Docket Number EPA

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Page 2 of 28 Potassium Hypochlorite Registration Review Team

Human Health
Jonathan Leshin Timothy Dole

Environmental Fate and Effects David Bays
Srinivas Gowda Najm Shamim

Risk Management
Donna Kamarei
James Parker

Office of General Counsel Philip RossDocket Number EPA

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Page 3 of 28 TERMS, ABBREVIATIONS AND SYMBOLS

AD Antimicrobials Division

A.I. or a.i. active ingredient

aPAD a cute p opulation a djusted d ose ASRI a ctivated sludge r espiration i nhibition

atm

- m 3 /mole a tmospheric pressure

- cubic meter per mole

BCF b ioconcentration f actor
°C d egrees Celsius

CaSO 4 c alcium s ulfate
CaSO 3 c alcium s ulfite
CAS Chemical Abstracts Service

CCA c hromated c opper a rsenate
CFR Code of Federal Regulati ons CHO Chinese h amster o vary CMA Chemical Manufacturers Association

CO 2 c arbon dioxide
COC c oncentration

- of

- c oncern cPAD c hronic p opulation a djusted d ose CS 2 c arbon disulfide
DCI data call

- in

EC 50 m edian (or 50 percent) e ffect c oncentration
EC 05 5 p ercent e ffect c oncentration
ECOTOX ECOTOXicology

EDI e stimated daily i ntake
EDSP E ndocrine Disruptor Screening Program

E

- FAST Exposure and Fate Assessment Screening Tool
EPI Suite Estimation Program Interface Suite

EPA Environmental Protection Agency

FDA Food and Drug Administration
FFDCA Feder al Food, Drug, and Cosmetic Act

FGD f

lue

- g as d esulfurization

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FQPA Food Quality Protection Act

FWP Final Work Pl an g/mol g rams per mole

GLN guideline number

HPV h igh production v olume
IDS Incident Data System

K DDC potassium d imethyldithiocarbamate

Koc o rganic carbon normalized soil

- water partition coefficient
Kd s oil

- water partition coefficient

Kow o ctanol

- water partition coefficient

LC 50 m edian (or 50 percent) l ethal c oncentration

LD 50 m edian (or 50 percent) l ethal d ose LOAEC l owest

- o bserved

- a dverse

- e ffect

- c oncentration

LOEC l owest

- o bserved

- e ffect

- c oncentration
LOAEL lowest

- observed

- adverse

- e ffect

- l evel Log K
ow l ogarithm of the octanol

- water partition coefficient

μg m icrogram ml/g m illiliter p er g ramDocket Number EPA

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Page 4 of 28 mg/kg m illigram p er k ilogram mg/kg/day m illigram p er k ilogram p er d ay mg/L m illigram p er l iter mm Hg m illimeter of mercury

MOE m argin of e xposu re MRID Master Record Identification Number

MRL m aximum r esidue l imit

N/A n ot a pplicable

Na DDC s odium d imethyldithiocarbamate s alt

nm n anometers
NOAEC no

- observed

- adverse

- effect

- c oncentration
NOAEL n o

- o bserved

- a dverse

- e ffect

- l evel

OCSPP Office of Chemical Safety and Pollution Prevention
OECD Organization for Economic Co

- operation and Development

OPP Office of Pesticide Programs

PAD p opulation a djusted d ose PAI p ure active i ngredient

PDM Probabilistic Dilution Model

% p ercent
PC Code Pesticide Chemical Code
PCF p ounds p er c ubic foot pH power of h ydrogen or power of the con centration of the hydrogen ion

PHED Pesticide Handler’s Exposure Data

PIS primary i rritation s core pKa p ower of the acid dissociation constant or negative base

- 10 logarithm of the acid

dissociation constant of a solution ppb p arts p er b illion

ppm p arts p er m illion

PWP Preliminary Work Plan QSAR q uantitative s tructure

- a ctivity r elationship

RED Rere gistration Eligibility Decision

SAR s tructure a ctivity r elationship
SF s afety f

actor
SSTS Section Seven Tracking System

SO 2 s ulfur dioxide

TEP t ypical e nd

- u se p roduct

TGAI t echnical grade active i ngredient

TMDL total maximum daily l oads

UF uncertainty factor

UV/VIS ultraviolet/v isible light a bsorption

% w / w p ercent weight per weight.

WP w ettable powder

WWTPs w astewater treatment plantsDocket Number EPA

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Page 5 of 28 

### Table of Contents

1 Introduction

................................ ................................ ................................ ............................. 7
1.1 Statutory and Regulatory Authority

................................ ................................ ................. 7
1.2 Updates to the Workplan

................................ ................................ ................................ .. 9
1.3 Case Overview

................................ ................................ ................................ ................. 9
1.4 Chemical Identification and Properties

................................ ................................ ............ 9
1.5 Use/Usage Description

................................ ................................ ................................ ... 10

1. 5.1 Registrations

................................ ................................ ................................ ........... 10
1.5.2 Summary of Registered Uses

................................ ................................ .................. 10

1.6 Regulatory History

................................ ................................ ................................ ......... 12

1.6.1 Tolerance Information

................................ ................................ ............................ 12

1.7 Incidents

................................ ................................ ................................ ......................... 13

1.7.1 Human Health

................................ ................................ ................................ ......... 13

1.7.2 Ecological

................................ ................................ ................................ ............... 13

2 Anticipated Data Needs

................................ ................................ ................................ ........ 13

3 Human Health Risk Assessment

................................ ................................ ........................... 13

3.1 Existing Toxicological Endpoints

................................ ................................ .................. 13

3.2 Dietary Exposure

................................ ................................ ................................ ............ 14

3.3 Occupational and Residential Exposures

................................ ................................ ....... 14

3.4 Aggregate and Cumulative Exposure

................................ ................................ ............. 14

3.4.1 Aggregate Exposures

................................ ................................ .............................. 14

3.4.2 Cumulative Exposures

................................ ................................ ............................ 14

4 Environmental Risk Assessment

................................ ................................ ........................... 14

4.1 Environmental Fate Assessment

................................ ................................ .................... 15

4.1.1 Leaching [Wood/Paint/Antifoulant Paint/Plastic/Textiles/e.g., treated article]

...... 15

4.1.2 Water and Sediment

................................ ................................ ................................ 15

4.1.3 Soil

................................ ................................ ................................ .......................... 15

4.1.4 Air

................................ ................................ ................................ ........................... 15
4.1.5 Other media

................................ ................................ ................................ ............. 15

4.1.6 Waste Water Treatment Plants (WWTP)

................................ ................................ 16

4.1.7 Water Quality

................................ ................................ ................................ .......... 16

4.2 Ecological Effects Assessment

................................ ................................ ....................... 16

4.2.1 Mode of Action

................................ ................................ ................................ ....... 16

4.2.2 Measures of Effect (Ecotoxicology Assessment Endpoints)

................................ .. 16

4.3 Exposure Analysis Plan

................................ ................................ ................................ .. 17

4.3.1 Aquatic and Terrestrial Wildlife Exposure Estimates

................................ ............ 17

4.4 Effects Analysis Plan

................................ ................................ ................................ ..... 17
5 Endocrine Disruptor Screening Program (EDSP)

................................ ................................ . 17

6 Next Steps

................................ ................................ ................................ ............................. 18

7 References

................................ ................................ ................................ ............................. 20

Appendix A T oxicology Profile

................................ ................................ ............................... 21 Appendix B Environmental Fate and Transport of Potassium Hypochlorite

.......................... 22 Appendix C Ecotoxicology Profile

................................ ................................ .......................... 23 Appendix D Product Chemistry

................................ ................................ ............................... 27Docket Number EPA

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Page 6 of 28 List of Tables
Table 1

– Summary of Anticipated Risk Assessments and Data Needs: Potassium Hypochlorite 8
Table 2

– Anticipated Registration Review Schedule

................................ ................................ .... 8
Table 3

– Chemical Identification of Potassium Hypochlorite

................................ ....................... 9
Table 4

– Physical

- Chemical and Environmental Fate Properties for Potassium Hypochlorite

. 10
Table 5

– Summary of Potassium Hypochlorite Registered Uses

................................ ................ 10
Table 6

– Acute Toxicity Studies for Potassium Hypochlorite

................................ .................... 21

List of Figures

None.Docket Number EPA

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Page 7 of 28 

## 1 Introduction

This document is the United States Environmental Protection Agency’s ( USEPA, EPA or “the

a gency”) Final Work Plan ( F WP) for potassium h ypochlorite (case 5076) . The F WP document explains what EPA's Office of Pesticide Programs (OPP) knows about p otas sium h ypochlorite

, highlighting anticipated data and assessment needs, identifying the types of information that

wou ld be especially useful to the a gency in conducting the review, and providing an anticipated timeline for completing p otassium h ypochlorite’s review.

The registration review process was designed to include a public participation component to solicit input from interested stakeholders. Th e a gency intends, by sharing this information in the docket, to inform the public of what it knows about p ot assium h ypochlorite and what types of
new data or other inform ation would be helpful for the a gency to receive as it moves toward a
decision on pota ssium h ypochlorite

. As explained further in this document, i n the future, if appropriate the agency will evaluate this chemical with sodium and calcium hypochlorite (c ase 0029).



## 1.1 Statutory and Regulatory Authority

The Food Quality Protection Act (FQP A) of 1996 mandated a registration review program. All pesticides distributed or sold in the United States generally must be registered by the USEPA based on scientific data showing that they will not cause unreasonable risks to human health or
the environ ment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the re gistration review program, the a gency periodically reevaluates pesticides to make sure th at as change occurs, products in the marketplace can be used safely. Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/

.

The a gency is implementing th e registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration

. The regulations governing registration review begin at 40 CF R 155.40. The a gency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened fo r each case. The docket is the

a gency’s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration review decision. Further, the agency believes that potassium hypochlorite is similar to and can be considered with the
chemicals in c ase 0029, sodium and calcium hypochlorite. The docket for the sodium and calcium hypochlorite case opened in March 2012. No risk assessments are considered necessary for any of the three compounds since EPA has con cluded that the currently registered uses of the hypochlorites will not result in unreasonable adverse effects to the environment. Since no risk assessments are necessary, after the final workplan for potassium hypochlorite is issued, the agency intends t o issue a combined proposed decision for all three compounds.Docket Number EPA

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Page 8 of 28 The potassium hypochlorite Preliminary Work Plan (PWP) was published on March 26, 2014
and the 60

- day comment period ended on May 27, 2014. The agency did not receive any submissions during the public comment period on the initial docket.

Documents associ ated with this registration review can be viewed at http://www.regulations.gov
in docket EPA

- HQ

- OPP

- 2014

- 0157.

Tables 1 and 2 below summarize the issues relevant to this registration review case and the anticipat ed registration review schedule.

Table 1

– Summary of Anticipated Risk Assessments and Data Needs : Potassium Hypochlorite

Risk Assessment Assessment Necessary to Support Registration
Review Date of Most

Recent
Assessment Type of Assessment

Required (New/Updated) Data Anticipated as Needed

Dietary (food) No None None None

Dietary (drinking water) No None None None

Occupational Handler No None None None

Residential Handler No None None None

Residental Post Application No None None None

Aggregate No None None None

Cumulative No None None None

Tolerance Review No None None None

Ecological No None None None

Table 2

– Anticipated Registration Review Schedule

Anticipated Activity Target Date * Completion Date Phase 1: Opening the Docket

Open Docket and 60

- Day Comment Period for Preli minary Work Plan 2014

- 03 2014

- 03

- 26

Close Public Comment Period 2014

- 05 2014

- 05

- 27 Phase 2: Case Development

Issue Final Work Plan 2014

- 09 2014

- 08

Issue Data Call

- In (DCI) N/A

Receive Data to be Considered in Risk Assessment N/A Open 30

- Day Public Comment Period for Preliminary Risk Assessment(s) N/A

Close Public Comment Period N/A Phase 3: Registration Review Decision and Implementation Open 60

- Day Public Comment Period for Pro posed Decision 2016

- 09

Close Public Comment Period 2016

- 11

Issue Final Decision 2017

- 03 Begin Post

- Decision Followup 2017Docket Number EPA

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Page 9 of 28 Total (years) 3

* The anticipated schedule will be revised as necessary ( e.g ., need arising under the Endocrine Disruptor Screening Program with respect to the active ingredients in this case). N/A = Not applicable



## 1.2 Updates to the Workplan

Since the publication of the PWP, the a gency has made the following updates:

 Corrected the timeline in Table 2, the “A nticipated Registration R eview Schedule” table

.

 Updated section 4.3.1 “ Aquatic and Terrestrial Wildlife Exposure Estimates ”

.

 Deleted the “Guidance for Commenters” s ection

.

 Updated section 6

, “ Next Steps ”

.

 Updated Appendix B “Environmental Fate and Transport of Potassium Hypochlorite”.

Since no public c omments were received on the initial docket

, no modifications were made to the anticipated data needs or registration review schedule in the p otassium h ypochlorite PWP

. T his document makes final the work plan for the potassium hypochlorite registration review process.



## 1.3 Case Overview

The docket for the potassium h ypochlorite case (c ase 5076 ) has been established at http://www.regulations.gov in docket number EPA

- HQ

- OPP

- 2014

- 0157

.



## 1.4 Chemical Identification and Properties

Table 3 presents the activ e ingredient to be assessed in c ase 5076 : potassium h ypochlorite (PC Code 129053).

Table 3

– Chemical Identification of Potassium Hypochlorite

Chemical Name Potassium hypochlorite

Chemical Classification Halogen

PC Code 129053

CAS Number 7778

- 66

- 7

Molecular Formula KOCl
Molecular Weight (grams/mole) 90.55 Purity 12.5%

Available chlorine Contains approximately 1.0 lb of Available Chlorine/Gallon

Molecular Structure

The potassium hypochlorite product chemistry information relevant to risk assessment is
summarized in Table 4 (source: MRIDs KOCl: 47382901, 47445101, and 47594501).Docket Number EPA

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Page 10 of 28 Table 4

– Physical

- Chemical and Environmental Fate Properties for Potassium Hypochlorite

Guideline No. Parameter Potassium hypochlorite (12.5%)
Physical/Chemical Properties

830.7000 pH 10.14

- 1% w/w solution in de

- ionized water at 21.1

- 21.8° C

830.7050 UV/Visible Absorption Does not absorb in uv v isible range

830.7200 Melting point No t required

830.7220 Boiling point ( o C) Decomposes prior to boiling

830.7300 Density 1.1701 g/ml (9.75 lbs/gal) at 20.1°C

830.7370 Dissociation constant (pKa) Potassium hypochlorite dissociates completely on dissolving in water.

830.7550 Octanol

- water partition coefficient at 25 ° C

(Log K
ow ) NA

830.7840 Solubility in water (mg/L) Complete

830.7950 Vapor pressure (mmHg) NA

atm

- m 3 /mol = atmosphere cubic meter per mole; o C = degrees Celsius; mg/L = milligrams per liter; mmHg = millimeters of mercury

.



## 1.5 Use/Usage Description

1.5.1 Registrations

There is one product (EPA Reg. Number 63838

- 10) that c ontains potassium hypochlorite. The product is a soluble concentrate and it contains 1 2.5 percent potassium hypochlorite which is equivalent to approximately 1.0 lb of available chlorine per gallon . Th e product was registered on March 3, 2011.



### 1.5.2 Summary of Registered Uses

Table 5 presents a summary of the registered uses of potassium h ypochlorite that will be assessed in this registration review

.

Table 5

– Summary of Potassium Hypochlorite Registered Uses

Use Treatment

Type Application Method Product Application Rate Available
Chlorine (ppm)

Agricultural Premises and Equipment

Farm Premises Sanitization Surface and Immersion 14 oz/10 ga 1000 ppm

Irrigation SystemsDocket Number EPA

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Page 11 of 28

Use Treatment

Type Application Method Product Application Rate Available
Chlorine (ppm)

Irrigation Systems Bacteria and Algae Growth Sprinkler, Flood, Furrow,

Border or Drip Irrigation 5 ppm

Food Handling/Storage Establishments, Premises and Equipment

Food Egg Sanitization Sanitization Spray 2.5 oz/10 ga 200 ppm

Fresh Fruits and Vegetables ( with potable water r inse ) Sanitization Submersion or Drench 31 oz/250 ga 100 ppm

Fruit and Vegetable Washing (w ithout potable water rinse ) Sanitization Spray 6.2 oz/200 ga 25 ppm

Meat and Poultry Plants Processing Water Sanitization Circulate 1.4 oz/200 ga 5 ppm

Non

- Porous Food Contact
Surfaces Sanitization Rinse, Immerse, Circulate 2.5 oz/10 ga 200 ppm

Spray/Fog 7.5 oz/10 ga 600 ppm

Porous Food Contact
Surfaces Sanitization Rinse, Immerse, Circulate 7.5 oz/10 ga 600 ppm

Spray/Fog 7.5 oz/10 ga 600 ppm

Potatoes Sanitization Spray 0.5 oz/2 ga 500 ppm

Poultry chiller water and
carcass wash water Sanitization Circulate 14.4 oz /200 ga 50 ppm

Commercial, Institutional and Industrial Premises and Equipment

N on

- Porous Non

- Food
Contact Surfaces Sanitization Rinse, Immerse, Circulate 2.5 oz/10 ga 200 ppm

Spray/Fog 2.5 oz/10 ga 200 ppm

Non

- Porous Non

- Food
Contact Surfaces Disinfection Rinse, Immerse 7.5 oz/10 ga 600 ppm

Porous Non

- Food Contact
Surfaces Sanitization Rinse, Immerse 7.5 oz/10 ga 600 ppm

Laundry (Commercial) Sanitization Soak, Wash 2.5 oz/10 ga 200 ppm

Residential and Public Access Premises

Laundry (Household) Sanitization Soak, Wash 2.5 oz/10 ga 200 ppm

Human Drinking Water Systems

Drinking Water Disinfection Injection As needed * 0.6 ppm in system

Public Water Systems

Mains New Tanks, Basins
Sand Filters Well Casing Equipment Equipment
Tank Cars Disinfection Injection Open Pour Open Pour Open Pour Open Pour Spray Spray As needed *

25 oz/5 ft 3

100 oz/150 ft 3 6.2 oz/10 ga
26 oz/5 ft 3 6.2 oz/5 ga 6.2 oz/10 ga 50 ppm

500 ppm Unspecified

50 0 ppm 500 ppm 1000 ppm 500 ppm

Industrial Processes and Water SystemsDocket Number EPA

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Page 12 of 28

Use Treatment

Type Application Method Product Application Rate Available
Chlorine (ppm)

Cooling Towers Slug

Maintenance Open Pour 130 oz/10,000 ga 14 oz/10,000 ga 10 ppm 1 ppm

Pulp and Paper Process

Water Slug

Maintenance Open Pour 130 oz/10,000 ga 14 oz/10,000 ga 10 ppm

1.0 ppm

Sewage and Wastewater Effluent

Filter Beds Open Pour As needed
100 oz/20 ft 2 0.5 ppm

Unspecified

Swimming Pools and Spas

Swimming Pool Shock

Maintenance Open Pour 130 oz/10,000 ga 14 oz/10,000 ga 10

1.0

Spas and Hot Tubs Shock

Maintenance Open Pour 10 oz/500 ga 6.5 oz/1000 ga 19

5.0

Aquatic Areas

Fish Hatchery Pond Open Pour 2.5 oz/10 ga 200 ppm

Fish Pond Equipment Open Pour 2.5 oz/10 ga 200 ppm

Fish Ponds Open Pour 130 oz /10,000 ga 10 ppm

Maine Lobster Ponds Open Pour 7,700 oz/10,000 ga 600 ppm

* The application rate is specified in terms of the chlorine residual and the amount of product applied will vary depending on the chlorine demand of the system being treated.



## 1.6 Regulatory Histor y

The first product containing potassium hypochlorite as an active ingredient was registered in 1998; by 2005 all the registered products were canceled. As of 2011 there was a new registration, with a variety of uses as outlined in T able 5

.

A Reregistration Eligibility Decision (RED) was not completed for potassium hypochlorite because it was registered after November 1, 1984.



### 1.6.1 Tolerance Information

An exemption from the requirement of a tolerance is established for residues of potassium hypochlorite in or on all commodities [ 40 CFR § 180.1300 ]

. 1

1 http://www.ecfr.gov/cgi

bin/retrieveECFR?gp=1&SID=2035ef80559449db2dfc1f34c286e7ca&ty=HTML&h=L&r=SECTION&n=40y2 5.0.
1.1.27.4.19.197Docket Number EPA

- HQ

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Page 13 of 28 

## 1.7 Incidents

1.7.1 Human Health

As of January 30, 2013, no human health incidents are listed for potassium hypochlorite in the OPP’s Incident Data System (IDS ).



### 1.7.2 Ecological

As of February 5, 2013, no ecological incidents are listed for potassium hypochlorite in OPP’s Incident Data System (IDS).



## 2 A nticipated Data Needs

The agency does not anticipate needing to call in any data to support this registration review

.


## 3 Human Health Risk Assessment

Based on the toxicity profile and exposure scenarios for potassium hypochlorite, EPA believes that risks from chronic and subchronic exposures to this pesticide would be minimal and without consequences to human health. The a gency believes that any acute corrosive risks will be sufficiently mitigated by precautionary labeling requiring protection of eyes and skin while using this pesticide.



## 3.1 Existing Toxicological Endpoints

During the generation of the 2014 registration review preliminary wor k plan, t he a gency conducted an in

- depth review of the similarities between potassium hypochlorite and the existing registered active ingredients sodium hypochlorite and calc ium hypochlorit e. Based upon this review, the a gency has determined that the data available to support the registrations of these active ingredients are also applicable to potassium hypochlorite. See Appendix A for toxicology profile.

No additional generic or product

- specific acute, chronic or subchronic toxicological studies are

requ ired for this registration review . All toxicology data will be bridged from studies on sodium and calcium hypochlorites based on their chemical similarity. 2

Potassium hypochlorite is extremely corrosive and can cause severe damage to eyes and skin

, and t herefore has been classified Toxicity Category I based on these acute effects. The a gency has determined that these risks are adequately mitigated through the use of the specific precautionary and first aid statements that have been proposed on the product labeling. Based on its similarity to sodium and calcium hypochlorite, potassium hypochlorite was assigned acute

2 U.S. EPA 2012. Registration Review Final Work Plan: Na & Ca Hypochlorite. Docket Number EPA

– HQ

- OPP

2012

- 0004.Available at: http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2012

- 0004

- 0006.Docket Number EPA

- HQ

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Page 14 of 28 oral and dermal toxicities to category IV and acute inhalational toxicity to category III. This
chemical is not a dermal sensitizer. 2



## 3.2 Dietary E xposure

There are no toxicological endpoints for potassium hypochlorite; therefore, dietary food and drinking water exposures do not need to be assessed for registration review.



## 3.3 Occupational and Residential Exposures

There are no toxicological endpoints for potassium hypochlorite; therefore, occupational and
residential exposures do not need to be assessed for registration review.



## 3.4 Aggregate and Cumulative Exposure

3.4.1 Aggregate Exposures

T here are no toxicological endpoints f or potassium hypochlorite; therefore aggregate exposures do not need to be assessed for registration review.



### 3.4.2 Cumulative Exposures

T here are no toxicological endpoints for potassium hypochlorite; therefore, cumulative exposures do not need to be assessed f or registration review.



## 4 Environmental Risk Assessment

The a gency has not previously conducted a risk assessment that supports a complete endangered species determination for potassium hypochlorite

. A risk assessment was conducted on sodium and calcium hypochlorite salts for the RED in 1991. Since these chemicals are very similar in their mode of action, all are hypochlorites and release chlorine as the active ingredient, the information from the pre vious assessment of sodium and calcium hypochlorites will be used for potassium hypochlorite

. If determined necessary during the regi stration review process, the

a gency will determine potential acute and chronic risks to aquatic organisms exposed to
potas sium hypochlorite that are transported from treatment sites into the aquatic environment.

Such sites include pulp and paper mill process water systems

.

The registration review process will allow the a gency to determine whether each use of the potassium hypochlorite has 'no effect' or 'may affect' federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use 'may affect' a listed species or its de signated criti cal habitat, the a gency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.Docket Number EPA

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Page 15 of 28 

## 4.1 Environmental Fate Assessment

As with the sodium and calcium hypochlorite case, the agency does not antic ipate the need for an environmental fate assessment for potassium hypochlorite. Potassium hypochlorite uses are exclusively in aqueous medium, and potassium hypochlorite belongs to the hypochlorite class of compounds including lithium, sodium, and calcium hypochlorites. These hypochlorites dissociate in water to form hypochlorous acid (HOCl), which acts as the active in disinfecting
and sanitizing scenarios. OCSPP’s test guideline series 835 are not applicable to inorganic
substance s , and thus the traditio nal fate studies like hydrolysis, photolysis

, etc. are not appropriate for inorganic molecules like potassium hypochlorite

. 3

H ypochlorite (HOCl) oxidize s to chlorite (ClO 2 - ), chlorate (ClO 3 - ), and perchlorate (ClO 4 - ) or
reduce s to chloride (Cl

- )

.

The a gency has not conducted any environmental and transport exposure assessment for potassium hypochlorite. Potassium chemistry is similar to the same group cations like sodium
and calcium. All salts of t hese metals are highly water soluble. Th e a gency does not intend to conduct a down the drain assessment for potassium hypochlorite as further explained in section

4.1.6

.



### 4.1.1 Leaching [Wood/Paint/ Antifoulant Paint/

Plastic/ Textiles/ e.g., treated article]

Potas sium hypochlorite is not registered for uses in wood treatment or as an antifoulant for boat and ship bottoms, or in paints . I t is not embedded into plastics or used in surface treatment of
textiles

.



### 4.1.2 Water and Sediment

Potassium ions exist in earth’s crust

, sediments, soils , clay and the binding is strong. Hypochlorite in water and soils speciate into oxidized species (chlorite, chlorate, perchlorate) or reduce to chloride, depending on the pHs of the medium

. 4



### 4.1.3 Soil

The chemical behavior of potassium and hypochlorite in soil is the same in other media like water, sediment and clays. 4



### 4.1.4 Air

Potassium ions can vaporize along with other species, but deposit back to the soils and dissolve
in water. 4



### 4.1.5 Other media

It is a key element for plants. It is pre sent in the intercellular f l uids in mammalian systems. Its recommended daily intake is: 3500 mg

. 4

3 F.A. Cotton & G. Wilkinson (Advan ced Inorganic Chemistry, 7 th edition; chapter 4 and 5).

4 F.A. Cotton & G. Wilkinson (Advanced Inorganic Chemistry, 7 th edition; chapter 4 and 5).Docket Number EPA

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Page 16 of 28 

### 4.1.6 W aste W ater T reatment P lants (WWTP)

A down

- the

- drain assessment is not required for potassium hypochlorite, which fo rms hypochlorous acid instantly. H ypochlorous acid degrades and is unlikely to reach WWTP.
Potassium ions are not of concern for WWTP

. 4



### 4.1.7 Water Quality

Potassium hypochlorite is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at the

a gency’s National Pesticides Cause of Impairme nt of Waters website (searched February 6,

201 4 )

. 5 In addition, no Total Maximum Daily Loads (TMDL) have been developed for potassium hypochlorite, based on infor mation provided at the a gency’s National Pes ticide TMDL web site (searched February 6, 2014 ) 6

. Potassium ions are not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act,
based on informat ion provided at the a gency’s National Pesticides Cause of Impairme nt of Waters website (February 6 , 201 4 ) 7

. There are 175 TMDL/ impaired water bodies (OW’s list 303(d)) listed for total residual chlorine (TRC) on a national level recorded between 2000

- 200 7.
TRC is defined as the “amount of remaining chlorine remaining after contact time and is equal to
available residual chlorine + free available chlorine

. ” More information on impaired water
bodies and TMDLs can be found at http://www.epa.gov/owow/tmdl/

.



## 4.2 Ecological Effects Assessment

4.2.1 Mode of Action

In the aquatic environment, toxic action is largely due to hypochlorous acid formed when potassium hypochlorite reacts with water. A dverse effects of hypochlorous acid are due mainly to its corrosive action. Acute necrosis may occur. Fish gills

- structure may be damaged; gill necrosis can lead to respiratory problems and asphyxiation. The protective slime coating on fish also may be removed due to corrosive action.



### 4.2.2 Measures of Effect (Ecotoxicology Assessment Endpoints)

4.2.2.1 Submitted Data

Ecological effects data are used as measures of direct and indirect effects to aquatic and terrestrial organisms

. Acute and chronic toxicity data from registrant

- submitted studies
conducted in accordance with the 850 OCSSP Harmonized Test Guidelines will be used to evaluate the potential direct and indirect effects of potassium hypochlorite to animals and plants.
Add itionally, as described below, relevant data from the EPA’s Office of Water and from the open literature also may be used to evaluate potential direct and indirect effects.

5 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

6 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_ group_name=PESTICIDES

7 http://iaspub. epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885Docket Number EPA

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Page 17 of 28 All available ecotoxicity endpoints from studies submitted by registrants are ta bulated and referenced in the Ecological Effects Profile (Appendix C). OPP uses the most sensitive of these endpoints for assessing acute and chronic risks to each aquatic receptor group. The potassium ion is an essential, naturally occurring element whic h is assumed to be non

- toxic at the levels released by potassium hypochlorite use.

4.2.2.2 Office of Water Data

EPA’s Office of Water’s Ambient Water Quality Criteria for Chlorine 8 provides additional data

that will be used in th is registration review case . The document contains a review of open literature on acute and chronic effects of chlorine. Based on the available toxicological endpoints, freshwater and saltwater organism acute and chronic water quality criteria (expressed as total residual chlorine (TRC) for freshwater and chlorine

- produced oxidants (CPO) for seawater) are derived. The current values are as follows:

 Freshwater Criterion Maximum Concentration = 19 μg/L;

 Freshwater Criterion Continuous Concentration = 11 μg/L;

 Saltwater Criterion Maximum C oncentration = 13 μg/L; and

 Saltwater Criterion Continuous Concentration = 7.5 μg/L

.

4.2.2.3 Open Literature

Since the agency does not anticipating conducting an environmental risk assessment, no effects analysis plan is needed ; therefore no ECOTOxicology (ECOTOX) will be conducted.



## 4.3 Exposure Analysis Plan

4.3.1 Aquatic and Terrestrial Wildlife Exposure Estimates

Since the agency does not anticipate conducting an environmental risk assessment, no exposure

estimates are needed.



## 4.4 Effects Analysis Plan

Since the agency does not anticipate conducting an environmental risk assessment, no effects analy sis plan is needed.



## 5 Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and

chroni c toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology,

8 See EPA’s Office of Water’s Ambient Water Quality Criteria for Chlorine

- 1984 (EPA, 1985) at: http://water.epa.gov/scitech/swguidance/standards/upload/2001_10_12_criteria_ambientwqc_chlorine1984.pdfDocket Number EPA

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Page 18 of 28 organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developme ntal and reproductive effects in different taxonomic groups. As part of its most recent registration decision for potassium hypochlorite

, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment

scenarios from the exi sting hazard database. However, as required by FFDCA section 408(p), potassium hypochlorite is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substance s (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tie red approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemic als that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the availabl e data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and

establish a dose

- response relationship between the dose and the E, A, or T effect.

U nder FFDCA section 408(p), the a gency must screen all pe sticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals

identified for EDSP sc reening was published on June 14, 2013 9 and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists should be construed as a list of known or likely endocrine disruptors.

For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our
website. 10



## 6 Next Steps

As stated in this work plan, the agency does not anticipate needing any data to support the registration review of potassium hypochlorite; f urther more , the agency believes that potassium hypochlorite is similar to and can be considered with the chemicals in case 0029, sod ium and calcium hypochlorite. The docket for the sodium and calcium hypochlori te case opened in March

of 2012. No risk assessments are considered necessary for any of the three compounds since

E PA has concluded that the currently registered uses of the hypochlorites will not result in

9 See http://www. regulations.gov/#!documentDetail;D=EPA

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of
chemicals.

10 http://www.epa.gov/endo/Docket Number EPA

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Page 19 of 28 unreasonable adverse effects to human health or the environment. Since no risk assessments are necessary, after the final workplan for potassium hypochlorite is is sued, the agency intends to issue a combined proposed decision for all three compounds in September of 2016

.Docket Number EPA

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Page 20 of 28 

## 7 References

U.S. Environmental Protection Agency (EPA). 20 1 2. Registration Review Final Work Plan: Na & Ca Hypochlorite

. Docket Number EPA

– HQ

- OPP

- 2012

- 0004.

Available at : http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2012

- 0004

- 0006

.Docket Number EPA

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Page 21 of 28 

# Appendix A T oxicology Profile

Acute Toxicity for Product Labeling

No toxicological studies are required to be submitted. All toxicology data are waived based on the chemical’s similarity with sodium and calcium hypochlorites. Agency reviews regarding potassium hypochlorite have suggested that the registration review of this chemical may be treated similarly for the proposed us es. The decision not to require acute toxicity testing is supported by the proposed chemicals’ similarities with sodium, calcium and lithium hypochlorite and the chlorinated isocyanurates, whose RED documents considered their acute hazard data bases to be complete. 12

Table 6

– Acute Toxicity Studies for Potassium Hypochlorite

Guideline No./ Study Type MRID No. Results Toxicity Category

870.1100/ Acute oral toxicity Waived N/A IV

870.1200/ Acute dermal toxicity Waived N/A IV

870.1300/ Acute inhalation toxicity Waived N/A III

870.2400/ Acute eye irritation Waived N/A I

870.2500/

Acute dermal irritation Waived N/A I

870.2600/
Skin sensitization Waived N/A Non

- sensitizer

N/A=Not available

All studies, subchronic and chronic, are not anticipated to be required for this chemical due to its similarities with sodium, calcium and lithium hypochlorite

.

12 http://www.epa.gov/opp00001/chem_search/reg_actions/reregistration/red_G

- 77_1

- Feb

- 92.pdfDocket Number EPA

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Page 22 of 28 

# Appendix B Environmental Fate and Transport of Potassium Hypochlorite

Office of Chemical Safety and Pollution Prevention (OCSPP) Guideline studies are designed for organic compounds and do not provide useful information on inorganic molecules such as hypochlorite.Docket Number EPA

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Page 23 of 28 

# Appendix C Ecotoxicology Profile

For the ecotoxicity assessment of potassium hypochlorite, studies testing sodium and calcium hypochlorite were used. No studies are available testing the potassium ion. This is acceptable,
since all hypochlorite s ha ve a similar mode of toxicity. They are chlorine release rs, which can

ca use toxic ity to non

- target organisms.



### Toxicity to Terrestrial Organisms

Birds

An acceptable acute

- oral (LD50) stud y categorizes sodium and calcium hypochlorite as being practica lly non toxic to birds. The guideline for an acute

- oral test (850.2100) is satisfied. Dietary studies (850.2200) are not anticipated to be required. However, four dietary studies have been
submitted and indicate that hypochlorites are practically non toxic to birds when administered in the diet. No additional data avian toxicity data are needed.

Avian Acute

- oral and Dietary Toxicity

Test Species Toxicity Toxicity Category EPA Study

ID

Mallard ( Anas platyrhynchos ) LC50 >5000 ppm Practically nontoxic 00007404 Acceptable

Northern bobwhite ( Colinus virginianus ) L D 50 = 3474 ppm for Ca hypochlorite

LD50 = 2510 for Na hypochlorite Practically nontoxic 00007403 Acceptable

LC50 >, 5 000 ppm Practically nontoxic 00007405 Acceptable

Nontarget Insects

Toxicity data for beneficial insects (850.3020, 850.3030) are not required for the use patterns of
potass ium hypochlorite.



### Toxicity to Aquatic Organisms

Freshwater Fish

The available acute toxicity studies categorize sodium and calcium hypochlorite as b eing highly toxic to freshwater fish. The guideline (850.1075) for acute toxicity testing is satisfied. No chronic data (fish early

- life stage, 850.1400) are available. However, the need for chronic toxicity data can be fulfilled from EPA’s Office of W ater’s Ambient Water Quality Criteria for
Chlorine

- 1984 (EPA 1985). No additional fish toxicity data are anticipated to be needed.Docket Number EPA

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Page 24 of 28 Acute Toxicity to Freshwater Fish

Freshwater Invertebrates

The acute toxicity study for the waterflea categorizes sodium hypochlorite as being very highly toxic to freshwater invertebrates. The guideline (850.1010) for acute toxicity testing is satisfied. No chronic data (life

- cycle, 850.1300) are available. How ever, the need for chronic toxicity data

can be fulfilled from EPA’s Office of Water’s Ambient Water Quality Criteria for Chlorine

- 1984 (EPA 1985). No additional aquatic invertebrate toxicity data are anticipated to be needed.

Toxicity to Freshwater Invertebrates

Test Species Toxicity Endpoint

(μg ai/L) Toxicity Category EPA Study

ID

Waterflea ( Daphnia magna ) 48

- hr EC50 = 0.037 to 2.3

ppm Very highly toxic 00007402
00019313 Acceptable

Estuarine/Marine Fish and Invertebrates

The a gency anticipates using the available data from EPA’s Office of Water’s Ambient Water Quality Criteria for Chlorine

- 1984 (EPA 1985). Test Species Toxicity Endpoint

(μg ai/L) Toxicity Category EPA Study

ID

Rainbow Trout ( Oncorhynchus mykiss) 96

- hr LC50 = 0.13 to 1.35

ppm Highly toxic 000 08191 Acceptable

Bluegill ( Lepomis
macrochirus ) 96

- hr LC50 = 0. 28 to 2.1

ppm Highly toxic 000 08190 Acceptable Test Species Toxicity Endpoint

(μg ai/L) Toxicity Category EPA Study

IDDocket Number EPA

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Page 25 of 28 Aquatic Plants

No data are available. Studies needed for the TGAI include a toxicity test with a vascular species (850.4400), toxicity tests (850.4500) with 3 algal species (green algae, freshwater diatom, marine diatom), and a toxicity test using cyanobacteria (850.455 0); to address these needs, t he a gency anticipates using the available data from EPA’s Office of Water’s Ambient Water Quality Criteria for Chlorine

- 1984 (EPA 1985).

Sediment toxicity

Based on the environmental

- fate properties of potass ium hypochlorite ( see section 4.1) , sediment toxicity data are not anticipated to be required.

Appendix C References

00007403 Beavers, J.B.; Fink, R.; Grimes, J.; et.al. (1978) Final Report: Acute Oral LD 50

-

Bobwhite Quail: Project No. 158

- 103. (Unpublished study received Jan 19 under unknown admin. No.; prepared by Wildlife International, Ltd. In cooperation with Washington College, submitted by Chlorine Institute, Inc., New York, N.Y.;

CDL236804

- B)

00007404 Beavers, J.B.; Fink, R.; Grimes, J.; et.al. (1978) Final Repor t: Eight

- Day Dietary

LC 50

- mallard Duck: Project No. 158

- 102. (Unpublished study received Jan 19,
1979 . U nder unknown admin. No.; prepared by Wildlife International, Ltd. In cooperation with Washington, submitted by Chlorine Institute, Inc., New York, N.Y.; CDL:236804

- C)

00007405 Beavers, J.B.; Brown, R. (1978) Final Report: Eight

- Day Dietary LC 50

- Bobwhite Test Species Toxicity Endpoint (μg ai/L) Toxicity Category EPA Study

ID

Marine Fish

( Cyprinodon variegates ) 96

- hr LC50 = 0.38 mg/L

NOAEC = 0.225 mg/ Highly toxic 47642401 Acceptable

Mysid Shrimp ( Americamysis bahia) 96

- hr LC50 = 0 .16 mg/L

NOAEC = 0. 14 mg/ Highly toxic 4764240 2

Acceptable

Eastern Oyster ( Crassostrea virginica ) 96

- hr E C50 = 0.20 mg ai /L

NOAEC = 0.13 mg ai/L Highly toxic 47642403

AcceptableDocket Number EPA

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Page 26 of 28

Quail: Project No. 158

- 101. (Unpublished study received Jan 19, 1979 under
unknown admin. No.; prepared by Wildlife International, Ltd., submitted by Chlorine Institute, inc., New York, N.Y.; CDL:236804

- D)

00008190 Calmbacher, C.W. (1978) Acute Toxicity of Sodium hypochlorite Solution to the

Bluegill Sunfish “ Lepomis macrochirus” Rafinesque: UCES Proj. No. 11506

- 72

- 01. (Unpublished study received Apr 4, 1978 under 35317

- 1; prepared by Union
Carbide Corp., submitted by Kuehne Chemical Co., Inc., Cranford, N.J.;
CDL:233389

- A)

00008191 Calmbacher, C.W. (1978) Acute Toxicity of Sodium hypochlorite Solution to the

Rainbow Trout, “ Salmo gairdneri” Richards on: UCES Project. No. 11506

- 72

- 02. (Unpublished study received Apr 4, 1978 under 35317

- 1; prepared by Union
Carbide Corp., submitted by Kuehne Chemical Co., Inc. Cranford, N.J.;
CDL:233390

- A)

00019313 LeBlanc, G.A. (1977) Acute Toxicity for Sodium hypoch lorite Solution to the

Water Flea ( Daphnia magna ): ICG/T

- 78

- 076. (Unpublished study received Dec 7,

1978 under 230

- 69; prepared by EG&G, Bionomics, submitted by FMC Corp.,
Industrial Chemical Group, Philadelphia, Pa.; CDL:236584

- B)

47642401 MacGregor, R. (2008) Marine Fish ( Cyprinodon variegates ) Definitive 96

- hour

Acute Toxicity Test with Daily Dosing. Prepared by Baroid Bioassay Lab;
submitted by Halliburton Energy Services, Inc, OK; Study No.: S4546

47642402 MacGregor, R. (2008) Mysid Shrimp ( America mysis bahia ) Definitive 96

- hour

Acute Toxicity Test with Daily Dosing; prepared by Baroid Bioasssay Lab;
submitted Halliburton Energy Services, OK; Study No.: S4547

47462403 Gallagher, S.P.; Kendall, T.Z.; Krueger, H.O. (2008) BE

- 7 antimicrobial (Sodium

Hypochlorite 12.5% w/v): A 96

- hour Shell Deposition Test with the Eastern Oyster ( Crassostrea virginica ); prepared by Wildlife International, Ltd; submitted by Halliburton Energy Services, Inc., OK; Study No.: 666A

- 101Docket Number EPA

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Page 27 of 28 

# Appendix D Product Chemistry

Potassium hypochlorite product chemistry information is summarized in Table D 1 (source:

MRIDs 47382901, 47445101, and 47594501 )

.

Table D1

– P roduct Chemistry of Potassium hypochlorite

Guideline

No. Physical and Chemical Properties Potassium hypochlorite

830.1550 Product identity and composition Refer to Table 3

. 830.1600 Description of materials used to produce

the product Confidential Business Information (CBI)

.

830.1620 Description of production process CBI

. 830.1650 Description of Formulation Process CBI

. 830.1670 Discussion of Formation of Impurities CBI

. 830.1700 Preliminary analysis CBI

. 830.1750 Certified limits CBI

.

830.1800 Enforcement analytical method The enforcement analytical method for potassium hypochlorite
solutions is based on ASTM D 2002

- 89(2003) entitled “Standard Test Methods of Sampling and Chemical Analysis of

Chlorine

- Containing Bleaches”.

830.1900 Submittal of samples CBI

. 830.6302 Color Pale yellow

.

830.6303 Physical State Aqueous solution

- pale yellow

. Liquid at 20.1 ° C

. 830.6304 Odor Chlorine bleach smell

.

830.6313 Stability to normal and elevated

temperature, metals/metal ions Stable under ordinary conditions of use and storage. Unstable at elevated temperatures.

Reacts vigorously with amine, ammonium, salts, reducing agents, methanol, acids and most organics.

Strong reducing agents such as nitrites, sulfides, sulfites, metabisulfites, and thiosulfates are incompatible, and their contact with potassium hypoch l orite should be prevented.

830.6314 Oxidation/Reduction Strong Oxidizing Agent.

830.6315 Flammability Not applicable. Noncombustible.

830.6316 Explodability Not explodable

.

830.6320 Corrosion Characteristic Corrosive

. Potassium hypochlorite solution is corrosive to metals such as stainless steel, mild steel, iron, copper, zinc, and aluminum. Potassium hypochl orite solution should not contact these

materials.

830.7000 pH 10.14

- 1% w/w solution in de

- ionized water at 21.1

- 21.8°C

. 830.7050 UV/Visible Absorption Not reported.

830.7100 Viscosity 1.1 mm 2 /sec at 20.6°C and 0.9 mm 2 /sec at 40°C

. 830.7200 Melting point No t required

. 830.7220 Boiling point Decomposes prior to boiling

. 830.7300 Density 1.1701 g/ml (9.75 lbs/gal) at 20.1°C

.Docket Number EPA

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Page 28 of 28 Guideline

No. Physical and Chemical Properties Potassium hypochlorite

830.7370 Dissociation Constant Potassium hypochlorite dissociates completely on dissolving
in water.

830.7550 Partition coefficient ( n

- octanol/water) Not applicable

. 830.7840 Solubility in water Complete

. 830.7860 Solubility in organic solvents NA Product should be mixed only with water

. 830.7950 Vapor pressure Approximately that of air

. A Confidential business information

atm

- m 3 /mol = atmosphere cubic meter per mole; o C = degrees Celsius; mg/L = milligrams per liter; mmHg = millimeters of mercury

.