![](media/image1.png){width="0.78125in" height="0.78125in"}**UNITED
STATES ENVIRONMENTAL PROTECTION AGENCY**

**WASHINGTON, D.C. 20460**

**OFFICE OF PREVENTION, PESTICIDES**

**AND TOXIC SUBSTANCES**

**[MEMORANDUM]{.underline}**

**DATE:** June 27, 2007

**SUBJECT:** **Bromonitrostyrene (BNS)**: Antimicrobials Division's Risk
Assessment for Issuance of the Reregistration Eligibility Decision (RED)
Document.

Case No. 2065

PC Code: 101401

DP Barcode: 338739

**FROM:** Jenny J. Tao, Toxicologist

David Bays, Microbiologist

Jonathan Chen, Ph. D., Toxicologist

Srinivas Gowda, Microbiologist/Chemist

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

And

> Timothy Leighton, Biologist/ORE Assessor

Najm Shamim, Ph. D., Chemist

Regulatory Management Branch II (RMB II)

Antimicrobials Division

**TO:** ShaRon Carlisle, Chemical Review Manager

Diane Isbell, Team Leader

Mark Hartman, Chief

Regulatory Management Branch II

Antimicrobials Division

**THROUGH:** Norm Cook, Chief

Risk Assessment and Science Support Branch

Antimicrobials Division

**REGISTRANT:** The Dow Chemical Company

Attached is the Preliminary Risk Assessment for Bromonitrostyrene (BNS)
for the purpose of issuing a Reregistration Eligibility (RED) Decision.
The disciplinary science chapters and other supporting documents for the
Bromonitrostyrene (BNS) RED are also included as attachments as follows:

1.  Bromonitrostyrene (BNS): Toxicology Disciplinary Chapter for the
    Issuance of the Reregistration Eligibility Decision (RED)
    Document, J. Tao, Toxicologist. March 22, 2007. D338740.

2.  Product Chemistry of Bromonitrostyrene (BNS), Memorandum from S.
    Gowda, Microbiologist/Chemist, to J. Tao. February 1, 2007. D336266.

3.  Bromonitrostyrene (BNS): Dietary Risk Assessment for Reregistration
    Eligibility Decision (RED), Memorandum from N. Shamim, Ph.D.,
    Chemist, to J. Tao. April 2, 2007. D?

4.  Occupational and Residential Exposure Assessment for
    Bromonitrostyrene (BNS), Memorandum from T. Leighton, Biologist,
    to J. Tao. March 22, 2007. D?

5.  Ecological Hazard and Environmental Risk Assessment:
    Bromonitrostyrene (BNS). From D. Bays, Microbiologist, to Mark
    Hartman/ShaRon Carlisle. May 14, 2007. D336286?.

6.  Environmental Fate Assessment of Bromonitrostyrene (BNS) for the
    Reregistration Eligibility Decision (RED) Document. From S. Gowda,
    Microbiologist/Chemist, to J. Tao. February 22, 2007. D336286.

7.  Incident Reports Associated with Bromonitrostyrene (BNS). From J.
    Chen, Ph.D. Toxicologist, to J. Tao. April 2007.

**Bromonitrostyrene**

PC Code: 101401

Case No.: 2065

**Preliminary Risk Assessment**

**for the Reregistration Eligibility Decision (RED) Document**

06/27/2007

**Jenny J. Tao**

**Antimicrobials Division**

**Office of Pesticide Programs**

**U.S. Environmental Protection Agency**

**1200 Pennsylvania Avenue, NW**

**Washington, DC 20460-0001**

**TABLE OF CONTENTS**

**1.0 EXECUTIVE
SUMMARY...................................................................................5**

**2.0 PHYSICAL AND CHEMICAL
PROPERTIES.........................................................13**

**3.0 HAZARD
CHARACTERIZATION........................................................................14**

**3.1 HAZARD
PROFILE..........................................................................................14**

**3.2 DOSE-RESPONSE
ASSESSMENT........................................................................17**

**3.3 FQPA CONSIDERATIONS
..................................................................................19**

**3.4 ENDOCRINE
DISRUPTION....................................................................\...\...\...\...\...\...20**

**4.0 EXPOSURE ASSESSMENT AND
CHARACTERIZATION....................................\...\...\....20**

**4.1 SUMMARY OF REGISTERED
USES\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...20**

**4.2 DIETARY EXPOSURE AND
RISK\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....21**

**4.3 RESIDENTIAL EXPOSURES/RISK
PATHWAYS\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...24**

**5.0 AGGREGATE RISK ASSESSMENT AND
CHARACTERIZATION...........................\...30**

**6.0 CUMULATIVE EXPOSURE AND
RISK............................................................\...\...31**

**7.0 OCCUPATIONAL EXPOSURE
ASSESSMENT...................................................\...\...32**

**7.1 OCCUPATIONAL HANDLER
EXPOSURES\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...34**

**7.2 OCCUPATIONAL POST-APPLICATION
EXPOSURES\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....35**

**7.3 DATA
LIMITATIONS/UNCERTAINTIES\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....37**

**8.0
ENVIRONMENTALRISKS....................................................\...\...\...\...\...\...\...\...\...\...\...\...\...38**

**8.1 ECOLOGICAL
HAZARD\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\.....38**

**8.2 ENVIRONMENTAL FATE
ASSESSMENT\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...39**

**8.3 ENVIRONMENTAL EXPOSURE AND ECOLOGICAL RISK
ASSESSMENT\...\...\...\...\...\...\...40**

**8.4 ENDANGERED SPECIES
CONSIDERATIONS\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....48**

**9.0 INDCIDENT
REPORTS.................................................................................\...\...49**

**10.0
REFERENCES\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\....50**

**11.0 APPENDIX
A..............................................................................................\...\....59**

# **1.0 EXECUTIVE SUMMARY** 

This document provides a risk assessment of Bromonitrostyrene for the
issuance of the Reregistration Eligibility Decision (RED) document.
Bromonitrostyrene (β-bromo-β-nitrostyrene, BNS, CAS No. 7166-19-0) is an
aromatic nitro-vinyl halide. The *cis* and *trans* isomers occur as
yellow solids that are soluble in most organic solvents. Its solubility
in water is low. Bromonitrostyrene is a wide-spectrum organo-nitrogen
biocide and is used as an antimicrobial agent (fungicide, slimicide,
molluscide, mildewcide, algaecide, and microbicide/microbiostat) and in
the manufacture of a variety of materials as an in-can preservative
including industrial lubricants, polymer emulsions, aqueous emulsions,
cutting oils, acrylic-based paints, starch-based adhesives, and fuel
oil. It is most frequently used as a fungicide to combat the formation
of slime in metalworking fluids, recirculating water cooling systems and
in paper and pulp mill operations. Its use in paper and pulp mill
operations may result in indirect contact with food; therefore, dietary
risks from food residues have been assessed. The concentration of
Bromonitrostyrene as an active ingredient in products is 25%.

**Hazard Characterization**

The toxicology database for Bromonitrostyrene is considered to be
incomplete. For a complete hazard characterization of Bromonitrostyrene,
see the supporting disciplinary chapter for Bromonitrostyrene (D338740).

Bromonitrostyrene has a moderate to severe acute toxicity via the oral
and inhalation routes (both Toxicity Category II) and a moderate acute
toxicity by the dermal route of exposure (Toxicity Category III).
Bromonitrostyrene causes moderate to severe irritation to the eyes
(Toxicity Category II) and is corrosive to the skin (Toxicity Category
I). It exhibited a moderate potential to produce dermal sensitization in
guinea pigs. Bromonitrostyrene was found to cause treatment-related
histopathological lesions in the forestomach, glandular stomach, cecum,
nasal passages, gallbladder mucosa, and testis in subchronic oral
studies in rats and mice. Male rats were more adversely affected than
females. Genotoxicity data show that Bromonitrostyrene is genotoxic.
There are no carcinogenicity data for Bromonitrostyrene. A determination
of carcinogenic potential cannot be made based on the available data.

The Agency has decided that no neurotoxicity studies are required at
this time. From the available repeated-dose toxicity studies, there was
no evidence of neurotoxicity of Bromonitrostyrene. It is concluded that
there is no concerns for neurotoxicity resulting from exposure to
Bromonitrostyrene based on the fact that no neurotoxicity findings in
the available studies.

**Dose-Response Assessment**

An internal toxicity endpoint selection committee formed with scientists
in Antimicrobials and Health Effects Divisions evaluated the toxicology
database of Bromonitrostyrene and selected the toxicity endpoints for
acute and chronic dietary risk assessments as well as for
occupational/residential exposure risk assessments. It is decided that
**Number range CHAPTERNumber range CHAPTERno** special hazard-based
safety factor under the Food Quality Protection Act (FQPA) of 1996 is
needed for Bromonitrostyrene based on its current registered use
patterns. Instead, additional database uncertainty factors have been
used to take into account the incompleteness of the database as well as
regarding infants and children's susceptibility.

For dietary risk assessment, the acute and chronic toxicity endpoints
were chosen for all populations including infants and children and
females 13-49 based on a NOAEL value of a 28-day oral toxicity study in
rats (NTP study). An uncertainty factor of 100 (10x inter-species
extrapolation, 10x intra-species variation) and 1000 (10x inter-species
extrapolation, 10x intra-species variation, 10x database uncertainty) is
assigned to the acute and chronic dietary risk assessment, respectively.

The incidental oral toxicity endpoints include short- and
intermediate-term, which were selected based on the NOAEL value of the
NTP's 28-day oral toxicity study in rats. An uncertainty factor of 100
(10x inter-species extrapolation, 10x intra-species variation) and 300
(10x inter-species extrapolation, 10x intra-species variation, 3x
database uncertainty) is assigned to the short- and intermediate-term
incidental oral toxicity endpoints, respectively.

For the short-term (1-30 days), intermediate-term (1-6 months) and
long-term (\>6 months) dermal risk assessment, a NOAEL (systemic) value
was selected from a 21-day dermal toxicity study in rabbits. An
uncertainty factor of 100 was assigned for short-and intermediate-term
risk assessment (10x inter-species extrapolation, 10x intra-species
variation), and an uncertainty factor of 300 was assigned for long-term
risk assessment (10x inter-species extrapolation, 10x intra-species
variation, 3x for use of a subchronic endpoint for the long-term
endpoint).

For the inhalation risk assessment (all durations), the NOAEL value was
chosen from the NTP's 28-day oral toxicity study in rats, and an
uncertainty factor of 1000 was selected (10x inter-species
extrapolation, 10x intra-species variation, 10x route-to-route
extrapolation.

**FQPA Considerations**

The toxicology database for Bromonitrostyrene with respect to assessing
sensitivity of infants and children is not complete. There is only one
developmental toxicity study in rats available for this chemical. There
are no data on developmental toxicity in a non-rodent species and no
data on reproductive toxicity. Uncertainties exist with respect to
determination of both developmental and reproductive effects of
Bromonitrostyrene. Lacks of a reproductive toxicity study and a
developmental toxicity study in a non-rodent species raise the level of
concern for adequately characterizing potential susceptibility of
Bromonitrostyrene.

Based on its current registered use patterns, it is decided that
**Number range CHAPTERNumber range CHAPTERno** special hazard-based
safety factor under the FQPA is needed for Bromonitrostyrene. Instead,
additional database uncertainty factors will be used to take into
account the incompleteness of the database as well as regarding infants
and children's susceptibility.

**Classification of Carcinogenic Potential**

There are no carcinogenicity data for bromonitrostyrene. A determination
of carcinogenic potential cannot be made based on the available data.
Metalworking cutting fluid use triggers the requirement of
carcinogenicity studies as described on the 1987 Antimicrobial Data
Call-In Notice. In addition, the positive findings of *in vitro* and
inclusive results of *in vivo* genetic toxicity studies warrant a
carcinogenicity study.

**Occupational and Residential Exposure and Risk**

The occupational and residential assessment was based on examination of
a single product label that describes the uses (EPA Reg. No. 464-686).
It has been determined that there are no residential products that are
applied directly. Only the use of Bromonitrostyrene as an in-can
preservative applies to residential handlers. In addition, articles
treated with Bromonitrostyrene in occupational settings may also have
the potential for post-application residential exposure.
Bromonitrostyrene-treated articles that may routinely be used in the
residential market include, but are not limited to, material
preservative uses in clothing, leather, inks, and paper. Occupational
handlers may be exposed in the manufacturing of other products (e.g.,
textiles, paints, etc), during treatment of water systems, commercial
painters, and metalworking fluids (MWF). The representative scenarios
selected by EPA for assessment were evaluated using maximum application
rates as stated on the product label. The representative scenarios are
believed to represent high-end uses resulting in dermal, inhalation, and
incidental oral exposures.

To assess the handler risks, EPA used surrogate unit exposure data from
the Chemical Manufacturers Association (CMA) antimicrobial exposure
study and the Pesticide Handlers Exposure Database (PHED). Post
application/bystander exposures were assessed using EPA's standard
assumptions (e.g., Health Effects Division's (HED) *Standard Operating
Procedures (SOPs) for Residential Exposure Assessment*).

***Residential Handler Risk Summary***

[Dermal]{.underline}

The residential handler dermal exposure scenarios are best represented
by the short-term duration (i.e., painting with a brush and airless
sprayer are considered to be intermittent in nature). The short-term
dermal Margin of Exposure (MOEs) for the paint brush and airless sprayer
are 1,500 and 590, respectively, which were above the target MOE of 100,
and therefore, are not of concern. The residential scenarios assume no
Personal Protection Equipment (PPE).

[Inhalation]{.underline}

For the residential painting inhalation assessment, the inhalation MOEs
were above the target MOE of 100 for all scenarios, and therefore, are
not of concern (and no need for a confirmatory inhalation toxicity
study).

***Residential Post Application /Bystander Risk Summary***

[Dermal and Oral]{.underline}

The residential post-application short-and intermediate-term dermal and
incidental oral risks were assessed for children and/or adults coming in
contact with or wearing treated textiles such as clothing. Dermal risks
for toddlers and adults are not of concern even when 100% residue
transfer is assumed from treated clothing (i.e., toddler dermal MOE =
170 and adult dermal MOE = 260). In addition, the incidental oral
exposures from children mouthing treated fabric is not of concern (oral
MOE = 14,000). Because a 100% transfer of residue is used in the
assessment, a confirmatory residue transfer study is not required.

[Inhalation]{.underline}

Based on the low vapor pressure of Bromonitrostyrene and application
methods, inhalation post-application exposure is expected to be minimal.

***Occupational Handler Risk Summary***

[Dermal]{.underline}

For the occupational handler dermal exposure and risk assessment, the
MOEs were above the target MOE of 100 for all scenarios, and therefore,
are not of concern (Note: Closed systems are required for the pulp &
paper, cooling water, and drilling muds for large applications).

[Inhalation]{.underline}

For the occupational handler inhalation exposure and risk assessment,
the MOEs were above the target MOE of 100 for all scenarios, and
therefore, are not of concern (Note: Closed systems are required for the
pulp & paper, cooling water, and drilling muds for large applications).

***Occupational Post Application/Bystander Risk Summary***

Based on the low vapor pressure of Bromonitrostyrene and application
methods, inhalation post-application exposure are expected to be
minimal.

[]{.mark}

**Aggregate Exposure and Risk**

The residential uses that could potentially be aggregated are the paint
applications and the textiles. The likelihood of co-occurrence is
minimal because of the limited frequency of a resident paints coupled
with not all paints and/or textiles treated with Bromonitrostyrene.
Therefore, residential uses are not recommended to be aggregated. In
addition, the inhalation and dermal endpoints are based on different
toxicological effects, and therefore, it is not appropriate to estimate
total MOEs (same situation for the dermal and oral routes for
post-application).

**Environmental Fate Assessment**

Bromonitrostyrene is most likely to degrade rapidly through hydrolysis
and photodegradation in buffer solutions at 25°C. The half-lives for
Bromonitrostyrene were 10.32 hours, 6.17 hours, 4.68 hours, and 3.40
hours at pH 5, pH 7 (HEPES), pH 7 (TRIS), and pH 9, respectively.

Bromonitrostyrene was slightly to moderately mobile in soil with an
estimated Koc value of 770 to 1,570. It also has a low vapor pressure
(4.14 x 10^-4^ mm Hg at 25 ^0^C from a test and 6.76 x 10^-4^ mm Hg at
25 ^0^C by estimation); it may be susceptible to direct photolysis with
a half-life of 1.7 hours. Therefore, Bromonitrostyrene is not likely to
be volatile from dry soil surfaces and may be expected to degrade
rapidly by photolysis.

The output of EPI Suite indicates that Bromonitrostyrene is
non-biodegradable according to the standard test of the Japanese
Ministry of Industry and Trade (MITI). Although Bromonitrostyrene has a
Log K~ow~ of 2.34 and bioaccumulation in fish guideline study found no
signs of distress or death in Bluegills at concertrations of 0.05 ppm,
0.1 ppm or 2 ppm, caution needs to be taken when assessing
bioaccumulation of Bromonitrostyrene in environmental media. A
confirmatory ready biodegradation guideline study is recommended for
conducting a complete environmental fate assessment of Bromonitrostyrene
based on its current registered use patterns.

**Ecological/Environmental Risk Assessment**

***Ecological Hazard***

For the "indoor" uses of Bromonitrostyrene, avian acute oral toxicity
testing (850.2100), preferably using the bobwhite quail**,** freshwater
fish acute toxicity testing (850.1075), preferably the rainbow
trout**,** freshwater invertebrate acute toxicity testing (850.1010),
and terrestrial and aquatic plant testing, all on the technical grade of
the active ingredient (TGAI), are generally required to establish the
toxicity and to support the registered uses of this chemical.

Honeybees are not expected to be exposed to Bromonitrostyrene because of
the indoor use patterns of this pesticide. Therefore, the honeybee
contact LD~50~ test testing is not required.

For the once-through industrial water systems use of Bromonitrostyrene,
fish early life stage testing is required, and acute toxicity testing
with estuarine and marine organisms is conditionally required for the
wood preservative uses of Bromonitrostyrene. Both testing are required
to be carried out with the TGAI.

The results of the avian dietary studies indicate that Bromonitrostyrene
is practically non-toxic to both mallard duck and bobwhite quail. In the
avian acute oral study, the chemical did not cause any deaths, but the
birds regurgitated the test substance within 15 minutes. Therefore, the
study was considered supplemental and did not satisfy guideline
requirements. The dietary studies were considered to be core and met
guideline requirements at the time they were submitted to the Agency.
These studies together in general fulfill guideline requirements
(850.2100).

The acute toxicity to freshwater fish classified Bromonitrostyrene as
being very highly toxic to both warmwater and coldwater fish species.
These studies fulfill guideline requirements (850.1075).

One fish early life stage study was submitted and the results of the
study fulfill guideline requirements (850.1400) based on the
hatchability, survival, and growth data.

Bromonitrostyrene is very highly toxic to aquatic invertebrates based on
the results of the acute toxicity to freshwater invertebrates. The study
fulfills guideline requirements (850.1010).

Several acute toxicity studies on marine/estuarine invertebrates were
found in the Agency's files. The results of these studies showed
Bromonitrostyrene is very highly toxic to mysid shrimp, sheepshead
minnow and eastern oyster. These studies fulfill guideline requirements
(850.1025; 850.1035; 850.1045; 850.1055; 850.1075).

Plant testing is required for the registered uses of Bromonitrostyrene:
Seedling emergence--dose response using rice (*Oryza* sativa) (850.4225)
and Aquatic plant growth (algal and aquatic plant toxicity) -- Tier II
(850.4400/850.5400). No studies were submitted for determining toxicity
to plant species. The Registrant must submit these studies to support
the current use pattern of this chemical.

***Environmental Exposure and Ecological Risk Assessment***

Freshwater and estuarine/marine aquatic organisms and plants could
potentially be exposed to Bromonitrostyrene discharged into the aquatic
environment. The Agency conducted modeling in 2007 to estimate the
exposure and environment risk resulting from such discharges from the
once-through cooling tower use.

Tier I 2005 Probabilistic Dilution Model was used. This model presents
an environmental exposure assessment for releases of Bromonitrostyrene
used for control of mollusks and bacterial, algal, and fungal slimes in
once-through cooling water systems. EPA used the Probabilistic
Distribution Model (version 4) to estimate the number and percentage of
days per year that Bromonitrostyrene concentrations exceed ecotoxicity
benchmarks of concern. Analyses were performed for six Bromonitrostyrene
treatment scenarios derived from product label information. The approach
used for this assessment is based on the methodology EPA developed in
support of Ecological Hazard and Environmental Risk Assessment Chapter
for Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) (Petrie and
Montague, 2006). Components of the methodology described in this section
include the probabilistic distribution model (PDM), BNS application
rates, environmental exposure concentrations of concern (COCs), model
facilities and flow data, and modeling scenarios.

EPA developed six modeling scenarios by combining assumptions about the
treatment type (i.e., target organism, initial vs. maintenance
treatment), application dose, and application frequency. Scenarios 1 and
2 are for initial and maintenance control, respectively, of mollusks
based on the maximum label application rate. Scenario 2 is intended to
simulate maintenance treatment for four hours every other day. Because
PDM cannot be run for alternating days, Scenario 2 includes treatment
for two hours every day.

Scenarios 3 through 6 are for control of bacterial, algal, and fungal
slimes using the continuous method (Scenarios 3 and 4) and intermittent
method (Scenarios 5 and 6). The initial treatment scenarios (i.e.,
Scenarios 3 and 5) include the maximum label application rate, whereas,
the maintenance treatment scenarios use the midpoint of the range of
application rates specified on the label.

The number of release days assumed for all scenarios was 250. This
approach assumes that BNS is not applied on weekends and holidays.

Based on the scenarios included in this analysis, the intermittent
treatment method for bacterial, algal, and fungal slimes resulted in
fewer COC exceedences than the continuous treatment method. Scenarios 5
and 6 simulate the intermittent application method for control of
bacterial, algal, and fungal slimes and resulted in the fewest
exceedences. These scenarios use the same treatment dosages as Scenarios
3 and 4, but the treatment duration is 15 minutes per day instead of 24
hours per day.

This analysis is a screening level evaluation of the potential for
discharges from once-through cooling water systems to exceed
Bromonitrostyrene ecotoxicity COCs in receiving streams. There are
limitations using this methodology. Variables such as stream flow rate
and Bromonitrostyrene dissipation, degradation, and 1/2 life were not
considered in this Tier I model but should be considered in higher tier
modeling. Confirmatory data are needed for monitoring and/or Tier II
modeling of once-through cooling tower effluents to establish EEC's for
risk assessment, and to evaluate degradation and decline of
Bromonitrostyrene (and major transformation products) residues in
effluent and receiving surface waters.

**Endangered Species**

For certain use categories, the Agency assumes there will be minimal
environmental exposure, and only a minimal toxicity data set is required
(Overview of the Ecological Risk Assessment Process in the Office of
Pesticide Programs U.S. Environmental Protection Agency - Endangered and
Threatened Species Effects Determinations, 1/23/04, Appendix A, Section
IIB, page 81). Chemicals in these categories therefore do not undergo a
full screening-level risk assessment, and are considered low exposure.

The industrial processes and water system wastes use of
Bromonitrostyrene will have potential for environmental exposure via
down-the-drain or runoff to surface waters. Industrial disposal water,
sewage systems, and once-through cooling tower water uses may generate
waste water residues that may reach the environment. The once-thru
cooling tower use is considered to be representative of a worst-case
example (highest potential for impacting the environment), and
therefore, this site was modeled.

> The "best case" once-through cooling tower scenario using 1/2 the
> maximum recommended label dosage intermittently applied in a low water
> flow resulted in LOC exceedances for all aquatic organisms used in the
> model, including freshwater fish, green alga, freshwater
> invertebrates, and marine invertebrates. The Agency is not aware of
> any endangered or threatened green algae. Because Bromonitrostyrene is
> rapidly degraded through hydrolysis and photodegradation, impacts to
> aquatic organisms may be less than modeled. However, the once-through
> cooling tower model does not account for degradation and the output of
> EPI Suite indicates that Bromonitrostyrene is non-biodegradable
> according to the standard test of the Japanese Ministry of Industry
> and Trade (MITI); therefore, further assessment is required prior to
> making an Agency's endangered species determination.
>
> The preliminary analysis indicates that there is a potential for
> Bromonitrostyrene industrial water waste discharges to overlap with
> listed species and that a more refined assessment is warranted, to
> include direct, indirect and habitat effects. The more refined
> assessment should involve clear delineation of the action area
> associated with proposed use of Bromonitrostyrene and best available
> information on the temporal and spatial co-location of listed species
> with respect to the action area. This analysis has not been conducted
> for this assessment. **An endangered species effect determination will
> not be made at this time.**

**Incident Reports**

The Agency reviewed the available sources of information for human
poisoning incidents related to Bromonitrostyrene use. In the data
available to the Agency, no reports of serious illness have been
associated with human exposure to Bromonitrostyrene.

In conclusions, the database of Bromonitrostyrene is not complete. No
data are available for reproductive toxicity, chronic toxicity and
carcinogenicity of Bromonitrostyrene. Additional studies are required to
assess exposure in the occupational setting for the current registered
uses: a 90-day inhalation study, carcinogenicity and chronic toxicity
studies, a developmental study in a non-rodent species and a
2-generational reproductive toxicity study. In addition, because of the
severity and uncertainty of the effects (true systemic effects or
secondary to the dermal effects) seen in the 21-day dermal study,
particularly death at the high-dose level, a 90-day dermal study in
rabbits is needed.

# **2.0 PHYSICAL AND CHEMICAL PROPERTIES**

The physical and chemical properties for Bromonitrostyrene assessed in
this document are provided in Table 2.1 and 2.2. The detailed
information is provided in the product chemistry chapter (memo from S.
Gowda, February 2007, D336266).

  ------------------------- ----------------------------------------------------
  **Table 2.1 Active        
  Ingredients for           
  Bromonitrostyrene**       

  **Parameter**             **Bromonitrostyrene (TGAI)**

  **PC Chemical Code**      101401 (active)

  **CAS Number**            7166-19-0

  **Molecular Formula**     C~8~H~6~BrNO~2~

  **Synonyms**              β-bromo-β-nitrostyrene, BNS

  **Structure**             ![](media/image2.png){width="1.7708333333333333in"
                            height="1.4979166666666666in"}
  ------------------------- ----------------------------------------------------

+-------------------------+--------------------------------------------+
| **Table 2.2             |                                            |
| Physical/Chemical       |                                            |
| Properties for          |                                            |
| Bromonitrostyrene**     |                                            |
+-------------------------+--------------------------------------------+
| **Parameter**           | **Bromonitrostyrene (TGAI)**               |
+-------------------------+--------------------------------------------+
| **Molecular Weight**    | 228.04 g/mol                               |
+-------------------------+--------------------------------------------+
| **Color**               | Yellow Powder                              |
+-------------------------+--------------------------------------------+
| **Physical State**      | Yellow Powder                              |
+-------------------------+--------------------------------------------+
| **Odor**                | Weak musty                                 |
+-------------------------+--------------------------------------------+
| **Melting Point**       | 65-66 ^O^C                                 |
+-------------------------+--------------------------------------------+
| **Boiling Point**       | N/A                                        |
+-------------------------+--------------------------------------------+
| **Density**             | 2.2753 g/ml (20 ^O^C)                      |
+-------------------------+--------------------------------------------+
| **Water Solubility**    | 0.001 g/100 ml (25 ^O^C)                   |
+-------------------------+--------------------------------------------+
| **Solubility in Organic | (g/100 ml at 25˚C)                         |
| Solvents**              |                                            |
|                         | 95% Ethanol 4                              |
|                         |                                            |
|                         | Acetone 100                                |
|                         |                                            |
|                         | Benzene 100                                |
|                         |                                            |
|                         | Propylene glycol 3                         |
|                         |                                            |
|                         | Isopropyl myristate 14                     |
|                         |                                            |
|                         | Mineral oil 4                              |
|                         |                                            |
|                         | Dimethyl sulfoxide 90                      |
|                         |                                            |
|                         | Dimethyl formamide 125                     |
|                         |                                            |
|                         | Dioxane 150                                |
+-------------------------+--------------------------------------------+
| **Log K~ow~**           | 2.34                                       |
+-------------------------+--------------------------------------------+
| **Vapor Pressure**      | 4.14 x 10^-4^ mm Hg (25 ^o^C)              |
+-------------------------+--------------------------------------------+
| **pH**                  | 4 (25^o^ C)                                |
+-------------------------+--------------------------------------------+
| **Stability**           | Stable under normal storage conditions     |
+-------------------------+--------------------------------------------+

**3.0 HAZARD CHARACTERIZATION**

##  3.1 Hazard Profile

The acute oral toxicity of Bromonitrostyrene is moderate to severe
(Toxicology Category II), with mortality, urinary and fecal staining,
soft stool, nasal and/or oral discharge, unthrifty coat, hypoactivity,
and decreased food consumption observed in acute oral toxicity studies.
The acute dermal toxicity of Bromonitrostyrene is moderate (Toxicity
Category III); effects such as black discoloration, eschar formation,
and scabs were noted, in addition to lacrimation. Bromonitrostyrene has
a moderate to severe toxicity via the inhalation route (Toxicity
Category II), substantial weight losses and frequent respiratory and
secretory symptoms were reported. Bromonitrostyrene is a Toxicology
Category II eye irritant; conjunctival, corneal, and iridial irritation
were observed and positive scores for opacity and ulceration were
obtained in the primary eye irritation study. Severe dermal irritation
effects (Toxicology Category I) were noted in the primary dermal
irritation studies, including erythema, subepidermal necrosis, and
subepidermal damage. Bromonitrostyrene exhibited a moderate potential to
produce dermal sensitization in guinea pigs.

The acute toxicity data for Bromonitrostyrene is summarized in Table 3.1
below.

+-------+-----------------------+----------+------------------+-------+
| **    |                       |          |                  |       |
| Table |                       |          |                  |       |
| 3.1.  |                       |          |                  |       |
| Acute |                       |          |                  |       |
| Tox   |                       |          |                  |       |
| icity |                       |          |                  |       |
| Pr    |                       |          |                  |       |
| ofile |                       |          |                  |       |
| for   |                       |          |                  |       |
| Brom  |                       |          |                  |       |
| onitr |                       |          |                  |       |
| ostyr |                       |          |                  |       |
| ene** |                       |          |                  |       |
+=======+=======================+==========+==================+=======+
| *     | **Study Type/**       | **MRID   | **Results**      | **Tox |
| *Guid |                       | N        |                  | icity |
| eline | **Test substance (%   | umber/** |                  | Categ |
| Num   | a.i.)**               |          |                  | ory** |
| ber** |                       | **Ci     |                  |       |
|       |                       | tation** |                  |       |
+-------+-----------------------+----------+------------------+-------+
| 870   | Acute Oral- Rat       | 41603501 | LD~50~(M): 446   | II    |
| .1100 |                       |          | mg/kg LD~50~(F): |       |
|       | Giv 2-0820 (99.1%     |          | 466 mg/kg        |       |
|       | a.i.)                 |          | LD~50~(M/F): 457 |       |
|       |                       |          | mg/kg            |       |
+-------+-----------------------+----------+------------------+-------+
| 870   | Acute Oral- Rat       | 41603506 | LD~50~(M): 1837  | III   |
| .1100 |                       |          | mg/kg LD~50~(F): |       |
|       | ß                     |          | 1464 mg/kg       |       |
|       | -bromo-ß-nitrostyrene |          | LD~50~(M/F):     |       |
|       |                       |          | 1678 mg/kg       |       |
|       | (25.1% a.i.)          |          |                  |       |
+-------+-----------------------+----------+------------------+-------+
| 870   | Acute Dermal- Rabbit  | 44524506 | LD~50~: \> 2000  | III   |
| .1200 |                       |          | mg/kg bw         |       |
|       | Giv-Gard BNS (25%     |          |                  |       |
|       | a.i.)                 |          |                  |       |
+-------+-----------------------+----------+------------------+-------+
| 870   | Acute Inhalation- Rat | 43452701 | LC~50~(M): 0.14  | II    |
| .1300 |                       |          | mg/L             |       |
|       | Bromonitrostyrene     |          |                  |       |
|       |                       |          | LC~50~ (F): 0.30 |       |
|       | (98.2% a.i.)          |          | mg/L             |       |
|       |                       |          |                  |       |
|       |                       |          | LC~50~ (M/F):    |       |
|       |                       |          | 0.20 mg/L        |       |
+-------+-----------------------+----------+------------------+-------+
| 870   | Primary Eye           | 44524509 | Moderate to      | II    |
| .2400 | Irritation- Rabbit    |          | Severe Irritant  |       |
|       |                       |          |                  |       |
|       | Giv-Gard BNS (25%     |          |                  |       |
|       | a.i.)                 |          |                  |       |
+-------+-----------------------+----------+------------------+-------+
| 870   | Primary Dermal        | 41744601 | Corrosive        | I     |
| .2500 | Irritation- Rabbit    |          |                  |       |
|       |                       |          |                  |       |
|       | ß                     |          |                  |       |
|       | -bromo-ß-nitrostyrene |          |                  |       |
|       | (25.1% a.i.)          |          |                  |       |
+-------+-----------------------+----------+------------------+-------+
| 870   | Primary Dermal        | 44178401 | Corrosive        | I     |
| .2500 | Irritation- Rabbit    |          |                  |       |
|       | Bromonitrostyrene     |          |                  |       |
|       | (25% a.i.)            |          |                  |       |
+-------+-----------------------+----------+------------------+-------+
| 870   | Primary Dermal        | 44524508 | Severe,          | II    |
| .2500 | Irritation- Rabbit    |          | Reversible       |       |
|       | Giv-Gard BNS (25%     |          | Dermal           |       |
|       | a.i.)                 |          | Irritation       |       |
+-------+-----------------------+----------+------------------+-------+
| 870   | Dermal Sensitization  | 44524510 | Moderate         | N/A   |
| .2600 | -- Guinea Pig         |          | Sensitization    |       |
|       |                       |          |                  |       |
|       | Giv-Gard BNS (25%     |          |                  |       |
|       | a.i.)                 |          |                  |       |
+-------+-----------------------+----------+------------------+-------+
| 870   | Dermal Sensitization  | 45094806 | Moderate         | N/A   |
| .2600 | -- Guinea Pig         |          | Sensitization    |       |
|       |                       |          |                  |       |
|       | Spectrum RX4101 (9.2% |          |                  |       |
|       | a.i.)                 |          |                  |       |
+-------+-----------------------+----------+------------------+-------+

Mortality and clinical signs of toxicity including diarrhea, lethargy,
ruffled fur, weight loss, nasal and eye discharge, oral and anal
discharge, and abnormal breathing were observed in a 4-week oral
toxicity study (NTP study) in rats and mice with β-bromo-β-nitrostyrene
(trans isomer; 99% a.i.). Body weight gain and final mean body weights
were lower in male rats. Absolute and relative thymus organ weights were
also lower with no corresponding gross or microscopic pathology.
Histopathological lesions were noted in the forestomach, glandular
stomach, cecum, nasal passages, and testis with male rats more adversely
affected than females.

Dose-related dermal irritation (erythema, edema, atonia, and
desquamation) was seen in all treatment groups after the first week of
treatment in a 21-day dermal toxicity study in rabbits (99.1% a.i.). The
dermal responses generally decreased in severity in the second and third
week of study, and only very slight or slight erythema with little or no
edema and generally moderate atonia and desquamation remained at the end
of the study. Microscopic findings of treated skin included minimal to
slight hyperkeratosis and minimal to moderated surface accumulation of
inflammatory cells/cell debris and minimal to moderate acute/subacute
inflammation of the dermis (in increased incidence and severity relative
to controls). Minimal congestion of the dermis and hyperplasia and
vesicle formation involving the stratified epithelium was also revealed.

Systemic toxicity was observed only in the high dose group, evidenced by
mortalities (sacrifice in a moribund condition) in two females, reduced
body weight gains or weight losses and poor food consumption.
Statistically significant elevations in serum potassium levels were also
seen in high-dose males and females at termination; these were more
pronounced (p≤0.01) in females.

In a developmental toxicity study in rats with ß-bromo-ß-nitrostyrene
(99.1%), an increased incidence of excessive salivation was noted in the
mid-dose group. A further increased incidence of excessive salivation
and additional symptoms including moist rales, anogenital staining, a
reduced mean weight gain (21.2% below the control value, not
statistically significant) occurred in the high-dose group. In addition,
two dams died at this dose level only two days after dosage was
initiated. Mean fetal body weights were significantly reduced in the
high-dose group. There was no indication of any effect involving
external or visceral anomalies; the fetal (litter) incidences of
skeletal malformations were observed in both the treatment groups and
controls. The most common malformation was wavy ribs.

No data are available for reproductive toxicity of Bromonitrostyrene.

Genotoxicity data show that Bromonitrostyrene is genotoxic.

In a NTP performed microbial gene mutation assay, Bromonitrostyrene
caused a dose-dependent increase in the mean revertant frequency over
the value of the solvent control in *Salmonella typhimurium* strains
TA98 and TA100 in the absence of metabolic activation system. In another
two independently performed microbial gene mutation assay,
ß-brom-ß-nitrostyrol induced a positive, dose-related mutagenic response
was elicited in strain TA100 at the histidine locus both in the absence
and presence of S9 mix.

ß-bromo-ß-nitrostyrene was positive as a clastogen in an *in vitro*
mammalian chromosome aberration test with Chinese hamster ovary (CHO)
cells, and was positive in inducing frequency of micronuclei (p≤0.005,
but not in a dose-response manner) in peripheral blood erythrocytes in
male mice in an *in vivo* mammalian cytogenetics assay performed by the
NTP and negative in a guideline *in vivo* mouse micronucleus assay.

There were no evidence that ß-bromo-ß-nitrostyrene induced a genotoxic
response in an unscheduled DNA synthesis (UDS) assay with primary rat
hepatocytes.

No data are available for chronic toxicity or carcinogenicity of
Bromonitrostyrene. A determination of carcinogenic potential of
Bromonitrostyrene cannot be made based on the available data.

From the available repeated-dose toxicity studies, there was no evidence
of neurotoxicity of Bromonitrostyrene. These studies are not required at
this time. It is concluded that there is no concerns for neurotoxicity
resulting from exposure to Bromonitrostyrene based on the fact that no
neurotoxicity findings in the available studies.

Additional studies are required to assess exposure in the occupational
setting for the current registered uses: a 90-day inhalation study, a
developmental study in a non-rodent species and a 2-generational
reproductive toxicity study. Metalworking cutting fluid use triggers the
requirement for carcinogenicity studies and chronic toxicity studies as
described on the 1987 Antimicrobial Data Call-In Notice. In addition,
because of the severity and uncertainty of the effects (true systemic
effects or secondary to the dermal effects) seen in the 21-day dermal
study, particularly death at the high-dose level, a 90-day dermal study
in rabbits is needed.

Number range CHAPTER Complete information on the non-acute mammalian
toxicity of Bromonitrostyrene can be found in the Toxicology
Disciplinary Chapter for Bromonitrostyrene (D338740).

The toxicity profile of Bromonitrostyrene is provided in Appendix A.

**3.2 Dose-Response Assessment**

An internal toxicity endpoint selection committee formed with scientists
in Antimicrobials and Health Effects Divisions evaluated the toxicology
database of Bromonitrostyrene and selected the toxicity endpoints for
acute and chronic dietary risk assessments as well as for
occupational/residential exposure risk assessments. It is decided that
**Number range CHAPTERNumber range CHAPTERno** special hazard-based
safety factor under the Food Quality Protection Act (FQPA) of 1996 is
needed for Bromonitrostyrene based on its current registered use
patterns. Instead, additional database uncertainty factors will be used
to take into account the incompleteness of the database as well as
regarding infants and children's susceptibility. Detail information can
be found in the Toxicology Disciplinary Chapter for Bromonitrostyrene
(D338740). A summary of the toxicological endpoints for
Bromonitrostyrene is provided in Table 3.2.

+------------+---------------+-----------------+-----------------------+
| **Table    |               |                 |                       |
| 3.2        |               |                 |                       |
| Summary of |               |                 |                       |
| Tox        |               |                 |                       |
| icological |               |                 |                       |
| Doses and  |               |                 |                       |
| Endpoints  |               |                 |                       |
| for        |               |                 |                       |
| Bromonitr  |               |                 |                       |
| ostyrene** |               |                 |                       |
+============+===============+=================+=======================+
| **Exposure | **Dose Used   | **Target MOE,   | **Study and**         |
| Scenario** | in**          | UF, Special     |                       |
|            |               | FQPA SF, for    | **Toxicological       |
|            | **Risk        | Risk            | Effects**             |
|            | Assessment**  | Assessment**    |                       |
|            |               |                 |                       |
|            | **            |                 |                       |
|            | (mg/kg/day)** |                 |                       |
+------------+---------------+-----------------+-----------------------+
| **Dietary  |               |                 |                       |
| Risk       |               |                 |                       |
| Ass        |               |                 |                       |
| essments** |               |                 |                       |
+------------+---------------+-----------------+-----------------------+
| **Acute    | **NOAEL** =   | **UF** = 100    | 28-day (Oral)         |
| Dietary**  | 37            | (10x            | Toxicity Study in     |
|            |               | inter-species   | Rats (NTP study)      |
| (all       |               | extrapolation,  |                       |
| po         |               | 10x             | **LOAEL** = 75        |
| pulations) |               | intra-species   | mg/kg/day based on    |
|            |               | variation)      | histopathology        |
|            |               |                 | findings in the       |
|            |               |                 | forestomach           |
+------------+---------------+-----------------+-----------------------+
|            | **aRfD** =    |                 |                       |
|            | 0.37          |                 |                       |
|            | mg/kg/day     |                 |                       |
+------------+---------------+-----------------+-----------------------+
| **Chronic  | **NOAEL**= 37 | **UF** = 1000   | 28-day (Oral)         |
| Dietary**  |               | (10x            | Toxicity Study in     |
|            |               | inter-species   | Rats (NTP study)      |
| (all       |               | extrapolation,  |                       |
| po         |               | 10x             | **LOAEL** = 75        |
| pulations) |               | intra-species   | mg/kg/day based on    |
|            |               | variation, 10x  | histopathology        |
|            |               | database        | findings in the       |
|            |               | uncertainty)    | forestomach           |
+------------+---------------+-----------------+-----------------------+
|            | **cRfD** =    |                 |                       |
|            | 0.037         |                 |                       |
|            | mg/kg/day     |                 |                       |
+------------+---------------+-----------------+-----------------------+
| **Non      |               |                 |                       |
| Dietary    |               |                 |                       |
| Risk       |               |                 |                       |
| Ass        |               |                 |                       |
| essments** |               |                 |                       |
+------------+---------------+-----------------+-----------------------+
| **         | **NOAEL**=37  | Residential =   | 28-day (Oral)         |
| Incidental |               | 100 (10x        | Toxicity Study in     |
| Oral**     |               | inter-species   | Rats (NTP study)      |
|            |               | extrapolation,  |                       |
| Short-Term |               | 10x             | **LOAEL** = 75        |
|            |               | intra-species   | mg/kg/day based on    |
| (1-30days  |               | variation)      | histopathology        |
|            |               |                 | findings in the       |
|            |               | Occupational =  | forestomach           |
|            |               | NA              |                       |
+------------+---------------+-----------------+-----------------------+
| **         | **NOAEL**=37  | Residential =   | 28-day (Oral)         |
| Incidental |               | 300 (10x        | Toxicity Study in     |
| Oral**     |               | inter-species   | Rats (NTP study)      |
|            |               | extrapolation,  |                       |
| Interme    |               | 10x             | **LOAEL** = 75        |
| diate-Term |               | intra-species   | mg/kg/day based on    |
|            |               | variation and   | histopathology        |
| (1-6       |               | 3x database     | findings in the       |
| months)    |               | uncertainty)    | forestomach           |
|            |               |                 |                       |
|            |               | Occupational =  |                       |
|            |               | NA              |                       |
+------------+---------------+-----------------+-----------------------+
| **Dermal** | **NOAEL** =   | **MOE** = 100   | 21-Day (Dermal)       |
|            | 50            | (10x            | Subchronic Toxicity   |
| Short-Term |               | inter-species   | Study in Rabbits      |
| (1-30      |               | extrapolation,  | (MRID 40830101)       |
| days) and  |               | 10x             |                       |
| Interme    |               | intra-species   | **LOAEL** = 100       |
| diate-Term |               | variation)      | mg/kg/day based on    |
|            |               |                 | mortality in 2/5      |
| (1-6       |               |                 | females, reduced mean |
| months)    |               |                 | body weights in both  |
|            |               |                 | sexes, and            |
|            |               |                 | statistically         |
|            |               |                 | significant           |
|            |               |                 | elevations in serum   |
|            |               |                 | potassium levels in   |
|            |               |                 | both males and        |
|            |               |                 | females.              |
+------------+---------------+-----------------+-----------------------+
| **Dermal** | **NOAEL** =   | **MOE** = 300   | 21-Day (Dermal)       |
|            | 50            | (10x            | Subchronic Toxicity   |
| Long-Term  |               | inter-species   | Study in Rabbits      |
|            |               | extrapolation,  | (MRID 40830101)       |
| (\> 6      |               | 10x             |                       |
| months)    |               | intra-species   | **LOAEL** = 100       |
|            |               | variation, 3x   | mg/kg/day based on    |
|            |               | for use of a    | mortality in 2/5      |
|            |               | subchronic      | females, reduced mean |
|            |               | endpoint for    | body weights in both  |
|            |               | the long-term   | sexes, and            |
|            |               | endpoint)       | statistically         |
|            |               |                 | significant           |
|            |               |                 | elevations in serum   |
|            |               |                 | potassium levels in   |
|            |               |                 | both males and        |
|            |               |                 | females.              |
+------------+---------------+-----------------+-----------------------+
| **In       | **NOAEL** =   | **MOE** =       | 28-day (Oral)         |
| halation** | 37 ^a^        | 1000^b^ (10x    | Toxicity Study in     |
|            |               | inter-species   | Rats (NTP study)      |
| (All       |               | extrapolation,  |                       |
| Durations) |               | 10x             | **LOAEL** = 75        |
|            |               | intra-species   | mg/kg/day based on    |
|            |               | variation, 10x  | histopathology        |
|            |               | route-to-route  | findings in the       |
|            |               | extrapolation)  | forestomach           |
+------------+---------------+-----------------+-----------------------+
| **Cancer** | No            |                 |                       |
|            | ca            |                 |                       |
| (oral,     | rcinogenicity |                 |                       |
| dermal,    | data          |                 |                       |
| i          | available for |                 |                       |
| nhalation) | bromo         |                 |                       |
|            | nitrostyrene. |                 |                       |
+------------+---------------+-----------------+-----------------------+

UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL
= lowest observed adverse effect level, RfD = reference dose, MOE =
margin of exposure

^a^ A 100% inhalation absorption value is used for route-to-route
extrapolation.

^b^ An extra 10x is used because the current inhalation endpoint is
based on an oral NOAEL, and although the target inhalation MOE is 1000,
if the MOE is below 1000, the Agency may request a confirmatory
inhalation toxicity study.

## 3.3 FQPA Considerations 

The toxicology database for Bromonitrostyrene with respect to assessing
sensitivity of infants and children is not complete. There is only one
developmental toxicity study in rats available for this chemical. There
are no data on developmental toxicity in a non-rodent species and no
data on reproductive toxicity. Number range CHAPTERUncertainties exist
with respect to determination of both developmental and reproductive
effects of Bromonitrostyrene, as the data are limited to the one
developmental toxicity study. Lacks of a reproductive toxicity study and
a developmental toxicity study in a non-rodent species raise the level
of concern for adequately characterizing potential susceptibility of
Bromonitrostyrene. For this reason, extra uncertainty factors will be
employed to account for the lack of a complete database.

It is decided that **Number range CHAPTERNumber range CHAPTERno**
special hazard-based safety factor under the Food Quality Protection Act
(FQPA) of 1996 is needed for Bromonitrostyrene based on its current
registered use patterns. Instead, additional database uncertainty
factors will be used to take into account the incompleteness of the
database as well as regarding infants and children's susceptibility.

**3.4 Endocrine Disruption**

EPA is required under the Federal Food, Drug and Cosmetic Act (FFDCA),
as amended by the Food Quality Protection Act (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 endocrine effects as the Administrator may designate."
Following recommendations of its Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen and
thyroid hormone systems, in addition to the estrogen hormone system. EPA
also adopted EDSTAC's recommendation that EPA include evaluations of
potential effects in wildlife. For pesticides, EPA will use FIFRA and,
to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA authority to require the
wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine
Disruptor Screening Program (EDSP).

When the appropriate screening and/or testing protocols being considered
under the Agency's EDSP is developed, Bromonitrostyrene may be subject
to additional screening and/or testing to better characterize effects
related to endocrine disruption.

**4.0 EXPOSURE ASSESSMENT AND CHARACTERIZATION**

**4.1 Summary of Registered Antimicrobial Uses**

## Bromonitrostyrene is used as a fungicide, slimicide, molluscide, mildewcide, algaecide, and microbicide/microbiostat. The single product containing Bromonitrostyrene as the active ingredient (a.i.) is formulated as a soluble concentrate (EPA Reg. No. 464-686). The concentration of Bromonitrostyrene in this product is 25 percent. 

The Agency determines potential exposures to handlers of pesticide
products by indentifying exposure scenarios from the various application
methods that are plausible, given the labeled uses. The following Use
Site Categories (USC) were identified based on a review of the
brominitrostyrene product labels:

-   \(III\) Commercial, institutional d industrial premises and
    equipment,

-   \(VII\) Material preservatives, and

-   \(VIII\) Industrial processes and water systems.

Specific uses within these use categories are identified in Table 4.1.
From Table 4.1, EPA has selected representative exposure scenarios to
assess Bromonitrostyrene in this document. These scenarios were selected
to be representative of the vast majority of uses and are believed to
provide high-end degrees of dermal, inhalation, or incidental ingestion
exposure.

+----------------------+-----------------------+-----------------------+
| **Table 4.1.         |                       |                       |
| Potential Use        |                       |                       |
| Scenarios Based on   |                       |                       |
| Product Labels for   |                       |                       |
| Bromonitrostyrene**  |                       |                       |
+----------------------+-----------------------+-----------------------+
| Use Site Category    | Example Use Sites     | Scenarios             |
+----------------------+-----------------------+-----------------------+
| **Use Site Category  | Commercial laundry    | -   Liquid pour       |
| III**                |                       |                       |
|                      |                       |                       |
| Commercial/          |                       |                       |
| Inst                 |                       |                       |
| itutional/Industrial |                       |                       |
+----------------------+-----------------------+-----------------------+
| **Use Site Category  | Used in the           | -   Liquid pour       |
| VII**                | preservation of       |                       |
|                      | various products such | -   Liquid pump       |
| Material             | as paints, leather,   |                       |
| Preservatives        | textiles, MWF, etc.   | -   Painting          |
|                      |                       |                       |
|                      |                       | -   MWF machinists    |
|                      |                       |                       |
|                      |                       | -   Textiles          |
+----------------------+-----------------------+-----------------------+
| **Use Site Category  | Used in water systems | -   Liquid pour       |
| VIII**               | such as pulp & paper  |                       |
|                      | mills, cooling tower  | -   Liquid pump       |
| Industrial Processes | water, oil recovery   |                       |
| and water systems    | injection water, etc. |                       |
+----------------------+-----------------------+-----------------------+

## 4.2 Dietary Exposure and Risk 

The detailed information on exposure and risk assessment can be found in
the supporting disciplinary chapter entitled [Dietary Risk Assessment
(Indirect Food Contact) from Indoor Uses of Bromonitrostyrene
(BNS)]{.underline} by N. Shamim. Summary information is provided in this
section.

When conducting the dietary exposure assessment, the Agency generally
carries out a registered label review. All applications of a specific
chemical used as a pesticide are assessed for any dietary concerns from
indirect migration of the pesticide into foods, fruits and vegetables.

A label search has shown that Bromonitrostyrene is used in the following
use patterns shown in the table below which may result in indirect food
contact scenarios, and a dietary risk assessment becomes necessary.

  ---------------------- -------------------- ----------------------------
  **Table 4.2.1 Use                           
  Patterns and                                
  Application Rates for                       
  Registered Products of                      
  Bromonitrostyrene**                         

  **Product Name/EPA     **Use Scenario**     **Application Rate**
  REG#**                                      

  Canguard 777/464-686   Paper mill/pulp      0.3 lbs./ton paper of 25%
                                              formulation

  Canguard 777/464-686   Paperboard           8 lbs/ton of 25% formulation

  Canguard 777/464-686   Paper coatings       2.0 lbs/ 1000 lbs of product

  Canguard 777/464-686   Adhesives/sealants   2.0 lbs/1000 lbs of product

  Canguard 777/464-686   Printing inks        2.0 lbs/1000 lbs of product

  Canguard 777/464-686   Coatings/ mineral    2.0 lbs/1000 lbs of product
                         slurries             
  ---------------------- -------------------- ----------------------------

All uses of Bromonitrostyrene are nonagricultural, and no residue
chemistry data based on Agency's Residue Chemistry Guidelines (OPPTS GLN
860.xxx) were submitted nor did the Agency ask for it. In the absence of
residue data, the Food and Drug Administration (FDA) methodologies were
adopted to estimate the residue levels that may occur in food. The
Agency calculates the Estimated Daily Intake (EDI) and Daily Dietary
Dose (DDD) using these estimated residue levels provided in the FDA
guidance. These daily estimates, along with the acute and chronic
dietary endpoints from toxicity data, were conservatively used to assess
acute and chronic dietary risks by calculating the % aPAD (acute
population-adjusted dose) and % cPAD (chronic population-adjusted dose),
the overall risks to general and subgroups of the population. Risks
exceed the Agency's level of concern (LOC) when the % cPAD exceeds 100%.

***Paper/Paperboard Use***

The FDA Method makes a number of assumptions for calculating migration
of active from food contact surfaces (paper): 1) Food contact surface
(paper) can be a one time use/day or a repeat use material; 2)
Consumption factor (CF) or fraction of daily food which comes in to
contact with the packaging surface (paper). CF represents the actual
weight of food that comes into contact with the paper to the weight of
all food packaged with paper; 3) The CF varies from one type of
packaging (type of paper) to the other (type of paper). The FDA
methodology of migration of active assumes a 100% migration to the food
commodities (this represents a worst case scenario).

The estimations for dietary exposure from paper/pulp/paperboard is
presented in Table 4.2.2 belo

+------------+------------+--------------+--------------+--------------+
| **Table    |            |              |              |              |
| 4.2.2      |            |              |              |              |
| Dietary    |            |              |              |              |
| Exposure   |            |              |              |              |
| E          |            |              |              |              |
| stimations |            |              |              |              |
| from       |            |              |              |              |
| P          |            |              |              |              |
| aper/Pulp/ |            |              |              |              |
| Paperboard |            |              |              |              |
| Uses of    |            |              |              |              |
| BNS**      |            |              |              |              |
+------------+------------+--------------+--------------+--------------+
| **Dietary  | *          | **Daily      | **% aPAD**   | **% cPAD     |
| Conc. of   | *Estimated | Dietary Dose |              | (cPAD =      |
| BNS**      | Daily      | (DDD):       | **(aPAD =    | 0.037        |
|            | Intake     | mg/kg/day**  | 0.37         | mg/kg/day)** |
|            | (EDI)**    |              | mg/kg/day)** |              |
+------------+------------+--------------+--------------+--------------+
| 20.0 µ g   | Adult:     | Adult: 27.6  | Adult:       | Adult:       |
|            | 27.6 µg    | µg/70 kg/day | 0.00039      | 0.00039      |
|            |            | = **0.00039  | mg/kg/day ∕  | mg/          |
|            |            | mg/kg/day**  | 0.37         | kg/day/0.037 |
|            |            |              | mg/kg/day x  | mg/kg/day x  |
|            |            |              | 100          | 100 =        |
|            |            |              |              | **0.0105%**  |
|            |            |              | **= 0.105%** |              |
+------------+------------+--------------+--------------+--------------+
|            | Child:     | Child:       | Child:       | Child:       |
|            | 13.8 µg    | 13.8µg/ 15   | 0.00092      | 0.00092      |
|            |            | kg/day **=   | mg/kg/day ∕  | mg/kg/day /  |
|            |            | 0.00092      | 0.37         | 0.037        |
|            |            | mg/kg/day**  | mg/kg/day =  | mg/kg/day =  |
|            |            |              | **0.24%**    | **0.024%**   |
+------------+------------+--------------+--------------+--------------+

***Adhesive Use***

For adhesive use, the FDA has provided guidance for dietary estimation
that a maximum of 7 ppb of a pesticide is likely to migrate from the
food packaging material into the food. The quantity of 7 ppb, then, is
used to calculate the Estimated Daily Intake (EDI) and Daily Dietary
Dose (DDD). The overall risks to general and subgroups of the
populations, in terms of % aPAD and % cPAD, can be calculated using
these estimations along with the acute and chronic dietary endpoints.

The estimations for dietary exposure from paper/pulp/paperboard are
presented in Table 4.2.3 below. These calculations assume that the
adhesive use is 100% of the chemical produced, which is not a likely
scenario. The actual % cPAD is going to be much lower than the estimated
one. The Agency has no chronic dietary concerns from the use of
Bromonitrostyrene in adhesives.

+------+------+----------------+--------------+---------+------------+
| **T  |      |                |              |         |            |
| able |      |                |              |         |            |
| 4    |      |                |              |         |            |
| .2.3 |      |                |              |         |            |
| Die  |      |                |              |         |            |
| tary |      |                |              |         |            |
| Expo |      |                |              |         |            |
| sure |      |                |              |         |            |
| Est  |      |                |              |         |            |
| imat |      |                |              |         |            |
| ions |      |                |              |         |            |
| from |      |                |              |         |            |
| Adhe |      |                |              |         |            |
| sive |      |                |              |         |            |
| Uses |      |                |              |         |            |
| of   |      |                |              |         |            |
| B    |      |                |              |         |            |
| NS** |      |                |              |         |            |
+------+------+----------------+--------------+---------+------------+
| **U  | *    | **Estimated    | **Daily      | **%     | **% cPAD** |
| se** | *Die | Daily Intake   | Dietary Dose | aPAD**  |            |
|      | tary | (EDI)          | (DDD)        |         | **( cPAD = |
|      | C    | µg/p/day**     | mg/kg/day**  | *       | 0.037      |
|      | onc. |                |              | *(aPAD= | mg/kg/d)** |
|      | (pp  |                |              | 0.37    |            |
|      | b)** |                |              | mg/     |            |
|      |      |                |              | kg/d)** |            |
+------+------+----------------+--------------+---------+------------+
| Adhe | 7    | Adult: 7µg/g x | Adult: 21    | Adult:  | Adult:     |
| sive |      | 3000g = 21     | µg/70 kg/day | 0.00    | 0.0003     |
|      |      | µg/p/day       | = 0.0003     | 03/0.37 | mg/kg/day  |
|      |      |                | mg/kg/day    | x 100)  | ∕ 0.037    |
|      |      | Child: 7 µg/g  |              | =       | mg/kg/day  |
|      |      | x 1500 g =     | Child: 10.5  | **0     | x100 =     |
|      |      | 10.5 µg/p/day  | µg/15kg/day  | .081%** | **0.81%**  |
|      |      |                | = 0.0007     |         |            |
|      |      |                | mg/kg/day    | Child:  | Child:     |
|      |      |                |              | 0.00    | 0.0007     |
|      |      |                |              | 07/0.37 | mg/kg/day  |
|      |      |                |              | x100 =  | ∕ 0.037    |
|      |      |                |              | **0     | mg/kg/day  |
|      |      |                |              | .019%** | x 100 =    |
|      |      |                |              |         | **0.19 %** |
+------+------+----------------+--------------+---------+------------+

***Paper Coatings***

The criteria used to calculate the estimations for dietary exposure from
paper coatings are presented in Table 4.2.4 below.

  ------------------- ------------ ------------ ------------ --------------- ---------------
  **Table 4.2.4                                                              
  Application Rates                                                          
  for Registered                                                             
  Products of                                                                
  Bromonitrostyrene                                                          
  in Paper Coatings**                                                        

  **Max. Rate of      **Paper      **Standard   **Food Mass: **Migration**   **Consumption
  Applications**      Coating Mass Basis of     Surface Area                 Factor**
                      to Wt. of    Paper**      of Treated                   
                      paper**                   Paper**                      

  2 lbs/1000lbs       10%          50 mg/in^2^  10 g/in^2^   100%            10%
  product = 2000 ppm                                                         
  ------------------- ------------ ------------ ------------ --------------- ---------------

The estimations for dietary exposure from paper coatings are shown in
Table 4.2.5 using FDA's assumption for food intake for an adult (3000 g)
and a child (1500 g).

+---------------------+----------------------+------------------------+
| **Table 4.2.5       |                      |                        |
| Dietary Exposure    |                      |                        |
| Estimations from    |                      |                        |
| Paper Coatings**    |                      |                        |
+---------------------+----------------------+------------------------+
| **Daily Dietary     | **% aPAD ( a PAD) =  | **% cPAD (cPAD = 0.037 |
| Dose (mg/kg/day)**  | 0.37 mg/kg/day)**    | mg/kg/day)**           |
+---------------------+----------------------+------------------------+
| 4.3 µ g/kg/day      | Adult: 4.3 =0.0043   | Adult: 0.0043          |
|                     | mg/kg/day/0.37 x 100 | mg/kgday/0.037 mg x    |
|                     | = **1.16%**          | 100= 11.6%             |
|                     |                      |                        |
|                     | Child: 10/1000 =     | Child: 0.001/0.037     |
|                     | 0.001 mg/kg/day/     | x100 = **2.7%**        |
|                     | 0.37 x 100 =         |                        |
|                     | **0.27%**            |                        |
+---------------------+----------------------+------------------------+

**4.3 Residential Exposure/Risk Pathway**

Although there are no registered products containing Bromonitrostyrene
that can be applied directly by the homeowner, there is a homeowner
application of Bromonitrostyrene when it is used as an in-can
preservative for latex paint. The consumer and household product uses
listed in EPA Reg. No. 464-686 for dishwashing liquids, surface
cleaners, laundry cleaners, and polishes are no longer supported by the
registrant (Trueblood, 2007). Articles treated with Bromonitrostyrene in
occupational settings may also have the potential for post-application
residential exposure. Bromonitrostyrene-treated articles that may
routinely be used in the residential market include, but are not limited
to, material preservative uses in clothing, leather, inks, and paper.

The exposure scenarios assessed in this document for the representative
uses of Bromonitrostyrene selected by EPA are listed in Table 4.3. The
table also shows the maximum application rate associated with the
representative use and the EPA label registration number. Handler dermal
and inhalation exposures are assessed for the in-can preservative use in
paint. Post-application dermal, inhalation, and/or incidental ingestion
exposures are assessed for treated articles including clothing.
Post-application/bystander inhalation exposures are expected to be
minimal for most uses because of the low vapor pressure and non spray
uses, except for the airless spray painting. The inhalation of
bystander's exposure to aerosols generated during painting are assumed
to be less than that of the applicator and are therefore not assessed
separately.

+-------------+-----------+--------------+-----------+----------------+
| **Table 4.3 |           |              |           |                |
| Rep         |           |              |           |                |
| resentative |           |              |           |                |
| Uses        |           |              |           |                |
| Associated  |           |              |           |                |
| with        |           |              |           |                |
| Residential |           |              |           |                |
| Exposure to |           |              |           |                |
| Bromonit    |           |              |           |                |
| rostyrene** |           |              |           |                |
+=============+===========+==============+===========+================+
| Rep         | Ap        | Exposure     | Example   | Application    |
| resentative | plication | Scenario     | Reg       | Rate           |
| Use         | Method    |              | istration |                |
|             |           |              | Number    |                |
+-------------+-----------+--------------+-----------+----------------+
| Paint       | -   Brush | ST Handler:  | 464-686   | 0.0005 lb      |
|             |     and   | adult dermal |           | ai/gallon      |
|             |           | and          |           |                |
|             |   airless | inhalation.  |           | \[2 lbs        |
|             |           |              |           | product x 25%  |
|             |   sprayer |              |           | ai / 1000 lb   |
|             |           |              |           | paint = 0.0005 |
|             |           |              |           | lb ai/gallon   |
|             |           |              |           | of paint; or   |
|             |           |              |           | 2000 ppm       |
|             |           |              |           | product x 25%  |
|             |           |              |           | ai = 500 ppm   |
|             |           |              |           | BNS; or 0.05%  |
|             |           |              |           | BNS\]          |
+-------------+-----------+--------------+-----------+----------------+
| Textiles    | -   NA^a^ | ST Post-app: | 464-686   | 8.1E-5 lb      |
|             |           | wearing      |           | ai/lb fabric   |
| (exposures  |           | treated      |           | or 80 ppm BNS  |
| to treated  |           | clothing,    |           |                |
| articles    |           | adult        |           | (1 oz product  |
| are         |           | dermal;      |           | x 25% ai per   |
| represented |           | child        |           | 200 lbs fabric |
| by exposure |           | incidental   |           | in final       |
| to          |           | ingestion    |           | rinse; or 320  |
| clothing)   |           | and dermal   |           | ppm product x  |
|             |           |              |           | 25% ai = 80    |
|             |           |              |           | ppm BNS )      |
+-------------+-----------+--------------+-----------+----------------+

a The handlers scenarios were not assessed for residents because the
products can only be applied occupationally.

Additional information for the residential exposure assessment is
provided in the supporting disciplinary chapter entitled
[Bromonitrostyrene: Occupational and Residential Exposure
Assessment]{.underline} by T. Leighton.

**4.3.1 Residential Handler Exposures**

To assess the handler risks, the Agency used surrogate unit exposure
data from the Chemical Manufacturers Association (CMA) antimicrobial
exposure study and the Pesticide Handlers Exposure Database (PHED).

The residential handler scenarios described in Table 4.3 were assessed
to determine dermal and inhalation exposures using PHED and CMA data and
the equations provided in the supporting document of Bromonitrostyrene
Occupational and Residential Exposure Assessment (Section 1.2, Criteria
for Conducting the Risk Assessment).

The resulting short-term inhalation and dermal exposures and MOEs for
the representative residential handler scenarios are presented in Tables
4.3.1. The calculated inhalation Margin of Exposure (MOEs) are above the
target MOE of 100 for all scenarios. Therefore, the risks do not exceed
EPA's Level of Concern (LOC). In addition, the inhalation MOEs are
greater then 1,000 using the route-to-route extrapolation, and
therefore, a confirmatory inhalation study is not warranted for the
residential paint application.

<table>
<colgroup>
<col style="width: 11%" />
<col style="width: 11%" />
<col style="width: 11%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 10%" />
<col style="width: 8%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="10"><strong>Table 4.3 Bromonitrostyrene Short-Term
Residential Handler Inhalation and Dermal MOEs.</strong></td>
</tr>
<tr class="even">
<td rowspan="2"><p>Exposure Scenario</p>
<p>Application Method</p></td>
<td rowspan="2">Application Method</td>
<td rowspan="2">Application Rate<sup>a</sup></td>
<td rowspan="2">Quantity Handled/ Treated per day<sup>b</sup></td>
<td colspan="2"><p>Unit Exposure</p>
<p>(mg/lb a.i.)</p></td>
<td colspan="2">Daily Dose (mg/kg/day) <sup>c</sup></td>
<td colspan="2"><p>MOE <sup>d</sup></p>
<p>(Target MOE = 100)</p></td>
</tr>
<tr class="odd">
<td>Inhalation</td>
<td>Dermal</td>
<td>Inhalation</td>
<td>Dermal</td>
<td>Inhalation</td>
<td>Dermal</td>
</tr>
<tr class="even">
<td rowspan="2">Painting</td>
<td>Paint brush</td>
<td rowspan="2"><p>0.0005 lb a.i./gal</p>
<p>(0.05% a.i.)</p></td>
<td>2 gallons</td>
<td>0.28</td>
<td>230</td>
<td>4.1E-5</td>
<td>0.033</td>
<td>900,000</td>
<td>1,500</td>
</tr>
<tr class="odd">
<td>Airless sprayer</td>
<td>15 gallons</td>
<td>0.83</td>
<td>79</td>
<td>0.00089</td>
<td>0.085</td>
<td>42,000</td>
<td>590</td>
</tr>
</tbody>
</table>

a Application rates are the maximum application rates determined from
EPA registered label for BNS.

b Amount handled per day values are estimated.

c Daily dose (mg/kg/day) = \[unit exposure (mg/lb a.i.) x application
rate (% a.i. weight or lb ai/gal) x quantity treated (lb/day or gal/day)
x absorption factor (1.0 for inhalation and dermal)\]/ Body weight (70
kg).

d MOE = NOAEL / Daily Dose. \[Where short-term inhalation NOAEL = 37
mg/kg/day and the short-term dermal NOAEL = 50 mg/kg/day\]. Target MOEs
= 100.

**4.3.2 Residential Post-application Exposures**

Post-application exposures are likely to occur in residential settings
by contacting treated articles such as clothing. Post
application/bystander exposures were assessed using EPA's standard
assumptions (e.g., Health Effects Division's (HED) *Standard Operating
Procedures (SOPs) for Residential Exposure Assessment*).

For the purposes of this screening level assessment, post-application
scenarios represent a high end exposure scenario for all products
represented. Representative post-application scenarios assessed include
wearing treated clothing (dermal exposure to adults and children and
incidental oral exposure to children).

[]{.mark}

**4.3.2.1 Textiles**

***Dermal Exposure to Adults and Toddlers from Contacting Treated
Clothing***

There is the potential for dermal exposure to adults and children from
wearing clothing treated via the final rinse during manufacturing as a
preservative (i.e., to prevent mildew in laundry or treated fabric). A
post-application assessment assuming no laundering by the homeowner was
conducted as a conservative measure (i.e., the effect on dislodgeable
residues over time during washing is not quantifiable at this time). It
should be noted that not all articles of clothing are treated with
Bromonitrostyrene products or worn on a continuous basis. In general, it
is believed that most treated textiles used in a residential setting
will result in exposures occurring over a short-term time duration (1 to
30 days) because residents are assumed to be exposed to treated textiles
with varying active ingredients, not exclusively Bromonitrostyrene
treated textiles. Nonetheless, the short-term dermal toxicological
endpoint is protective of the intermediate-term duration because the
same endpoint value is used to assess both durations.

**[Exposure Calculations]{.underline}**

Potential doses are calculated as follows:

PDD = [W x % applied x % a.i. x % transfer]{.underline}

BW

where:

> PDD = potential daily dose (mg/kg/day);
>
> W = weight of clothing worn (g/day);
>
> \% applied = percent of product applied (%);
>
> \% a.i. = percent active ingredient in product (%);
>
> \% transfer = percent transferred (%); and
>
> BW = body weight (kg).

And

W = (SW/SSA) \* BSA

where:

> W = weight of clothing worn (g/day);
>
> SW = weight of medium shirt (g);
>
> SSA = surface area of medium shirt (cm^2^); and
>
> BSA = surface area of body covered (cm^2^).

**[Assumptions]{.underline}**

-   The formulated product is applied at rates as high 320 ppm of
    product which is 25% a.i. (0.032% product by weight) or 80 ppm
    Bromonitrostyrene (i.e., 0.008% a.i. by weight).

-   The median surface area of clothing contacting skin for a 3-year-old
    toddler is 5,670 cm^2^ (total body surface area minus the head)
    (USEPA, 1997). For adults, the median surface area is 16,900 cm^2^
    (total body surface area minus the head) (USEPA, 1997).

-   The textile density is 10 mg/cm^2^ based on the density of mixed
    cotton and synthetics (HERA 2003). It is assumed that the mixed
    cotton/synthetic is used to cover the body for both adults and
    toddlers, minus the head surface area. Therefore, the total amount
    of fabric worn per day is equal to the density of the fabric (10 mg
    or 0.01 grams per cm^2^) times the surface area covered (5,670 cm^2^
    for toddlers, 16,900 cm^2^ for adults), or 56.7 g/day for toddlers,
    and 169 g/day for adults.

-   Potential doses were calculated using a conservative residue
    transfer factor of 100%, which assumes that all residues are
    transferable from clothing surfaces to the skin. In cases where the
    MOEs did not meet the Agency's target MOE, potential doses were also
    calculated using a less conservative residue transfer factor of 5%,
    which is based on the amount of residue assumed to be transferable
    from carpeted surfaces (USEPA, 2000 and 2001). In these cases,
    confirmatory data are needed to support the use of the lower
    transfer factor.

```{=html}
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```
-   Toddlers (3 years old) are assumed to weigh 15 kg. This is the mean
    of the median values for male and female toddlers (USEPA, 1997). For
    adults, a body weight of 70 kg has been assumed (USEPA, 1997).

**[Results]{.underline}**

The calculations of the intermediate-term dermal doses and MOEs for
adults and toddlers wearing treated clothing are shown in Table 4.4. The
dermal MOEs for adults and toddlers are greater than 100 assuming a 100%
residue transfer factor. Therefore, the risks are not of concern and a
confirmatory residue transfer factor/study is not warranted at this
time.

+---------+------+-------+------+----------+-------+-----------------+
| **Table |      |       |      |          |       |                 |
| 4.3.2   |      |       |      |          |       |                 |
| Dermal  |      |       |      |          |       |                 |
| Po      |      |       |      |          |       |                 |
| st-appl |      |       |      |          |       |                 |
| ication |      |       |      |          |       |                 |
| Ex      |      |       |      |          |       |                 |
| posures |      |       |      |          |       |                 |
| and     |      |       |      |          |       |                 |
| MOEs    |      |       |      |          |       |                 |
| for     |      |       |      |          |       |                 |
| T       |      |       |      |          |       |                 |
| oddlers |      |       |      |          |       |                 |
| and     |      |       |      |          |       |                 |
| Adults  |      |       |      |          |       |                 |
| Con     |      |       |      |          |       |                 |
| tacting |      |       |      |          |       |                 |
| Treated |      |       |      |          |       |                 |
| Clo     |      |       |      |          |       |                 |
| thing** |      |       |      |          |       |                 |
+=========+======+=======+======+==========+=======+=================+
| E       | We   | Pe    | Per  | Percent  | Daily | Dermal MOE^c^   |
| xposure | ight | rcent | cent | residue  | do    | (Target         |
| S       | of   | BNS   | of   | tra      | se^b^ | MOE=100)        |
| cenario | clot | in    | pro  | nsferred |       |                 |
|         | hing | pr    | duct | from     | (mg   |                 |
|         | worn | oduct | app  | clothing | a.i./ |                 |
|         | (g   | (%)   | lied | to skin  | kg    |                 |
|         | /day |       | (%)  | (%)      | /day) |                 |
|         | )^a^ |       |      |          |       |                 |
+---------+------+-------+------+----------+-------+-----------------+
| Toddler | 56.7 | 25%   | 0.   | 100      | 0.302 | 170             |
|         |      |       | 032% |          |       |                 |
+---------+------+-------+------+----------+-------+-----------------+
| Adult   | 169  | 25%   | 0.   | 100      | 0.193 | 260             |
|         |      |       | 032% |          |       |                 |
+---------+------+-------+------+----------+-------+-----------------+

a\. Weight of clothing worn (g/day) = (Density of fabric 0.01 g/cm^2^)
\* (surface area of body covered, cm^2^) \* 1 outfit/day

b\. Absorbed Daily Dose (mg/kg/day) = \[(weight of clothing worn, g/day)
\* (percent a.i. in product, %) / 100 \* (percent of product applied, %)
/ 100 \* (percent residue transferred from clothing to skin, %) \*
(dermal absorption factor, 1) \* (conversion factor, 1000 mg/g)\] /
(body weight, 70 kg).

c\. Dermal MOE = NOAEL (mg/kg/day) / Daily Dose \[Where dermal NOAEL =
50 mg/kg/day\]. Target MOE = 100.

***Incidental Oral Exposure to Toddlers Mouthing Treated Textiles
(Clothing/Blankets)***

**[Exposure Calculations]{.underline}**

There is the potential for incidental oral exposure to toddlers from
mouthing textiles treated with Bromonitrostyrene.

Potential doses are calculated as follows:

PDD = [C x SE x SA]{.underline}

BW

where:

> PDD = potential daily dose (mg/kg/day);
>
> C = concentration on clothing (mg/cm^2^);
>
> SE = saliva extraction efficiency (%);
>
> SA = surface area mouthed (cm^2^/day); and
>
> BW = body weight (kg).

And

C = % a.i. x % applied x W x CF1 x CF2

where:

> C = concentration on clothing (mg/cm^2^);
>
> \% applied = percent of product applied (%);
>
> \% a.i. = percent active ingredient in product (%);
>
> W = weight of clothing (g/m^2^);
>
> CF1 = unit conversion factor (1,000 mg/g); and
>
> CF2 = unit conversion factor (0.0001 m^2^/cm^2^).

**[Assumptions]{.underline}**

-   The formulated product is applied at rates as high 320 ppm of
    product which is 25% ai (0.032% product by weight) or 80 ppm
    Bromonitrostyrene (i.e., 0.008% a.i. by weight).

-   The textile density is 10 mg/cm^2^ based on the density of mixed
    cotton and synthetics (HERA 2003).

-   The saliva extraction efficiency was 50% (USEPA, 2000 and 2001).

-   The surface area of textiles mouthed by toddlers is 100 cm^2^
    (professional judgment).

-   Toddlers (3 years old) are used to represent the 1 to 6 year old age
    group. For three-year olds, the median body weight is 15 kg (USEPA,
    1997).

**[Results]{.underline}**

Table 4.5 shows the calculation of the short- and intermediate-term oral
dose and oral MOE for toddlers mouthing treated textiles. The MOE value
is greater than target MOE of 100 for the maximum concentration allowed
on the label (MOE = 14,000).

+----------+-----+-------+--------+--------+---------+--------------+
| **Table  |     |       |        |        |         |              |
| 4.3.3    |     |       |        |        |         |              |
| In       |     |       |        |        |         |              |
| cidental |     |       |        |        |         |              |
| Oral     |     |       |        |        |         |              |
| E        |     |       |        |        |         |              |
| xposures |     |       |        |        |         |              |
| and MOEs |     |       |        |        |         |              |
| for      |     |       |        |        |         |              |
| Toddlers |     |       |        |        |         |              |
| Wearing  |     |       |        |        |         |              |
| Treated  |     |       |        |        |         |              |
| Textiles |     |       |        |        |         |              |
| (Clot    |     |       |        |        |         |              |
| hing/Bla |     |       |        |        |         |              |
| nkets)** |     |       |        |        |         |              |
+----------+-----+-------+--------+--------+---------+--------------+
| Weight   | \%  | Con   | S      | Saliva | Po      | Incidental   |
| of       | P   | centr | urface | extr   | tential | Oral MOE^c^  |
| clothing | rod | ation | area   | action | daily   | (Target MOE  |
| (        | uct | on    | m      | effi   | dose    | =300)        |
| g/cm^2^) | A   | c     | outhed | ciency |         |              |
|          | ppl | lothi | (cm^2  |        | (mg     |              |
|          | ied | ng^a^ | ^/day) | (%)    | a.i./   |              |
|          |     | (mg/c |        |        | kg/day) |              |
|          |     | m^2^) |        |        |         |              |
+----------+-----+-------+--------+--------+---------+--------------+
| 0.01     | 0.0 | 0     | 100    | 50     | 0.0027  | 14,000       |
|          | 32% | .0008 |        |        |         |              |
+----------+-----+-------+--------+--------+---------+--------------+

a\. Concentration on clothing (mg/cm^2^) = (25 percent a.i. in product,
%) / 100 \* (percent product applied, %) / 100 \* (weight of clothing,
g/cm^2^) \* 1,000 mg/g

b\. Potential Daily Dose (mg/kg/day) = (concentration on clothing,
mg/cm^2^) \* (surface area mouthed, cm^2^/day) \* (saliva extraction
efficiency, %)/100 / (body weight, 15 kg).

c Oral MOE = NOAEL (mg/kg/day) / Potential Daily Dose \[Where short- and
intermediate-term incidental oral NOAEL = 37 mg/kg/day\]. Target MOE =
100.

> **4.3.3 Data Limitations and Uncertainties**

There are several data limitations and uncertainties associated with the
residential handler and post-application exposure assessments. These
include the following:

-   Surrogate dermal and inhalation unit exposure values were taken from
    the proprietary Chemical Manufacturers Association (CMA)
    antimicrobial exposure study (USEPA, 1999: DP Barcode D247642) or
    from the Pesticide Handler Exposure Database (USEPA, 1998). Most of
    the CMA data are of poor quality, therefore, EPA requires that
    confirmatory monitoring data be generated to support the values used
    in these assessments.

-   The quantities handled/treated were estimated based on information
    from various sources, including HED's Standard Operating Procedures
    (SOPs) for Residential Exposure Assessments (USEPA, 2000 and 2001).
    In certain cases, no standard values were available for some
    scenarios. Assumptions for these scenarios were based on EPA
    estimates and could be further refined from input from registrants.

**5.0 AGGREGATE RISK ASSESSMENT AND CHARACTERIZATION**

In order for a pesticide registration to continue, it must be shown
"that there is reasonable certainty that no harm will result from
aggregate exposure to pesticide chemical residue, including all
anticipated dietary exposures and other exposures for which there are
reliable information." Aggregate exposure is the total exposure to a
single chemical (or its residues) that may occur from dietary (i.e.,
food and drinking water), residential, and other non-occupational
sources, and from all known or plausible exposure routes (oral, dermal,
and inhalation).

In examining aggregate exposure, FFDCA section 408 (b)(2)(d)(vi)
stipulates that "when establishing, modifying, leaving in effect, or
revoking a tolerance or exemption for a pesticide chemical residue, that
EPA considers available information concerning the aggregate exposure
levels of consumers (and major identifiable subgroups of consumers) to
the pesticide chemical residue" in food and all other non-occupational
exposures, including drinking water from ground water or surface water
and exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

The Office of Pesticide Programs has published guidance outlining the
necessary steps to perform aggregate exposure and risk assessments
(General Principles for Performing Aggregate Exposure and Risk
Assessments, November 28, 2001; available at
http://www.epa.gov/pesticides/trac/science/aggregate.pdf). Steps for
deciding whether to perform aggregate exposure and risk assessments are
listed, which include: identification of toxicological endpoints for
each exposure route and duration; identification of potential exposures
for each pathway (food, water, and/or residential); reconciliation of
durations and pathways of exposure with durations and pathways of health
effects; determination of which possible residential exposure scenarios
are likely to occur together within a given time frame; determination of
magnitude and duration of exposure for all exposure combinations;
determination of the appropriate technique (deterministic or
probabilistic) for exposure assessment; and determination of the
appropriate risk metric to estimate aggregate risk.

The residential uses that could potentially be aggregated are the paint
applications and the textiles. The likelihood of co-occurrence is
minimal because of the limited frequency of a resident paints coupled
with not all paints and/or textiles treated with Bromonitrostyrene.
Therefore, residential uses are not recommended to be aggregated. In
addition, the inhalation and dermal endpoints are based on different
toxicological effects, and therefore, it is not appropriate to estimate
total MOEs (same situation for the dermal and oral routes for
post-application).

**6.0 CUMULATIVE EXPOSURE AND RISK**

The Food Quality Protection Act (FQPA) stipulates that when determining
the safety of a pesticide chemical, EPA shall base its assessment of the
risk posed by the chemical on, among other things, available information
concerning the cumulative effects to human health that may result from
dietary, residential, or other non-occupational exposure to other
substances that have a common mechanism of toxicity. The reason for
consideration of other substances is due to the possibility that
low-level exposures to multiple chemical substances that cause a common
toxic effect by a common toxic mechanism could lead to the same adverse
health effect as would a higher level of exposure to any of the
substances individually. A person exposed to a pesticide at a level that
is considered safe may in fact experience harm if that person is also
exposed to other substances that cause a common toxic effect by a
mechanism common with that of the subject pesticide, even if the
individual exposure levels to the other substances are also considered
safe.

For information regarding EPA's efforts to determine which chemicals
have a common mechanism of toxicity and to evaluate the cumulative
effects of such chemicals, see the policy statements released by EPA's
Office of Pesticide Programs concerning common mechanism determinations
and procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at
<http://www.epa.gov/pesticides/cumulative/>.

Before undertaking a cumulative risk assessment, the Agency will follow
procedures for identifying chemicals that have a common mechanism of
toxicity as set forth in the *A* *Guidance for Identifying Pesticide
Chemicals and Other Substances that Have a Common Mechanism of Toxicity*
(64 FR 5795-5796, February 5, 1999).

The Health Effects Division, Office of Pesticide Programs, has developed
a framework proposed for conducting cumulative risk assessments on
substances that have a common mechanism of toxicity. This guidance was
issued for public comment on January 16, 2002 (67 FR 2210-2214) and is
available from the OPP Website at:
http://www.epa.gov/pesticides/trac/science/cumulative_guidance.pdf. In
the guidance, it is stated that a cumulative risk assessment of
substances that cause a common toxic effect by a common mechanism will
not be conducted until an aggregate exposure assessment of each
substance has been completed.

Unlike the pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not yet
initiated a review to determine if there were any other chemicals that
have a mechanism of toxicity common with that of Bromonitrostyrene.
Risks summarized in this document are those that result only from the
use of Bromonitrostyrene. Therefore, the Agency did not perform a
cumulative risk assessment as part of this RED for Bromonitrostyrene.
For purposes of this RED, the Agency has assumed that Bromonitrostyrene
does not have a common mechanism of toxicity with other substances. If
the Agency identifies other substances that share a common mechanism of
toxicity with Bromonitrostyrene, the Agency will perform aggregate
exposure assessments on each chemical, and will begin to conduct a
cumulative risk assessment. Upon the Agency's request and according to a
schedule determined by the Agency, the Registrant must submit such
information as needed in order to evaluate issues related to whether
Bromonitrostyrene shares a common mechanism of toxicity with any other
substance.

# **7.0 OCCUPATIONAL EXPOSURE AND RISK** 

A complete explanation of the occupational exposure and risk assessment
can be found in the supporting disciplinary chapter entitled
[Bromonitrostyrene: Occupational and Residential Exposure
Assessment]{.underline} by T. Leighton. Summary information is provided
in this section.

The exposure scenarios assessed in this document for the representative
uses selected by EPA are shown in Table 7.1. The table also shows the
maximum application rate associated with the representative use and the
appropriate EPA Registration number for the product label. It should be
noted that for the calculation of application rates in which 8.34 lb/gal
is noted, the product is assumed to have the density of water because no
product-specific density is available.

Potential occupational handler exposure for Bromonitrostyrene can occur
in three Use Categories: commercial/institutional/industrial premises
and equipment, material preservatives, and industrial processes and
water systems.

+-------------+-------------+------------+----------+------------------+
| **Table 7.1 |             |            |          |                  |
| Rep         |             |            |          |                  |
| resentative |             |            |          |                  |
| Exposure    |             |            |          |                  |
| Scenarios   |             |            |          |                  |
| Associated  |             |            |          |                  |
| with        |             |            |          |                  |
| O           |             |            |          |                  |
| ccupational |             |            |          |                  |
| Exposures   |             |            |          |                  |
| to BNS**    |             |            |          |                  |
+=============+=============+============+==========+==================+
| Rep         | Method of   | Exposure   | Example  | Application Rate |
| resentative | Application | Scenario   | Regi     |                  |
| Use         |             |            | stration |                  |
|             |             |            | \#       |                  |
+-------------+-------------+------------+----------+------------------+
| **Co        |             |            |          |                  |
| mmercial/In |             |            |          |                  |
| dustrial/In |             |            |          |                  |
| stitutional |             |            |          |                  |
| Premises    |             |            |          |                  |
| (Use        |             |            |          |                  |
| Category    |             |            |          |                  |
| III)**      |             |            |          |                  |
+-------------+-------------+------------+----------+------------------+
| MWF         | Liquid pour | ST/IT/LT   | 464-686  | 500 ppm ai or    |
| Machinist   |             | handler/   |          | 0.05% ai         |
|             | Machinist   | machinist: |          |                  |
|             |             |            |          | \[up to 2000 ppm |
|             |             | Dermal     |          | product x 25% ai |
|             |             |            |          | = 500 ppm BNS\]  |
|             |             | Inhalation |          |                  |
+-------------+-------------+------------+----------+------------------+
| Painting    | Paint       | ST/IT      | 464-686  | 0.0005 lb        |
|             | brush,      | Handler:   |          | ai/gallon        |
| (commercial |             |            |          |                  |
| painters)   | Airless     | Inhalation |          | \[2 lbs product  |
|             | sprayer     |            |          | x 25% ai / 1000  |
|             |             | Dermal     |          | lb paint =       |
|             |             |            |          | 0.0005 lb        |
|             |             |            |          | ai/gallon of     |
|             |             |            |          | paint; or 2000   |
|             |             |            |          | ppm product x    |
|             |             |            |          | 25% ai = 500 ppm |
|             |             |            |          | BNS; or 0.05%    |
|             |             |            |          | BNS\]            |
+-------------+-------------+------------+----------+------------------+
| **Material  |             |            |          |                  |
| Pr          |             |            |          |                  |
| eservatives |             |            |          |                  |
| (Use        |             |            |          |                  |
| Category    |             |            |          |                  |
| VII)**      |             |            |          |                  |
+-------------+-------------+------------+----------+------------------+
| Paint       | Liquid pour | ST/IT      | 464-686  | 0.0005 lb        |
|             |             | Handler:   |          | ai/gallon or     |
|             |             | inhalation |          | 0.05% ai         |
|             |             |            |          |                  |
|             |             | dermal     |          | \[2 lbs product  |
|             |             |            |          | x 25% ai / 1000  |
|             |             |            |          | lb paint =       |
|             |             |            |          | 0.0005 lb        |
|             |             |            |          | ai/gallon of     |
|             |             |            |          | paint; or 2000   |
|             |             |            |          | ppm product x    |
|             |             |            |          | 25% ai = 500 ppm |
|             |             |            |          | BNS; or 0.05%    |
|             |             |            |          | BNS\]            |
+-------------+-------------+------------+----------+------------------+
| **Number    |             |            |          |                  |
| range       |             |            |          |                  |
| CHAPTE      |             |            |          |                  |
| RIndustrial |             |            |          |                  |
| processes   |             |            |          |                  |
| and water   |             |            |          |                  |
| systems     |             |            |          |                  |
| (Use        |             |            |          |                  |
| Category    |             |            |          |                  |
| VIII)**     |             |            |          |                  |
+-------------+-------------+------------+----------+------------------+
| Pulp and    | Metered     | ST/IT      | 464-686  | Initial: 0.075   |
| Paper       | pump        | Handler:   |          | lb ai/ton        |
|             |             | Inhalation |          |                  |
| (mill       |             |            |          | Continuous: 0.05 |
| process     |             | dermal     |          | lb ai/ton        |
| water)      |             |            |          |                  |
|             |             |            |          | \[**Initial**:   |
|             |             |            |          | 0.3 lbs          |
|             |             |            |          | product/1 ton    |
|             |             |            |          | pulp/paper;      |
|             |             |            |          |                  |
|             |             |            |          | **Continuous     |
|             |             |            |          | feed**: 0.2 lbs  |
|             |             |            |          | product/ 1 ton   |
|             |             |            |          | pulp.            |
|             |             |            |          |                  |
|             |             |            |          | Where product is |
|             |             |            |          | 25% ai x lb      |
|             |             |            |          | product/ton.\]   |
+-------------+-------------+------------+----------+------------------+
| Re          | Metered     | ST/IT      | 464-686  | Initial: 18 ppm  |
| circulating | pump        | Handler:   |          | ai               |
| Cooling     |             | Inhalation |          |                  |
| Water       |             |            |          | Continuous: 5    |
|             |             | dermal     |          | ppm ai           |
|             |             |            |          |                  |
|             |             |            |          | \[**Initial:**   |
|             |             |            |          | 0.6 lb           |
|             |             |            |          | product/1000 gal |
|             |             |            |          | or 72 ppm        |
|             |             |            |          | product.         |
|             |             |            |          |                  |
|             |             |            |          | **Continuous     |
|             |             |            |          | feed:** 0.16 lb  |
|             |             |            |          | product/1000 gal |
|             |             |            |          | or 20 ppm        |
|             |             |            |          | product.         |
|             |             |            |          |                  |
|             |             |            |          | Where product is |
|             |             |            |          | 25% ai x rate\]  |
+-------------+-------------+------------+----------+------------------+
| Once        | Metered     | ST/IT      | 464-686  | Maintenance: 9   |
| Through     | pump        | Handler:   |          | ppm ai           |
| Cooling     |             | Inhalation |          |                  |
| Water       |             |            |          | Mollusca: 21 ppm |
|             |             | dermal     |          | ai               |
|             |             |            |          |                  |
|             |             |            |          | \[               |
|             |             |            |          | **Maintenance:** |
|             |             |            |          | 0.3 lb           |
|             |             |            |          | product/1000 gal |
|             |             |            |          | or 36 ppm        |
|             |             |            |          | product.         |
|             |             |            |          |                  |
|             |             |            |          | **Mollusca:**    |
|             |             |            |          | 0.7 lb           |
|             |             |            |          | product/1000 gal |
|             |             |            |          | or 84 ppm        |
|             |             |            |          | product.         |
|             |             |            |          |                  |
|             |             |            |          | Where product is |
|             |             |            |          | 25% ai x rate\]  |
+-------------+-------------+------------+----------+------------------+
| Packer      | Liquid pour | ST/IT      | 464-686  | 125 lb ai/ 1000  |
| Fluids and  |             | Handler:   |          | barrels or 200   |
| Drilling    | Metered     | Inhalation |          | ppm ai.          |
| Muds        | pump        |            |          |                  |
|             |             | dermal     |          | \[500 lbs        |
|             |             |            |          | product x 25% ai |
|             |             |            |          | / 1000 barrels = |
|             |             |            |          | 125 lb ai/1000   |
|             |             |            |          | barrels; or 800  |
|             |             |            |          | ppm product x    |
|             |             |            |          | 25% ai = 200 ppm |
|             |             |            |          | ai\]             |
+-------------+-------------+------------+----------+------------------+

**7.1 Occupational Handler Exposures**

The occupational handler scenarios included in Table 7.1 were assessed
to determine inhalation and dermal exposures. The general assumptions
and equations that were used to calculate occupational handler
inhalation and dermal risks are provided in the supporting document of
Bromonitrostyrene Occupational and Residential Exposure Assessment
(Section 1.2, Criteria for Conducting the Risk Assessment). The majority
of the scenarios were assessed using CMA data and Equations 1-3.
However, for the occupational scenarios in which CMA data were
insufficient, other data and methods were applied.

**[Exposure Calculations and Results]{.underline}**

The resulting inhalation and dermal exposures and MOEs for the
representative occupational handler scenarios are presented in Table
7.2. The calculated MOEs were above the target MOE of 100 for all
scenarios.

<table>
<colgroup>
<col style="width: 13%" />
<col style="width: 13%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 9%" />
<col style="width: 7%" />
<col style="width: 9%" />
<col style="width: 6%" />
</colgroup>
<thead>
<tr class="header">
<th colspan="10"><strong>Table 7.2. Short- and Intermediate-Term Risks
Associated with Occupational Handlers</strong></th>
</tr>
<tr class="odd">
<th rowspan="2">Exposure Scenario</th>
<th rowspan="2">Method of Application</th>
<th colspan="2"><p>Unit Exposure</p>
<p>(mg/lb a.i.)</p></th>
<th rowspan="2">Application Rate</th>
<th rowspan="2">Quantity Handled/ Treated per day</th>
<th colspan="2">Daily Dose (mg/kg/day)<sup>a</sup></th>
<th colspan="2"><p>MOE<sup>b</sup></p>
<p>(Target MOE = 100)</p></th>
</tr>
<tr class="header">
<th>Inhalation</th>
<th>Dermal</th>
<th>Inhalation</th>
<th>Dermal</th>
<th>Inhalation</th>
<th>Dermal</th>
</tr>
</thead>
<tbody>
<tr class="odd">
<td colspan="10"><strong>Number range CHAPTERCommercial, Institutional
and Industrial Premises and Equipment (Use Site Category III
)</strong></td>
</tr>
<tr class="even">
<td>MWF</td>
<td>Liquid pour</td>
<td>0.00854</td>
<td>0.184</td>
<td>0.05% ai</td>
<td>300 gal (2,500 lbs)</td>
<td>0.00015</td>
<td>0.0033</td>
<td>240,000</td>
<td>15,000</td>
</tr>
<tr class="odd">
<td rowspan="2">Painting (commercial)</td>
<td>Paint brush</td>
<td>0.28</td>
<td>180</td>
<td rowspan="2">0.05% ai</td>
<td>5 gallons</td>
<td>0.0001</td>
<td>0.064</td>
<td>370,000</td>
<td>780</td>
</tr>
<tr class="even">
<td>Airless sprayer</td>
<td>0.83</td>
<td>38</td>
<td>50 gallons</td>
<td>0.003</td>
<td>0.14</td>
<td>12,000</td>
<td>270</td>
</tr>
<tr class="odd">
<td colspan="10"><strong>Material Preservatives (Use Site Category
VII)</strong></td>
</tr>
<tr class="even">
<td rowspan="2">Paint (manufacturing process)</td>
<td>Liquid pour</td>
<td>0.00346</td>
<td>0.135 (gloves)</td>
<td rowspan="2">0.05% ai</td>
<td>2000 lbs</td>
<td>0.000049</td>
<td>0.0019</td>
<td>150,000</td>
<td>26,000</td>
</tr>
<tr class="odd">
<td>Liquid pump</td>
<td>0.000403</td>
<td>0.454</td>
<td>10,000 lbs</td>
<td>0.000029</td>
<td>0.032</td>
<td>1.3E6</td>
<td>1,500</td>
</tr>
<tr class="even">
<td colspan="10"><strong>Industrial Processes and Water Systems (Use
Site Category VIII)</strong></td>
</tr>
<tr class="odd">
<td>Pulp and Paper</td>
<td>Metering pump</td>
<td>0.000265</td>
<td><p>0.00454</p>
<p>(gloves)</p></td>
<td><p>0.075</p>
<p>lb ai/ton</p></td>
<td>500 tons</td>
<td colspan="4" rowspan="3">Closed loading systems are expected to
result in minimal exposure. Specify closed loading system on label along
with long pants, long sleeved-shirts, and chemical resistant
gloves.</td>
</tr>
<tr class="even">
<td>Recirculating Cooling Water</td>
<td>Metering pump</td>
<td>0.000265</td>
<td><p>0.00454</p>
<p>(gloves)</p></td>
<td>5 ppm</td>
<td>5E7 gallons</td>
</tr>
<tr class="odd">
<td>Once Through Cooling Water</td>
<td>Metering pump</td>
<td>0.000265</td>
<td><p>0.00454</p>
<p>(gloves)</p></td>
<td>9 ppm</td>
<td>2E6 to 5E8 gallons</td>
</tr>
<tr class="even">
<td rowspan="2">Packer Fluids and Drilling Muds</td>
<td>Pour liquid</td>
<td>0.45</td>
<td><p>10.1</p>
<p>(gloves)</p></td>
<td rowspan="2"><p>200 ppm</p>
<p>(0.02% ai)</p></td>
<td><p>5 gallons</p>
<p>(41.7 lbs)</p></td>
<td>0.000054</td>
<td>0.0012</td>
<td>6.9E5</td>
<td>42,000</td>
</tr>
<tr class="odd">
<td>Metering pump</td>
<td>0.000265</td>
<td><p>0.00454</p>
<p>(gloves)</p></td>
<td>Up to 420,000 gallons</td>
<td colspan="4">See closed loading language above.</td>
</tr>
</tbody>
</table>

^a^ Absorbed Daily dose (mg/kg/day) = \[unit exposure (mg/lb a.i.) x
absorption factor (1.0) x application rate x quantity treated / Body
weight

(70 kg).

^b^ MOE = NOAEL (mg/kg/day) / Daily Dose \[Where ST and IT inhalation
NOAEL = 37 mg/kg/day and ST and IT dermal NOAEL = 50

mg/kg/day\]. Target MOE = 100.

2.  **Occupational Post-application Exposures**

    Occupational post-application dermal and inhalation exposures are
    assumed to be negligible except for the machinist exposed to
    Bromonitrostyrene -treated metalworking fluids.

    **Metalworking Fluids: Machinist**

There is a potential for dermal and inhalation exposure when a worker
handles treated metalworking fluids. This route of exposure occurs after
the chemical has been incorporated into the metalworking fluid and a
machinist is using/handling this Bromonitrostyrene treated end-product.

***Dermal Exposures***

**[Exposure Calculations]{.underline}**

Short-, intermediate- and long-term exposure estimates were derived
using the 2-hand immersion model from ChemSTEER. The model is available
at [www.epa.gov/opptintr/exposure/docs/chemsteer.htm]{.underline}. The
2-hand immersion equation is as follows:

PDR = [SA x % a.i. x FT x FQ]{.underline}

BW

where:

PDR = Potential dose rate (mg/kg/day);

SA = Surface area of both hands (cm^2^);

\% a.i. = Fraction active ingredient in treated metalworking fluid
(unitless)

FT = Film thickness of metal fluid on hands (mg/cm^2^)

FQ = Frequency of events (event/day);

BW = Body weight (kg)

**[Assumptions]{.underline}**

-   The surface of area of both hands is 840 cm^2^ (USEPA 1997)

-   The body weight of an adult is 70 kg (USEPA 1997)

-   The percent active ingredient in treated metalworking fluid is 2000
    ppm of a 25% a.i. product or 500 ppm a.i. or 0.05 % a.i. (EPA
    Registration No. 464-686).

-   For short-, intermediate- and long-term durations, the film
    thickness on the hands is 1.75 mg/cm^2^, which was extracted from
    the document entitled, "A Laboratory Method to Determine the
    Retention of Liquids on the Surface of Hands" (USEPA, 1992). The
    film thickness is based on a machinist immersing both hands in
    metalworking fluid and then partially cleaning hands with a rag. The
    film thickness was chosen because the dermal endpoint for short-,
    intermediate- and long-term durations is based on systemic effects.

***Inhalation Exposures***

**[Exposure Calculations]{.underline}**

A screening-level intermediate- and long-term inhalation exposure
estimate for treated metalworking fluids has been developed using the
OSHA PEL for oil mist. The equation used for calculating the inhalation
dose is:

PDR = [PEL x IR x % a.i. x ED]{.underline}

BW

where:

PDR = Potential dose rate (mg/kg/day);

PEL = OSHA PEL (mg/m^3^);

IR = Inhalation rate (m^3^ /hr)

\% a.i. = Fraction active ingredient in treated metalworking fluid
(unitless)

ED = Exposure duration (hrs/day);

BW = Body weight (kg)

**[Assumptions]{.underline}**

-   The high-end oil mist concentration is based on OSHA's Permissible
    Exposure Limit (PEL) of 5 mg/m^3^ (NIOSH, 1998).

-   The percent active ingredient in treated metalworking fluid is 2000
    ppm of a 25% a.i. product or 500 ppm a.i. or 0.05 % a.i. (EPA
    Registration No. 464-686).

-   The inhalation rate for a machinist is 1.0 m^3^ /hr.

-   A machinist is exposed to the metalworking fluid 8 hours a day, for
    5 days a week.

-   The body weight of an adult is 70 kg (USEPA 1997).

***Dermal and Inhalation Results***

Table 7.3 shows the calculation of the absorbed daily dose and MOE for a
machinist working with metalworking fluids. The dermal and inhalation
MOE values are above the target MOE of 100 for all durations. Although
the target inhalation MOE is 100, if the MOE is below 1,000, the Agency
may request a confirmatory inhalation toxicity study because the current
inhalation endpoint is based on an oral NOAEL. Since the inhalation MOEs
are above 1,000, a confirmatory inhalation toxicity study is **not**
warranted based on the results of this scenario.

<table>
<colgroup>
<col style="width: 4%" />
<col style="width: 7%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 9%" />
<col style="width: 7%" />
<col style="width: 6%" />
<col style="width: 12%" />
<col style="width: 15%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="11"><strong>Table 7.3. Short-, Intermediate-, and Long-Term
Risks Associated with Postapplication Exposure to Metalworking Fluids
treated with BNS (Machinist)</strong></td>
</tr>
<tr class="even">
<td rowspan="3">% a.i.</td>
<td colspan="3">Dermal Inputs</td>
<td colspan="3">Inhalation Inputs</td>
<td colspan="2">Absorbed Daily Dose (mg/kg/day)</td>
<td colspan="2">MOE</td>
</tr>
<tr class="odd">
<td rowspan="2">Hand Surface Area (cm<sup>2</sup>)</td>
<td rowspan="2">Film thickness (mg/cm<sup>2</sup>)</td>
<td rowspan="2">Frequency (event/day)</td>
<td rowspan="2">OSHA PEL (mg/m<sup>3</sup>)</td>
<td rowspan="2"><p>Inhal. rate</p>
<p>(m<sup>3</sup>/hr)</p></td>
<td rowspan="2">Exposure Duration (hrs/day)</td>
<td rowspan="2">Dermal <sup>a</sup></td>
<td rowspan="2">Inhal. <sup>b</sup></td>
<td><p>Dermal MOE</p>
<p>(Target MOE = 100 for ST/IT and 300 for LT)<sup>c</sup></p></td>
<td><p>Inhalation MOE</p>
<p>(Target MOE = 100)<sup>d</sup></p></td>
</tr>
<tr class="even">
<td>ST/IT/LT</td>
<td>ST/IT/LT</td>
</tr>
<tr class="odd">
<td>0.05</td>
<td>840</td>
<td>1.75</td>
<td>1</td>
<td>5</td>
<td>1.0</td>
<td>8</td>
<td>0.011</td>
<td>0.0004</td>
<td>4,800</td>
<td>93,000</td>
</tr>
</tbody>
</table>

a Dermal Daily Dose (mg/kg/day) = \[(% active ingredient \* hand surface
area\* dermal absorption factor (1)\* film thickness (mg/cm^2^)\*
Frequency (event/day)\] / Body weight (70 kg).

b Inhalation Daily Dose (mg/kg/day) = % active ingredient \* OSHA PEL
(mg/m^3^) \* Inhalation rate (m^3^/hr) \* exposure duration (hr/day) \*
inhalation absorption factor (1)/ body weight (70 kg)

c Dermal MOE = NOAEL (mg/kg/day) / Daily Dose (mg/kg/day) \[Where:
ST/IT/LT dermal NOAEL = 50 mg/kg/day; ST/IT target MOE = 100 and for LT
the target MOE = 300 \].

d Inhalation MOE = NOAEL (mg/kg/day) / Daily Dose (mg/kg/day) \[Where:
inhalation NOAEL = 37 mg/kg/day for all durations; target MOE = 100 for
all durations\]

**7.3 Data Limitations and Uncertainties**

There are several data limitations and uncertainties associated with the
occupational handler and post application exposure assessments. These
include:

-   Surrogate dermal and inhalation unit exposure values were taken from
    the proprietary Chemical Manufacturers Association (CMA)
    antimicrobial exposure study (USEPA, 1999: DP Barcode D247642) or
    from the Pesticide Handler Exposure Database (USEPA, 1998). Since
    the CMA data are of poor quality, the Agency requires that
    confirmatory data be submitted to support the occupational scenarios
    assessed in this document.

-   The quantities handled/treated were estimated based on information
    from various sources, including HED's Standard Operating Procedures
    (SOPs) for Residential Exposure Assessments (USEPA, 2000 and 2001),
    and personal communication with experts. In particular, Number range
    CHAPTERthe use information for the pulp and paper processing,
    drilling mud uses, and cooling water tower uses are based on
    personal communication with biocide manufacturers for these types of
    uses. The individuals contacted have experience in these operations
    and their estimates are believed to be the best available without
    undertaking a statistical survey of the uses. In certain cases, no
    standard values were available for some scenarios. Assumptions for
    these scenarios were based on EPA estimates and could be further
    refined from input from registrants.

# **8.0 ENVIRONMENTAL RISK**

**8.1 Ecological Hazard**

Detailed information on the ecological hazard and environmental risk
assessment for Bromonitrostyrene can be found in the ecological hazard
and environmental risk assessment chapter by D. Bays. Here only summary
information is provided.

For the "indoor" uses of Bromonitrostyrene, avian acute oral toxicity
testing (850.2100), preferably using the bobwhite quail**,** freshwater
fish acute toxicity testing (850.1075), preferably the rainbow
trout**,** freshwater invertebrate acute toxicity testing (850.1010),
and terrestrial and aquatic plant testing, all on the technical grade of
the active ingredient (TGAI), are generally required to establish the
toxicity and to support the registered uses of this chemical.

For the once-through industrial water systems use of Bromonitrostyrene,
fish early life stage testing is required, and acute toxicity testing
with estuarine and marine organisms is conditionally required for the
wood preservative uses of Bromonitrostyrene. Both testing are required
to be carried out with the TGAI.

Honeybees are not expected to be exposed to BNS because of the indoor
use patterns of this pesticide. Therefore, the honeybee contact LD~50~
test testing is not required.

The results of the avian dietary studies (MRIDs 406413-04 and 406413-05)
indicate that Bromonitrostyrene is practically non-toxic to both mallard
duck and bobwhite quail (LC~50\ \>~ 5620; NOEC = 3160). In the avian
acute oral study, the chemical did not cause any deaths, but the birds
regurgitated the test substance within 15 minutes. Therefore, the study
was considered supplemental and did not satisfy guideline requirements.
The dietary studies were considered to be core and met guideline
requirements at the time they were submitted to the Agency. These
studies in general fulfill guideline requirements (850.2100).

The acute toxicity to freshwater fish (MRIDs 411648-02 and 416035-05)
was 27 ug a.i./l for rainbow trout and 17 ug/l for bluegill sunfish.
This classified Bromonitrostyrene as being very highly toxic to both
warmwater and coldwater fish species. These studies fulfill guideline
requirements (850.1075).

One fish early life stage study was submitted (MRID 423997-01). Based on
the hatchability, survival, and growth data from this 35-day fathead
minnow early life stage study, the NOEC and LOEC were 8.9 and 20 ug
a.i./l, respectively. The study fulfills guideline requirements
(850.1400).

The acute toxicity to freshwater invertebrates was 24 ug a.i./l (48-hour
EC~50~) and NOEC of 14 ug a.i./l for *Daphnia magna* (MRID 411648-01).
Bromonitrostyrene is very highly toxic to aquatic invertebrates. The
study fulfills guideline requirements (850.1010).

Several acute toxicity studies on on marine/estuarine invertebrates were
found in the Agency's files. The results of these studies showed
Bromonitrostyrene is very highly toxic to mysid shrimp, sheepshead
minnow and eastern oyster. The sheepshead minnow studies (MRIDs
411813-01 and 406413-07) and one of the mysid shrimp studies (MRID
411813-02) were core. The other two studies (mysid shrimp, MRID
406413-08 and eastern oyster, MRID 411813-03) were supplemental. These
studies fulfill guideline requirements (850.1025; 850.1035; 850.1045;
850.1055; 850.1075).

Plant testing is required for the registered uses of Bromonitrostyrene:
Seedling emergence--dose response using rice (*Oryza* sativa) (850.4225)
and Aquatic plant growth (algal and aquatic plant toxicity) -- Tier II
(850.4400/850.5400). No studies were submitted for determining toxicity
to plant species. The Registrant must submit these studies to support
its registered uses.

2.  **Environmental Fate Assessment**

> Detailed information on environmental fate assessment for
> Bromonitrostyrene is

presented in the supporting disciplinary chapter by S. Gowda (February
22, 2007, D336286). A brief summary is provided below.

The environmental fate assessment for Bromonitrostyrene is based on six
guideline studies submitted to the Agency and US EPA's Estimation
Programs Interface (EPI) Suite. EPI Suite provides estimations of
physical/chemical and environmental fate properties.

When Bromonitrostyrene is introduced into the environment, it is most
likely to degrade rapidly through hydrolysis and photodegradation. In
abiotic and aqueous buffered conditions over the pH 5-9 range at 25°C,
the half-lives for Bromonitrostyrene in pH 5, pH 7 (HEPES), pH 7 (TRIS),
and pH 9 buffer solutions were 10.32 hours, 6.17 hours, 4.68 hours, and
3.40 hours, respectively.

Bromonitrostyrene was slightly to moderately mobile in soil. Based on
the output of EPI Suite, the Koc value of 770 to 1,570 further supports
the expected soil mobility. Bromonitrostyrene has a low vapor pressure
(4.14 x 10^-4^ mm Hg at 25 ^0^C from a test and 6.76 x 10^-4^ mm Hg at
25 ^0^C by estimation); it may be susceptible to direct photolysis with
a half-life of 1.7 hours. Bromonitrostyrene is not likely to be volatile
from dry soil surfaces and may be expected to degrade rapidly by
photolysis.

The output of EPI Suite indicates that Bromonitrostyrene is
non-biodegradable according to the standard test of the Japanese
Ministry of Industry and Trade (MITI). Although Bromonitrostyrene has a
Log K~ow~ of 2.34 and bioaccumulation in fish guideline study found no
signs of distress or death in Bluegills at concertrations of 0.05 ppm,
0.1 ppm or 2 ppm, caution needs to be taken when assessing
bioaccumulation of Bromonitrostyrenin in environmental media. A
confirmatory ready biodegradation guideline study is recommended for
conducting a complete environmental fate assessment of Bromonitrostyrene
to support its current registered use patterns.

The environmental fate data is presented in the table below.

+--------------------------------+-------------------------------------+
| **Parameter**                  | **Value**                           |
+================================+=====================================+
| Molecular weight               | 228.1 g/mol                         |
+--------------------------------+-------------------------------------+
| Molecular formula              | C~8~H~6~BrNO~2~                     |
+--------------------------------+-------------------------------------+
| Water Solubility (g/100 mL) at | 0.001                               |
| 25°C.                          |                                     |
+--------------------------------+-------------------------------------+
| Other Solubility (g/100 mL) at | 95% Ethanol: 4                      |
| 25°C.                          |                                     |
|                                | Acetone: 100                        |
|                                |                                     |
|                                | Benzene: 100                        |
|                                |                                     |
|                                | Propylene glycol: 3                 |
|                                |                                     |
|                                | Isopropyl myristate: 14             |
|                                |                                     |
|                                | Mineral Oil: 4                      |
|                                |                                     |
|                                | Dimethyl sulfoxide: 90              |
|                                |                                     |
|                                | Dimethyl formamide: 125             |
|                                |                                     |
|                                | Dioxane: 150                        |
+--------------------------------+-------------------------------------+
| Vapor Pressure/Volatility at   | 4.14 x 10^-4^ mm Hg                 |
| 25˚C ± 0.5˚C                   |                                     |
+--------------------------------+-------------------------------------+
| pK~a~                          | Does not dissociate                 |
+--------------------------------+-------------------------------------+
| K~ow~/log K~ow~Number range    | Log P~o/w~ = 2.34 (EPI Suite)       |
| CHAPTER                        |                                     |
|                                | Log PBNS = 2.71 (Calculated value)  |
+--------------------------------+-------------------------------------+
| Number range CHAPTERStability  | Stable under normal storage         |
| of compound at room            | conditions and in nonalcoholic      |
| temperature                    | solvents in the dark or artificial  |
|                                | light.                              |
+--------------------------------+-------------------------------------+

> **8.3 Environmental Exposure and Ecological Risk Assessment**

Freshwater and estuarine/marine aquatic organisms, and plants could
potentially be exposed to Bromonitrostyrene discharged into the aquatic
environment. The Agency conducted modeling in 2007 to estimate the
exposure and environment risk resulting from such discharges of
Bromonitrostyrene from the once-through cooling tower use.

***Tier I 2005 Probabilistic Dilution Modeling for once-through cooling
tower use***

This model presents an environmental exposure assessment for releases of
Bromonitrostyrene used for control of mollusks and bacterial, algal, and
fungal slimes in once-through cooling water systems. EPA used the
Probabilistic Distribution Model (version 4) to estimate the number and
percentage of days per year that Bromonitrostyrene concentrations exceed
ecotoxicity benchmarks of concern. Analyses were performed for six
Bromonitrostyrene treatment scenarios derived from product label
information. The approach used for this assessment is based on the
methodology EPA developed in support of Ecological Hazard and
Environmental Risk Assessment Chapter for Alkyl Dimethyl Benzyl Ammonium
Chloride (ADBAC) (Petrie and Montague, 2006). Components of the
methodology described in this section include the probabilistic
distribution model (PDM), Bromonitrostyrene application rates,
environmental exposure concentrations of concern (COCs), model
facilities and flow data, and modeling scenarios.

PDM is a screening-level exposure assessment tool developed by EPA to
model chemical releases from point sources to flowing surface waters.
For this analysis, the Agency used the PDM component within EPA's
Exposure and Fate Assessment Screening Tool Version 2.0 (E-FAST2).

PDM uses detailed U.S. Geological Survey (USGS) stream flow data and
facility-specific data from National Pollutant Discharge Elimination
System (NPDES) permits to model chemical releases from actual
facilities. For a modeling period of a given number of days, PDM
calculates probability distribution of the chemical concentration in the
receiving stream, and then estimates the number of days during which the
in-stream chemical concentration is expected to exceed a COC. PDM counts
a day as having an exceedence of a COC if the COC is exceeded for any
part of a 24-hour day. As a screening-level model, PDM outputs do not
include the duration, location, or aerial extent of exceedences.

Inputs to PDM include facility NPDES number, pretreatment release (i.e.,
loading rate), post-treatment release, number of release days, and COCs.

EPA developed six modeling scenarios by combining assumptions about the
treatment type (i.e., target organism, initial vs. maintenance
treatment), application dose, and application frequency. The six
scenarios are shown in Table 8.3.1. Scenarios 1 and 2 are for initial
and maintenance control, respectively, of mollusks based on the maximum
label application rate (84 ppm). Scenario 2 is intended to simulate
maintenance treatment for four hours every other day. Because PDM cannot
be run for alternating days, Scenario 2 includes treatment for two hours
every day.

Scenarios 3 through 6 are for control of bacterial, algal, and fungal
slimes using the continuous method (Scenarios 3 and 4) and intermittent
method (Scenarios 5 and 6). The initial treatment scenarios (i.e.,
Scenarios 3 and 5) include the maximum label application rate, 36 ppm.
The maintenance treatment scenarios (i.e., Scenarios 4 and 6) use the
midpoint (i.e., 16 ppm) of the range of application rates specified on
the label (i.e., 4 to 36 ppm).

The number of release days assumed for all scenarios was 250. This
approach assumes that Bromonitrostyrene is not applied on weekends and
holidays.

PDM was run once for each combination of facility and scenario. The
numbers of days exceeding each COC were copied electronically from the
PDM output files into Microsoft ^®^ Excel workbooks where averages and
standard deviations were calculated for each scenario. In addition, we
calculated the percent of days per year above COCs. Because the number
of release days per year was 250 for all scenarios, the highest possible
percent of days per year above COCs was 68 percent. The Agency also
calculated the percent of days during the release period above COCs
(maximum 100 percent). Standard deviations also were calculated for all
average percent of day's calculations.

+------+---------+----------+----------+---------+---------+--------+
| **T  |         |          |          |         |         |        |
| able |         |          |          |         |         |        |
| 8    |         |          |          |         |         |        |
| .3.1 |         |          |          |         |         |        |
| Mode |         |          |          |         |         |        |
| ling |         |          |          |         |         |        |
| S    |         |          |          |         |         |        |
| cena |         |          |          |         |         |        |
| rios |         |          |          |         |         |        |
| for  |         |          |          |         |         |        |
| B    |         |          |          |         |         |        |
| romo |         |          |          |         |         |        |
| nitr |         |          |          |         |         |        |
| osty |         |          |          |         |         |        |
| rene |         |          |          |         |         |        |
| T    |         |          |          |         |         |        |
| reat |         |          |          |         |         |        |
| ment |         |          |          |         |         |        |
| in   |         |          |          |         |         |        |
| Once |         |          |          |         |         |        |
| -thr |         |          |          |         |         |        |
| ough |         |          |          |         |         |        |
| Coo  |         |          |          |         |         |        |
| ling |         |          |          |         |         |        |
| W    |         |          |          |         |         |        |
| ater |         |          |          |         |         |        |
| S    |         |          |          |         |         |        |
| yste |         |          |          |         |         |        |
| ms** |         |          |          |         |         |        |
+------+---------+----------+----------+---------+---------+--------+
| **   | *       | **In     | **Conti  | **Appl  | **Appl  | **R    |
| Scen | *Target | itial/** | nuous/** | ication | ication | elease |
| ario | Orga    |          |          | Dose    | Freq    | Days   |
| Numb | nisms** | **Mai    | **Inte   | (ppm)** | uency** | per    |
| er** |         | ntenance | rmittent |         |         | Year** |
|      |         | Tre      | Method** |         |         |        |
|      |         | atment** |          |         |         |        |
+------+---------+----------+----------+---------+---------+--------+
| 1    | M       | Initial  | Inte     | 84 ppm  | 4       | 250    |
|      | ollusks |          | rmittent |         | hrs/day |        |
+------+---------+----------+----------+---------+---------+--------+
| 2    | M       | Mai      | Inte     | 84 ppm  | 2       | 250    |
|      | ollusks | ntenance | rmittent |         | hrs/day |        |
+------+---------+----------+----------+---------+---------+--------+
| 3    | BFA^a^  | Initial  | Co       | 36 ppm  | 24      | 250    |
|      |         |          | ntinuous |         | hrs/day |        |
+------+---------+----------+----------+---------+---------+--------+
| 4    | BFA     | Mai      | Co       | 16 ppm  | 24      | 250    |
|      |         | ntenance | ntinuous |         | hrs/day |        |
+------+---------+----------+----------+---------+---------+--------+
| 5    | BFA     | Initial  | Inte     | 36 ppm  | 15 min  | 250    |
|      |         |          | rmittent |         | /day    |        |
+------+---------+----------+----------+---------+---------+--------+
| 6    | BFA     | Mai      | Inte     | 16 ppm  | 15      | 250    |
|      |         | ntenance | rmittent |         | min/day |        |
+------+---------+----------+----------+---------+---------+--------+

^a^ BFA = Bacteria, fungi, and algae

+----------------------------------------+-----------------------------+
| **Table 8.3.2 Values of Concentration  |                             |
| of Concerns**                          |                             |
+----------------------------------------+-----------------------------+
| Taxa                                   | LC50/EC50/NOEC              |
+----------------------------------------+-----------------------------+
| Eastern oyster NOEC                    | 3.2 ppb                     |
+----------------------------------------+-----------------------------+
| Freshwater fish -- Bluegill LC~50~     | 17 ppb                      |
+----------------------------------------+-----------------------------+
| Freshwater fish -- Fathead minnow LOEC | 20 ppb                      |
+----------------------------------------+-----------------------------+
| Freshwater invertebrate --             | 24 ppb                      |
|                                        |                             |
| Daphnia EC~50~                         |                             |
+----------------------------------------+-----------------------------+
| Freshwater fish --                     | 27 ppb                      |
|                                        |                             |
| Rainbow LC~50~                         |                             |
+----------------------------------------+-----------------------------+
| Mysid shrimp - NOEC                    | 33 ppb                      |
+----------------------------------------+-----------------------------+
| Marine fish -- Sheepshead minnow       | 57 ppb                      |
| LC~50~                                 |                             |
+----------------------------------------+-----------------------------+
| Marine invertebrate -- Mysid shrimp    | 120 ppb                     |
| LC~50~                                 |                             |
+----------------------------------------+-----------------------------+
| Marine fish - Sheepshead minnow LC~50~ | 146 ppb                     |
+----------------------------------------+-----------------------------+
| Green algae                            | No data                     |
+----------------------------------------+-----------------------------+

Results for Scenarios 1 through 6 are presented in Tables 8.3.3 through
8.3.8, respectively. Each table shows the average numbers of days when
downstream concentrations of Bromonitrostyrene were predicted to exceed
each of the nine COCs. The average numbers of days were calculated from
the modeling results for the 30 individual facilities. Because the
numbers of days with exceedences varied among the facilities, standard
deviations are presented with each of the averages.

Tables 8.3.3 through 8.3.8 also present the averages and standard
deviations of the percentage of days per year and the percentage of the
250 release days with exceedences of the COCs. Figure 1 compares the
percentages of release days with exceedences for the six scenarios.

All six treatment scenarios resulted in exceedence of the lowest COC
(3.2 µg/L) on at least 53 percent of the days when Bromonitrostyrene is
applied. Scenario 3, in which Bromonitrostyrene is added continuously
for initial control of bacterial, algal, and fungal slimes, resulted in
the highest number of exceedences. In particular, the average percentage
of release day with downstream Bromonitrostyrene concentrations above
COCs with Scenario 3 ranged from 73 percent for the highest COC (146
µg/L) to 99 percent for the lowest COC. The second highest number of
exceedences occurred with the continuous maintenance treatment scenario
for bacterial, algal, and fungal slimes (i.e., Scenario 4).

As shown in Figure 1 the initial control scenarios (i.e., Scenarios 1,
3, and 5) resulted in more exceedences of the COC than the associated
maintenance scenarios (i.e., Scenarios 2, 4, and 6, respectively). The
reason for this result is that the maintenance scenarios included lower
Bromonitrostyrene treatment doses or lower daily treatment durations or
frequencies than the corresponding initial control scenarios.

+---------+---------+---------+---------+---------+---------+---------+
| **Table |         |         |         |         |         |         |
| 8.3.3   |         |         |         |         |         |         |
| Number  |         |         |         |         |         |         |
| and     |         |         |         |         |         |         |
| percent |         |         |         |         |         |         |
| of Days |         |         |         |         |         |         |
| with    |         |         |         |         |         |         |
| Dow     |         |         |         |         |         |         |
| nstream |         |         |         |         |         |         |
| Bro     |         |         |         |         |         |         |
| monitro |         |         |         |         |         |         |
| styrene |         |         |         |         |         |         |
| Concent |         |         |         |         |         |         |
| rations |         |         |         |         |         |         |
| Ex      |         |         |         |         |         |         |
| ceeding |         |         |         |         |         |         |
| COCs -- |         |         |         |         |         |         |
| S       |         |         |         |         |         |         |
| cenario |         |         |         |         |         |         |
| 1**     |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| **COC** | *       |         | **      |         | **      |         |
|         | *Number |         | Percent |         | Percent |         |
| **(     | of Days |         | of Days |         | of      |         |
| µg/L)** | With    |         | with    |         | Release |         |
|         | Exceed  |         | Exce    |         | Days    |         |
|         | ences** |         | edences |         | with    |         |
|         |         |         | per     |         | Exceed  |         |
|         |         |         | Year**  |         | ences** |         |
+---------+---------+---------+---------+---------+---------+---------+
|         | **      | **S     | **      | **S     | **      | **S     |
|         | Average | tandard | Average | tandard | Average | tandard |
|         | Days    | Devi    | Days    | Devi    | Days    | Devi    |
|         | COC     | ation** | COC     | ation** | COC     | ation** |
|         | Exc     |         | Exc     |         | Exc     |         |
|         | eeded** |         | eeded** |         | eeded** |         |
+---------+---------+---------+---------+---------+---------+---------+
| 3.2     | 230     | 47      | 63%     | 13%     | 92%     | 19%     |
+---------+---------+---------+---------+---------+---------+---------+
| 17      | 203     | 76      | 56%     | 21%     | 81%     | 30%     |
+---------+---------+---------+---------+---------+---------+---------+
| 20      | 199     | 80      | 54%     | 22%     | 79%     | 32%     |
+---------+---------+---------+---------+---------+---------+---------+
| 24      | 194     | 84      | 53%     | 23%     | 78%     | 33%     |
+---------+---------+---------+---------+---------+---------+---------+
| 27      | 192     | 86      | 53%     | 24%     | 77%     | 34%     |
+---------+---------+---------+---------+---------+---------+---------+
| 33      | 188     | 89      | 51%     | 24%     | 75%     | 36%     |
+---------+---------+---------+---------+---------+---------+---------+
| 57      | 177     | 92      | 49%     | 25%     | 71%     | 37%     |
+---------+---------+---------+---------+---------+---------+---------+
| 120     | 159     | 94      | 43%     | 26%     | 63%     | 38%     |
+---------+---------+---------+---------+---------+---------+---------+
| 146     | 153     | 94      | 42%     | 26%     | 61%     | 37%     |
+---------+---------+---------+---------+---------+---------+---------+

Scenario 1: Initial treatment of mollusks with 84 ppm 4, hrs/day for 250
days

+---------+---------+---------+---------+---------+---------+---------+
| **Table |         |         |         |         |         |         |
| 8.3.4   |         |         |         |         |         |         |
| Number  |         |         |         |         |         |         |
| and     |         |         |         |         |         |         |
| percent |         |         |         |         |         |         |
| of Days |         |         |         |         |         |         |
| with    |         |         |         |         |         |         |
| Dow     |         |         |         |         |         |         |
| nstream |         |         |         |         |         |         |
| Bro     |         |         |         |         |         |         |
| monitro |         |         |         |         |         |         |
| styrene |         |         |         |         |         |         |
| Concent |         |         |         |         |         |         |
| rations |         |         |         |         |         |         |
| Ex      |         |         |         |         |         |         |
| ceeding |         |         |         |         |         |         |
| COCs -- |         |         |         |         |         |         |
| S       |         |         |         |         |         |         |
| cenario |         |         |         |         |         |         |
| 2**     |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| **COC** | *       |         | **      |         | **      |         |
|         | *Number |         | Percent |         | Percent |         |
| **(     | of Days |         | of Days |         | of      |         |
| µg/L)** | With    |         | with    |         | Release |         |
|         | Exceed  |         | Exce    |         | Days    |         |
|         | ences** |         | edences |         | with    |         |
|         |         |         | per     |         | Exceed  |         |
|         |         |         | Year**  |         | ences** |         |
+---------+---------+---------+---------+---------+---------+---------+
|         | **      | **S     | **      | **S     | **      | **S     |
|         | Average | tandard | Average | tandard | Average | tandard |
|         | Days    | Devi    | Days    | Devi    | Days    | Devi    |
|         | COC     | ation** | COC     | ation** | COC     | ation** |
|         | Exc     |         | Exc     |         | Exc     |         |
|         | eeded** |         | eeded** |         | eeded** |         |
+---------+---------+---------+---------+---------+---------+---------+
| 3.2     | 221     | 61      | 60%     | 17%     | 88%     | 24%     |
+---------+---------+---------+---------+---------+---------+---------+
| 17      | 187     | 89      | 51%     | 24%     | 75%     | 36%     |
+---------+---------+---------+---------+---------+---------+---------+
| 20      | 184     | 90      | 50%     | 25%     | 74%     | 36%     |
+---------+---------+---------+---------+---------+---------+---------+
| 24      | 181     | 91      | 49%     | 25%     | 72%     | 37%     |
+---------+---------+---------+---------+---------+---------+---------+
| 27      | 178     | 92      | 49%     | 25%     | 71%     | 37%     |
+---------+---------+---------+---------+---------+---------+---------+
| 33      | 174     | 93      | 48%     | 26%     | 69%     | 37%     |
+---------+---------+---------+---------+---------+---------+---------+
| 57      | 161     | 94      | 44%     | 26%     | 64%     | 38%     |
+---------+---------+---------+---------+---------+---------+---------+
| 120     | 137     | 93      | 38%     | 25%     | 55%     | 37%     |
+---------+---------+---------+---------+---------+---------+---------+
| 146     | 130     | 92      | 36%     | 25%     | 52%     | 37%     |
+---------+---------+---------+---------+---------+---------+---------+

Scenario 2: Maintenance treatment of mollusks with 84 ppm, 2 hrs/day for
250 days

+---------+---------+---------+---------+---------+---------+---------+
| **Table |         |         |         |         |         |         |
| 8.3.5   |         |         |         |         |         |         |
| Number  |         |         |         |         |         |         |
| and     |         |         |         |         |         |         |
| percent |         |         |         |         |         |         |
| of Days |         |         |         |         |         |         |
| with    |         |         |         |         |         |         |
| Dow     |         |         |         |         |         |         |
| nstream |         |         |         |         |         |         |
| Bro     |         |         |         |         |         |         |
| monitro |         |         |         |         |         |         |
| styrene |         |         |         |         |         |         |
| Concent |         |         |         |         |         |         |
| rations |         |         |         |         |         |         |
| Ex      |         |         |         |         |         |         |
| ceeding |         |         |         |         |         |         |
| COCs -- |         |         |         |         |         |         |
| S       |         |         |         |         |         |         |
| cenario |         |         |         |         |         |         |
| 3**     |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| **COC** | *       |         | **      |         | **      |         |
|         | *Number |         | Percent |         | Percent |         |
| **(     | of Days |         | of Days |         | of      |         |
| µg/L)** | With    |         | with    |         | Release |         |
|         | Exceed  |         | Exce    |         | Days    |         |
|         | ences** |         | edences |         | with    |         |
|         |         |         | per     |         | Exceed  |         |
|         |         |         | Year**  |         | ences** |         |
+---------+---------+---------+---------+---------+---------+---------+
|         | **      | **S     | **      | **S     | **      | **S     |
|         | Average | tandard | Average | tandard | Average | tandard |
|         | Days    | Devi    | Days    | Devi    | Days    | Devi    |
|         | COC     | ation** | COC     | ation** | COC     | ation** |
|         | Exc     |         | Exc     |         | Exc     |         |
|         | eeded** |         | eeded** |         | eeded** |         |
+---------+---------+---------+---------+---------+---------+---------+
| 3.2     | 241     | 27      | 66%     | 7%      | 96%     | 11%     |
+---------+---------+---------+---------+---------+---------+---------+
| 17      | 224     | 60      | 61%     | 16%     | 90%     | 24%     |
+---------+---------+---------+---------+---------+---------+---------+
| 20      | 222     | 62      | 61%     | 17%     | 89%     | 25%     |
+---------+---------+---------+---------+---------+---------+---------+
| 24      | 219     | 65      | 60%     | 18%     | 88%     | 26%     |
+---------+---------+---------+---------+---------+---------+---------+
| 27      | 217     | 66      | 60%     | 18%     | 87%     | 27%     |
+---------+---------+---------+---------+---------+---------+---------+
| 33      | 214     | 69      | 59%     | 19%     | 86%     | 27%     |
+---------+---------+---------+---------+---------+---------+---------+
| 57      | 202     | 80      | 55%     | 22%     | 81%     | 32%     |
+---------+---------+---------+---------+---------+---------+---------+
| 120     | 187     | 89      | 51%     | 24%     | 75%     | 36%     |
+---------+---------+---------+---------+---------+---------+---------+
| 146     | 183     | 90      | 50%     | 25%     | 73%     | 36%     |
+---------+---------+---------+---------+---------+---------+---------+

Scenario 3: Initial Treatment of Bacteria, fungi, and algae with 36 ppm,
continuously for 250 days

+---------+---------+---------+---------+---------+---------+---------+
| **Table |         |         |         |         |         |         |
| 8.3.6   |         |         |         |         |         |         |
| Number  |         |         |         |         |         |         |
| and     |         |         |         |         |         |         |
| percent |         |         |         |         |         |         |
| of Days |         |         |         |         |         |         |
| with    |         |         |         |         |         |         |
| Dow     |         |         |         |         |         |         |
| nstream |         |         |         |         |         |         |
| Bro     |         |         |         |         |         |         |
| monitro |         |         |         |         |         |         |
| styrene |         |         |         |         |         |         |
| Concent |         |         |         |         |         |         |
| rations |         |         |         |         |         |         |
| Ex      |         |         |         |         |         |         |
| ceeding |         |         |         |         |         |         |
| COCs -- |         |         |         |         |         |         |
| S       |         |         |         |         |         |         |
| cenario |         |         |         |         |         |         |
| 4**     |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| **COC** | *       |         | **      |         | **      |         |
|         | *Number |         | Percent |         | Percent |         |
| **(     | of Days |         | of Days |         | of      |         |
| µg/L)** | With    |         | with    |         | Release |         |
|         | Exceed  |         | Exce    |         | Days    |         |
|         | ences** |         | edences |         | with    |         |
|         |         |         | per     |         | Exceed  |         |
|         |         |         | Year**  |         | ences** |         |
+---------+---------+---------+---------+---------+---------+---------+
|         | **      | **S     | **      | **S     | **      | **S     |
|         | Average | tandard | Average | tandard | Average | tandard |
|         | Days    | Devi    | Days    | Devi    | Days    | Devi    |
|         | COC     | ation** | COC     | ation** | COC     | ation** |
|         | Exc     |         | Exc     |         | Exc     |         |
|         | eeded** |         | eeded** |         | eeded** |         |
+---------+---------+---------+---------+---------+---------+---------+
| 3.2     | 232     | 44      | 64%     | 12%     | 93%     | 18%     |
+---------+---------+---------+---------+---------+---------+---------+
| 17      | 206     | 73      | 57%     | 20%     | 83%     | 29%     |
+---------+---------+---------+---------+---------+---------+---------+
| 20      | 202     | 76      | 55%     | 21%     | 81%     | 31%     |
+---------+---------+---------+---------+---------+---------+---------+
| 24      | 198     | 81      | 54%     | 22%     | 79%     | 32%     |
+---------+---------+---------+---------+---------+---------+---------+
| 27      | 195     | 83      | 53%     | 23%     | 78%     | 33%     |
+---------+---------+---------+---------+---------+---------+---------+
| 33      | 190     | 88      | 52%     | 24%     | 76%     | 35%     |
+---------+---------+---------+---------+---------+---------+---------+
| 57      | 180     | 92      | 49%     | 25%     | 72%     | 37%     |
+---------+---------+---------+---------+---------+---------+---------+
| 120     | 163     | 94      | 45%     | 26%     | 65%     | 38%     |
+---------+---------+---------+---------+---------+---------+---------+
| 146     | 157     | 94      | 43%     | 26%     | 63%     | 38%     |
+---------+---------+---------+---------+---------+---------+---------+

Scenario 4: Maintenance Treatment of Bacteria, fungi, and algae with 16
ppm, continuously for 250 days

+---------+---------+---------+---------+---------+---------+---------+
| **Table |         |         |         |         |         |         |
| 8.3.7   |         |         |         |         |         |         |
| Number  |         |         |         |         |         |         |
| and     |         |         |         |         |         |         |
| percent |         |         |         |         |         |         |
| of Days |         |         |         |         |         |         |
| with    |         |         |         |         |         |         |
| Dow     |         |         |         |         |         |         |
| nstream |         |         |         |         |         |         |
| Bro     |         |         |         |         |         |         |
| monitro |         |         |         |         |         |         |
| styrene |         |         |         |         |         |         |
| Concent |         |         |         |         |         |         |
| rations |         |         |         |         |         |         |
| Ex      |         |         |         |         |         |         |
| ceeding |         |         |         |         |         |         |
| COCs -- |         |         |         |         |         |         |
| S       |         |         |         |         |         |         |
| cenario |         |         |         |         |         |         |
| 5**     |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| **COC** | *       |         | **      |         | **      |         |
|         | *Number |         | Percent |         | Percent |         |
| **(     | of Days |         | of Days |         | of      |         |
| µg/L)** | With    |         | with    |         | Release |         |
|         | Exceed  |         | Exce    |         | Days    |         |
|         | ences** |         | edences |         | with    |         |
|         |         |         | per     |         | Exceed  |         |
|         |         |         | Year**  |         | ences** |         |
+---------+---------+---------+---------+---------+---------+---------+
|         | **      | **S     | **      | **S     | **      | **S     |
|         | Average | tandard | Average | tandard | Average | tandard |
|         | Days    | Devi    | Days    | Devi    | Days    | Devi    |
|         | COC     | ation** | COC     | ation** | COC     | ation** |
|         | Exc     |         | Exc     |         | Exc     |         |
|         | eeded** |         | eeded** |         | eeded** |         |
+---------+---------+---------+---------+---------+---------+---------+
| 3.2     | 159     | 94      | 43%     | 26%     | 63%     | 38%     |
+---------+---------+---------+---------+---------+---------+---------+
| 17      | 101     | 85      | 28%     | 23%     | 40%     | 34%     |
+---------+---------+---------+---------+---------+---------+---------+
| 20      | 95      | 83      | 26%     | 23%     | 38%     | 33%     |
+---------+---------+---------+---------+---------+---------+---------+
| 24      | 88      | 81      | 24%     | 22%     | 35%     | 32%     |
+---------+---------+---------+---------+---------+---------+---------+
| 27      | 84      | 79      | 23%     | 22%     | 33%     | 32%     |
+---------+---------+---------+---------+---------+---------+---------+
| 33      | 76      | 76      | 21%     | 21%     | 30%     | 30%     |
+---------+---------+---------+---------+---------+---------+---------+
| 57      | 55      | 66      | 15%     | 18%     | 22%     | 26%     |
+---------+---------+---------+---------+---------+---------+---------+
| 120     | 29      | 38      | 8%      | 11%     | 11%     | 15%     |
+---------+---------+---------+---------+---------+---------+---------+
| 146     | 23      | 31      | 6%      | 9%      | 9%      | 13%     |
+---------+---------+---------+---------+---------+---------+---------+

Scenario 5: Initial treatment of bacteria, fungi, and algae with 36 ppm,
15 minutes/day for 250 days

+---------+---------+---------+---------+---------+---------+---------+
| **Table |         |         |         |         |         |         |
| 8.3.8   |         |         |         |         |         |         |
| Number  |         |         |         |         |         |         |
| and     |         |         |         |         |         |         |
| percent |         |         |         |         |         |         |
| of Days |         |         |         |         |         |         |
| with    |         |         |         |         |         |         |
| Dow     |         |         |         |         |         |         |
| nstream |         |         |         |         |         |         |
| Bro     |         |         |         |         |         |         |
| monitro |         |         |         |         |         |         |
| styrene |         |         |         |         |         |         |
| Concent |         |         |         |         |         |         |
| rations |         |         |         |         |         |         |
| Ex      |         |         |         |         |         |         |
| ceeding |         |         |         |         |         |         |
| COCs -- |         |         |         |         |         |         |
| S       |         |         |         |         |         |         |
| cenario |         |         |         |         |         |         |
| 6**     |         |         |         |         |         |         |
+---------+---------+---------+---------+---------+---------+---------+
| **COC** | *       |         | **      |         | **      |         |
|         | *Number |         | Percent |         | Percent |         |
| **(     | of Days |         | of Days |         | of      |         |
| µg/L)** | With    |         | with    |         | Release |         |
|         | Exceed  |         | Exce    |         | Days    |         |
|         | ences** |         | edences |         | with    |         |
|         |         |         | per     |         | Exceed  |         |
|         |         |         | Year**  |         | ences** |         |
+---------+---------+---------+---------+---------+---------+---------+
|         | **      | **S     | **      | **S     | **      | **S     |
|         | Average | tandard | Average | tandard | Average | tandard |
|         | Days    | Devi    | Days    | Devi    | Days    | Devi    |
|         | COC     | ation** | COC     | ation** | COC     | ation** |
|         | Exc     |         | Exc     |         | Exc     |         |
|         | eeded** |         | eeded** |         | eeded** |         |
+---------+---------+---------+---------+---------+---------+---------+
| 3.2     | 133     | 92      | 36%     | 25%     | 53%     | 37%     |
+---------+---------+---------+---------+---------+---------+---------+
| 17      | 70      | 73      | 19%     | 20%     | 28%     | 29%     |
+---------+---------+---------+---------+---------+---------+---------+
| 20      | 64      | 71      | 18%     | 19%     | 26%     | 28%     |
+---------+---------+---------+---------+---------+---------+---------+
| 24      | 57      | 67      | 16%     | 18%     | 23%     | 27%     |
+---------+---------+---------+---------+---------+---------+---------+
| 27      | 53      | 64      | 15%     | 18%     | 21%     | 26%     |
+---------+---------+---------+---------+---------+---------+---------+
| 33      | 46      | 59      | 12%     | 16%     | 18%     | 24%     |
+---------+---------+---------+---------+---------+---------+---------+
| 57      | 26      | 36      | 7%      | 10%     | 11%     | 14%     |
+---------+---------+---------+---------+---------+---------+---------+
| 120     | 10      | 15      | 3%      | 4%      | 4%      | 6%      |
+---------+---------+---------+---------+---------+---------+---------+
| 146     | 8       | 12      | 2%      | 3%      | 3%      | 5%      |
+---------+---------+---------+---------+---------+---------+---------+

Scenario 6: Maintenance treatment of bacteria, fungi, and algae with 16
ppm, 15 minutes/day for 250 days

![](media/image3.wmf){width="6.5in" height="4.458333333333333in"}

> **Figure 8.3.1 Average Percent of Release Days with Downstream
> Bromonitrostyrene Concentration above COCs**

**[Conclusions for Once-through Cooling Tower Use of
Bromonitrostyrene]{.underline}**

Based on the scenarios included in this analysis, the intermittent
treatment method for bacterial, algal, and fungal slimes resulted in
fewer COC exceedences than the continuous treatment method. Scenarios 5
and 6 simulate the intermittent application method for control of
bacterial, algal, and fungal slimes. These scenarios use the same
treatment dosages (i.e., 36 ppm for initial control and 16 ppm for
maintenance) as Scenarios 3 and 4, but the treatment duration is 15
minutes per day instead of 24 hours per day. Tables 8.3.3 through 8.3.8
and Figure 8.3.1 show that Scenarios 5 and 6 resulted in the fewest
exceedences. For example, with initial control using the intermittent
treatment method (i.e., Scenario 5) the highest COC (146 µg/L) was
exceeded 63 percent of the 250 release days on average, and the lowest
COC (3.2 µg/L) was exceeded on nine percent of the 250 release days on
average.

> ***Maximum Expected Environmental Concentrations*:** The treatment
> scenario that resulted in the maximum expected environmental
> concentrations was #3 (continuous treatment using 36 ppm of
> Bromonitrostyrene 24 hours/day 250 days a year). The number of days
> that exceeded the LOCs ranged from 183 to 241 (Table 8.3.5) for all
> the aquatic species.
>
> ***Maximum Ecotoxicity Values*:** Eastern oyster has an NOEC of 3.2
> ppb; freshwater fish LC~50~s ranged from 17 to 27 ppb; freshwater
> invertebrate EC~50~ was 24 ppb; sheepshead minnow LC~50~ was 57 ppb;
> mysid shrimp LC~50~ was 120 ppb; and sheepshead minnow LC~50~ was 146
> ppb. Freshwater fish (fathead minnow) chronic LOEC was 20 ppb.
>
> ***Acute Freshwater Fish LOC's*:** Bluegill sunfish ranged from 70 to
> 224 days exceedence (See Tables 8.3.3 through 8.3.8). Rainbow trout
> ranged from 53 to 217 days exceedence (See Tables 8.3.3 through
> 8.3.8). All of the modeled scenarios exceeded the LOC's
>
> []{.mark}
>
> ***Acute Freshwater Aquatic Invertebrate LOC's*:** Daphnid ranged from
> 53 to 219 days exceedence (See Tables 8.3.3 through 8.3.8). All of the
> modeled scenarios exceeded the LOC's.
>
> []{.mark}
>
> ***Acute Aquatic Estuarine/Marine Species*:** The Eastern oyster
> ranged from 133 to 241 days exceedence: the mysid shrimp ranged from
> 46 to 214 days exceedence; and the Sheepshead minnow ranged from 8 to
> 202 days exceedence (See Tables 8.3.3 through 8.3.8). All the modeled
> scenarios exceeded the LOC's.
>
> ***Chronic Aquatic Toxicity Studies*:** Chronic fish study using the
> Fathead minnow ranged from 64 to 224 days exceedence (See Table 8.3.3
> through 8.3.8). All of the modeled scenarios exceeded the LOC's.
>
> ***Plant Toxicity Studies*:** No studies were available.
>
> ***Avian and Mammalian Species*:** The avian testing demonstrated no
> toxicity. No risk to avian species is expected from the use of
> Bromonitrostyrene.

This analysis is a screening level evaluation of the potential for
discharges from once-through cooling water systems to exceed
Bromonitrostyrene ecotoxicity COCs in receiving streams. There are
limitations using this methodology. Variables such as stream flow rate
and BNS dissipation, degradation, and 1/2 life were not considered in
this Tier I model but should be considered in higher tier modeling.
Field monitoring is suggested in the absence of higher Tier modeling.
However, confirmatory data are needed for monitoring and/or Tier II
modeling of once-through cooling tower effluents to establish EEC's for
risk assessment, and to evaluate degradation and decline of
Bromonitrostyrene (and major transformation products) residues in
effluent and receiving surface waters. Risk mitigation recommendations
should be based on dosing method and application rate instead of
facility size, however, it is not recommended at this time.

**8.4 Endangered Species Considerations**

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2),
requires all federal agencies to consult with the National Marine
Fisheries Service (NMFS) for marine and andronomus listed species, or
the United States Fish and Wildlife Services (FWS) for listed wildlife
and freshwater organisms, if they are proposing an \"action\" that may
affect listed species or their designated habitat. Each federal agency
is required under the Act to insure that any action they authorize,
fund, or carry out is not likely to jeopardize the continued existence
of a listed species or result in the destruction or adverse modification
of designated critical habitat. To jeopardize the continued existence of
a listed species means \"to engage in an action that reasonably would be
expected, directly or indirectly, to reduce appreciably the likelihood
of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of the species.\" 50
C.F.R. 402.02.

To facilitate compliance with the requirements of the Endangered Species
Act subsection (a)(2) the Environmental Protection Agency, Office of
Pesticide Programs has established procedures to evaluate whether a
proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed
species in the wild by reducing the reproduction, numbers, or
distribution of any listed species (U.S. EPA 2004). After the Agency's
screening-level risk assessment is performed, if any of the Agency's
Listed Species LOC Criteria are exceeded for either direct or indirect
effects, a determination is made to identify if any listed or candidate
species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the
proposed use areas, further biological assessment is 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.

For certain use categories, the Agency assumes there will be minimal
environmental exposure, and only a minimal toxicity data set is required
(Overview of the Ecological Risk Assessment Process in the Office of
Pesticide Programs U.S. Environmental Protection Agency - Endangered and
Threatened Species Effects Determinations, 1/23/04, Appendix A, Section
IIB, pg.81). Chemicals in these categories therefore do not undergo a
full screening-level risk assessment. Materials preservative uses (in
inks, dyes, textiles, adhesives, caulks, sealants, paper, paints,
polymers) are considered low exposure because:

1.  The amount that will actually reach the environment is very small
    based on usage data and use patterns (no homeowner/residential use
    for bathrooms) and containment methods (retaining ponds,
    recirculation, low residual upon release).

2.  Breakdown in the environment and via sewage treatment is rapid and
    well documented in the literature (See Environmental Fate Chapter
    for more detail). The Agency requires the following label statement:
    \"Do not discharge effluent containing this product into lakes,
    streams, ponds, estuaries, oceans, or other waters unless in
    accordance with the requirements of a National Pollutant Discharge
    Elimination System (NPDES) permit and the permitting authorities are
    notified in writing prior to discharge. Do not discharge effluent
    containing this product to sewer systems without previously
    notifying the local sewage treatment plant authority. For guidance
    contact your State Water Board or Regional Office of the EPA.\"
    There was no information in the Sewage Treatability Database on
    Bromonitrostyrene.

Bromonitrostyrene uses that have potential for environmental exposure
via down-the-drain or runoff to surface waters include industrial
processes and water system wastes. Industrial disposal water, sewage
systems, and once-through cooling tower water uses may generate waste
water residues that may reach the environment. The once-thru cooling
tower use is considered to be representative of a worst-case example
(highest potential for impacting the environment), and therefore, this
site was modeled.

> The "best case" once-through cooling tower scenario using 1/2 the
> maximum recommended label dosage intermittently applied in a low water
> flow resulted in LOC exceedances for all aquatic organisms used in the
> model, including freshwater fish, green alga, freshwater
> invertebrates, and marine invertebrates. The Agency is not aware of
> any endangered or threatened green algae. Because Bromonitrostyrene is
> rapidly degraded through hydrolysis and photodegradation, impacts to
> aquatic organisms may be less than modeled. However, the once-through
> cooling tower model does not account for degradation and the output of
> EPI Suite indicates that Bromonitrostyrene is non-biodegradable
> according to the standard test of the Japanese Ministry of Industry
> and Trade (MITI); therefore, further assessment is required prior to
> making an Agency's endangered species determination.
>
> This preliminary analysis indicates that there is a potential for
> Bromonitrostyrene industrial water waste discharges to overlap with
> listed species and that a more refined assessment is warranted, to
> include direct, indirect and habitat effects. The more refined
> assessment should involve clear delineation of the action area
> associated with proposed use of Bromonitrostyrene and best available
> information on the temporal and spatial co-location of listed species
> with respect to the action area. This analysis has not been conducted
> for this assessment. **An endangered species effect determination will
> not be made at this time.**

**9.0 INCIDENT REPORTS**

The Agency reviewed the following sources of information for human
poisoning incidents related to Bromonitrostyrene use: **(1) [OPP
Incident Data System (IDS)]{.underline}** - The Office of Pesticide
Programs (OPP) **[Incident Data System]{.underline}** contains reports
of incidents from various sources, including registrants, other federal
and state health and environmental agencies and individual consumers,
submitted to OPP since 1992; **(2)** **[California Department of
Pesticide Regulation (1982-2004)]{.underline}** -- The California
Department of Pesticide Regulation pesticide poisoning surveillance
program consists of reports from physicians of illness suspected of
being related to pesticide exposure since 1982.; **(3)** **[National
Pesticide Information Center (NPIC)]{.underline}** -- NPIC is a
toll-free information service supported by OPP that provides a ranking
of the top 200 active ingredients for which telephone calls were
received during calendar years 1984-1991; **(4) [National Poison Control
Centers (PCC)]{.underline}** (1993 -- 1996); **(5) [Published Scientific
Literature on Incidences]{.underline}**.

In the data available to the Agency, no reports of serious illness have
been associated with human exposure to Bromonitrostyrene.

# **10.0 REFERENCES**

**Product Chemistry References**

Leo, Hansch and Elkins (1971) An alternative to actual measurement of
the Kow, using the procedure of Leo, Hansch and Elkins. Chemical
Reviews, Vol. 71, No. 6, pp. 525-615, Dec. 1971.

MRID 93372 Givaudan Corporation (19??) Industrial Preservative: Giv-Gard
BNS (R)I 25%-AF. Clifton, N.J\>: Givaudan. (Technical bulletin BNS-AF;
also in unpublished submission received Nov. 6, 1974 under 824-10;
CDL:000927-D).

MRID 93373 Givaudan Corporation (1971) ?Dimethylformamide Safety Data\|.
(Com- pilation; unpublished study, including published data, received
Nov 6, 1974 under 824-10; CDL:000927-E)

MRID 108467 Givaudan Corp. (19??) Giv-Gard BNS Industrial Preservative.
Clifton, NJ: Givaudan. (Technical bulletin BNS 1B; also In unpublished
submission received Dec 18, 1972 under 824-8; CDL: 239102-A).

MRID 40641301 Levy, L. (1987) Determination of the Viscosity of GivGard
BNS 25% AF: Lab. Proj. ID GIV-1-29-87. Unpublished study prepared by
Givaudan Corp. 10 p.

MRID 40641302 Chorney, H. (1987) Determination of the Corrosion
Characteristics of GivGard BNS 25% AF. Unpublished study prepared by
City Testing & Research Laboratories, Inc. 4 p.

MRID 40661011 Valko, K. (1984) General approach for the estimation of
octanol/ water partition coefficient by reverse-phase high performance
liquid chromatography. Journal of Liquid Chromatography 7(7): 1405-1424.

MRID 41603502 Pesselman, R. (1990) Density Determination of Giv 2-0820:
Lab Project Number: HLA 6001-552. Unpublished study prepared by Hazleton
Laboratories America, Inc.

MRID 41603503 Pesselman, R. (1990) pH Value Determination of Giv 2-0820:
Final Report: Lab Project Number: HLA 6001-553. Unpublished study
prepared by Hazleton Laboratories America, Inc.

MRID 41603504 Pesselman, R. (1990) pH Value Determination of BNS 25% AF:
Lab Project Number: HLA 6001-554. Unpublished study prepared by Hazleton
Laboratories America, Inc.

MRID 41611401 Virgilio, J. (1990) Description of Manufacturing Process
for Giv- Gard BNS 25% AF, \... Containing the Active Ingredient
Beta-Bromo -Beta-Nitrostyrene: Lab Project Number: BNS-4/90. Unpublished
study prepared by Givaudan Corp.

MRID 41611402 Virgilio, J. (1990) Discussion of the Formation of
Impurities in Giv-Gard BNS 25% AF, \... Containing the Active Ingredient
Beta- Bromo-Beta-Nitrostyrene: Lab Project Number: BNS-8/90A.
Unpublished study prepared by Givaudan Corp.

MRID 41611403 Virgilio, J. (1990) Analysis and Certification of Product
Ingredients for Giv-Gard BNS 25% AF,\... Containing the Active
Ingredient Beta-Bromo-Beta-Nitro-styrene: Lab Project Number: BNS-8/
90b. Unpublished study prepared by Givaudan Corp.

MRID 42361405 Pesselman, R. (1992) Vapor Pressure Determinastion of GIV
2-0820: Final Report: Lab Project Number: 6412-100. Unpublished study
prepared by Hazleton Wisconsin, Inc.

MRID 42399703 Sack, T. (1992) Chemical Analysis of Giv-Gard BNS 25% AF
in Support of FIFRA Registration: Series 62-1 Preliminary Analysis,
Series 62-2 Certification of Limits Studies, and Series 62-3 Analytical
Methods: Lab Project Number: MRI 3006-F. Unpublished study prepared by
Midwest Research Institute.

MRID 42499401 Clark, A. (1992) Preliminary Analysis for Giv-Gard BNS 25%
AF: Supplementary Report of Product Chemistry ?MRID# 42399703\|: Lab
Project Number: 3006-F. Unpublished study prepared by Midwest Research
Institute.

MRID 42940601 Rives, D.; Lewis, B. (1993) Supplemental Data for MRID
#42399703 and 42499401: Certification of Ingredient Limits for Giv-Gard
BNS 25% AF, EPA Registration No. 824-10, Containing the Active
Ingredient beta-Bromo-beta-nitrostyrene: Lab Project Number: BNS-9/93.
Unpublished study prepared by Givaudan-Roure Corporation, Specialty
Division Quality Assurance Lab. 8 p.

MRID 44524501 Bollmeier, A. (1998) Product Chemistry for Bioban BNS 25%
BA. Unpublished study prepared by Angus Chemical Co. 39 p.

MRID 92011020 Lewis, B and Manovitz, M. (1990) Givaudan Phase 3 Summary
of MRID 00093372 and Related MRID 00108467. Physical and Chemical
Characteristics of beta-bromo-beta-nitrostyrene (sic).

MRID 92011999 Givaudan (1990) Reregistration Phase 3 Response:
Bromo-b-nitrostyrene (Note: b = beta). Correspondence and Supporting
Material.

**Ecotox References**

Petrie, R. and Montague, K. (2006) Ecological Hazard and Environmental
Risk Assessment Chapter, Alkyl Dimethyl Benzyl Ammonium Chloride
(ADBAC), PC Code: 069105, Case No: 0350, U.S. Environmental Protection
Agency, Office of Pesticide Programs, Antimicrobial division, August 2,
2006.

MRID# 406413-03: Grimes, J. and Jaber, M. (1987) GIV2-0820: An acute
oral toxicity study with the mallard duck (*Anas platyrhynchos*).
Wildlife International.

MRID# 406413-04: Grimes, J. and Jaber, M. (1987) GIV2-0820: A dietary
LC50 study with the mallard. Wildlife International.

MRID# 406413-05: Grimes, J. and jabber, M. (1987) GIV2-0820: A dietary
LC50 study with the bobwhite. Wildlife International.

MRID# 406413-08: Surprenant, D.C. (1987) Acute Toxicity of GIV2-0820 to
Mysid Shrimp (*Mysidopsis* bahia) Under flow-through conditions.
Springborn Laboratories, Inc.

MRID# 411648-01: McNamara, P.C. (1989) Acute toxicity of GIV2-0820 to
daphnids (*Daphnia magna*) during a 48-hour flow-through acute exposure.
Springborn Life Sciences, Inc.

MRID# 411648-02: Sousa, J. (1989) Acute Toxicity of GIV2-0820 to rainbow
trout (*Salmo* gairdneri) under flow-through conditions. Springborn Life
Sciences, Inc.

MRID# 411813-01: Sousa, J.V. (1989) Acute toxicity of GIV2-0820 to
sheepshead minnow (*Cyprinodon variegates*) under flow-through
conditions. Springborn Life Sciences, Inc.

MRID# 411813-02: Hoberg, J.R. (1989) Acute toxicity of GIV2-0820 to
mysid shrimp(*Mysidopsis bahia*) under flow-through conditions.
Springborn Life Sciences, Inc.

MRID# 411813-03: Dionne, E. (1989) Acute toxicity of GIV2-0820 to
eastern oysters under flow-through conditions. Springborn Life Sciences,
Inc.

MRID# 416035-05: Bowman, J. and Stuerman, L. (1990) Acute flow-through
toxicity of GIV2-0820 to bluegill (*Lepomis macrochirus).* ABC
Laboratories, Inc.

MRID# 423997-01: Cohle, P. and Stratton, J. (1992) Early Life-Stage
Toxicity of BNS to Fathead Minnows in a flow-through system ABC
Laboratories.

**Dietary References**

FDA, 2003, A Guidance For Industry: Preparations of Food Contact
Notifications and Food Additive Petitions for Food Contact Substances,
Chemistry Recommendations. Final Guidance, April 2003.
[http://www.cfsan.fda.gov](http://www.cfsan.fda.gov/)

FDA, 2003. Sanitizing Solutions: Chemistry Guidance for Food Additive
Petitions, January 2003.
[Http://www.cfsan.fda.gov](http://www.cfsan.fda.gov/)

**Environmental Fate References**

Friend, P.L. and Whitekettle, W.K. (1980). Biocides and Water Cooling
Towers. Dev. Ind. Microbiol. 21, 123-131.

Givaudan Corp (1973) Evaluation of Environmental Data for
B-Bromo-B-nitrostyrene. Reg. No. 824-8. Unpublished study prepared by
Givaudan Corp. EFED Document No. 2020700.

The Estimation Programs Interface (EPI) Suite. Windows based suite of
physical/chemical properties and environmental estimaton models
developed by the U.S. EPA's Office of Pollution, Prevention and Toxics
(OPPT) and Syracuse Research Institute (SRC). Physical properties of
Bromonitrostyrene. EPI Suite Summary (v3.12).
<http://www.epa.gov/opptintr/exposure/docs/EPISuitedl.htm>

Guidance document: Standard Soil Mobility Classification Guidance dated
April 21, 2006, by Roxolana Kashuba, Dana Spatz, and Stevan Bradbury,
Fate and Transport Technology Team, Environmental Fate and Effects
Division, Office of Pesticide Programs.

MRID 124516 Porcaro, P.; Shubiak, P. (1972) Analyses of
Beta-bromo-beta-nitro- styrene and It\'s Hydrolysis Products.
(Unpublished study received Dec 21, 1972 under 824-8; submitted by
Givaudan, Clifton, NJ; CDL:004462-A)

MRID 124521 Brandman, H. (1971) Hydrolysis of Giv-Gard BNS at Various
pH\'s. (Unpublished study received Dec 21, 1972 under 824-8; submitted
by Givaudan, Clifton, NJ; CDL:101505-C)

MRID 40817701 Martinson, J. (1988) Determination of Adsorption and
Desorption Coefficients of Giv 2-0820: SLS Report #88-06-2753: Study
#11629-6101. Unpublished study prepared by Springborn Life Sciences,
Inc. 68 p.

MRID 40916801 Martinson, J. (1988) Determination of the Biodegradability
of GIV 2-0820 in Soil and Water under Aerobic Conditions: Final Report:
SLS Report: 88-11-2865: Study No.: 11629-0787-6103. Unpublished study
prepared by Springborn Life Sciences, Inc. 114 p.

MRID 40916901 Martinson, J. (1988) Determination of the Biodegradability
of GIV 2-0820 in Soil and Water under Anaerobic Conditions: SLS Report:
88-11-2866: Study No.: 11629-0787-6103. Unpublished study pre- pared by
Springborn Life Sciences, Inc. 115 p.

MRID 40930901 Martinson, J. (1988) Mobility in Soils of GIV 2-0820 by
the Soil Column Leaching Method: Final Report: SLS Report #88-10-2838:
Laboratory Study No.: 11629-0787-6102. Unpublished study prepared by
Springborn Life Sciences, Inc. 35 p.

MRID 41191601 Martinson, J. (1988) Mobility in Soils of GIV 2-0820 by
the Soil Column Leaching Method: Rev. Final Report: SLS Report #88-10-
2838. Unpublished study prepared by Springborn Life Sciences, Inc. 45 p.

MRID 42361401 Williamson, K.; Williams, M. (1992) Determination of the
Aqueous Photolysis Rate of BNS: Final Report: Lab Project Number: 40045.
Unpublished study prepared by ABC Laboratories, Inc. 57 p.

MRID 42361402 Williamson, K.; Williams, M. (1992) Determination of the
Aqueous Photolysis Rate of BNS: Final Report: Lab Project Number:
40045R. Unpublished study prepared by ABC Laboratories, Inc. 733 p.

MRID 42361403 Williamson, K.; Williams, M. (1992) Hydrolysis of BNS as a
Function of pH at 25(degree)C: Final Report: Lab Project Number: 40044.
Unpublished study prepared by ABC Laboratories, Inc. 78 p.

MRID 42361404 Williamson, K.; Williams, M. (1992) Hydrolysis of ?carbon
14\|-BNS as a Function of pH at 25(degree)C: Final Report: Lab Project
Number: 40044R. Unpublished study prepared by ABC Laboratories, Inc.
1484 p.

MRID 42538501 Williams, M.; Bashir, M. (1992) Hydrolysis of BNS as a
Function of pH at 25 degrees celsius\--Supplemental Report: Lab Project
Number: 400441. Unpublished study prepared by ABC Labs, Inc. 30 p.

MRID 42538502 Williams, M.; Bashir, M. (1992) Determination of the
Aqueous Photolysis Rate of BNS\--Supplemental Report: Lab Project
Number: 400451. Unpublished study prepared by ABC Labs, Inc. 29 p.

MRID 45900901 Gonsior, S.; Rivard, M.; Stock, M. (2002) Estimating the
Soil Adsorption Coefficient (Koc) for a Series of Biocides by HPLC Using
OECD Method 121: Lab Project Number: STUDY 011094: 011094: 121.
Unpublished study prepared by The Dow Chemical Company. 41 p.

MRID 92011016 Lewis, B.; Manowitz, M. (1990) Givaudan Phase 3 Summary of
MRID 40916901. Determination of the Biodegradability of Giv 2-0820 in
Soil and Water under Anaerobic Conditions: Project No. 88-11-2866.
Prepared by SPRINGBORN LIFE SCIENCES, INC. 17 p

MRID 92011017 Lewis, B.; Manowitz, M. (1990) Givaudan Phase 3 Summary of
MRID 40916801. Determination of the Biodegradability of Giv 2-0820 in
Soil and Water under Aerobic Conditions: Project No. 88-11-2865.
Prepared by SPRINGBORN LIFE SCIENCES, INC. 14 p.

MRID 92011018 Lewis, B.; Manowitz, M. (1990) Givaudan Phase 3 Summary of
MRID 40817701. Determination of Adsorption and Desorption Coefficients
of Giv 2-0820: Project No. 88-06-2753. Prepared by SPRINGBORN LIFE
SCIENCES, INC. 12 p.

MRID 92011019 Lewis, B.; Manowitz, M. (1990) Givaudan Phase 3 Summary of
MRID 41191601. Mobility in Soils of Giv 2-0820 by the Soil Column
Leaching Method: Project No. 88-10-2838. Prepared by SPRINGBORN LIFE
SCIENCES, INC. 14 p.

**Toxicology References**

Bucher, J. (1994) NTP Technical Report on Toxicity Studies of
β-Bromo-β-nitrostyrene administered by gavage to F344 rats and B6C3F~1~
mice. Microbiological Associates, Inc. NTP Toxicity Report Series No.:
40, August, 1994. MRID \# not assigned at this time. Published (NIH
Publication 94-3389).

Ingram, K. (2006) Re: Bromonitrostyrene: A letter to the Agency for
cancellation of product labels, Slime-Trol RX-41 (74655-5), Slime-Trol
RX-45 (74655-8), Slime-Trol RX-52 (74655-13). October 31, 2006.

MacGregor, J., C. Wehr, P. Heniks, et al. (1990). The *in vivo*
erythrocyte micronucleus test: Measurement at steady state increases
assay efficiency and permits integration with toxicity studies.
Fundamentals of Applied Toxicology*.* 14, 513-522.

Zeiger E., B. Anderson, S. Haworth S, et al. (1992) Salmonella
mutagenicity tests: V. Results from the testing of 311 chemicals.
Environmental Molecular Mutagenesis. 19 Suppl 21:2-141.

MRID 00150524 Fogleman, R. (1969) Short-term toxicity of GIV 0820 to
albino rats. Affiliated Medical Enterprises, Inc., Princeton, New
Jersey. Laboratory Contract No.: 20-284-9-69, October 30, 1969.
Unpublished

MRID 00150525 Fogleman, R. (1970) Thirty-day subacute oral toxicity in
rats on compound GIV 0820. Affiliated Medical Enterprises, Inc.,
Princeton, New Jersey. Laboratory Contract No.: 120-285-9-69, February
17, 1970. Unpublished.

MRID 40641309 Ivett, JL (1987) Mutagenicity Test on GIV 2-0820 in an *In
Vitro* Cytogenetic Assay Measuring Chromosomal Aberration Frequencies in
Chinese Hamster Ovary (CHO) Cell. Hazleton Laboratories, Inc.,
Kensington, MD; HLA Study No. 9725-0-437; report Date: April 1, 1987.
Unpublished.

MRID 40641310 Cifone, MA (1987) Mutagenicity Test on GIV 2-0820 in the
Rat Primary Hepatocyte Unscheduled DNA Snthesis Assay; Hazleton
Laboratories, Inc., Kensington, MD; HLA Study No. 9720-0-447; report
Date: August 6, 1987. Unpublished.

MRID 40691401 Timm A. (1987) Salmonella/Mammalian Microsome Mutagenicity
Test with β-brom-β-nitrostyrol: CCR, Cytotest Cell Research GmbH & Co.,
KG-6100, Darmstadt, Federal Republic of Germany; CCR Project #102205;
Reprot Date: July 8, 1987. Unpublished.

MRID 40691402 Schroeder, R. (1987) A Range-Finding Study to Evaluate the
Toxicity of Giv 2-0820 in the Pregnant Rat: Project No. 87-3162.
Unpublished study prepared by Bio/dynamics, Inc.

MRID 40728701 Schroeder, R. (1988) A Teratogenicity Study in Rats with
GIV 2-0820. Bio/Dynamics Inc., East Millstone, NJ 08875-2360. Project
No. 87-3163. 6 July 1988. Unpublished.

MRID 40830101 Auletta, CS. (1988) A 21-day Dermal Toxicity Study in
Rabbits with GIV 2-0820. Bio/Dynamics, Inc. Project No. 4541-87; July
28, 1988. Unpublished.

MRID 41603501 Blaszcak, D. (1990) Acute Oral Toxicity Study in Rats with
Giv 2-0820: Final Report: Lab Project Number: 5723-89. Unpublished study
prepared by Bio/dynamics, Inc.

MRID 41603506 Blaszcak, D.L. (1990) Acute Oral Toxicity in Rats with BNS
25% AF: Final Report: Lab Project Number 5753-89. Unpublished Study
prepared by Bio/dynamics., Inc.

MRID 41744601 Blaszcak, D. (1990) Primary Dermal Irritation Study in
Rabbits with BNS 25% AF: Lab Project Number: 5876-90. Unpublished study
prepared by Bio/dynamics, Inc.

MRID 43452701 Hoffman, G. (1994) An Acute (4-Hour) Inhalation Toxicity
Study of BNS in the Rat via Nose-Only Exposure: Lab Project Number: 94
-5176. Unpublished study prepared by Pharmaco LSR Inc.

MRID 44178401 Blanset, D. (1996) Skin Corrosivity Evaluation of BNS 25%
AF in the Rabbit: Lab Project Number: 96-1498. Unpublished study
prepared by Huntingdon Life Sciences. 21 p.

MRID 44524506 Madarasz, A. (1997) Acute Dermal Toxicity Study in
Rabbits: GIV-GARD BNS 25% BA: Final Report: Lab Project No. 97-1653.
Unpublished study prepared by Huntingdon Life Sciences.

MRID 44524508 Madarasz, A. (1997) Primary Dermal Irritation Study in
Rabbits: GIV-GARD BNS 25% BA: Final Report: Lab Project Number: 97-1654.
Unpublished study prepared by Huntingdon Life Sciences. 18 p.

MRID 44524509 Madarasz, A. (1997) Primary Eye Irritation Study in
Rabbits: GIV-GARD BNS 25% BA: Final Report: Lab Project Number: 97-1655.
Unpublished study prepared by Huntingdon Life Sciences. 25 p.

MRID 44524510 Madarasz, A. (1997) Guinea Pig Maximization Test (Method
of Magnusson and Kligman): GIV-GARD BNS 25% BA: Final Report: Lab
Project Number: 97-1656. Unpublished study prepared by Huntingdon Life
Sciences. 33 p.

MRID 45094806 Hoffman, G. (1999) Guinea Pig Maximization Test (Method of
Magnusson and Kligmann): Spectrum RX4101: Final Report: Lab Project
Number: 98 -1866. Unpublished study prepared by Huntingdon Life
Sciences. 39 p.

MRID 46972603 Cifone, M. A. (2001) *In vivo/in vitro* unscheduled DNA
synthesis in rat primary hepatocyte cultures at two time points with a
dose rangefinding assay with β-brom-β-nitrostyrol. Covance Laboratories
Inc., Vienna, VA. Covance Study No.: 21569-0-494OECD, Dow Study No.:
001099, January 25, 2001. Unpublished.

MRID 47010001 Spencer, P.J., T.A. Hammond and D.J. Beuthin. (2001)
Evaluation of β-bromo-β-nitrostyrene in the mouse bone marrow
micronucleus test. Toxicology & Environmental Research and Consulting,
The Dow Chemical Company, Midland, MI. Laboratory Project Study ID.:
001150, January 16, 2001. Unpublished.

**Occupational and Residential Exposure Assessment References**

American Chemical Council (ACC), 2005. Slimicide Use in Papermaking
(Powerpoint Presentation). ACC Biocides Council, September 17, 2003.

Number range CHAPTERFreeman, N , Jimenez M, Reed KJ,Gurunathan S,
Edwards RD, Roy A, Adgate JL, Pellizzari ED, Quackenboss J, Sexton K,
Lioy PJ, 2001. Quantitative analysis of children's microactivity
patterns: The Minnesota Children's Pesticide Exposure Study. Journal of
Exposure Analysis and Environmental Epidemiology. 11(6): 501-509.

Trueblood, A. 2007. EPA Reg. Number 464-686 (Bromonitrostyrene). An
e-mail sent to the Agency, February 22, 2007.

USEPA. 1992. A Laboratory Method to Determine the Retention of Liquids
on the Surface of Hands, Exposure Evaluation Division, Office of
Pollution Prevention and Toxic, USEPA, EPA 747-R-92-003, September,
1992.

USEPA. 1996. Office of Research and Development, Descriptive Statistics
Tables from a Detailed Analysis of the National Human Activity Pattern
(NHAPS) Data; EPA/600/R-96/148, July 1996. Data Collection Period
October 1992 - September 1994 .

USEPA. 1997. Exposure Factors Handbook. Volume I-II. Office of Research
and Development. Washington, D.C. EPA/600/P-95/002Fa. August 1997.

USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure
from the Pesticide Handler Exposure Database Version 1.1. Washington,
DC: U.S. Environmental Protection Agency.

Number range CHAPTERUSEPA. 1999. Evaluation of Chemical Manufacturers
Association Antimicrobial Exposure Assessment Study (Amended on 8
December 1992). Memorandum from Siroos Mostaghimi, PH.D., USEPA to Julie
Fairfax, USEPA. Dated November, 4 1999. DP Barcode D247642.

USEPA. 2000. Residential SOPs. EPA Office of Pesticide Programs, Human
Health Effects Division. Dated April 5, 2000.

USEPA. 2001. HED Science Advisory Council for Exposure. Policy Update,
November 12. Recommended Revisions to the Standard Operating Procedures
(SOPs) for Residential Exposure Assessment, February 22, 2001.

USEPA. 2007. Tao, J. (2007). Bromonitrostyrene (BNS): Toxicology
Disciplinary Chapter for the Issuance of the Reregistration Eligibility
Decision (RED) Document. D338740, U.S. Environmental Protection Agency,
Office of Pesticide Programs, Antimicrobial division, March 22, 2007.

[]{.mark}

**APPENDIX A**

**Subchronic, Chronic and Other Toxicity Profiles for
Bromonitrostyrene**

+-------------------+---------------------+---------------------------+
| **Subchronic,     |                     |                           |
| Chronic and Other |                     |                           |
| Toxicity Profiles |                     |                           |
| for               |                     |                           |
| Br                |                     |                           |
| omonitrostyrene** |                     |                           |
+===================+=====================+===========================+
| **Guideline       | **MRID Number       | **Results**               |
| Number/**         | (Year)/**           |                           |
|                   |                     |                           |
| **Study Type/**   | **Classification/   |                           |
|                   | Doses**             |                           |
| **Test Substance  |                     |                           |
| (% a.i.)**        |                     |                           |
+-------------------+---------------------+---------------------------+
| **Subchronic      |                     |                           |
| Toxicity**        |                     |                           |
+-------------------+---------------------+---------------------------+
| 870.3100          | NTP study (1994)    | **NOAEL: 37 mg/kg/day     |
|                   |                     | (males) and 75 mg/kg/day  |
| 28-day Oral --    | **Acceptable --     | (females)**               |
| Rat               | Non-guideline**     |                           |
|                   |                     | **LOAEL: 75 mg/kg/day     |
| Bromonitrostyrene | 0, 37, 75, 150,     | (males) and 150 mg/kg/day |
|                   | 300, or 600         | (females)**, based on     |
| Purity: \>99%     | mg/kg/day           | histopathology findings   |
| (*trans isomer*)  |                     | in the forestomach.       |
+-------------------+---------------------+---------------------------+
| 870.3100          | NTP study (1994)    | **NOAEL: 150 mg/kg/day**  |
|                   |                     |                           |
| 28-day Oral --    | **Acceptable --     | **LOAEL: 300 mg/kg/day**  |
| Mouse             | Non-guideline**     | based on microscopic      |
|                   |                     | pathology of the          |
| Bromonitrostyrene | 0, 37, 75, 150,     | forestomach and           |
|                   | 300, or 600         | gallbladder.              |
| Purity: \>99%     | mg/kg/day           |                           |
| (*trans isomer*)  |                     |                           |
+-------------------+---------------------+---------------------------+
| 870.3100          | 150525 (1970)       | **NOAEL: 300 mg/kg/day    |
|                   |                     | (2500 ppm)**              |
| 30-day Oral --    | **Unacceptable**    |                           |
| Rat               |                     | **LOAEL: Not              |
|                   | 0, 50, 110, or 300  | established** (although   |
| Giv 0820          | mg/kg/day (0, 500,  | increased kidney-body     |
|                   | 1000, 2500 ppm)     | weight ratio in the males |
| Purity: Not       |                     | were observed, no         |
| reported          | 150524 (1969)       | toxicity or               |
|                   |                     | histopathological changes |
| Rang-finding --   | **Unacceptable**    | were noted).              |
| Rat               |                     |                           |
|                   | 0, 110, 300 or 370  | **NOAEL: 110 mg/kg/day    |
| Giv 0820          | mg/kg/day (0, 1000, | (1000 ppm)**              |
|                   | 2500, 5000 ppm)     |                           |
| Purity: Not       |                     | **LOAEL: 300 mg/kg/day    |
| reported          |                     | (2500 ppm)** based on     |
|                   |                     | decreased food efficiency |
|                   |                     | ratios in both sexes.     |
+-------------------+---------------------+---------------------------+
| 870.3200          | 40830101 (1988)     | **[Systemic               |
|                   |                     | Toxicity]{.underline}**   |
| 21-day Dermal -   | **Acceptable -      |                           |
| Rabbit            | Guideline**         | **NOEL: 50 mg/kg/day**    |
|                   |                     |                           |
| GIV 2-0820        | 0, 10, 50, or 100   | **LOEL: 100 mg/kg/day**   |
|                   | mg/kg/day           | based on mortality in 2/5 |
| Purity: 99.1%     |                     | females, reduced mean     |
|                   |                     | body weights in both      |
|                   |                     | sexes, and statistically  |
|                   |                     | significant elevations in |
|                   |                     | serum potassium levels in |
|                   |                     | both males and females at |
|                   |                     | termination.              |
|                   |                     |                           |
|                   |                     | **[Dermal                 |
|                   |                     | Toxicity]{.underline}**   |
|                   |                     |                           |
|                   |                     | **NOEL: ≤ 10 mg/kg/day    |
|                   |                     | (LDT)** based on dermal   |
|                   |                     | irritation effects        |
|                   |                     | observed at all dose      |
|                   |                     | levels.                   |
+-------------------+---------------------+---------------------------+
| **Developmental   |                     |                           |
| Toxicity**        |                     |                           |
+-------------------+---------------------+---------------------------+
| 870.3700          | 40691402 (1987)     | At 300 mg/kg/day, 2/5     |
|                   |                     | females were sacrificed   |
| Developmental --  | **Acceptable --     | moribund (gestation days  |
| Rat (a            | Non-guideline**     | 8 and 11), and at 600     |
| range-finding     |                     | mg/kg/day 5/5 females     |
| study)            | 0, 30, 75, 150,     | died on gestation days    |
|                   | 300, and 600        | 7-10 (after receiving 1-4 |
| Bromonitrostyrene | mg/kg/day           | doses of the test         |
|                   |                     | material). During the     |
| Purity: 99.1%     |                     | treatment period, mean    |
|                   |                     | body weight gains were    |
|                   |                     | similar in controls and   |
|                   |                     | the 30 and 75 mg/kg/day   |
|                   |                     | groups, but were reduced  |
|                   |                     | in the 150 mg/kg/day      |
|                   |                     | group (by 16.7%) and the  |
|                   |                     | 300 mg/kg/day group (by   |
|                   |                     | 31%).                     |
|                   |                     |                           |
|                   |                     | There was no indication   |
|                   |                     | of fetotoxicity (no ↑     |
|                   |                     | number of late            |
|                   |                     | resorption, no dead       |
|                   |                     | fetuses, no effect on     |
|                   |                     | mean fetal body weight)   |
|                   |                     | at doses of up to 300     |
|                   |                     | mg/kg/day at termination. |
+-------------------+---------------------+---------------------------+
| 870.3700          | 40728701 (1988)     | **[Maternal               |
|                   |                     | Toxicity]{.underline}**   |
| Developmental -   | **Acceptable -      |                           |
| Rat               | Guideline**         | **NOAEL: 75 mg/kg/day**   |
|                   |                     |                           |
| GIV 2-0820        | 0, 30, 75, or 150   | **LOAEL: 150 mg/kg/day**  |
|                   | mg/kg/day           | for increased incidence   |
| Purity: 99.1%     |                     | of excessive salivation   |
|                   |                     | along with a reduced in   |
|                   |                     | mean weight gain (21.1%   |
|                   |                     | below the control value   |
|                   |                     | but not statistically     |
|                   |                     | significant) during the   |
|                   |                     | treatment period (6-15    |
|                   |                     | days of gestation).       |
|                   |                     |                           |
|                   |                     | **[Developmental          |
|                   |                     | Toxicity]{.underline}**   |
|                   |                     |                           |
|                   |                     | **NOAEL: 75 mg/kg/day**   |
|                   |                     |                           |
|                   |                     | **LOAEL: 150 mg/kg/day**  |
|                   |                     | for a statistically       |
|                   |                     | significant decrease in   |
|                   |                     | mean fetal body weight    |
|                   |                     | (p≤0.01) and a slight     |
|                   |                     | increased incidence of    |
|                   |                     | skeletal malformations,   |
|                   |                     | mostly wavy ribs (not     |
|                   |                     | statistically             |
|                   |                     | significant).             |
+-------------------+---------------------+---------------------------+
| **Mutagenicity**  |                     |                           |
+-------------------+---------------------+---------------------------+
| 870.5100          | 40691401 (1987)     | **Positive**              |
|                   |                     |                           |
| *Salmonella       | **Partially         | (TA100 in the absence and |
| typhimurium*      | Acceptable -        | presence of S9 mix)       |
| Reverse Mutation  | Guideline**         |                           |
| Test              |                     |                           |
|                   | Without S9          |                           |
| β-b               | activation:         |                           |
| rom-β-nitrostyrol |                     |                           |
|                   | 0.01 to 3.33        |                           |
| Purity: \> 92%    | µg/plate (TA 1535,  |                           |
|                   | TA 1537, TA 1538,   |                           |
|                   | and TA 98);         |                           |
|                   |                     |                           |
|                   | and                 |                           |
|                   |                     |                           |
|                   | 0.10 to 33.33       |                           |
|                   | µg/plate (TA 100);  |                           |
|                   |                     |                           |
|                   | With S9 activation: |                           |
|                   |                     |                           |
|                   | 1.0 to 333.3        |                           |
|                   | μg/plate (all       |                           |
|                   | strains)            |                           |
+-------------------+---------------------+---------------------------+
| 870.5100          | NTP study (1994)    | **Positive**              |
|                   |                     |                           |
| *Salmonella       | **Acceptable --     | (TA98 and TA100 in the    |
| typhimurium*      | Non-guideline**     | absence of S9 mix)        |
| Reverse Mutation  |                     |                           |
| Test              | Without S9          |                           |
|                   | activation: 0, 1,   |                           |
| β-b               | 3.3, 5, 10, 15, or  |                           |
| rom-β-nitrostyrol | 20 µg/plate (TA97,  |                           |
|                   | TA98, and TA100)    |                           |
| Purity: \> 95%    |                     |                           |
|                   | and                 |                           |
|                   |                     |                           |
|                   | 0, 0.3, 1, 3.3, 10, |                           |
|                   | or 20 µg/plate      |                           |
|                   | (TA1535)            |                           |
|                   |                     |                           |
|                   | With S9 activation  |                           |
|                   | (5% hamster or rat  |                           |
|                   | S9): 0, 1, 3.3, 10, |                           |
|                   | 15, 20, 33, or 100  |                           |
|                   | µg/plate (TA97,     |                           |
|                   | TA98, and TA100)    |                           |
|                   |                     |                           |
|                   | and                 |                           |
|                   |                     |                           |
|                   | (10% hamster or rat |                           |
|                   | S9): 0, 3.3, 10,    |                           |
|                   | 33, 100 or 200      |                           |
|                   | µg/plate (TA97,     |                           |
|                   | TA98, TA100, and    |                           |
|                   | TA1535)             |                           |
+-------------------+---------------------+---------------------------+
| 5375.             | 40641309 (1987)     | **Positive**              |
|                   |                     |                           |
| *In Vitro*        | **Acceptable -      |                           |
| Mammalian         | Guideline**         |                           |
| Chromosome        |                     |                           |
| Aberration Test   | 1.00 to 3.00 μg/mL  |                           |
|                   | (first assay,       |                           |
| GIV 2-0820        | without S9          |                           |
| Purity: 99.1%     | activation) 2.25 to |                           |
|                   | 5.00 μg/mL (second  |                           |
|                   | assay, without S9   |                           |
|                   | activation) 0.997   |                           |
|                   | to 7.48 μg/mL (with |                           |
|                   | S9 activation)      |                           |
+-------------------+---------------------+---------------------------+
| 870.5395          | NTP study (1994)    | **Positive**              |
|                   |                     |                           |
| *In Vivo*         | **Acceptable --     | (significant increase in  |
| Mammalian         | Non-guideline**     | the frequency of          |
| Cytogenetics -    |                     | micronucleated            |
| Erythrocyte       | 0, 37, 75, 150, 300 | normochromatic            |
| Micronucleus      | or 600 mg/kg/day in | erythrocytes)             |
| Assay             | 5 mL/kg bw of corn  |                           |
|                   | oil                 |                           |
| β-b               |                     |                           |
| rom-β-nitrostyrol |                     |                           |
|                   |                     |                           |
| Purity: \> 99%    |                     |                           |
+-------------------+---------------------+---------------------------+
| 870.5395          | 47010001 (2001)     | **Negative**              |
|                   |                     |                           |
| *In Vivo*         | **Acceptable --     |                           |
| Mammalian         | Guideline**         |                           |
| Cytogenetics -    |                     |                           |
| Erythrocyte       | 0, 75, 150, or 300  |                           |
| Micronucleus      | mg/kg in 10 mL/kg   |                           |
| Assay             | bw of corn oil      |                           |
|                   |                     |                           |
| β-b               |                     |                           |
| rom-β-nitrostyrol |                     |                           |
|                   |                     |                           |
| Purity: \> 99%    |                     |                           |
+-------------------+---------------------+---------------------------+
| 870.5550          | 40641310 (1987)     | **Negative**              |
|                   |                     |                           |
| Unscheduled DNA   | **Acceptable --     |                           |
| Synthesis in      | Guideline**         |                           |
| Mammalian Cells   |                     |                           |
| in Culture - Rat  | 0.25 to 25 µg/mL    |                           |
|                   |                     |                           |
| GIV 2-0820        |                     |                           |
|                   |                     |                           |
| Purity: 99.1%     |                     |                           |
+-------------------+---------------------+---------------------------+
| 870.5550          | 46972603 (2001)     | **Negative**              |
|                   |                     |                           |
| Unscheduled DNA   | **Acceptable --     |                           |
| Synthesis in      | Nonguideline**      |                           |
| Mammalian Cells   |                     |                           |
| in Culture - Rat  | 0, 350, 700 mg/kg   |                           |
|                   | in 20 mL/kg bw of   |                           |
| β-b               | corn oil            |                           |
| rom-β-nitrostyrol |                     |                           |
|                   |                     |                           |
| Purity: \>99%     |                     |                           |
+-------------------+---------------------+---------------------------+
| **Metabolism**    |                     |                           |
+-------------------+---------------------+---------------------------+
| 870.7485          | NTP study (1994)    | [Absorption:]{.underline} |
|                   |                     |                           |
| Metabolism and    | **Acceptable --     | **Oral:** 84%, 100%, 91%  |
|                   | Nonguideline**      | (1.0, 10, 100 mg/kg,      |
| Pharmacokinetics  |                     | respectively)             |
| -- Rat            | Oral (gavage): 1.0, |                           |
|                   | 10, 100 mg/kg       | **Dermal:** 56%, 55%, 9%  |
| β-bro             |                     | (1.0, 10, 100 mg/kg,      |
| mo-β-nitrostyrene | IV: 9.1 mg/kg       | respectively)             |
|                   |                     |                           |
| Purity: 98%       | Dermal: 0.1, 10,    | [Excretion:]{.underline}  |
|                   | 100 mg/m^2^         |                           |
|                   |                     | **Oral:** 49-57% (24 hr)  |
|                   |                     | and 50-66% (72 hr) in     |
|                   |                     | urine; 27-37% (24 hr) and |
|                   |                     | 33-40% (72 hr) in feces   |
|                   |                     |                           |
|                   |                     | **IV:** 67% (12 hr) in    |
|                   |                     | urine and 11-13% (0-24    |
|                   |                     | hr) in feces              |
|                   |                     |                           |
|                   |                     | **Dermal:** 0-24 hr: 45%  |
|                   |                     | and 8% (0.1 and 10        |
|                   |                     | mg/m^2^, respectively) in |
|                   |                     | urine and 17% and 18%     |
|                   |                     | (0.1 and 10 mg/m^2^,      |
|                   |                     | respectively) in exhaled  |
|                   |                     | as volatiles              |
|                   |                     |                           |
|                   |                     | [                         |
|                   |                     | Metabolites:]{.underline} |
|                   |                     |                           |
|                   |                     | **In urine:**             |
|                   |                     |                           |
|                   |                     | 1-pheny                   |
|                   |                     | l-2-nitroethyl-1-sulfonic |
|                   |                     | acid (PNSA):              |
|                   |                     | oral\>IV\>dermal          |
|                   |                     |                           |
|                   |                     | Hippurate:                |
|                   |                     | dermal\>IV\>oral          |
+-------------------+---------------------+---------------------------+