The NOAEL for this same study was 3 mg/kg/day.
Therefore, based on these developmental studies in rats and rabbits and reproductive
toxicity study in rats, fetal or neonatal toxicity from the administration of acrolein does not
occur at doses lower than doses causing effects in parental animals.
Carcinogenicity and Mutagenicity Toxicity
The evidence for the carcinogenicity of acrolein is equivocal, with a significant tumor
incidence found in a single animal drinking water study. While the potential carcinogenicity of
acrolein cannot be determined definitively due to insufficient data, the Agency does not believe
cancer studies are required based on use patterns, anticipated exposure patterns, severe acute
toxicity, and available data on mutagenicity and carcinogenicity. Oral exposures to acrolein
via dietary and drinking exposure are not expected or assessed based on use patterns and
physical/chemical property data. Continuous chronic exposures via inhalation and dermal
pathways are not expected based on established use patterns. In vitro studies have shown
acrolein to be weakly mutagenic.
Glycidol is a metabolite of acrolein reported in a fish metabolism study. Glycidol is
reasonably anticipated to be a human carcinogen based on sufficient evidence of
carcinogenicity in experimental animals (NTP 1990, IARC 2000). Two-year studies were
conducted with mice and rats that were administered glycidol by gavage. Rats showed
increased incidences of various effects such as tumors. To quantify the carcinogenic response
of glycidol, a multistage model BMD analysis was performed to derive a slope factor of 0.16
(mg/kg/day)"1. This method is explained further in the following section (Endpoint Selection)
as well as in the Acrolein HED Risk Assessment for Reregistration Eligibility Decision (RED)
Document.
Neurotoxicity Studies
The central nervous system does not appear to be a target of acrolein toxicity based on
an Agency for Toxic Substances Disease Registry (ATSDR) 2005 review. Symptoms of
central nervous system depression were observed in rodents after oral exposure to acrolein, but
only after lethal concentrations (Sprince et al. 1979). No such effects were observed in animals
after inhalation. In addition, no behavioral changes were observed in animals exposed to
acrolein by any route. There were no studies addressing the neurotoxicity of acrolein
13
-------
following dermal exposure. As such, the available data do not indicate that the central nervous
system is the major target of acrolein toxicity.
2. Endpoint Selection
Acrolein
The inhalation endpoint was selected from a 1977 study in human volunteers (Weber-
Tschopp et al. 1977; MRID 47060601). Acrolein is a component of cigarette smoke and the
human study was conducted to determine the effects of different components of cigarette
smoke on human volunteers. This study was subject to review by the Human Studies Review
Board (HSRB). The HSRB reviewed the study at its June 2007 meeting and determined it to
be ethically acceptable and sufficiently sound from a scientific perspective, to be used to
estimate a safe level of acute inhalation exposure to acrolein. Because a human study is being
used for the short-term intermittent inhalation exposure scenario for acrolein, an interspecies
uncertainty factor is not necessary. To account for the individual variability, an intraspecies
uncertainty factor of 10X applies. The endpoint selected was based on LOAELs for both (1)
eye irritation and (2) nasal and throat irritation and decreased respiratory rate.
For eye irritation effects, the LOAEL was determined to be 0.09 ppm. Because a
minimal (relatively non-severe) LOAEL threshold effect is used, a 3X uncertainty factor is
sufficient along with the intraspecies factor. Therefore, a total of SOX uncertainty factor is
applied to the endpoint.
For nasal and throat irritation and decreased respiratory rate, the LOAEL was
determined to be 0.3 ppm. This LOAEL was divided by a factor of 100 (10X for using a
LOAEL and 10X for human variability).
Therefore, based on both the LOAEL of 0.09 ppm for eye irritation and the LOAEL of
0.3 ppm for nasal and throat irritation, the concentration of concern for humans is determined
to be 0.003 ppm when appropriate uncertainty factors are considered. Thus, the study provides
the most comprehensive description available of acute/short-term effects in humans and
provides the best information available for establishing a Point of Departure (PoD) for short-
term intermittent inhalation worker and residential bystander exposure scenarios.
Glvcidol
The Agency's Benchmark Dose (BMD) software (version 1.3.2) was used to fit a
multistage model to the human lifetime average daily dose (LADDs). The benchmark
response was randomly selected to be 10% (note that when calculating slope factors, the
selection of benchmark response does not greatly affect the calculated slope factor). The
BMDio was calculated to be 0.79 mg/kg/day and the lower 95% confidence limit on the
BMDio, the Benchmark Dose Level (BMDL)io, was calculated to be 0.63 mg/kg/day. Thus,
the slope factor is obtained by dividing the benchmark response level (0.1 or 10%) by the
BMDLio of 0.63 mg/kg/day which equates to 0.16 (mg/kg/day)"1.
14
-------
Table 6 summarizes the toxicological doses and endpoints used in the human health risk
assessment of acrolein.
Table 6: Summary of Toxicological Doses and Endpoints for Acrolein for Use in
Human Health Risk Assessment
Exposure
Scenario
Dose Used in
Risk Assessment
Uncertainty/Safety
Factor
Study and Toxicological
Effects
Acute and Chronic
Dietary -
(All populations)
Acute and chronic oral (dietary and drinking water) exposures to acrolein are not
expected based on use patterns, physical-chemical properties, and plant metabolism
data. Therefore, RfDs are not required and were not selected for this assessment.
Incidental Oral (all
durations)
There are no residential uses for acrolein. Therefore, incidental oral exposure
endpoints are not required and not selected for this assessment.
Dermal
(all durations)
Worker dermal exposures are not expected based on use patterns and personal
protective equipment requirements. There are no residential uses for acrolein and
dermal exposures to residential bystanders are not expected based on use patterns and
physical-chemical properties. Therefore dermal exposure endpoints are not required
and have not been selected for this assessment.
Short -Term
Inhalation
(1-30 days)
LOAELs
0.09ppmforeye
irritation
0.3 ppm for nasal
and throat irritation
Occupational LOC=30
Residential LOC=30
Eye irritation
UFH = 10x
SxlackofaNOAEL
Nasal and throat irritation
UFH =10x
lOxlackofaNOAEL
Human volunteers (healthy male
and female college students)
exposed by inhalation for 60
minutes (Weber-Tschopp et al.
1977) based on a minimal effect
LOAEL of 0.09 ppm for eye
irritation. The LOAEL of 0.3 ppm
for nasal and throat irritation and
decreased respiratory rate is also
considered for endpoint selection.
(MRID 47060601)
Cancer (oral,
dermal and
inhalation)
"The potential carcinogenicity of acrolein is inconclusive; however, exposure to parent
acrolein is not expected.
Glycidol is a metabolite of acrolein in fish. Glycidol is anticipated to be a human
carcinogen by NTP and IARC. To quantify the carcinogenic response of glycidol, a
multistage model BMD analysis was performed to derive a cancer slope factor of 0.16
mg"1kg"1day"1 at a 0.95 confidence level.
LTFH = uncertainty factor for potential variation in sensitivity among members of the human population (intraspecies), NOAEL
= no observed adverse effect level, LOAEL = lowest observed adverse effect level, MOE = margin of exposure, LOG = level
of concern, RiD = Reference Dose
3. Dietary Exposure and Risk (All Populations)
Acrolein
Dietary exposures (acute and chronic) to acrolein are not expected based on the use
pattern (no direct applications of acrolein to crops except through irrigation) and available data
on plant metabolism. A lettuce metabolism study indicates that acrolein is readily
decomposed/incorporated into natural products showing that the only residue of concern is
acrolein on the day of application by irrigation. Since it is unlikely that plants would be
harvested immediately after irrigation, there is little likelihood that there would be dietary
exposure from irrigation water applied to the crop.
15
-------
Additionally, risks from drinking water exposures were not assessed. There is currently
no Maximum Contaminant Level (MCL) set for the protection of drinking water for acrolein
under the Safe Drinking Water Act. Also, the Agency did not calculate quantitative estimated
environmental concentrations (EECs) for use in the risk assessment since acrolein is applied to
irrigation water and there is a holding period before irrigation water is discharged to natural
waters, which could serve as drinking water sources. While uncertainties remain regarding the
potential for drinking water exposure, such exposures are considered unlikely due to the fact
that most, if not all, of any acrolein that could reach a drinking water source from an irrigation
ditch would volatilize before and during the aeration stages of drinking water treatment.
Glycidol
An assessment of potential dietary exposure of subsistence fishermen to glycidol, a
metabolite of acrolein in fish, was also conducted. Based on Agency data on acrolein
concentrations in fishable waters and on the location and fishing habits of tribes living in areas
proximate to treated canals, the Agency believes that a subsistence fisherman scenario is
possible.
No glycidol was noted in plant metabolism studies and would not be expected from
animal studies since acrolein exposure is not expected for terrestrial animals.
In the residue study in fish and shellfish, glycidol accounted for as much as 10 ppb of
the total radioactive residue in catfish in a study conducted at 20 ppb water concentration of
acrolein. Normalizing the water concentration to account for a mean fish LC50 of 34 ppb
would result in a estimated glycidol residue concentration of 17 ppb or 0.17 ug/g. Based on
data provided in EPA's Exposure Factors Handbook Volume II dated August 1997, the mean
Native American subsistence fish harvest is 70 g/day. Multiplying 0.17 ug/g by the
recommended mean intake of 70 grams/day would give 11.9 ug/day or 0.0119 mg/day of
glycidol. This value must be divided by the weight of an adult in kilograms (70 kg) which
gives 0.00017 mg/kg/day. The maximum number of applications reported in the states of
Washington, Oregon, and Idaho was 17 applications during a year for a ratio of 17/365 or
0.0466. Multiplying 0.00017 mg/kg/day by 0.0466 would give 7.9 X 10"6 mg/kg/day. This
value is then multiplied by the glycidol Qi* of 0.16 to give a conservative estimated cancer risk
of 1.2 X 10" . Therefore, based on this conservative assessment, dietary exposure of
subsistence fishermen to glycidol does not present cancer risks of concern.
The Agency recognizes that 70 grams offish/day is a mean value and is not the
maximum reported. However, the projected concentration of glycidol in fish is expected to be
very conservative since it is based on the assumption that all fish consumed are exposed to 34
ppb acrolein for 17 applications per year.
4. Residential (Non-Occupational) Exposure and Risk
Acrolein products are restricted-use pesticides. The sale and use of these products is
limited to certified applicators or persons under their direct supervision. The products may
only be applied for uses covered by the certified applicators certification. However, inhalation
16
-------
exposure to acrolein may occur from the volatilization of MAGNACIDE H from irrigation
canals during treatment.
In 2005, California Air Resources Board (CARB) collected acrolein air monitoring data
during the application of acrolein into an irrigation canal as part of a pilot study conducted in
2005 to determine the applicability of the proposed field test methods before proceeding to the
full scale study. Six samples were collected with acrolein levels ranging from 15.9 to 59.8
ppb. In 2006, CARB collected acrolein air monitoring information during the application of
acrolein (MAGNACIDE H) into an irrigation canal as part of a full scale study conducted in
2006. These data summarized in Table 7 can be found at
http://www.cdpr.ca.gov/docs/empm/pubs/tac/studies/acrolein.htm. Air monitoring was
conducted during a 4 hour application period and for 4 hours post-application. The treatment
rate was 4.0 ppm with a canal flow rate of 357 cubic feet per second. Acrolein levels ranged
from 8.4 to 24 ppb during application and from 1.2 to 5.3 ppb in the post-application period.
These data are considered to be very high quality, but only represent one set of conditions at
one location. For additional information regarding the results of the CARB monitoring, please
refer to the Acrolein HED Risk Assessment for Reregistration Eligibility Decision (RED)
Document, dated March 25, 2008, which is available in the public docket.
Table 7. Results of 2006 CARB Monitoring of Acrolein During Application
Test Location
Application Rate
Canal Flow
Kern County
California
4.0 ppm
357 cfs
Sampling Site
(AP = Application Point)
4 Hour Application Period
1. West bank AP
2. West bank AP collocated sample
3. East bank AP
4. East bank AP collocated sample
5. West bank 25 m south, 9.6 m west of AP
6. East bank 19.5 m south, 10m east of AP
7. West bank 50m south of AP at Canal's Edge
8. East bank 42 m south of AP at Canal's Edge
9. West bank 100 m south of AP at Canal's Edge
lO.East bank 88 m south of AP at Canal's Edge
11. West bank 150 m south of AP at Canal's Edge
12. East bank 137m south of AP at Canal's Edge
13. West bank 200 m south of AP at Canal's Edge
14. East bank 187 m south of AP at Canal's Edge
15. West bank 250 m south of AP at Canal's Edge
16. East bank 237 m south of AP at Canal's Edge
Air Concentration
(ppb)
11
10
11
15
10
9.5
8.4
14
17
20
16
13
13
18
24
11
Results of 2006 CARB Monitoring of Acrolein Four Hours after Application
Kern County
California
4.0 ppm
357 cfs
1. West bank AP
2. East bank AP
3. West bank 25 m south, 9.6 m west of AP
4. East bank 19.5 m south, 10m east of AP
5. West bank 50 m south of AP at Canal's Edge
6. East bank 42 m south of AP at Canal's Edge
7. West bank 100 m south of AP at Canal's Edge
S.East bank 88 m south of AP at Canal's Edge
5.3
3.2
1.4
2.2
2.7
2.7
1.9
2.2
17
-------
Table 7. Results of 2006 CARB Monitoring of Acrolein During Application
Test Location
Application Rate
Canal Flow
Sampling Site
(AP = Application Point)
4 Hour Application Period
9. West bank 150 m south of AP at Canal's Edge
10. East bank 137m south of AP at Canal's Edge
1 1 . West bank 200 m south of AP at Canal's Edge
12. East bank 187 m south of AP at Canal's Edge
13. West bank 250 m south of AP at Canal's Edge
14. East bank 237 m south of AP at Canal's Edge
Air Concentration
(ppb)
2.6
3.2
1.2
1.4
2.4
1.7
In reference to the air monitoring studies listed above, Table 8 provides a summary of
the results from the MAGNACIDE H Field Air Monitoring samples that were collected in
2002. The highest result of 63 ppb occurred at the California #1 Test Location where a leak
reportedly occurred. The results at the other two test locations ranged from not detectable to
30 ppb. The limit of detection was not specified but was estimated to be approximately 1 ppb
based on the lowest reported result, which was 1.5 ppb.
Table 8. Results of MAGNACIDE H Field Air Monitoring (MRID 469769-12)
Test Location, Application
Rate,
Canal Flow
Washington,
1.98ppm,
840 cubic feet per second (cfs)
Central California # 1
8 ppm for 2 hours
200 cfs
Central California #2
7.2 ppm for 2 hours
48 cfs start
38 cfs finish
Sampling Site
Application point
Downstream, right-of-way
Downstream, right-of-way
Downstream, 150 feet into field
Downstream, 150 feet into field
Application point
Downstream, right-of-way
Downstream, right-of-way
Downstream, 150 feet into field
Downstream, 150 feet into field
Application point
Downstream, right-of-way
Downstream, right-of-way
Downstream, 150 feet into field
Downstream, 150 feet into field
Air Concentration (ppb)
25
4
None Detected
2
None Detected
63*
38
13
None Detected
7.8
13
20
30
1.5
7.9
' Equipment leak experienced and operating vehicle entered the test site
c.) Residential Exposure
There are no residential handler (applicator) uses for acrolein. However, residential
bystander exposure through the inhalation pathway can occur as a result of the application of
MAGNACIDE H to irrigation canals, which may be located near residential areas. There are no
requirements for the establishment of area restrictions in the proximity of the application site or
the treated canal.
18
-------
The acrolein exposure level at which inhalation risks are not of concern is 3 ppb.
Measured air concentrations based on monitoring data associated with sites near irrigation
ditches ranged from 1.5 to 63 ppb (see Table 8). The target LOG or MOE for short-term
inhalation exposure to acrolein is 30. Short-term MOEs for residential exposure calculated
using concentrations from the air monitoring data ranged from 1.5 to 60 (see Table 9).
Therefore, depending on the scope to which residential areas are located within the vicinity of
treated canals and/or non-workers are conducting activities near treated canals (during or near
the time of treatment), inhalation MOEs for residential bystander exposure exceed the Agency's
level of concern.
Monitoring data indicates that air concentrations of acrolein generally decrease with
distance from the source (e.g., the treated canal). Therefore, the highest potential risks are to
persons standing adjacent to the canal and the exposures decrease away from the treated water
body. It should be noted that available monitoring data provide insufficient information to
determine the appropriate dimensions of a restricted area relative to the application point or area
source (e.g.., the canal).
Although, the current acrolein label does not prohibit swimming during applications,
irrigation district personnel discourage swimming in canals because of public safety concerns,
particularly the risks of drowning in the canal. While a separate swimmer assessment was not
conducted due to lack of appropriate endpoints for dermal and oral exposure, the Agency notes
that acrolein is irritating at low concentrations and would presumably present some risks to
swimmers.
5. Aggregate Exposure and Risk
The Agency has not conducted a quantitative or qualitative aggregate assessment for
acrolein. An aggregate exposure assessment considers the different pathways (food, water,
occupational, and residential) through which exposure to acrolein may occur when there are
potential residential exposures to the pesticide. Since there are no anticipated dietary/drinking
water exposures to residues of acrolein, an assessment of aggregate exposure from food and
non-food sources is not required. Further, the metabolite of acrolein, glycidol, only forms in
fish and depurates quickly. Although a dietary cancer assessment was conducted for glycidol,
exposures to glycidol via drinking water, inhalation, and dermal pathways are not expected.
Therefore, an aggregate assessment is not required.
6. Occupational Exposure and Risk
a) Occupational Handler/Application Assessment
Based on current use patterns, acrolein exposure to occupational handlers can occur.
MAGNACIDE H and MAGNACIDE B are applied through a closed system transfer from steel
cylinders designed to prevent applicator exposure. Both products are supplied in pressurized
containers where nitrogen is used to force the liquid chemical out of the container through a
metering device. It is then injected directly below the surface of moving water in the canal
where it is carried along by the flow (MAGNACIDE H) or is injected into closed injection well
19
-------
piping (MAGNACIDE B) through sealed hoses. It is important to note that applicators must
use only specified application equipment built specifically for use of these particular products
as directed by the technical registrant Baker Petrolite.
Magnacide H
During the set up and/or break down of equipment, exposure to acrolein from the
application of MAGNACIDE H is not expected because applicators must comply with
stringent label requirements for personal protective equipment (PPE) (i.e., full face air
purifying respirator, butyl rubber gloves, etc.) throughout these activities. Use of a closed
application system combined with stringent training, certification and PPE requirements is
expected to effectively prevent dermal exposures of concern to workers during handling and
application activities.
However, since the application of MAGNACIDE H can vary in time (30 minutes to 8
hours) and respiratory protection is not required after initial set up and prior to break down of
equipment, inhalation exposures to workers during application is possible. The exposure level
at which inhalation risks are not of concern is 3 ppb (90 ppb LOAEL + UF 30). The target
MOE for short-term inhalation exposure to acrolein is 30 and all MOE's >30 are potentially of
concern.
Table 9: Estimated Inhalation Exposure and Risk to Workers and Bystanders
Range of Measured Concentrations
(ppb) (see Tables 7 and 8)
1.5 -63 (0.0015-0.063 ppm)
LOAEL
(ppb)
90 (0.09 ppm)
Target MOE
30
Calculated
MOE
1.5-60
Calculated MOE = Acute Inhalation NOAEL (90 ppb) -^ estimated inhalation concentration (1.5-63 ppb).
Some of the calculated MOEs exceed the Agency's level of concern for worker
exposure during the application period between set up and breakdown of equipment as well as
after disassembling of the equipment has been completed.
The Baker Petrolite Corporation also submitted summary results from a MAGNACIDE
H HERBICIDE Industrial Hygiene Monitoring Study. The Industrial Hygiene Monitoring
Results reported by Baker Petrolite from an air sampler near the worker's breathing zone
indicated that acrolein applicator exposures were all below the limit of detection (LOD), which
ranged from 2.2 to 70 ppb.
Magnacide B (biocide)
Occupational exposures to acrolein from the use of MAGNACIDE B are not expected
because it is applied via a closed system. MAGNACIDE B Microbiocide is applied in injection
systems associated with petroleum production. The MAGNACIDE B product is applied by
pumping acrolein from pressurized containers into closed injection well piping systems. The
closed application system combined with stringent training and PPE requirements is intended to
effectively prevent exposures of concern from any MAGNACIDE B biocide product.
20
-------
b) Occupational Post-application Exposures
Post-application exposures of MAGNACIDE H to workers may also occur depending
on the length of time the worker remains in the area after application has been completed and
the equipment disassembled. Therefore, depending on the extent to which workers remain in
the vicinity of the treated canal after acrolein has been applied and the requirement for use of a
respirator is no longer applicable, inhalation MOEs for worker post-application exposure may
exceed the Agency's level of concern.
7. Endocrine Disruption
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator may designate. "
Following the recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there were scientific bases for including, as part
of the program, androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations
of potential effects in wildlife. When the appropriate screening and/or testing protocols being
considered under the Agency's Endocrine Disrupter Screening Program (EDSP) have been
developed and vetted, acrolein may be subjected to additional screening and/or testing to better
characterize effects related to endocrine disruption.
8. Incident Reports
The following data bases were consulted for poisoning incident data on the active
ingredient acrolein; OPP Incident Data System (IDS), Poison Control Centers, California
Department of Pesticide Regulation, National Pesticide Telecommunications Network
(NPTN), and National Institute of Occupational Safety and Health's (NIOSH) Sentinel Event
Notification System for Occupational Risks (SENSOR).
Three incident reports in the OPP Incident Data System (IDS) were related to acrolein.
One incident occurred in 1999, when a valve on a cylinder that contained Magnacide H, was
struck by an overhead obstacle while entering a service station. A man at the site reported eye
irritation, difficulty breathing, and chemical burns. Two of the incidents resulted in death,
which was directly attributable to an applicator not wearing the required personal protective
equipment. The incident in 1999 occurred when the applicator accidentally ran over and
damaged parts of the delivery system, spilling a few gallons of the product. The applicator
proceeded, without personal protective equipment, to close off the cylinder valve of the
delivery system. He then washed himself off in the canal and traveled to the hospital where he
was treated and then released. He was later found unconscious in his home and died the next
day. The latest incident in 2007 occurred when the applicator was sprayed directly in his face
with acrolein that was under pressure, after he attempted to tighten a connection in the delivery
system. An initial evaluation showed signs of respiratory distress so he was transported to a
medical center where he received immediate treatment. Despite the treatment, the individual
died within several days.
21
-------
Based on exposures reported to Poison Control Centers from 1993 through 2003, 47
cases were reported. A wide range of symptoms were reported including eye
irritation/lacrimation (4 cases reported), headache (3 cases), nausea (2 cases), cough/choke (2
cases), superficial burns (2 cases), and one single event of throat irritation, vomiting, erythema
skin irritation, and pruritus.
Fifteen cases submitted to the California Pesticide Illness Surveillance Program (1982-
2003) were reviewed. In 14 of these cases, acrolein was used alone or was judged to be
responsible for the health effects. Applicator and coincidental activities were associated with 8
of the 14 reported exposure related illnesses. These illnesses included symptoms of coughing,
headache, nausea, and burns on the arm.
The National Pesticide Information Center (NPIC) received calls from 1984-1991 and
acrolein was not reported to be involved in human incidents. There have been no reported
incidents involving bystanders or persons exposed in residential settings. From 1998 to 2003
there was one case reported in the NIOSH SENSOR database involving acrolein. The exposed
individual reported blurred vision and a feeling of warmth. Poison Control Center Data
generally support the finding that acrolein's main effect is due to its irritant properties.
Incidents involving more severe effects resulted from accidental exposures or misuse of the
acrolein product Magnacide H.
In conclusion, if acrolein products are applied according to their labels and user
manuals, the Agency does not anticipate human health incidents from registered acrolein uses.
B. Environmental Fate and Ecological Risk Assessment
The Agency conducted an environmental fate and ecological risk assessment for
acrolein for the purpose of making a reregi strati on decision. The environmental fate and
effects risk assessment is largely based on field studies and monitoring data. Since these
monitoring studies only report the parent active ingredient, data are only available to consider
the risks due to the parent acrolein at this time. In addition, based on available information
regarding volatilization, persistence, and direct and indirect toxicity, acrolein has the potential
to compromise survival and cause sub-lethal effects in non-target aquatic animals and plants,
terrestrial mammals, birds and plants. As such, the assessment endpoints for acrolein include
survival, reproduction and growth of birds, mammals, freshwater fish and invertebrates,
estuarine/marine fish and invertebrates, terrestrial plants, insects, and aquatic plants and algae.
A summary of the environmental risk assessment findings and conclusions is provided below.
For more detail on the acrolein environmental exposure and risk assessment, refer to the
Environmental Fate and Ecological Risk Assessment Chapter in Support of Phase V of the
Reregistration Eligibility Decision on Acrolein, dated July 23, 2008, which is available in the
public docket.
1. Environmental Fate and Transport
Acrolein is considered a contact herbicide that is phytotoxic to most submersed aquatic
vegetation. Submersed aquatic plants treated with Magnicide H are intended to gradually
22
-------
disintegrate into small fragments and then float downstream. Contact herbicides act quickly by
destroying plant cells; however, they do not kill plant roots and re-application may be required.
Due to the reactivity with organic matter, acrolein is not likely to persist in the environment.
However, despite the lack of persistence, it can move considerable distances in fast moving
water such as within irrigation canals.
Degradation and volatilization are believed to be the major pathways for dissipation of
acrolein in water. Acrolein may also bind to plant material and this may serve as an additional
route of dissipation from the water column. The Agency has no acceptable data to assess
microbial degradation or photolysis. Therefore, it is unknown whether these pathways are
significant routes of degradation in the environment.
No acceptable data are available for estimating desorption coefficient (Ka) values for
acrolein. In the aerobic (MRID 43227101) and anaerobic (MRTD 42949201) aquatic
metabolism studies, acrolein was not identified in the sediment of the test vessels which
suggests that acrolein does not partition into sediment to any major degree. In addition, the
very high solubility (237 g/L at 25°C) would indicate a very low tendency to absorb to
sediment.
Acrolein does not undergo hydrolytic degradation in aqueous solution. Rather, it goes
into equilibrium with a hydration product, 3-hydroxypropanal, where water has added to the
double bond. The equilibrium constant is assumed to be independent of pH.
Data of the dissipation rate of acrolein from foliage is not of sufficient quality to allow
for the estimation of a degradation rate. However, even though the data was limited in its
quality; the Agency was able to utilize a 1-day foliar dissipation half-life. Usually, in the
absence of this information, the Agency relies on a default foliar dissipation half-life of 35
days to estimate potential residues on terrestrial animal forage items. However, given the
volatility and reactivity of acrolein, the default value of 35 days is not justifiable. Thus, given
the uncertainties of the submitted data, a 1-day foliar dissipation half-life was used. It is
noteworthy that monitoring studies, included in the ecological risk assessment, show the
toxicity of acrolein is such that even with a dissipation half-life of less than 1 day, acrolein is
persistent enough to move long distances with concentrations that remain a concern for
wildlife.
2. Ecological Exposure and Risk
In ecological risk assessments, the ecological effects characterization describes the
types of effects a pesticide can potentially produce in an animal or plant. This characterization
is generally based on registrant-submitted studies that describe acute and chronic effects
information for various aquatic and terrestrial animals and plants; however, these data may also
be supplemented by data reported in ECOTOX
(http://www.epa.gov/med/Prods_Pubs/ecotox.htm) or open/public literature sources that have
met Agency criteria for acceptability.
To estimate potential ecological risk, the EPA integrates the results of exposure and
ecotoxicity studies using the risk quotient method. The risk quotient (RQ) approach is used in
23
-------
this assessment to reach conclusions regarding the potential for adverse effects associated with
the proposed use of acrolein. The basis of the RQ approach is a comparison of the ratio of
exposure concentrations to effects endpoints with predetermined levels of concern (LOCs).
Risk quotients are calculated by dividing estimated environmental concentrations (EECs),
based on environmental fate characteristics, by ecotoxicity values (acute and chronic) for
various wildlife and plant species. RQs are then compared to LOCs, and when the RQs exceed
the level of concern for a particular category, the Agency presumes a potential risk of concern
to that category.
Although risk is often defined as the likelihood and magnitude of adverse ecological
effects, the risk quotient-based approach does not provide a quantitative estimate of likelihood
and/or magnitude of an adverse effect. These LOCs are indicators of whether a pesticide, used
as directed on the label, has the potential to cause adverse effects on non-target organisms. See
Table 10 for the Agency's LOCs. Risk characterization provides further information on
potential adverse effects and the possible impact of those effects by considering the fate of the
chemical and its degradates in the environment, organisms potentially at risk, and the nature of
the effects observed. To the extent feasible, the Agency seeks to reduce environmental
concentrations in an effort to reduce the potential for adverse effects to non-target organisms.
Table 10. EPA's Levels of Concern and Associated Risk Presumptions
Risk Presumption RQ LOC
Terrestrial animals (birds and wild mammals)
Acute High (Non-listed) Risk
Acute Endangered (Listed) Species
Chronic Risk
EEC'/LCso or LD50/ft2 or LD50/day3
EEC/LC50 or LD5t/ft2 or LD50/day
EEC/NOAEC
0.5
0.1
1
Aquatic animals
Acute High (Non-listed) Risk
Acute Endangered (Listed) Species
Chronic Risk
EEC4/LC50 or EC50
EEC/LC50 or EC50
EEC/NOAEC
0.5
0.05
1
Terrestrial and Semi-Aquatic Plants
Acute High (Non-listed) Risk
Acute Endangered (Listed) Species
EEC5/EC25
EEC/EC05 or NOAEC
1
1
Aquatic Plants
Acute (Non-listed) Risk
Acute Endangered (Listed) Species
EEC6/EC50
EEC/EC05 or NOAEC
1
1
abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalian food items
2 mg/ft2 3 mg of toxicant consumed/day 4 EEC = (ppm or ppb) in water 5 EEC = Ibs ai/A 6 EEC = (ug/L or mg/L) in water
LD50 * wt. of bird LD50 * wt. of bird
24
-------
a. Terrestrial Organisms Exposure and Risk
1) Bird and Mammal Toxicity
Avian
Acrolein is very highly toxic (LD50<10 mg/kg) to birds on an acute oral exposure basis.
The acute oral toxicity of acrolein to the mallard duck (Anasplatyrhynchos) and northern
bobwhite quail (Colinus virginiand) was assessed in separate single-dose studies. Male
mallard ducks were dosed with 92% acrolein, which resulted in a LDso of 9.1 mg/kg a.i. with
sub-lethal effects including weakness, withdrawal, muscular debility, and imbalance. Sub-
lethal effects were also observed at 3.3 mg/kg treatment intervals (MRID 00117668). Another
acceptable mallard duck study via oral dosing with 95.09% acrolein resulted in a LD50 of 28
(18-38) mg a.i./kg-bw. Sub-lethal effects were noted such as lethargy, labored breathing,
tremors, anorexia among others. Body weight and food consumption reductions were also
noted (MRID 42183301). In addition, data in a supplemental study for the oral toxicity of 92%
acrolein to bobwhite quail resulted in a LD50 of 19 mg/kg (MRID 92001003). Therefore, the
most sensitive endpoint used to assess the acute oral toxicity of acrolein is 9.1 mg a.i./kg-bw.
Refer to Table 11 below for a complete listing of the acute toxicity values for birds used in the
risk assessment.
Table 11. Summary of acute toxicity data for terrestrial organisms (birds) exposed to acrolein.
Species Mean Tpst
Measure End- ^ . .. „ Study Reference
(common ofeffect point Concentration Substance Classification (MRID)
name) (C.I.) (% »•»•)
Mallard duck
Anas
platyrhynchos
Mortality
LD50
9.11 mg a.i./kg
(6.32-13.1)
92
Acceptable
00117668
No data are available to evaluate the subacute dietary toxicity (LDso) of acrolein to
birds either through registrant-submitted data or through a search of the open literature
contained in ECOTOX.
In addition, no data are available to evaluate the chronic toxicity of acrolein to birds
either through registrant-submitted data or through a search of the open literature contained in
ECOTOX. Therefore, due to a lack of chronic toxicity data for birds, only acute, dose-based
exposures to birds were considered in the assessment.
In order to assess the risk to birds from inhalation, it is necessary to estimate the
inhalation LD50 for acrolein from rat inhalation toxicity data since there are no direct
measurements of acrolein inhalation toxicity available for birds. The oral LD50 for gulls and
songbirds were estimated using the weight of the bird relative to the weight and LDso of the
mallard. The method for calculating the expressed values listed below in Table 12 are outlined
in the Environmental Fate and Ecological Risk Assessment Chapter in Support of Phase V of
25
-------
the Reregistration Eligibility Decision on Acrolein., dated July 23, 2008, which is referenced in
Appendix D of this document.
Table 12. LDso for representative birds estimated from the acute oral LDso for
mallard duck and the adjusted rat inhalation LD50.
Species
Mallard
Ring-bill gull
Songbird
Body weight
(g)
1580
350
20
Oral LD50 (mg-kg *)
9.1
7.251
4.721
Inhalation LDso (mg-kg"1)
0.5743
0.4582
0.2983
Oral LD50(oral) A) -LD50(oral) mdlKd)Q3WAf&Wmailaldy
H1113.l3.QOri LjLx50finrL sull) — -^-^50 for £..„
adjusted LD5o(inh) for mallard and songbird: LD5o(inh,A) =LD<
Mammal
Acrolein is highly toxic (LDso 10-50 mg/kg) to mammals on an acute oral exposure
basis. In an acute study on rats (Rattus norvegicus; MRID 41257001), acrolein was
administered by gavage to male and female rats. The acute oral LD50 for male and female rats
was 10.3 and 11.8 mg/kg, respectively. The rats were observed for 4 hours, with sublethal
signs of toxicity that included lethargy, hypothermia, changes in respiration and weight loss.
Acrolein is also considered to be a skin/mucous membrane and eye (lacrimator) irritant. In
addition, due to the volatility of acrolein, wildlife may also be exposed through the inhalation
route. The inhalation LCso for acrolein is 17 mg/m3/4 hours in rats. However, for assessment
purposes, this value was converted to a dose-based toxicity value to determine risks from
inhalation of acrolein. For further detail on the process of this conversion, please refer to the
Environmental Fate and Ecological Risk Assessment referenced above in this section. Table
13 provides a summary of the results for acute oral toxicity.
/(LD50(or) rat)*Fre /LD50(lnhjrat)
t)), Fre calculation is in text)
-15"1'
Table 13. Summary of acute toxicity data for terrestrial organisms (mammals) exposed to
acrolein.
Species
(common
name)
Laboratory
rat
Rattus
norvegicus
Measure
of effect
Mortality
End-
point
LD50
Mean
Concentration
(C.I.)
Males: 10.3
(6.4-16.7) mg/kg
Females: 11.8
(7.9-17.6) mg/kg
Test
Substance
(% a.i.)
96.58
Study
Classification
Acceptable
Reference
(MRID)
412570-01
In a 2-generation (rat) reproduction study (MRID 41869101), a LOAEL of 6 mg/kg/day
was determined for parental toxicity. This value was based on decreases in body weight and in
food consumption as well as other adverse effects. The NOAEL was determined to be 3
mg/kg/day for parental toxicity. Likewise, the LOAEL and NOAEL for offspring toxicity are
6 mg/kg/day based on body weight decrease in the FI generation, and 3 mg/kg/day,
respectively.
26
-------
2) Bird and Mammal Exposure
The EEC values for residues on food and feed items used for terrestrial exposure are
derived from the Kenaga nomograph, as modified by Fletcher et al. (1994). Risk quotients are
based on the most sensitive LD50 for birds (mallard) and LD50 and NOAEL values from rat
studies.
In order to estimate risks to terrestrial mammals and birds inhabiting and eating in
fields irrigated with acrolein-treated water, it was necessary to calculate the application rate of
acrolein to a field in units of Ibs a.i./A. This calculation requires conversion from the
concentration of acrolein in irrigation water (mg/L) to the amount of acrolein that could
potentially remain on the foliage after an irrigation event. Note: this method is relevant when
sprinkler irrigation is used in order that the irrigation water is applied to the foliage. Thus,
dietary exposure (other than drinking water) should not be a concern for flood or furrow
irrigation as there is little contact of the irrigation water with the above ground foliage. To
achieve this estimate, a measure of the amount of irrigation water that sticks to the crop was
required. Therefore, in order to provide conservative estimates of risk, the CINTCP value (a
parameter used in the Pesticide Root Zone Model (PRZM) that defines the maximum
interception storage of a crop) for orchards was utilized to estimate exposures to terrestrial
mammals and birds consuming food in fields receiving irrigation water containing various
concentrations of acrolein.
Although acrolein is applied directly to irrigation water and terrestrial plants are not
initially treated with acrolein, the label requires that treated water is to be applied to fields and
thus, terrestrial organisms may potentially be exposed to acrolein-treated water. Typically,
screening-level ecological risk assessments do not take drinking water exposure into account;
however, terrestrial animals could potentially drink water from treated irrigation canals.
Therefore, in order to assess potential risks, dose-based exposures were estimated for several
representative mammalian and avian species, including mink, river otter, spotted sandpiper,
belted kingfisher, herring gull, osprey, mallard duck, great blue heron and bald eagle.
The EEC values used to assess exposure to birds and mammals can be found in the
Environmental Fate and Ecological Risk Assessment Chapter in Support of Phase V of the
Reregistration Eligibility Decision on Acrolein., dated July 23, 2008, which is available in the
public docket.
3) Bird and Mammal Risk
Birds
For the drinking water only exposure, no acute risk LOG is exceeded for non-listed
birds, the acute risk LOG for Federally listed endangered and threatened (listed) species
(RQ>0.1) is exceeded for the spotted sandpiper and belted kingfisher. Therefore, the Agency's
screening-level assessment indicates a potential for acute risk to listed birds (especially smaller
birds) consuming drinking water treated with acrolein at the maximum label rate. Thus, an
analysis will be conducted to determine if any listed or candidate species may co-occur in the
area of acrolein application or areas downstream that could be contaminated from drift or
27
-------
runoff. If it is determined that listed or candidate species may be present in the proposed
application areas (irrigation canals and reservoirs), further biological assessment will be
undertaken. The extent to which listed species may be at risk then determines the need for the
development of a more comprehensive consultation package as required by the Endangered
Species Act. Refer to Table 14 for additional information.
Table 14. Acute dose-based RQ values for birds exposed to Acrolein through drinking water.
Avian Species
Spotted Sandpiper
Belted kingfisher
Herring gull
Osprey
Mallard duck
Great blue heron
Bald eagle
1 Exceeds the acute LOC (0
BW
(kg-bw)
0.043
0.148
1.1
1.5
1.58
2.39
4.65
1) for listed species.
DW
(L/kg-
hw/rl^
0.167
0.111
0.057
0.052
0.051
0.044
0.036
EEC
(mg/kg-bw/d)
2.500
1.662
0.858
0.774
0.761
0.664
0.533
Adjusted
Toxicity
Values
(mg/kg-bw)
5.31
6.39
8.63
9.04
9.11
9.69
10.71
Acute RQs
0.4711
0.2601
0.099
0.086
0.084
0.068
0.050
The acute risk LOC (RQ>0.5) is exceeded for all-sized birds feeding on all forage
categories except large birds (1000 g) feeding on fruits/pods/large insects at application rates of
0.54 Ibs a.i./A representing water treatment rate of 15 mg a.i./L. At an application rate of 0.05
Ibs a.i./A (representing water treatment rate of 1.5 mg a.i./L), the acute risk LOC is exceeded
for small (20 g) and medium (100 g) birds feeding on short grasses, tall grasses and broadleaf
plants/small insects (RQ range 0.78 - 3.09). The acute listed species LOC is exceeded across
all-sized birds feeding in all forage categories except fruits/pods/large insects at application
rates equivalent to 0.05 Ibs a.i./A or greater. At the lowest application rate evaluated (0.005 Ibs
a.i./A) (representing water treatment rate of 0.15 mg a.i./L), the acute risk to listed species
LOC is exceeded for small birds feeding on all forage categories except fruits/pods/large
insects and for medium sized birds feeding on short grasses (Table 15).
Table 15. Acute dose-based RQs for birds of different size and feeding classes exposed to acrolein
on foodstuffs treated with irrigation water.
Food Type
Small (20 g)
Medium (100 g) Large (1000 g)
Application Rate: 0.535 (15 mg/L in water)
Short Grass
Tall Grass
Broadleaf plants/sm insects
Fruits/pods/lg insects
30.921 2
14.171'2
17.391'2
1.931'2
13.851'2
6.351 2
7.791'2
0.871'2
4.3912
2.0112
2.471'2
0.27 2
Application Rate: 0.0535 (1.5 mg/L in water)
Short Grass
Tall Grass
Broadleaf plants/sm insects
Fruits/pods/lg insects
3.091 2
1.4212
1.741'2
0.192
1.381'2
0.6312
0.781'2
0.09
0.4412
0.201 2
0.251'2
0.03
28
-------
Table 15. Acute dose-based RQs for birds of different size and feeding classes exposed to acrolein
on foodstuffs treated with irrigation water.
Food Type
Small (20 g) Medium (100 g) Large (1000 g)
Application Rate: 0.00535 (0.15 mg/L in water)
Short Grass
Tall Grass
Broadleaf plants/sm insects
Fruits/pods/lg insects
0.3112
0.142
0.172
0.02
0.142
0.06
0.08
0.01
0.04
0.02
0.02
0.00
1 Exceeds LOG (RQ>0.5) for acute exposures to non-listed terrestrial birds.
2 Exceeds LOG (RQ>0.1) for acute exposures to listed terrestrial birds.
Foliar dissipation half life: 1 day
Number of applications: 1
Avian LD50: 9.11 (mallard duck)
Lower bound RQs are calculated from CARB monitoring data and do not exceed the
Agency's LOG except for listed, small birds. Upper-bound risk quotients for acute mortality to
birds based on inhalation exceed the acute risk LOG for all birds. Upper-bound concentrations
used to calculate these RQs assume that the air along the sides of the canal is in equilibrium
with the canal water. However, because volatilization from the water's surface is a time-
dependent process, the water is moving, and the air in and around the canal is unbounded; it is
unlikely that equilibrium would ever be approached (Table 16).
Table 16. Acute risk RQs for birds via the inhalation route.
Species
Mallard
Gull
Songbird
Inhalation
LD50 mg-kg"1
0.574
0.458
0.298
Lower Bound
VID mg-kg1
2.21 x 10"2
3.12xlO"2
6.03 x 10"2
Upper Bound
VID
mg-kg"1
2.17 xlO1
3.0.7 xlO1
5.93 x 101
Lower Bound
RQ
mg-kg"1
0.04
0.07
0.201
Upper Bound
RQ
mg-kg"1
382
672
1992
'Exceeds LOG (RQ > 0.1) for listed birds and for restricted use for birds
2 Exceed LOG (RQ > 0.5) for high risk to birds
Mammals
Although no acute risk LOG is exceeded for non-listed mammals, for the drinking
water only exposure scenario the acute risk LOG for endangered species (RQ>0.1) is exceeded
for mammals. Therefore, there is a potential for acute risk to listed mammals consuming
drinking water treated with acrolein at the maximum label rate. No chronic risk LOG is
exceeded for mammals (Table 17).
Table 17. Acute and chronic dose-based RQ values for mammals exposed to Acrolein
through drinking water.
Mammalian
Species
Mink
River otter
BW
(kg-
bw)
1.0
8.0
DW
(L/kg-
bw/d)
0.099
0.080
EEC
(mg/kg-
bw/d)
1.485
1.206
Adjusted Toxicity
Values
(mg/kg-bw)
Acute
7.92
4.71
Chronic
2.31
1.37
Risk Quotients
Acute
0.1871
0.2561
Chronic
0.644
0.879
1 Exceeds the acute LOG (0.1) for listed species.
29
-------
The acute risk LOG (RQ>0.5) is exceeded for all sized mammals feeding on all forage
categories except large mammals (1000 g) feeding on grass, broadleaf plants and small insects
at application rates of 0.54 Ibs. a.i./A (representing water treatment rate of 15 mg a.i./L). At
the highest application rate of acrolein, RQs exceed the LOG for listed species of all sizes and
feeding categories of mammals, with the exception of granivores. At an application rate of
0.0535 Ibs a.i./A (representing water treatment rate of 1.5 mg a.i./L), the acute risk LOG is
exceeded only for small-sized (15 g) mammals feeding on short grasses (RQ=0.54). The acute
listed species LOG for mammals is exceeded for all sized mammals feeding on short grass,
broadleaf plants and small insects (Table 18).
Table 18. Acute dose-based RQs for mammals of different size and feeding classes exposed to
acrolein.
Food Type
Short Grass
Tall Grass
Broadleaf plants/sm insects
Fruits/pods/lg insects
Seeds (granivore)
Short Grass
Tall Grass
Broadleaf plants/sm insects
Fruits/pods/lg insects
Seeds (granivore)
Small (15 g)
Application Rate: 0.534
5.4112
2.481'2
3.0412
0.342
0.08
Application Rate: 0.0534
0.541 2
0.252
0.302
0.03
0.01
Medium (35 g)
Ibs a.i.A (15 mg/L in water)
4.6212
2.121'2
2.6012
0.292
0.06
Ibs a.i./A (1.5 mg/L in water)
0.462
0.212
0.262
0.03
0.01
Large (1000 g)
2.481'2
1.1312
1.3912
0.152
0.03
0.252
0.1 12
0.142
0.02
<0.01
1 Exceeds LOG (RQ>0.5) for acute exposures to non-listed terrestrial mammals.
2 Exceeds LOG (RQ>0.1) for acute exposures to listed terrestrial mammals.
Foliar dissipation half life: 1 day
Number of applications: 1
Mammalian LD50: 10.30
The inhalation LCso for rats exposed to acrolein is 18 mg/m3/4 hours with an LD50 of
2.0 mg-kg"1. For mammals, the lower bound inhalation RQ based on monitoring is >0.1 and
the calculated upper bound inhalation RQ is 20 which exceeds the LOG (RQ >0.5) for acute
risks to mammals.
4) Non-target Terrestrial Plants
There are no terrestrial plant toxicity data with which to evaluate potential risks to
terrestrial plants; however, there is an incident report of adverse effects to agricultural crops to
which acrolein-treated water is routinely applied to dissipate the chemical. It has been
hypothesized that the waxy cuticle of terrestrial plants that protects them from dehydration may
also serve to protect them from the toxic effects of acrolein. However, no data have been
submitted with which to evaluate this hypothesis. Residue data collected from terrestrial plants
indicates dicysteine residues in terrestrial plants treated with acrolein; these data suggest that in
terrestrial plants acrolein can cross-link sulfhydryl residues in proteins.
30
-------
5) Non-target Insects
There are no data available in order to evaluate the acute toxicity of acrolein to
beneficial insects. However, risk is presumed for insects in the absence of data and based on
the chemical's mode of action.
b. Aquatic Organism Exposure and Risk
On an acute exposure basis acrolein is very highly toxic to freshwater fish and
invertebrates, estuarine/marine invertebrates and it is highly toxic to estuarine/marine fish.
Chronic exposure to acrolein resulted in reduced growth and survival in fish and reduced
survival in aquatic invertebrates. Available toxicity data indicate that aquatic animals are just
as sensitive, if not more so, to acrolein than aquatic plants.
1) Fish, Invertebrate, and Aquatic Plant Toxicity
Freshwater Fish/Amphibians
There are several 96-h LC50 values available to describe the acute toxicity of acrolein to
freshwater fish and amphibians. The most conservative value identified to describe the toxicity
of acrolein to freshwater vertebrates is a 96-h LCso of 7 jig a.i./L for larval African clawed frog
(Xenopus laevis) (Holcombe etal. 1987). Supplemental data submitted to the Agency using
guideline test species indicate that the 96-hr LC50 of acrolein (96.4% a.i.) to bluegill sunfish
(Lepomis macrochims), and rainbow trout (Oncorhynchus mykiss), under flow-through
exposures is 22.4 and <31 |ig a.i./L, respectively (MRIDs 415132-01 and 415132-03). Thus,
acrolein is classified as very highly toxic to freshwater fish on an acute exposure basis. The
most sensitive endpoint used to assess the acute toxicity of acrolein to freshwater fish is the 96-
hr LCso for fathead minnow (Pimephalespromelas) of 14 jig a.i./L (Geiger et al. 1990;
Holcombe et al. 1987); for aquatic-phase amphibians, the most sensitive endpoint is the
African clawed frog 96-h LCso of 7 jig a.i./L.
The chronic toxicity of acrolein to fathead minnow {Pimephalespromelas) and flag fish
(Jordanella floridae) were assessed. The NOEC from an EPA fish lifecycle study on fathead
minnow study was 11.4 jig a.i./L (MRID 05008271). Other toxicity data for fathead minnow
indicate that the NOEC for growth and survival are 14 and 35 jig a.i./L, respectively.
Additional data from chronic exposures of flag fish to acrolein indicate a NOEC for growth of
32 jig a.i./L. Thus, the most sensitive endpoints used to assess the chronic toxicity of acrolein
to freshwater vertebrates (fish) was a NOEC value of 11.4. Refer to Table 19.
-------
Table 19. Summary of acute and chronic toxicity data for freshwater fish exposed to acrolein.
Species
(common name)
African Clawed
Frog
Xenopus laevis
Bluegill Sunfish
Lepomis
macrochirus
Fathead minnow
Pimephales
promelas
Fathead minnow
Fathead Minnow
Fathead Minnow
Flagfish
Jor danella floridae
Measure
of
Effect
Mortality
Mortality
Mortality
Growth and
reproduction
Survival of newly
hatched fry
Survival
Survival and Growth
End-point
LC50
LC50
LC50
NOEC
NOEC
NOEC
NOEC
Duration
(days)
4
4
4
32
60
32
32
Mean
concentration
Oig a.i./L)
7.0
22.4
14
9.1
11.4
14
16
Ref. (MRID)
Holcombe 1987*
41513201
Geiger, 1990*
Sabourin 1986*
05008271
Spehar 1989*
Spehar 1989*
*Data value identified in ECOTOX literature search.
Freshwater Invertebrates
An acute 48-hour toxicity study was conducted to determine the effects of acrolein on
freshwater invertebrates. Data available for the waterflea (Daphnia magna) shows that the 48
hour EC50 values for immobilization are <31 and 57 jig a.i./L, based on two submitted studies.
Additional values describing the acute toxicity of acrolein to freshwater invertebrates (e.g.
midge) were identified in the ECOTOX literature search; however, these values were greater
(i.e., less sensitive) than those submitted to the Agency. Thus, the most sensitive endpoint
used to assess the acute toxicity of acrolein to freshwater invertebrates was <31 jig a.i./L.
Acrolein is classified as very highly toxic to freshwater invertebrates on an acute exposure
basis.
In an EPA study (MRID 05008271), three generations of water flea were exposed to
flow-through concentrations of acrolein for three weeks. A NOEC for survival of 7.1 jig a.i./L
was determined after two generations with a NOEC of 16.9 jig a.i./L after the third generation.
The draft aquatic life criteria from the Office of Water cited this study and used the higher
NOEC determined after the third generation. For calculating RQs, the lower value was chosen
consistent with more conservative assumptions used in a screening level risk assessment.
Refer to Table 20 for a summary of this study.
32
-------
Table 20. Summary of chronic toxicity data for freshwater invertebrates exposed to acrolein.
Species
(common name)
Water Flea
Daphnia magna
Measure of Effect
Survival
End-point
NOEC
Duration
(days)
3 Gener-
ations
Mean
concentration
(jig a.i./L)
7.1
Ref. (MRID)
05008271
Estuarine/Marine Fish
Results of an EPA study on acrolein for longnose killifish {Fundulus similis), and
sheepshead minnow (Cyprinodon variegates) indicated that the 48-h LCso value for longnose
killifish was 240 jig a.i./L and the 96-h LCso for sheepshead minnow was 428 jig a.i./L. The
most sensitive endpoint used to assess the acute toxicity of acrolein to estuarine/marine fish is
the 48-hr LCso value for longnose killifish. Acrolein is classified as highly toxic to
estuarine/marine fish on an acute exposure basis. Refer to Table 21 for referenced values.
Table 21. Summary of acute toxicity data for estuarine/marine fish exposed to acrolein.
Species
(common name)
Longnose killifish
Fundulus similis
Sheepshead
minnow
Cyprinodon
variegatus
Measure of Effect
Mortality
Mortality
End-point
LC50
LC50
Duration
(days)
48
96
Mean
concentration
(jig a.i./L)
240
428
Ref. (MRID)
40228401
43225202
No data are available to estimate the chronic toxicity of acrolein to estuarine/marine
fish. Thus, in the absence of data, risk is presumed for estuarine/marine fish.
Estuarine/Marine Invertebrates
A 96-hour acute toxicity study was conducted to determine the effect of acrolein on
Eastern oyster (Crassostrea virginica), brown shrimp (Penaeus aztecus), and mysid shrimp
(Americamysis bahia). The reported 96-h ECso values for Eastern oyster are 55 and 106 jig
a.i./L. Data available for brown and mysid shrimp are 48-h ECso of 100 jig a.i./L, and a 96-h
LCso of 500 jig a.i./L, respectively. The most sensitive endpoint used to assess the acute
toxicity of acrolein to estuarine/marine invertebrates is 55 jig a.i./L. Acrolein is classified as
very highly toxic to the estuarine/marine invertebrates on an acute exposure basis. Refer to
Table 22 for referenced values.
33
-------
Table 22. Summary of acute toxicity data for estuarine/marine invertebrates exposed to acrolein.
Species
(common name)
Eastern oyster
Crassostrea
virginica
Brown Shrimp
Penaeus aztecus
Eastern oyster
Crassostrea
virginica
Mysid shrimp
Americamysis
bahia
Measure of Effect
Shell Growth
Immobility
Shell Deposition
Mortality
End-point
EC50
EC50
EC50
LC50
Duration
(days)
96
48
96
96
Mean
concentration
(jig a.i./L)
55
100
106 (73-183)
500 (390-650)
Ref. (MRID)
40228401
40228401
43164302
43164301
No data are available to estimate the chronic toxicity of acrolein to estuarine/marine
invertebrates. Thus, in the absence of data, risk is presumed for estuarine/marine invertebrates.
Aquatic Plants
In separate Tier 2 (non-vascular) acute toxicity tests, green algae (Pseudokirchneriella
subcapitatum), blue-green algae (Anabaenaflos-aquae), freshwater diatom (Navicula
pelliculosa) and marine diatom (Skeletonema costatum) were exposed to acrolein for 5 days
(MRIDs 426209-01, 426209-02, 426209-03 and 426209-05). The most sensitive species tested
is the marine diatom, which has an ECso for reduction of cell density of 28 jig a.i./L
Also, in a freshwater vascular plant toxicity test for duckweed the NOAEC is 25 jig
a.i./L and the EC50 is 72 |ig a.i./L (MRID 42620904). Median effect concentrations for
vascular and non-vascular aquatic plants are 36 and 72 ug/L, respectively.
2) Fish, Invertebrate, and Aquatic Plant Exposure
Estimated Environmental Concentrations (EECs) for characterizing aquatic exposure
were represented by the maximum application rate of acrolein (15 mg/L) as well as by
available data from monitoring conducted in Washington State for the purpose of the National
Pollution Discharge Elimination System (NPDES).
3) Fish, Invertebrate, and Aquatic Plant Risk
At currently registered maximum treatment rates (15 mg/L for up to 8 hours), non-
target aquatic animals and plants in treated water ways will be exposed to acrolein and thus
exposure will likely result in acute mortality of aquatic animals and plants following a single
treatment. Monitoring data collected for NPDES permitting indicate that while many
34
-------
application events result in non-detections, several detections in the receiving water bodies at
the compliance points result in exceedances an order of magnitude above the Agency's LOG.
One data point showed acrolein concentrations up to 67 ppb have been measured up to 61
miles from the point of application and up to 54 hours after application. These data were
measured in Washington State which has a SLN allowing discharge to receiving waters 48
hours after treatment.
RQs in Table 23 were calculated based on the maximum application rate in the canal
and the highest measured concentrations from the discharge point of an irrigation canal in
Washington State following release after a two day holding period. For additional information
and an extensive review of the monitoring data, please refer to the Environmental Fate and
Ecological Risk Assessment Chapter in Support of Phase V of the Reregistration Eligibility
Decision on Acrolein, dated July 23, 2008, which is available in the public docket.
Table 23. Acute RQs for aquatic animals and plants.
Species
Fathead Minnow
Pimephales promelas
African clawed frog
Xenopus laevis
Water Flea
Daphnia magna
Sheepshead Minnow
Cyprinodon variegatus
Eastern Oyster
Crassostrea virginica
Blue-green Algae
Anabaena flos-aquae
Duckweed
Lemna gibba
Toxicity
Endpoint
(Hg/L)
14
7
<31
428
55
36
72
EEC
(Hg/L)
Max app rate
15,000
15,000
15,000
15,000
15,000
15,000
15,000
RQ*
From max app
rate
1,071
2,143
>484
35
273
417
208
EEC
(Hg/L)
Monitored
Concentration
67
67
67
67
67
67
67
RQ*a
(from
monitoring)
5
10
>2
0.15
1.2
1.8
0.9
* Risk Quotient = EEC/Toxicity
a Monitoring value from a Washington State NPDES permit Measurement at compliance point with release of canal water after 2-day
holding consistent with the Washington State Special Local Needs label.
Freshwater Fish/Amphibians
At the maximum treatment rate of 15 mg/L, acrolein concentrations in the canals
exceed acute risk LOCs (RQ>0.5) with RQs of up to 1071 for freshwater fish and up to 2143
for aquatic-phase amphibians. Monitoring data collected for NPDES permitting indicate that
while many application events result in non-detections, several detections in the receiving
water bodies at the compliance points result in exceedances an order of magnitude above the
Agency's LOG. Calculated RQs for fish and amphibians are up to 10 based on the highest
concentration observed in the monitoring studies after the required holding times. Most of the
NPDES monitoring values result in no risks of concern at the compliance points.
35
-------
Freshwater Invertebrates
Although aquatic invertebrates are less sensitive than fish and aquatic-phase
amphibians to acrolein, the acute risk level of concern (RQ>0.5) for freshwater invertebrates in
the canal is >484. As discussed above for the freshwater fish, the highest observed
concentration in the monitoring data would also result in an RQ of 2 which is above the
Agency's LOG. Most of the NPDES monitoring values result in no risks of concern at the
compliance points.
Estuarine/Marine Fish
Using the sheepshead minnow as a surrogate, the acute risk RQ for estuarine fish in the
canal is 35 which is above the LOG (RQ>0.5) for estuarine/marine fish; however, the acute risk
at the compliance point for the highest observed concentration in the monitoring data gives an
RQ of 0.15 which does not exceed the LOG.
Estuarine/Marine Invertebrates
Based on the toxicity of acrolein to the Eastern oyster, in the canal, the acute RQ is 273
which exceeds the LOG (RQ>0.5) for estuarine/marine invertebrates. The highest observed
concentration in the monitoring data resulted in an RQ of 1.2 at the compliance point. Most of
the NPDES monitoring values result in no risks of concern at the compliance points.
Aquatic Plants
Aquatic plants are particularly sensitive to acrolein. In the canal, the acute risk LOG
for vascular and non-vascular aquatic plants (RQ>1.0) is exceeded with RQs of 208 and 417,
respectively. In addition, RQ values exceed the acute risk to endangered species LOG
(RQ>1.0) for vascular and nonvascular plants with RQs of 600 and 1,250, respectively. For
the highest observed monitoring value, the RQs are 0.9 for vascular plants and 1.8 for non
vascular plants and the corresponding endangered plant RQs are 2.7 and 5.4. Most of the
NPDES monitoring values result in no risks of concern for listed or non-listed plants at the
compliance points.
c.) Listed Species Risk
Table 24 provides a summary of potential direct and indirect effects to listed species in
the irrigation canals. It is unlikely that listed species would be found in or around treated
irrigation canals since the canals are designed to deliver water to agricultural fields. While as
noted above, fish and invertebrate listed species are potentially at risk from the highest
observed concentration in the monitoring data, calculations using most of the compliance
monitoring data would not indicate risks of concern for listed species. Any inadvertent release
of treated canal water may have an effect on listed species in the immediate area, but these
risks are not assessed here.
36
-------
Table 24. Potential listed
to treatment of irrigation
Listed Taxon
species risks associated
canals with acrolein.
with direct or indirect
effects due
__ Direct Effects from Acute T ,. _„.
RQ _ Indirect Effects
Exposures
Aquatic
Aquatic vascular plants
Freshwater invertebrates
Marine/estuarine
invertebrates
Freshwater fish
Marine/estuarine fish
Aquatic phase amphibians
1,250
>484
273
1,071
35
2,143
Yes
Yes
Yes
Yes
Yes
Yes
Yes6
Yes4'5
Yes4'5
Yes4'5
Yes4'5
Yes4'5
Terrestrial
Semi-aquatic plants
Terrestrial plants
Insects
Birds
Terrestrial phase
amphibians
Reptiles
Mammals
presumed1
presumed1
presumed1
0.47
0.47
0.47
0.26
presumed1
presumed1
presumed1
Yes
Yes
Yes
Yes
presumed2
presumed2
presumed2
Yes3'4
Yes3
Yes3'4
Yes3'4
No toxicity data are available to define RQ values for this exposure.
2 Since the risks of direct effects to semi-aquatic and terrestrial plants are unknown, risks of indirect effects to
organisms relying upon these plants are unknown.
3Direct effects to small mammals, amphibians, reptiles and birds could result in indirect effects to animals that rely
upon them as food.
4Direct effects to aquatic animals could result in indirect effects to animals that rely upon them as food.
5Direct effects to aquatic plants (including unicellular and vascular) could result in indirect effects to animals that rely
upon them as food.
^Direct effects to aquatic plants (including unicellular and vascular) could result in alterations in the plant community
structure through changes in species interactions.
3.
Risk Characterization
The Agency has considered the ecological risks associated with the use of acrolein.
Based on the EPA's assessment and taking into account its use pattern, the use of acrolein
according to label directions may potentially result in direct acute or chronic effects to fish,
aquatic invertebrates and/or aquatic plants. Risk is expected for all aquatic organisms in the
canals at all recommended application rates. Risks in the natural fish bearing waters which
37
-------
receive canal outflow range from 0 up to an RQ of 10 for aquatic phase amphibians when label
required holding times are observed. The NPDES permit monitoring data are not extensive,
but most detected concentrations are low and do not violate the permit level of 21 ug/L And as
indicated by reported incidents, inadvertent releases can result in mortality for large numbers
offish.
Risk is presumed for terrestrial plants and insects in the absence of data and the
chemical's mode of action. Based on the most sensitive endpoint for each of the taxa
evaluated, the RQ values for acute effects to listed and non-listed species exceed the LOG for
acrolein. The potential for chronic risk of acrolein is uncertain and highly dependent on
location and treatment regimen. Additionally, the acute toxicity of acrolein suggests that few
biological receptors would survive the initial contact with the chemical; reducing the likelihood
of chronic exposure to acrolein.
Although there is no acute risk LOG exceeded for non-listed birds, there is a potential
for acute risk to listed birds consuming drinking water treated with acrolein at the maximum
label rate. There is also a potential for acute risk to listed mammals consuming drinking water
treated with acrolein at the maximum label rate. Based on upper-bound estimated
environmental concentrations for acrolein in the air surrounding treated canals, there is a risk
of acute mortality for both birds and mammals through inhaling acrolein fumes. Terrestrial
mammals and birds foraging on vegetation, seeds and insects in agricultural fields where
acrolein is applied as irrigation may also experience acute mortality depending on the size of
the animal and the nature of the forage material.
Although the potential for chronic risk cannot be precluded for acrolein, there are no
avian chronic toxicity data available with which to evaluate potential risk; this data gap
contributes to uncertainty. While there are chronic toxicity data for mammals, the potential for
chronic risk to mammals and/or birds is considered low since acrolein residues in treated water
are expected to deter most animals from consuming the water. Additionally, field monitoring
studies indicate that acrolein residues in treated fields dissipate with half-lives of less than 1
day; therefore, potential chronic exposure does not appear to be likely. While multiple
applications may represent a potential source of repeated exposure, frequent repeat applications
are conducted at much lower treatment concentrations than the maximum rate modeled in this
assessment and as discussed previously would be more appropriately characterized as pulsed
acute exposures. Therefore, the potential for chronic exposure is considered low and as such,
potential chronic risk from the use of acrolein is considered low.
a) Endangered Species
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on endangered and threatened species and to
implement mitigation measures that address these impacts. The Endangered Species Act
(ESA) requires federal agencies to ensure that their actions are not likely to jeopardize listed
species or adversely modify designated critical habitat. To analyze the potential of registered
pesticide uses that may affect any particular species, EPA uses basic toxicity and exposure data
and considers ecological parameters, pesticide use information, geographic relationship
between specific pesticide uses and species locations, and biological requirements and
38
-------
behavioral aspects of the particular species. When conducted, these analyses take into
consideration any regulatory changes recommended in this RED being implemented at that
time.
The ecological assessment that EPA conducted for this RED does not, in itself,
constitute a determination as to whether specific species or critical habitat may be harmed by
the pesticide. Rather, this assessment serves as a screen to determine the need for any species-
specific assessment that will evaluate whether exposure may be at levels that could cause harm
to specific listed species and their critical habitat. The species-specific assessment refines the
screening-level assessment to take into account information such as the geographic area of
pesticide use in relation to the listed species and the habits and habitat requirements of the
listed species. If the Agency's specific assessments for acrolein result in the need to modify
use of the pesticide, any geographically specific changes to the pesticide's registration will be
implemented through the process described in the Agency's Federal Register Notice (54 FR
27984) regarding implementation of the Endangered Species Protection Program.
4. Ecological Incidents
A review of the Ecological Incident Information System (EIIS) database identified a
total of 14 incidents that have been reported to the Agency, which may have involved
exposures of acrolein between 1971 and 2007. Of the 14 reported incidents, 1 involved
terrestrial plants; 12 involved effects to fish, amphibians and/or aquatic invertebrates and 1
involved effects to aquatic birds. About half of all reported incidents occurred in California.
It should be noted that many more incidents may have occurred due to acrolein exposures, but
may not have been reported due to various factors, such as a lack of reporting, or a lack of
witnessing effects. Therefore, the lack of an incident report may not accurately indicate an
overall absence of incidents.
In nearly all reported incidents involving acrolein, hundreds to tens of thousands offish
were reportedly killed. Some of the incidents were classified as accidental misuse, while the
majority was considered "probable" to "highly probable".
One incident occurred in 2004 to a private fish pond resulting in a fish kill involving
Koi (Cyprinus carpio), listed by the South San Joaquin Irrigation District in their monitoring
report. It was reported that the owner was not properly informed that the irrigation water for
his pond was being treated with acrolein.
The most recent incident (2007) associated with the use of acrolein involved the loss of
approximately 2400 game fish and 2800 non-game fish on a 1.5 mile stretch of the Cub River
in Idaho. Various species offish were killed as a result of the application of Magnacide® H to
the Cub River Canal adjacent to the Cub River. A leaky gate was observed 2 miles above the
fish kill; however, no dead fish were noted in the river above the beaver ponds which
impounded the water. No residues were collected, nor were any other pollutants reported;
investigators determined the incident was "unlikely" to be directly attributed to acrolein.
In 2008, one of the irrigation districts in Idaho noted that aquatic herbicides applied in a
particular irrigation district had traveled from the irrigation canals through a shallow 'karst-
39
-------
like' aquifer and resulted in fish kills at aquaculture facilities. For clarification purposes, it is
noted that at least some of these Idaho incidents are believed to be due to xylene. This district
no longer uses acrolein.
These reported incidents, as were previously mentioned, may not accurately reflect the
actual number that may be associated with the use of acrolein as an herbicide. Current data
indicate that roughly one third of the reported incidents resulted from the registered use of
acrolein; however, the incidents involving the highest level of mortality resulted from misuses.
To date, the largest loss of aquatic animals, i.e., 338,600 animals killed in 1977, resulted from
an inadequate holding time. However, given the toxicity of acrolein at maximum application
rates, direct contact of any aquatic animal would likely prove lethal within a relatively short
period of time. For a more detailed account of each reported incident, please refer to the
Environmental Fate and Ecological Risk Assessment Chapter in Support of Phase V of the
Reregistration Eligibility Decision on Acrolein, dated July 23, 2008, which is available in the
public docket.
IV. Risk Management and Reregistration Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregi strati on. The Agency has previously identified and required
the submission of the generic (i.e., active ingredient-specific) data required to support
reregi strati on of products containing acrolein as an active ingredient. The Agency has
completed its review of these generic data, and has determined that the data are sufficient to
support reregi strati on of all products containing acrolein. The Agency has determined that
acrolein is eligible for reregi strati on provided that the risk mitigation measures and label
amendments specified in this RED are implemented.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked extensively with
stakeholders and the public to reach the regulatory decisions for acrolein. EPA released its
revised risk assessments on acrolein for public comment on April 2, 2008, for a 60-day public
comment period (Phase 5 of the public participation process). During the public comment
period on the risk assessments, which closed on June 2, 2008, the Agency received comments
from the Washington Department of Ecology, Boise Project Board of Control, U.S.
Department of the Interior (Bureau of Reclamation), commercial applicators, a registrant
(SePRO Corporation), several irrigation districts and canal companies in the western U.S., as
well as the technical registrant Baker Petrolite. These comments in their entirety, responses to
the comments, as well as the preliminary and revised risk assessments, are available in the
public docket for acrolein (EPA-HQ-OPP-2007-0588) in the EPA's electronic docket at
http://www.regulations.gov.
40
-------
Benefits Analysis
The following is a summary of the Agency's review of submissions containing use
(application timing, pest spectrum, etc.) and economic information in response to comments
received during the latest comment period referenced above. The use of acrolein as a herbicide
in irrigation conveyance systems is considered by irrigation districts to be "vital" to their
mission to efficiently provide irrigation water at a low cost and with a minimal loss of water
(e.g. overflow). Based on the data provided in the comments, the cost of using acrolein is
substantially less than other possible alternatives; such is the case with mechanical methods
and biological controls. Although mechanical control does seem to be feasible in some
situations, the expenses of using these methods are substantially more than acrolein, and are
often debated whether or not they tend to expose workers to additional risks.
The alternatives to acrolein have other drawbacks, in addition to higher cost, that make
their use less than ideal. Labor intensive, cumbersome equipment, lack of accessibility,
damage to concrete lined and earthen canals, as well as problems with suspended plant debris
and sediment in the water are some of the many drawbacks. While there are many aquatic
herbicides on the market, a common restriction of these herbicides is that most are not labeled
for use in irrigation water. Those that are labeled for irrigation water have required holding
periods following application and prior to irrigation. Those herbicides that do not have a
holding or containment time in the canal will need to provide a rapid kill through either a high
use rate to maximize contact time with weeds, or will need to be able to work with a minimum
of contact time.
It is the flow of the irrigation water that presents challenges for weed control. The
primary need by water managers is an herbicide to control submerged aquatic vegetation as
well as an algaecide. Although the Agency believes that irrigation districts and canal
companies in the West would still be able to deliver irrigation water if alternative methods
were imposed, it is clear that costs to users would be substantially higher, and it is possible that
increased weed growth would adversely impact the delivery of needed irrigation water.
C. Risk Mitigation and Regulatory Position
The following is a summary of the rationale for managing risks associated with the use
of acrolein. For the use in the petroleum industry, no changes to the label or use pattern are
required for MAGNICIDE B based on the assumptions of completely closed delivery and use
systems. For acrolein use as an herbicide, labeling revisions are required and specific language
is set forth in the summary tables of Chapter V of this document.
1. Human Health Risk Management
There were several potential human health risks of concern identified for acrolein.
Based on the current use pattern, acrolein exposure to occupational handlers can occur. This is
due to the fact that the application of MAGNICIDE H can vary in time (depending on site) and
respiratory protection is not required after initial set up and prior to break down of equipment.
However, this period of time after initial setup and prior to break down of equipment can also
potentially be a concern for post-application risk to workers remaining in the vicinity of the
41
-------
treated canal that are not using respirators. However, if proper safety precautions are followed
as outlined in the Magnacide H Herbicide Application and Safety Manual, for acrolein
applicators, potential exposure can be limited.
In order to address risks to occupational handlers/workers, the following mitigation is
required:
• Instead of requiring the registrant-provided applicator training a minimum of every
three years, the training requirement will be annual.
• Upon request, the registrant must provide State Lead Agencies the names of all
applicators who have received registrant-specific training.
• During application, two trained applicators must be on site at all times.
• All applications must be made during daylight hours.
In order to reduce exposures to bystanders, the following mitigation is required:
• Applicators must post "Do Not Enter" "DANGER" "Pesticide Application in Progress"
signs at the site of application and around the application equipment.
• Certified applicators may only apply at sites where the irrigation district managers or
owners have "No Swimming" signs posted.
Additionally, the following changes to the March 2005 version of the Magnacide H
Herbicide Application and Safety Manual are required because these statements could be
interpreted to mean that acrolein is less toxic than it is:
• On Page 5, paragraph 2 the following language must be removed from the Note to
Physician: "Because of the extreme lacrymatory effect, the concentration tolerable by
man is far below the minimum lethal concentration."
• On Page 24, in Appendix A, remove the table indicating "probable human response" to
acrolein at various concentrations and times of exposure.
• On Page 24, in Appendix A, the paragraphs describing drinking water studies must be
removed.
• The following language should be added to Appendix A:
Adverse health effects have been shown to occur in humans at concentrations as
low as 0.09 ppm;
serious irreversible health effects may occur at concentrations as low as 0.4
ppm for 10 minutes;
OSHA does not allow workers to be exposed to concentrations over 0.3 ppm for
longer than 15 minutes;
- the 8-hour workplace standard is 0.1 ppm; and
- theIDLHis2.0ppm
42
-------
2. Ecological Risk Management
There were several ecological risks of concern identified for acrolein. Based on the
current use pattern, acrolein exposure to wildlife can occur. It is required that application of
acrolein directly to water be made only through close adherence to established standard
operation procedures (SOPs) provided in the acrolein manual. This will limit the extent to
which acrolein can move beyond targeted treated areas. In order to limit non-target effects,
rigorous SOPs should be adhered to for the application of acrolein to agricultural fields.
• The registrant is required to include a module on reducing wildlife exposures in the
annual training program and in theMagnacide H Herbicide Application and Safety
Manual. This module should focus on risks to fish and aquatic organisms and should
include information on the importance of limiting the contamination of natural fish
bearing waters by release of acrolein treated canal water. The current label statement
"Water treated with Magnacide H herbicide must be used for the irrigation of fields,
either crop-bearing, fallow or pasture, where the treated water remains on the field OR
must be held for 6 days before being released into fish bearing waters or where it will
drain into them. " should remain on the label and be included in the training and manual
along with instructions and examples of how to contain the irrigation water while the
acrolein is degrading.
Additionally, the following application restrictions are required to be added to all
acrolein product labels:
• Maximum of eight (8) applications- annually.
• Minimum two (2) week re-treatment interval per application.
V. What Registrants Need to Do
The Agency has determined that products containing acrolein (PC Code: 000701) are
eligible for reregi strati on provided that the risk mitigation measures identified in this document
are adopted and label amendments are made to reflect these measures. Additional data are
required to fill data gaps identified and to confirm this decision. The Agency intends to issue
Data Call-In Notices (DCIs) requiring product-specific data and generic (technical grade) data.
Generally, registrants will have 90 days from receipt of a DCI to complete and submit response
forms or request time extension and/or waiver requests with a full written justification. For
product specific data, the registrant will have 8 months to submit data and amend labels. For
generic data, due dates can vary depending on the specific studies being required.
For acrolein technical grade active ingredient products, the registrant needs to submit
the following items:
Within 90 days from receipt of the generic data call in (DCI):
1. Completed response forms to the generic DCI (i.e. DCI response form and
requirements status and registrant's response form); and
43
-------
2. Any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. Citations of any existing generic data that address data requirements or
submit new generic data responding to the DCI.
Please contact Laura Parsons at (703) 305-5776 with questions regarding generic
reregi strati on.
By U.S. Mail: By express or courier service:
Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD)
Laura Parsons Laura Parsons
U.S. EPA (7508P) Office of Pesticide Programs (7504P)
1200 Pennsylvania Ave., NW Room S-4900
Washington, DC 200460 One Potomac Yard
Arlington, VA 22202
For end-use products containing the active ingredient acrolein, registrants need
to submit the following items for each product.
Within 90 days from receipt of the product-specific data call-in (PDCI):
(1) completed response forms to the generic DCI (i.e. DCI response form and
requirements status and registrant's response form); and
(2) any time extension and/or waiver requests with a full written justification.
Within eight months from receipt of the PDCI:
(1) submit two copies of the confidential statement of formula, EPA form 8570-4;
(2) a completed original application for reregi strati on (EPA form 8570-1). Indicate on
the form that it is an "application for reregi strati on";
(3) five copies of the draft label incorporating all label amendments outlined in Table 7
of this document;
(4) a completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
(5) if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
(6) the product-specific data responding to the PDCI.
Within the time limit specified in the PDCI:
(l)Citations of any existing generic data that address data requirements or submit new
generic data responding to the DCI.
44
-------
Please contact Karen Jones at 703-308-8047 with questions regarding product
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI should
be addressed:
By U.S. Mail: By Express or Courier Service:
Document Processing Desk (DCI/SRRD) Document Processing Desk (DCI/SRRD)
Karen Jones Karen Jones
Office of Pesticide Programs (7508P) Office of Pesticide Programs (7508P)
1200 Pennsylvania Ave., NW Room S-4900
Washington, DC 200460 One Potomac Yard
Arlington, VA 22202
45
-------
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of acrolein has been reviewed. The
risk assessments identified the potential need for certain ecological, environmental fate, and
residue chemistry data. The studies are as follows:
Ecological and Environmental Fate
• Photodegradation (Water); (GDLN 835.2240)
• Photodegradation (Soil); {GDLN 835.2410}
• Photodegradation (Air); {GDLN 835.2370}
• Aerobic Aquatic Metabolism; {GDLN 835.4300}
• Aerobic Soil Metabolism; {GDLN 835.4100}
• Anaerobic Aquatic Metabolism; {GDLN 835.4400}
• Anaerobic Soil Metabolism; {GDLN 835.4200}
• Leaching (Adsorption/Desorption); {GDLN 835.1240/ 835.1230}
• Seedling Emergence/Vegetative Vigor; {GDLN 850.4100/ 850.4150}
Residue Chemistry
• Registrants need to submit the data required for the acrolein TGAIs/MPs, and must
either certify that the suppliers of beginning materials and the manufacturing processes
for these TGAIs/MPs have not changed since the last comprehensive product chemistry
review or submit complete updated product chemistry data packages.
• An enforcement analytical method must be developed and validated, including
validation by an independent laboratory, for the determination of glycidol in fish and
shellfish, if the registrant continues to support the SLN use in reservoirs and labels for
these uses are not revised to provide effective fishing prohibitions (e.g., posting,
restricted entry, etc.).
• If the registrant continues to support the SLN use in reservoirs and labels for these uses
are not revised to provide effective fishing prohibitions (e.g., posting, restricted entry,
etc.), magnitude of the residue of acrolein and glycidol in fish and shellfish are
required. The submission of a protocol is preferable prior to beginning any study.
• A confirmatory nature of the residue study in root and tuber (preferably radish) is
required.
2. Labeling for Technical and Manufacturing Use Products
To ensure compliance with FIFRA, technical and manufacturing use product (MP)
labeling should be revised to comply with all current EPA regulations, PR Notices and
applicable policies. In order to be eligible for reregi strati on, the technical registrants also must
amend all product labels to incorporate the risk mitigation measures outlined in Section IV.
46
-------
The technical and MP labeling should also bear the labeling statements contained in Table 26,
the Label Changes Summary Table.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g) (2) (B) of FIFRA calls for the Agency to obtain any needed product-
specific data regarding a pesticide after a determination of eligibility has been made. The
registrant must review previous data submissions to ensure they meet current EPA acceptance
criteria and if not, commit to conduct new studies. If a registrant believes that previously
submitted data meet current testing standards, then the study MRID numbers should be cited
according to the instructions in the Requirement Status and Registrations Response Form
provided for each product.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above.
Specific language to incorporate these changes is specified in Table 25, the Label Changes
Summary Table.
47
-------
C. Labeling Changes Summary Table
In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV. The
following table describes how language on the labels should be amended.
Table 25: Summary of Labeling Changes for Acrolein
Description
Amended Labeling Language
Placement on Label
End Use Products Intended for Occupational Use
Restricted Use
Requirement
"Restricted Use Pesticide due to a high acute toxicity. For retail sale to and use by
certified applicators and only for those uses covered by the certified applicator's
certification."
Top of the front panel
Manual
"THIS PRODUCT MUST BE ACCOMPANIED BY AN EPA-APPROVED
PRODUCT LABEL AND THE EPA-APPROVED 'Magnacide H Herbicide
Application and Safety Manual.' THE Magnacide H Herbicide Application
and Safety Manual IS LABELING. READ AND UNDERSTAND THE ENTIRE
LABELING AND MANUAL PRIOR TO USE. ALL PARTS OF THE LABELING
AND MANUAL ARE EQUALLY IMPORTANT FOR SAFE AND EFFECTIVE
USE OF THIS PRODUCT."
Immediately below the RUP
statement on the label and on
the cover page of the
Acrolein Manual.
PPE Requirements
Established by the
RED
"All certified applicators participating in the application during the setting up and
breaking down of application equipment and during visual inspection must wear:
• Long-sleeved shirt and long pants,
• Shoes and socks,
• Chemical-resistant gloves made of butyl rubber, and
• a NIOSH-approved full-face respirator with either
o organic-vapor-removing cartridges with a prefilter approved for
pesticides (MSHA/NIOSH approval number prefix TC-23C), or
o a canister approved for pesticides (MSHA/NIOSH approval number
prefix TC-14G)."
Immediately following/below
Precautionary Statements:
Hazards to Humans and
Domestic Animals
48
-------
Table 25: Summary of Labeling Changes for Acrolein
Description
Amended Labeling Language
Placement on Label
PPE Requirements
Established by the
RED
For all
Formulations
Respirator fit testing, medical qualification, and training:
Employers must ensure that all acrolein handlers are:
• Fit-tested and fit-checked using a program that conforms to OSHA's
requirements (see 29CFRPart 1910.134)
• Trained using a program that confirms to OSHA's requirements (see 29CFR
Part 1910.134)
Examined by a qualified medical practitioner to ensure physical ability to safely
wear the style of respirator to be worn. A qualified medical practitioner is a
physician or other licensed health care professional who will evaluate the ability of a
worker to wear a respirator. The initial evaluation consists of a questionnaire that
asks about medical conditions (such as a heart condition) that would be problematic
for respirator use. If concerns are identified, then additional evaluations, such as a
physical exam, might be necessary. The initial evaluation must be done before
respirator use begins. Handlers must be reexamined by a qualified medical
practitioner if their health status or respirator style or use-conditions change.
PPE Requirements
Established by the RED
For all
Formulations
User Safety
Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or
using the toilet.
Users should remove PPE immediately after handling this product. As soon as
possible, wash thoroughly and change into clean clothing."
Precautionary Statements
under: Hazards to Humans
and Domestic Animals
immediately following
Engineering Controls
User Safety
Requirements
"User Safety Requirements
If acrolein is spilled or leaked on clothing, gloves, or shoes, immediately remove
them and wash thoroughly with soap and water.
Follow manufacturer's instructions for cleaning/maintaining PPE. If no such
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
PPE requirements
49
-------
Table 25: Summary of Labeling Changes for Acrolein
Description
Amended Labeling Language
Placement on Label
instructions for washables exist, use detergent and hot water. Keep and wash PPE
separately from other laundry."
"Discard clothing, gloves, shoes, and other absorbent materials that have come into
contact with acrolein. Do not reuse them."
Engineering Controls
"Engineering Controls
"Handlers must use a closed system that is designed by the manufacturer to prevent
dermal and inhalation exposures by removing the product from the container and
applying the product below the water's surface. At any disconnect point, the system
must be equipped with a dry disconnect or dry couple shut-off device that will limit
drippage to no more than 2 ml per disconnect. The closed system must function
properly and be used and maintained in accordance with the manufacturer's written
operating instructions. Handlers must wear the personal protective equipment
required on this labeling."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
(Immediately following PPE
and User Safety
Requirements.)
Environmental Hazards
"The pesticide is extremely toxic to fish and wildlife.
Precautionary Statements
immediately following the
User Safety
Recommendations
Application
Restrictions: Certified
Applicator
Requirements
"At least two certified applicators must be at the application site and able to maintain
visual contact with all certified applicators participating in the application."
"No handlers are allowed to participate in the application unless they are state
certified applicators and have completed the registrant's training program with in the
last 12 months."
Directions for Use
Application
Restrictions
Maximum number of applications:
8 application per year
Directions for Use
50
-------
Table 25: Summary of Labeling Changes for Acrolein
Description
Application
Restrictions: Posting of
Application Equipment
Area
Other Application
Restrictions
Amended Labeling Language
Minimum retreatment interval:
2 weeks
"Posting of Application Equipment Area"
"The Certified Applicator in charge of the application must post signs around the
perimeter of the application equipment area (truck, hoses, and skids). Signs must be
no more than 15 feet apart and contain the following information:"
* Skull and crossbones symbol
* "DANGER/PELIGRO"
* "DO NOT ENTER/NO ENTRE: Pesticide Application/Aplicacion de Pesticidas"
* The name of the product applied
* The start date and time of application
* The end date and time of application.
* The name, address, and telephone number of the Certified Applicator in charge of
the application
"Signs must remain legible during the entire posting period and must be removed
once the application is completed and no later than 3 days after treatment."
"Applications with [Magnacide H] may only be made in canals with posted no
swimming signs.
Contact the local irrigation district if the signs are not posted."
Placement on Label
Directions for Use under the
heading "Posting of
Application Equipment Area"
Directions for Use
51
-------
ACROLEIN APPENDICES
Appendix A. Non-Food and Non-Feed Use Patterns Subject to the Reregistration of
Acrolein
Product
Type
Product Use Site
Max
A.I.
Max AR
Occupational Uses
PRL
Non-food Crops-Irrigation Canals
95
15 ppm (15mg/L)
Non-food Crops-Deep Well Injection
PRL
95
0.25 Ib a.i./lOOO sq. ft
FORMULATION CODES
PRL: Pressurized Liquid
52
-------
Appendix B. Data Supporting Guideline Requirements for Acrolein
Data Supporting Guideline Requirements for the Reregistration of Acrolein
Guideline
Number
Study Description
Citation(s)
PRODUCT CHEMISTRY
830.1550
830.1600
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.6313
830.7000
830.7200
830.7220
830.7300
830.7370
830.7550
830.7570
830.7840
830.7860
830.7950
Product Identity and Composition
Description of Materials Used
Preliminary Analysis
Certified Limits
Enforcement Analytical Method
Color
Physical State
Odor
Stability
PH
Melting Point
Boiling Point
Density
Dissociation Constant
Octanol / Water Partition
Coefficient
Solubility
Vapor Pressure
CSF (1-23-04)
CSF (1-23-04)
41896901,46181201
41896901, CSF (1-23-04)
41896901,46181201
40840601
40840601
40840601
40840601
40840601
N/A
40840601
40840601
N/A
40840604
40840601
40840603
ECOLOGICAL EFFECTS
850.1010
850.1025
850.1035
850.1045
850.1075
850.2100
850.2400
850.4100
850.4150
850.4400
850.4500
Aquatic Invertebrate Acute
Oyster Acute Toxicity Test
Mysid Acute Toxicity Test
Penaeid Acute Toxicity Test
Fish Acute Toxicity - freshwater
Fish Acute tox estuarine/marine
Avian Acute Oral Toxicity (Duck)
Mammal Toxicity (Rat)
Seedling Emergence and Growth
Vegetative Vigor
Aquatic Plant Growth
Algal Plant Toxicity
40228401, 41513202, 05008271
40228401
43164301
40228401
41513201, 41513203, 45205107
40228401,43225202
42183301,
41257001,41869101
Data gap
Data gap
42620904
42620901, 42620905, 4260902
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.3200
870.3700
Acute Oral Toxicity
Acute Dermal Toxicity
Acute Inhalation Toxicity
Acute Eye Irritation
Acute Dermal Irritation
21/28 -Day Dermal Toxicity-Rabbit
Prenatal Developmental Toxicity —
Rabbit
41257001
00141028
40945404
00141025
00141026
00141030
40392401
53
-------
870.3800
870.4100
870.4200
870.5300
870.5375
870.5900
870.7485
Prenatal Developmental Toxicity-
Rat
Reproduction and Fertility Effects,
2-Generation Reproduction
Chronic Oral Toxicity—Dogs
Chronic/Carcinogenicity Feeding--
Rats
Carcinogenicity
In vitro Mammalian Cell Gene
Mutation Assay
In vitro mammalian chromosomal
aberration assay- CHO
In vitro sister chromatid exchange
Metabolism and Pharmacokinetics
00156438
41869101
41071701
41306401, 46568001, 46568002
41334901
41579501
00141033
00141032
42031001, 43177101, 43275901
RESIDUE CHEMISTRY
860.1300
860.1300
860.1300
860.1300
860.1400
Nature of residue in plants (lettuce)
Nature of residue in plants (root
Nature of residue in animals
Nature of residue in fish
Potable water monitoring
43607101,42295101
Data gap
43942101,43938701
43225201
41855401
ENVIRONMENTAL FATE
835.1230
835.2120
835.2240
835.2410
835.2370
835.4100
835.4200
835.4300
835.4400
Leaching and Adsorption /
Desorption
Hydrolysis
Photodegradation in Water
Photodegradation in Soil
Photodegradation in Air
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Aerobic Aquatic Metabolism
Anaerobic Aquatic Metabolism
Data gap
40945401
Data gap
Data gap
Data gap
Data gap
Data gap
Data gap
Data gap
54
-------
Appendix C. Technical Support Documents
Additional documentation in support of the acrolein RED is maintained in the OPP
Regulatory Public Docket, located in Room S-4400 One Potomac Yard (South Building),
2777 S. Crystal Drive, Arlington, VA. It is open Monday through Friday, excluding legal
holidays, from 8:30 a.m. to 4:00 p.m. All documents may be viewed in the OPP Docket
room or viewed and/or downloaded via the Internet at http://www.regulations.gov. The
Agency's documents in support of this RED include the following:
1.) Daiss, B. Acrolein HED Risk Assessment for Reregi strati on Eligibility Decision
(RED) Document. March 25, 2008.
2.) Garber, K., Jones, R.D., and Steeger, T. Environmental Fate and Ecological Risk
Assessment for the Reregi strati on of Acrolein, 2nd Revision. July 18, 2008
3) Morton, T., Revised Dietary Risk and Exposure Estimate For Acrolein Through
Subsistence Diets for Indigenous People of United States. March 25, 2008
4) Phillips, W., Berwald, D., Acrolein Alternatives Assessment Summary and
Uncertainties. March 26, 3008
5) Daiss, B., Acrolein: Occupational and Residential Exposure Assessment and
Recommendations for the Reregi strati on Eligibility Decision. March 25, 2008
6) Morton, T., Acrolein: Revised Product and Residue Chemistry Considerations.
September 27, 2007
7) Jones., R.D., Assessment of Drinking Water Exposure and Acrolein
Concentrations to which Fish May be Exposed, 2n Revision. May 23, 2007
55
-------
Appendix D. Bibliography
In addition to the studies listed in Appendix B, this bibliography contains additional
citations considered to be part of the database supporting the reregi strati on decision for
acrolein.
In addition to the MRID study references listed in Appendix B, this bibliography
contains the expanded study citations as well as additional literature considered to be part of
the database supporting the reregi strati on decision for acrolein.
MRID
Citation
Human Health References
00141025
Dunn, G.R. and J. Goodband (1981) Summary report: Primary eye irritation study
for Acrolein in rabbits. Bioassay Systems Corporation, Woburn, MA. BSC Project
No.: 10258, July 20, 1981. . Unpublished. 7 pages
00141026
Dunn, G.R. and J. Goodband (1981) Summary report: Primary dermal irritation
study for Acrolein in rabbits. Bioassay Systems Corporation, Woburn, MA. BSC
Project No.: 10258, March 21, 1981. Unpublished. 5 pages.
00141028
Muni, I.A.(1981) Acute dermal toxicity (LD50) of Acrolein (Lot No. SFSL-5993) in
rabbits. Bioassay Systems Corporation, Woburn, MA. BSC Project No.: 10258,
September 17, 1981. Unpublished.
00141030
Muni, LA. (1982) 21-Day dermal test of Acrolein in rabbits. Bioassay Systems
Corporation, Woburn, MA. Project No.: 10258, July 28, 1982. Unpublished. 109
pages.
00141032
Loveday, K.S. (1982) Effects of Acrolein on the in vitro induction of sister
chromatid exchanges in Chinese hamster ovary cells. Bioassay Systems
Corporation, Woburn, MA. BSC Project No.: 10258, May 11, 1982. Unpublished
00141033
Gorodecki, J. and G.M. Seixas (1982) Effects of Acrolein on the in vitro induction
of chromosomal aberrations in Chinese hamster ovary cells. Bioassay Systems
Corporation, Woburn, MA. BSC Project No.: 10258, July 23, 1982. Unpublished.
00156438
King, M. (1982) Teratology study of acrolein in rats. Bioassay Systems
Corporation, Woburn, MA. Laboratory Project No.: 10258, November 12, 1982.
Unpublished. 82 pages.
40392401
Hoberman, A.M. (1987) Developmental toxicity (embryo/fetal toxicity and
teratogenic potential) study of acrolein administered orally (stomach tube) to New
Zealand White rabbits. Argus Research Laboratories, Inc., Horsham, PA.
Laboratory Project Id.: 603-001, May 20, 1987. Unpublished
40840601
Caravello, H. (1988) Physical Properties of Acrolein: A Summary: Study No. RD
0070.188. Unpublished study prepared by Baker Performance Chemicals, Inc. 41 p.
Robillard, K. (1988) Vapor Pressure of Acrolein: Laboratory Project ID: HAEL No.:
88-0300: Study No. EN-030-UKA001-1. Unpublished compilation prepared by
Health and Environment Laboratories. 31 p.
40840603
40840604
Matherly, R.; Hackerott, J.; Nguyen, N. (1987) Octanol/Water Parti- tion Coefficient
of Acrolein: Study No. RD0008.287. Unpublished study prepared by Baker
56
-------
Performance Chemicals. 24 p.
40945404
Nachreiner, DJ. and D.E. Dodd. (1987) Acute inhalation toxicity of Acrolein vapor
by one and four hour exposures. Union Carbide Corp., Bushy Run Research Center,
Export, PA. Laboratory Report No.: 49-170, February 2, 1987. MRID 40945404.
Unpublished. 45 pages.
41071701
Long, I.E. (1987) Acrolein - chronic (12 month) oral toxicity study in the dog.
Tegeris Laboratories, Inc., Laurel, MD. Laboratory Project ID.: TL 85016, October
23,1987. Unpublished. 1047 pages.
41068801
Long, I.E. (1986) Acrolein - range finding oral toxicity study in the dog. Tegeris
Laboratories, Inc., Laurel, MD. Laboratory Project ID.: TL 86003, August 7, 1986.
Unpublished. 54 pages.
41257001
David, R.M. (1989) Acute oral toxicity study of Acrolein, inhibited in rats.
Microbiological Associates Inc., Bethesda, MD. Laboratory Study No.: G-
7230.220, September 19, 1989. Unpublished. 87 pages.
41306401
Long, I.E. and J.A. Johnson (1989) 24-month chronic toxicity and oncogenicity
study in the rat with acrolein. Tegeris Laboratories, Inc., Temple Hills, MD.
Laboratory Project Id.: TL 85047, September 6, 1989. Unpublished. 3701 pages.
41334901
Long, J.; Johnson, J. (1989) 18-Month Oncogenicity Study in the Mouse with
Acrolein: Lab Project Number: TL/86057. Unpublished study prepared by Tegeris
Laboratories, Inc. 2267 p.
41579501
Harbell, J. (1989) CHO/HGPRT Mutation Assay with Confirmation: Acrolein: Lab
Project Number: T8403.332001. Unpublished study prepared by Microbiological
Associates, Inc. 36 p.
41855401
Jacobson, B.; Gresham, M. (1991) Magnitude of the Residue for Acrolein in Potable
Water-Arizona Site: Lab Project Number: 38983. Unpublished study prepared by
ABC Laboratories, Inc. 178 p.
41869101
Hoberman, A. (1991) Reproductive Effects of Acrolein Administered Orally via
Gavage to Crl:CD (SD)BR Rats for Two Generations, with one Litter per
Generation: Lab Project Number: 603/003: RD/ 0155/191. Unpublished study
prepared by Argus Research Laboratories, Inc. 1298 p.
41896901 Matherly, R.; Doane, B.; Caravello, H. (1991) Acrolein: Analysis and Certification of
Product Ingredients: Lab Project Number: RD 0139.190. Unpublished study prepared by
Baker Performance Chemicals, Inc. 110 p.
42031001 Sharp, D. (1991) Metabolism of Acrolein in Rats: Lab Project Number: HLA 6318-101.
Unpublished study prepared by Hazleton Labs America, Inc. 363 p.
42295101 Ewing, A.; Kimmel, E.; Ruzo, L. (1992) Interim Report ?carbon 41 Labeled Acrolein
Accumulation and Metabolism in Leaf Lettuce: Lab Project Number: 165W-1: 165W.
Unpublished study prepared by PTRL West, Inc. 122 p.
43177101 Sharp, D. (1994) Supplement No. 1 to Metabolism of Acrolein in Rats: (Preliminary and
Definitive Phases): Final Report: Lab Project Number: HWI/6318/101. Unpublished study
prepared by Hazleton Wisconsin, Inc. 247 p.
43225201 Biever, R. (1994) (Carbon 14)-Acrolein (Magnacide H): Nature and Magnitude of
Residues Study Using Freshwater Fish and Shellfish: Final Report: Lab Project Number:
57
-------
93-3-4701: 12167-0691-6102-145. Unpublished study prepared by Springborn Labs., Inc.
389 p.
43275901 Sharp, D. (1994) Metabolism of Acrolein in Rats (Preliminary and Definitive Phases):
Supplement No. 2: Final Report: Lab Project Number: HWI 6318-101. Unpublished study
prepared by Hazleton Wisconsin, Inc. 29 p.
43607101
43938701
43942101
46181201
46568001
46568002
41334901
41579501
41869101
42031001
43177101
43275901
Mao, J. (1994) (Carbon 14)Acrolein Accumulation and Metabolism in Leaf Lettuce:
Lab Project Numbers: 94-6-5322: 12167-0693-6108-791. Unpublished study
prepared by Springborn Labs, Inc. 304 p.
Berge, M.; Paust, D. (1996) Metabolic Fate of (carbon 14)-Acrolein Orally
Administered to Lactating Goats: Final Report: Lab Project Number: HWI 63 18-
104: 1 167: 1 167-3. Unpublished study prepared by Hazleton Wisconsin, Inc. 512 p.
Berge, M.; Hennes, M. (1996) Metabolic Fate of (carbon 14)-Acrolein Orally
Administered to Laying Hens: Final Report: Lab Project Number: 6318-103: 1168:
1 168-3. Unpublished study prepared by Hazleton Wisconsin, Inc. 489 p.
Matlach, W.; Baham, G. (2003) Determination of Acrolein and Its Impurities in Five
Samples of Acrolein from Baker Petrolite's Acrolein Plant. Project Number:
GLP/0074. Unpublished study prepared by Baker Petrolite Corporation. 137 p.
Gardner, F.M. and G.W. Gorder (2002) 24-month chronic toxicity and oncogenicity
study in the rat with acrolein: supplement to MRID 41306401 . Tegeris Laboratories,
Inc., Temple Hills, MD. Laboratory Project Id.: TL 85047, September 6, 1989;
Supplement June 20, 2002. Unpublished. 113 pages.
Gorder, G.W. (2005) 24-month chronic toxicity and oncogenicity study in the rat
with acrolein: supplement # 2 to MRID 41306401. Tegeris Laboratories, Inc.,
Temple Hills, MD. Laboratory Project Id.: TL 85047, September 6, 1989;
Supplement April 28, 2005. Unpublished. 50 pages.
Long, I.E. and J.A. Johnson (1989) 18-month oncogenicity study in the mouse with
acrolein. Tegeris Laboratories, Inc., Temple Hills, MD. Laboratory Project Id.: TL
86057, October 16, 1989. Unpublished. 2267 pages.
Harbell, J.W. (1989) CHO/HGPRT mutation assay with confirmation.
Microbiological Associates Inc., Rockville, MD. Laboratory Study No.:
T8403. 332001, May 25, 1989. Unpublished. 36 pages.
Hoberman, A.M. (1991) Reproductive effects of acrolein administered orally via
gavage to Crl:CD®(SD)BR rats for two generations, with one litter per generation.
Argus Research Laboratories, Inc., Horsham, PA. Laboratory Project ID.: 603-003;
Study No. RD 0155.191, April 12, 1991. Unpublished. 1298 pages.
Sharp, D. (1991) Metabolism of Acrolein in Rats: Lab Project Number: HLA 6318-
101. Unpublished study prepared by Hazleton Labs America, Inc. 363 p.
Sharp, D. (1994) Supplement No. 1 to Metabolism of Acrolein in Rats: (Preliminary
and Definitive Phases): Final Report: Lab Project Number: HWI/63 18/101.
Unpublished study prepared by Hazleton Wisconsin, Inc. 247 p.
Sharp, D. (1994) Metabolism of Acrolein in Rats (Preliminary and Definitive
Phases): Supplement No. 2: Final Report: Lab Project Number: HWI 6318-101.
Unpublished study prepared by Hazleton Wisconsin, Inc. 29 p.
58
-------
Ecological and Environmental Fate References
00117668
Tucker, R.; Hudson, R. 1970. Acrolein: Acute Oral LD50 for Mallard Drakes.
(Unpublished study received Mar 20, 1975 under 10707-9; prepared by U.S. Fish
and Wildlife Service, Denver Wildlife Research Center, Unit of Physiological and
Pharmacological Studies, submitted by Magna Corp., Santa Fe Springs, CA;
CDL:165015-A
05008271
Macek, K. 1, M. A. Lindberg, S. Sauter, K. S. Buxton, and P. A. Costa. 1976.
Toxicity of Four Pesticides to Water Fleas and Fathead Minnows. Duluth, Minn.:
U.S. Environmental Protection Agency, Environmental Research Laboratory. (EPA
report no. EPA-600/3-76-099; available from: NTIS, Springfield, VA; PB-262 912).
40228401
Mayer, F. 1986. Acute toxicity handbook of chemicals to estuarine organisms:
EPA/600/X-86/231. Prepared by USEPA Environmental Research Laboratory, Gulf
Breeze, FL. 275 p.
40840602
Robillard, Kenneth A. Water Solubility of Acrolein. Performed by Health and
Environmental Laboratories, Eastman Kodak Co. Rochester, NY. Study No. EN
040-UKA001-1. Submitted by Baker Performance Chemicals.. Houston, TX.
40945401
Haag, Werner. R., David Yao, Thomas Pettit, and Theodore Mill. 1988. Estimation
of Hydrolysis Rate Constants for Acrolein (Magnacide H Herbicide andMagnacide
B Microbiocide) in the Environment. Unpublished study performed by SRI,
International, Menlo Park, CA. SRI Project 3562-3. Study submitted by Baker
Performance Chemicals, Houston TX.
40945404
Nachreiner, D.; Dodd, D. (1987) Acute Inhalation Toxicity of Acrolein Vapor by
One and Four Hour Exposures: Project Report 49-170. Unpublished study prepared
by Union Carbide Bushy Run Research Center. 43 p.
41257001
David, R. (1989) Acute Oral Toxicity Study of Acrolein, Inhibited in Rats: Final
Report: Study G-7230.220. Unpublished study pre- pared by Microbiological
Associates, Inc. 87 p.
41513201
Bowman, J. 1990. Acute Flow-through Toxidty of Acrolein to Bluegill (Lepomis
macrochirus): Lab Project Number: 37669. Unpublished study prepared by
Analytical Bio-chemistry Laboratories, Inc. 35 p.
41513202
Blakemore, G. 1990. Acute Flow-through Toxicity of Acrolein to Daphnia magna:
Lab Project Number: 37671. Unpublished study prepared by Analytical Bio-
chemistry Laboratories, Inc. 269 p.
41513203
Bowman, J. 1990. Acute Flow-through Toxicity of Acrolein to Rainbow Trout
(Oncorhynchus mykiss): Lab Project Number: 37670. Un- published study prepared
by Analytical Bio-chemistry Laboratories, Inc. 285 p.
42183301
Pedersen, C., and B. Helsten. 1991. Acrolein: 21-Day Acute Oral LD50 Study in
Mallard Ducks: Lab Project Number: 118-001-04. Unpublished study prepared by
Bio-Life Associates, Ltd. 54 p.
41855401
Jacobson, Brian. 1991. Magnitude of Residue for Acrolein in Potable Water-
Arizona Site. Unpublished study performed by ABC Laboratories, Columbia, MO.
ABC Report No. 38983. Submitted by Baker Performance Chemicals, Houston,
TX.
41869101
Hoberman, A. 1991. Reproductive Effects of Acrolein Administered Orally via
Gavage to Crl:CD (SD)BR Rats for Two Generations, with one Litter per
Generation: Lab Project Number: 603/003: RD/ 0155/191. Unpublished study
59
-------
prepared by Argus Research Laboratories, Inc. 1298 p.
41933001
Jacobson, Brian and Mike Gresham. \99l.Magnitude of the Residue for Acrolein in
Potable Water - Washington Site. Unpublished study performed by ABC
Laboratories, Columbia, MO ABC Laboratories Final Report No. 38685. Submitted
by Baker Performance Chemicals.
42183301
Pedersen, C.; Helsten, B. (1991) Acrolein: 21-Day Acute Oral LD50 Study in
Mallard Ducks: Lab Project Number: 118-001-04. Unpublished study prepared by
Bio-Life Associates, Ltd. 54 p.
42620901
Hughes, J., and M. Alexander. 1992. The Toxicity of Acrolein to Anabaena flos-
aquae: Lab Project Number: B962-01-2. Unpublished study prepared by Malcolm
Pirnie, Inc. 36 p.
42620902
Hughes, J., and M. Alexander. 1992. The Toxicity of Acrolein toNavicula
pelliculosa: Lab Project Number: B962-01-3. Unpublished study prepared by
Malcolm Pirnie, Inc. 36 p.
42620903
Hughes, J., and M. Alexander. 1992. The Toxicity of Acrolein to Skeletonema
costatum: Lab Project Number: B962-01-4. Unpublished study prepared by
Malcolm Pirnie, Inc. 36 p.
42620904
Hughes, J., and M. Alexander. 1992. The Toxicity of Acrolein to Lemna gibba G3:
Lab Project Number: B962-01-5. Unpublished study prepared by Malcolm Pirnie,
Inc. 34 p.
42620905
Hughes, J. and M. Alexander. 1992. The Toxicity of Acrolein to Selenastrum
capricornutum: Lab Project Number: B962-01-1. Unpublished study prepared by
Malcolm Pirnie, Inc. 36 p.
42837601
Smith, A. M. 1993. ( C-Acrolein) -Determination of the aerobic aquatic
metabolism. Unpublished study performed by Springborn Laboratories, Inc.,
Wareham, MA; sponsored and submitted by Baker Performance Chemicals, Inc.,
Houston, TX. SLI Report: #91-3-3747; SLI Study #12167-0789-6100-750.
Experiment initiated December 4, 1992, and completed February 1, 1993 (p. 11).
Final report issued June 3, 1993.
42949201
Smith, A. M. 1993. (14C-Acrolein) -Determination of the anaerobic aquatic
metabolism. Unpublished study performed by Springborn Laboratories, Inc.,
Wareham, MA; sponsored and submitted by Baker Performance Chemicals, Inc.,
Houston, TX. SLI Report # 91-3-3680, SLI Study # 12167-1089-6101-755. The
experiment was initiated on November 9 and terminated on May 21, 1993 (p. 11).
Final report issued September 22, 1993.
43164301
Bettencourt, M. 1994. Acrolein—Acute Toxicity to Mysid Shrimp (Mysidopsis bahia)
Under Flow-Through Conditions: Final Report: Lab Project Number: 94-1-5148:
12167.0292.6106.515. Unpublished study prepared by Springborn Labs, Inc. 88 p
43164302
Bettencourt, M. 1994. Acrolein—Acute Toxicity to Eastern Oyster (Crassostrea
virginica) Under Flow-Through Conditions: Final Report: Lab Project Number: 94-
2-5151: 12167.0292.6107.504. Unpublished study prepared by Springborn Labs,
Inc. 88 p.
43225202
Bettencourt, M. (1994) Acrolein--Acute Toxicity to Sheepshead Minnow
(Cyprinodon variegatus) Under Flow-Through Conditions: Final Report: Lab
Project Number: 94-1-5150: 12167.0292.6105. 505. Unpublished study prepared by
Springborn Labs., Inc. 91 p.
60
-------
43037301
Chou, T. W., and R. J. Spanggord. 1990. Estimation of the aerobic biotransformation
rates for acrolein (Magnacide H Herbicide, Magnacide B Biocide) in soil. SRI
Project No. 3562-4. Unpublished study performed by SRI International, Menlo Park,
CA; and submitted by Baker Performance Chemicals, Inc., Houston, TX.
45205107
Lorz, H., S. Glenn, R. Williams, et al. 1979. Effects of Selected Herbicides on
Smoking ofCoho Salmon: Lab Project Number: R-804283: EPA-600/3-79-071.
Unpublished study prepared by Corvallis Environmental Research Laboratory. 103
46976905
Preus, Martin W., and Charles L. Kissel. 1982. Controlling Plant Growth in
Irrigation Systems: 1982 Nebraska Summer Research with Magnacide H. 1982
Nebraska Irrigation Expo & Water Conference. Performed by Magna Corporation,
Santa Fe Springs, NM, and submitted by Baker Petrolite, Bakersfield CA.
46976913
Baker Petrolite Corporation.2006. Magnacide H herbicide Application by State.
Submitted by Baker Petrolite Corporation.
46976916
Cardwell, Rick, Karen Games, and Brandon Ball. 2004. Engineering Report to
Support General Permit for Aquatic Weed Control in Irrigation Systems. Prepared
by Parametrix, Sumner, WA for the Washington State Water Resources Association.
Submitted by Baker Petrolite Corporation, November 6, 2006.
47008401
Irwin, Katherine. 1988. Henry's Law Constant for Acrolein (Magnacide H
Herbicide and Magnacide B Microbiocide). Performed by SRI International, 333
Ravenswood Avenue, Menlo Park, CA. Submitted by Baker Performance
Chemicals, 3920 Essex Lane Houston, TX. SRI Project PYU 3562.
47008403
Bonnivier, Bonnie, and Joseph Penkala. 2000. Magnacide H Herbicide Irrigation
Dissipation in Kern County Water Storage Districts. Study conducted and submitted
by Baker Petrolite, Bakersfield, CA.
47008404
Performance Chemicals. 1986 Washington Magnacide H Monitoring Report.
Submitted by Baker Petrolite, Bakersfield, CA.
47008407
Penkala, Joe. 2005. Acrolein Residual Analysis During Magnacide H Herbicide
Application in Support of Air Quality Monitoring in Kern Delta Irrigation District,
Bakersfield, CA. Submitted by Baker Petrolite Corporation, November 8, 2006.
92001003
Conn, R. 1990. Baker Performance Chemicals Inc. Phase 3 Summary ofMRID
00117672. Determination of LD50 Acrolein -Bobwhite Quail: Project K-l524.
Prepared by MBA Laboratories, Inc. 10 p.
References From the Open Literature
Human Health
Agency for Toxic Substances and Disease Registry (ATSDR). Division of Toxicology and
Environmental Medicine/Applied Toxicology Branch. U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES Public Health Service DRAFT TOXICOLOGICAL PROFILE
FOR ACROLEIN. September 2005 http://www.atsdr.cdc.gov/toxprofiles/tpl24.pdf
IRIS. TOXICOLOGICAL REVIEW OF ACROLEIN (CAS No 107-02-8)
In Support of Summary Information on the Integrated Risk Information System (IRIS)
61
-------
May 2003. US Environmental Protection Agency. EPA/635/R-03/003. http://www.epa.gov/iris
International Agency for Research on Cancer (IARC) - Summaries & Evaluations
VOL.: 63 (1995) (p. 337) CAS No.: 107-02-8. Chem. Abstr. Name: 2-Propenal. ACROLEIN
(Group 3). 5. Summary and Evaluation.
http: //www. inchem. org/documents/i arc/vol 63 /acrol ein. html
IpcsINCHEM. Acrolein (CICADS 43. 2002)
Ipcs INCHEM ACROLEIN http://www.inchem.org/documents/icsc/icsc/eics0090.htm
Canadian Environmental Protection Act, 1999. PRIORITY SUBSTANCES LIST
ASSESSMENT REPORT. Acrolein. 62 pages. Environment Canada. Health Canada. May
2000. http://www.ec.gc.ca/substances/ese/eng/psap/fmal/acrolein.cfm.
http ://www.tera. org/peer/nov98fmal .htm
Minnesota Department of Health. Risk Assessment Rules/Guidance. Acrolein: Acute Health-
Based Value for Air. May 4, 2004.
http://www.health.state.mn.us/divs/eh/risk/guidance/acroleinmemo.html
Feron V, Kruysse A, Immel H (1978) Repeated exposure to acrol ein vapour: subacute studies in
hamsters, rats and rabbits. Toxicology, 9:47-57.
Weber-Tschopp A, Fischer T, Gierer R, Grandjean E (1977) Experimentalle Reizwirkungen
von akrolein auf den menschen. [Experimental irritation by acrolein in humans.] Zeitschriftfur
Arbeitswissenschqft, 32:166-171 (in German) [cited in IPCS, 1992].
McCarty, Perry L. 1987. Chap. 4: Removal of Organic Substances from Water by Air
Stripping. In: Control of Organic Substances in Water and Wastewater. Bernard B. Berger
(editor). Noyes Data Corporation, Park Ridge, NJ.
Office of Pesticide Programs. 2001. The Incorporation of Water Treatment Effects on Pesticide
Removal and Transformations in Food Quality Protection Act (FQPA) Drinking Water
Assessments. Washington, DC.
Ecological and Environmental Fate
Butler, P. A. 1965. Effects of Herbicides on Estuarine Fauna. 18: 576-580.
3ni, Hugo A., Diego J. Bentivegna, and Miles R. Rhea. 2004. Irrigation of pepper plant
(Capsicum sp.) with water containing acrolein. Agricultural Water Management 67(2004):235-
240.
inment Australia. 2002. Environmental Assessment Report Magnicide H Herbicide containing
acrolein (950 g/L). Environmental Quality Division, Risk Assessment and Policy Section.
Geiger, D. L., L. T. Brooke, and D. J. Call. 1990. Acute Toxicities of Organic Chemicals to
Fathead Minnows (Pimephales promelas). 5(): 332 p.-.
Geiger, D. L., D. J. Call, and L. T. Brooke. 1988. Acute Toxicities of Organic Chemicals to Fathead
Minnows (Pimephales promelas). Q: 355-.
Ghilarducci, D. P. and Tjeerdema, R. S. 1995. Fate and Effects of Acrolein. Reviews of Environmental
Contamination and Toxicology 144:95-146.
nbe, G. W., G. L Phipps, A. H. Sulaiman, and A.D. Hoffman. 1987. Simultaneous multiple
species testing: Acute toxicity of 13 chemicals to 12 diverse freshwater amphibian, fish, and
invertebrate families. Archives of Environmental Contamination and Toxicology 16:697-710.
Hudson, R. H., R. K. Tucker, and M. A. Haegele. 1984. Handbook of Toxicity of Pesticides to
Wildlife. Second Edition. U.S. Fish and Wildlife Service. Patuxent Wildlife Research Center.
TRID 470214075.
Sabourin, T. D. 1986. A. Summary of the Results of Toxicity Tests Performed by Eattelle between March and
62
-------
August in 1986. Letter to L. Brooke, University of Wisconsin-Superior, Center for Lake Superior
Environmental Studies. September 3, 1986. 2 p
Salma, Tauseef. 2001. Henry's Lan> Constant for Acrolein. Baker Petrolite Internal Memorandum to
Miles Rhea, dated January 4, 2001.
Smith, Curtis W. 1962. A.crolein. John Wiley and Sons, London.
South San Joaquin Irrigation District. 2004. 2004 Annual Report. Statewide General NPDES
Permit for Discharges of Aquatic Pesticides. Waste Discharge Identification Number
5B39NP00023. Prepared for the California Regional Water Quality Control Board, Central
Valley Region.
Spehar R. L. 1989. Aquatic Toxicity Test Information on Acrolein with Fathead Minnows
(Pimephalespromelas) and Flagfish (Jordanellafloridae). (): 5 p.
State of Washington, Department of Ecology. 2002. Irrigation System Aquatic Weed Control National
Pollution Discharge Elimination System Waste Discharge General Permit, Permit No. WAG-91000.
Sunzenauer, Ingrid, Edward Fite, Timothy Barry, Henry Nelson, Edward Odenkirchen, and
Dirk Young. 2004. A Discussion with the FIFRA Scientific Advisory Panel Regarding the
Terrestrial and Aquatic Level II Refined Risk Assessment Models
(Version 2.0). Presentation to the FIFRA Science Advsiry Panel, March 4, 2004. Environmental
Fate and Effects Division, Office of Pesticide Programs, United States Environmental
Protection Agency. http://www.epa.gov/oppefedl/ecorisk/fifrasap/rra_title_cont.htm
USEPA. 1993. Wildlife Exposure Factors Handbook. United States Environmental Protection
Agency. Office of Research and Development. EPA/600/R-93/187.
USEPA. 2006. User's Guide: T-REX Version 1.3.1 (Terrestrial Residue Exposure model).
United States Environmental Protection Agency. Environmental Fate and Effects Division.
63
------- |