Docket Number: EPA-HQ-OPP-2010-0693

www.regulations.gov

1

Calcium Oxide 

Summary Document

Registration Review: Initial Docket

December 2010
Docket Number: EPA-HQ-OPP-20 I 0-0693 

www.regulations.gov 

Calcium Oxide 

Summary Document 

Registration Review: Initial Docket 

December 2010 

Case No. 5104 

Approved By: 

Date r J 

2 
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

3

TABLE OF CONTENTS

 Page #

I. Preliminary Work Plan (PWP) 5

II. Fact Sheet 13

________________________________________

Please Note

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's 

current position based on the following documents:

1. Preliminary Plan for Registration Review of: Calcium Hydroxide/Calcium Oxide. 

October 14, 2010.

2. Calcium Oxides (Calcium Oxide and Calcium Hydroxide): Human Health Assessment 

Scoping Document in Support of Registration Review. October 27, 2010.

Additional supporting documents for calcium oxide may be found in the registration review 

docket EPA-HQ-OPP-2010-0693 located on the internet at www.regulations.gov.
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

4

Calcium Oxide

Registration Review Team

Human Health & Environmental Effects 

Michelle Centra 

A. Najm Shamim

Risk Management

Rebecca von dem Hagen

Lance Wormell

Office of General Counsel

Philip Ross
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

5

I. Preliminary Work Plan – Calcium Oxide

Introduction:

The Food Quality Protection Act of 1996 mandated a registration review program. All pesticides 

sold or distributed in the United States generally must be registered by the Environmental 

Protection Agency (EPA), based on scientific data showing that they will not cause unreasonable 

risks to human health or the environment 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 registration review 

program, the Agency periodically reevaluates pesticides to make sure that 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 Agency is implementing the 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 Agency will consider benefits information and data as required by FIFRA. The 

public phase of registration review begins when the initial docket is opened for each case. The 

docket is the Agency’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. After reviewing and responding to comments and data received in the docket during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the registration review of calcium oxide.

The calcium oxide case (Case Number 5104) currently includes two active ingredients, calcium 

oxide (PC Code 075601) and calcium hydroxide (PC Code 075604). Calcium oxide is a 

baceteriocide/bacteriostat contained in a product registered for use in the treatment of medical 

waste. Calcium hydroxide, created by the mixing of calcium oxide and water, is a 

baceteriocide/bacteriostat contained in a manufacturing use product (MUP) registered for use for 

the manufacture of or fabrication into antimicrobial products to be used as coatings on or 

components of the following hard, inanimate surfaces and products: walls, floors, ceilings, tile, 

fixtures, tools, appliance exteriors, pipe exteriors, heating cooling ventilation (HVAC) 

equipment, duct work and related equipment (other than motors, fans and similar mechanical 

moving parts) interiors and exteriors, and concrete, stone, ceramic, plaster, wood, drywall 

substrates in residential dwellings, schools, day care centers, professional offices, commercial 

and industrial buildings, factories, animal housing facilities (barns, corrals, fences) and 

healthcare facilities (hospitals, medical office, nursing homes). 

Both calcium oxide and calcium hydroxide were new active ingredients in products registered in 

1976. In 1989 all of the then-existing registered products containing calcium oxide or calcium 
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

6

hydroxide were voluntarily cancelled; therefore, these active ingredients were not evaluated 

under reregistration. In 2002 and 2004 EPA registered new products containing calcium oxide 

and calcium hydroxide, respectively. The existing registrations are presented in Table 1. 

Documents associated with the registration review of the calcium oxide case can be viewed at 

www.regulations.gov in docket EPA-HQ-OPP-2010-0693. Below is a summary of the issues 

relevant to the registration review of calcium oxide.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, 

including an endangered species risk assessment, for all uses of calcium oxide and calcium 

hydroxide. The Agency also anticipates the need to conduct comprehensive human health risk

assessments. The Agency anticipates needing additional data to conduct the registration review 

of calcium oxide and calcium hydroxide. 

Ecological Risk:

• No ecological risk assessment has been performed for the calcium oxide case. 

• The Agency does not anticipate the need to complete an environmental fate risk 

assessment. Based on current use patterns no long term environmental impact is 

expected from calcium oxide or calcium hydroxide because once calcium enters the 

environment, it is expected to quickly reach background levels. No environmental fate 

data gaps exist for the present uses of these chemicals.

• The Agency has not conducted a risk assessment that supports a complete endangered 

species determination for the calcium oxide case. The ecological risk assessment planned 

during registration review will allow the Agency to determine whether calcium oxide or 

calcium hydroxide’s use 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 designated 

critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or 

National Marine Fisheries Services (the Services), as appropriate.

• The current database on ecological effects for the calcium oxide case is composed of 

studies from open literature and submitted studies that have not been fully reviewed. 

Because the existing data were generated on non-guideline studies and also on species 

not found in the United States, the Agency anticipates requiring the following ecotoxicity 

studies. 
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

7

o GDLN 850.1075 – Acute Freshwater Fish Toxicity 

o GDLN 850.5400 – Aquatic Growth, Tier II Green Algae 

• Please refer to Preliminary Plan for Registration Review of: Calcium Hydroxide/Calcium 

Oxide located in the docket, for a detailed discussion of these anticipated risk assessments

and data needs.

Human Health Risk:

• No human health risk assessment has been performed for the registered antimicrobial 

uses of calcium oxide and calcium hydroxide.

• The Agency intends to conduct residential and occupational exposure risk assessments 

based on current use patterns.

• Dietary (food and water) exposure is not expected from the registered use of calcium 

oxide because the chemical is applied in a closed system and must be disposed of in a 

sanitary landfill. Dietary exposure (food and water) is not expected from the registered 

calcium hydroxide manufacturing use product because it is not for use in or on coating or 

other antimicrobial pesticides that will be used on food contact, food preparation or food 

processing surfaces. The U.S. Food and Drug Administration considers calcium oxide 

and calcium hydroxide Generally Recognized as Safe (GRAS) for use in foods with no 

limitations except good manufacturing practices. Therefore, because non-occupational 

exposure and hazard are expected to be minimal, the Agency does not anticipate 

conducting dietary or aggregate risk assessments for the calcium oxide case.

• The Agency anticipates requiring the following data in order to conduct an occupational 

risk assessment for calcium oxide and occupational and residential risk assessments for 

calcium hydroxide. The Agency intends to reevaluate the existing submitted, cited and

published data and evaluate anticipated toxicology data for calcium oxide and calcium 

hydroxide during the registration review risk assessment in order to better characterize 

hazard and potential human health risks. The following Tier 1 toxicology studies have 

been identified as data gaps for the calcium oxide case.

Toxicology Data for Calcium Hydroxide or Calcium Oxide

o 870.3200 21/28-day Dermal Toxicity

o 870.3465 28-day Inhalation Toxicity

o 870.5100 Bacterial Reverse Mutation Test

o 870.5300 In vitro Mammalian Cell Gene Mutation Test or 870.5375 In vitro

Mammalian Chromosome Aberration Test

o 870.5385 Mammalian Bone Marrow Chromosomal Aberration Test or 870.5395 

Mammalian Erythrocyte Micronucleus Test
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

8

Exposure Data for Calcium Oxide (Occupational Applicator – Medical Waste; Loading; 

Open Pour)

o 875.1300 Inhalation Exposure- Outdoor

o 875.1400 Inhalation Exposure- Indoor

o 875.1600 Data Reporting and Calculations

o 875.1700 Product Use Information

Exposure Data for Calcium Hydroxide (Occupational/Residential Applicator –

Paints/Coatings; Brush, Roller, Spray-on)

o 875.1100 Dermal Exposure- Outdoor

o 875.1200 Dermal Exposure- Indoor

o 875.1300 Inhalation Exposure- Outdoor

o 875.1400 Inhalation Exposure- Indoor

o 875.1600 Data Reporting and Calculations

o 875.1700 Product Use Information

• Please refer to Calcium Oxides (Calcium Oxide and Calcium Hydroxide): Human Health 

Assessment Scoping Document in Support of Registration Review, located in the docket, 

for a detailed discussion of the anticipated human health risk assessment and data needs 

for the calcium oxide case. 

Product Chemistry:

• The Agency has reviewed the product chemistry database for the calcium oxide case and 

anticipates that no additional product chemistry data will be needed for registration 

review. 

• Please refer to Preliminary Plan for Registration Review of: Calcium Hydroxide/Calcium 

Oxide located in the docket, for more information on the calcium oxide case. 

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) to determine whether certain substances (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-tiered 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. Chemicals 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 available data. Tier 2 

testing is designed to identify any adverse endocrine related effects caused by the substance, and
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

9

establish a quantitative relationship between the dose and the E, A, or T effect.

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. 

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors.

Calcium Oxide and calcium hydroxide were not among the group of 58 pesticide active 

ingredients on the initial list to be screened under the EDSP. Under FFDCA sec. 408(p) the 

Agency must screen all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP 

orders/data call-ins for all Registration Review cases, including those for which EPA has already 

opened a Registration Review docket for a pesticide active ingredient. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.

Timeline:

EPA has created the following estimated timeline for the completion of the calcium oxide case 

registration review.

Registration Review for Calcium Oxide – Projected Registration Review Timeline

Activities Estimated Date

Opening the Docket

Open Docket and Public Comment Period December 2010

Close Public Comment February 2011

Case Development

Final Work Plan May 2011

Issue DCI May 2012

Data Submission May 2014

Open Public Comment Period for Draft Risk Assessments September 2015

Close Public Comment Period December 2015

Registration Review Decision

Open Public Comment Period for Proposed Registration Review 

Decision 

March 2016

Close Public Comment Period June 2016

Registration Review Decision and Begin Post-Decision Follow-up 2016

Total (years) 6
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

10

Guidance for Commenters:

The public is invited to comment on EPA’s preliminary registration review work plan and 

rationale. The Agency will carefully consider all comments as well as any additional 

information or data provided in a timely manner prior to issuing a final work plan for the calcium 

oxide registration review case.

Trade Irritants

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and 

other stakeholders are asked to comment on any trade irritant issues resulting from lack of 

Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key 

export markets, providing as much specificity as possible regarding the nature of the concern.

Water Quality

Calcium oxide 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 

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88

5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for calcium oxide, 

based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id

=885&p_pollutant_group_name=PESTICIDES. More information on impaired water bodies and 

TMDLs can be found at http://www.epa.gov/owow/tmdl/. The Agency invites submission of 

water quality data for this pesticide. To the extent possible, data should conform to the quality 

standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and 

Management Process (see: 

http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm) in order to ensure they 

can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to calcium oxide compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population.
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

11

Structure Activity Relationships 

EPA must rely upon information of appropriate quality and reliability for each decision made by 

the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide 

chemical traditionally begins with the applicant’s submission of a set of studies conducted with 

the specific pesticide chemical of interest. The use of the results of such testing (measured data) 

is a logical, scientifically rigorous process that identifies the physical, chemical, and 

environmental fate properties of the pesticide, as well as the dose and endpoints at which an 

adverse effect can occur in various animal species.

Today, there is significant interest in alternative techniques, i.e., techniques other than data

generation that could significantly inform the Agency’s decision-making process. Recently, 

OPP has made increasing use of structure activity relationship (SAR) as part of its regulatory 

decision-making process. In the SAR process, a chemical's molecular structure is compared to 

that of other chemicals for which data are available. These structural similarities are then used to 

make predictive judgments about a chemical’s physical, chemical, and biological properties. 

Thus, the chemical’s physical, chemical, and biological properties are a function of (or directly 

related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To 

develop a QSAR, a selected set of measured data on a single physical, chemical, or biological 

property is used to derive a model (an equation) to predict the value of that property.

Since SAR assessments and QSAR modeling are another set of tools that are available to Agency 

scientists, OPP has begun a process shift that envisions shifting from the current study-by-study 

approach to an approach in which the use of predicted data, generated using validated models, is 

considered along with information from open literature and studies specifically generated under 

Part 161 requirements. All relevant information would be considered as part of a weight-of-theevidence evaluation.

At this time, EPA believes that for certain endpoints, especially physical/chemical and fate 

properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements 

for many antimicrobial pesticide chemicals. When considering biological properties, at this 

time, EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of 

chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters. This is 

appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a 

screening-level assessment procedure rather than multiple tiers of assessments with progressively 

more data requirements.

If stakeholders believe that submission of predicted data can fulfill one of the data needs for 

calcium oxide, then the Agency invites submission of this information. The submitter would be 

expected to supply a rationale describing the utility of the information and provide 

documentation on the scientific validity of the information. The determination that the predicted 

data fulfills the data requirement would be at the sole discretion of the Agency. Pre-submission 

consultation with the Agency is encouraged.
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

12

Additional Information

Stakeholders are also specifically asked to provide available information and data that will assist 

the Agency in refining the risk assessments. The Agency is interested in receiving the following 

information.

1. Confirmation on the following label information:

a. Sites of application

b. Formulations 

c. Application methods and equipment

d. Maximum application rates

e. Frequency of application, application intervals and maximum number 

of applications

f. Geographic limitations on use

2. Use or potential use distribution 

3. Use history

4. Usage/use information for non-agricultural uses (e.g., materials preservation)

5. Typical application interval

6. State or local use restrictions

7. Ecological incidents (non-target plant damage and avian, fish, reptilian, 

amphibian and mammalian mortalities) not already reported to the Agency

8. Monitoring data

9. Structure Activity Relationships

Next Steps:

After the 60-day comment period closes, the Agency will review and respond to any comments 

received in a timely manner, and then issue a Final Work Plan for the calcium oxide case.
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

13

II. FACT SHEET

Background Information:

• Active ingredients: Calcium Oxide and Calcium Hydroxide

• Trade and Other Names: Hydrated Lime

• Registration Review Case Number: 5104

• PC Code: 075604 & 075601

• CAS#: 1305-78-8 & 1305-62-0

• Technical Registrants: Alistagen Corporation

• First approved for use in a registered product: 1976

• There are 2 registered products that contain calcium oxide & calcium hydroxide as active 

ingredients: 1 end use product (calcium oxide) and 1 manufacturing use product (calcium 

hydroxide)

• Calcium hydroxide is exempt from the requirement of a tolerance when used as an inert 

ingredient as a solid diluent or carrier in pesticide formulations applied to growing crops 

or to raw agricultural commodities (40 CFR 180.1001(c)).

• Antimicrobials Division Chemical Review Manager (CRM): Rebecca von dem Hagen; 

Vondem-Hagen.Rebecca@epa.gov

• Antimicrobials Division Product Manager (PM): Velma Noble; Noble.Velma@epa.gov

Use & Usage Information: (For additional details, please refer to the Appendix A: Registered 

Antimicrobial Uses of Calcium Oxide and Calcium Hydroxide)

• There is one end-use product (EUP) and one manufacturing use product (MUP)

• Calcium oxide and calcium hydroxide are registered as microbiocide/microbiostat

• Antimicrobial Use Sites: 

o Medical waste treatment facilities

o Manufacturing use product that can be used for the manufacture of or fabrication 

into antimicrobial pesticides to be used as coatings on, or components of the 

following hard, inanimate surfaces and products: walls, floors, ceiling, tile, 

fixtures, tools appliance exteriors, pipe exteriors HVAC equipment, ductwork and 

related equipment (other than motors, fans and similar mechanical moving parts) 

interiors and exteriors, and concrete, stone, ceramic, plaster wood, and drywall 

substrates

Recent and Pending Actions:

• There are no recent or pending actions involving calcium oxide or calcium hydroxide. 
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

14

Ecological Risk Assessment Status:

The Agency has not conducted an ecological risk assessment for the calcium oxide case. Please 

refer to Preliminary Plan for Registration Review of: Calcium Hydroxide/Oxide located in the 

docket, for a detailed discussion of the anticipated ecological risk assessments.

• No long term environmental impact is expected from calcium hydroxide or calcium oxide

based on current use patterns. No long term environmental impact is expected because 

once calcium enters the environment, it is expected to quickly reach background levels. 

• Based on ecotoxicity studies in the Agency’s database and collected from open literature, 

calcium oxide and calcium hydroxide appear to be nontoxic to western mosquito fish and 

invertebrates such as scud and midge; slightly toxic to African catfish (not native of 

USA); and moderately toxic to red-winged blackbird. For aquatic plants like blue-green 

algae only inhibition of nitrogen fixation has been observed.

Human Health Risk Assessment Status:

The Agency has not conducted a human health risk assessment for the calcium oxides case. At 

the time of registration, the Agency concluded that there were no significant risks expected from

the proposed uses of calcium hydroxide as the active ingredient (96.6%) in the MUP. Despite 

the limited toxicology database and the deficiencies of the submitted data, the Agency 

recognized that calcium hydroxide had a long history of use as a direct food additive, is 

Generally Recognized as Safe by the U.S. Food and Drug Administration (21 CFR 582.1205) 

and the potential exposures to calcium hydroxide from uses identified on the MUP label were 

considered minimal in comparison to direct exposure to the active ingredient in the diet. Please 

refer to Calcium Oxides (Calcium Oxide and Calcium Hydroxide): Human Health Assessment 

Scoping Document in Support of Registration Review, located in the docket, for a detailed 

discussion of the anticipated human health risk assessment.

Hazard Characterization:

• Calcium oxide and calcium hydroxide are corrosive and severe irritants. 

• Due to the corrosive and severely irritating nature of calcium oxide and calcium 

hydroxide, acute dermal and inhalation studies were waived in accordance with 40 CFR § 

158.340 and the chemicals were determined to be Toxicity Categories II and I, 

respectively.

Dietary (Food and Water):

• The U.S. FDA considers calcium oxide and calcium hydroxide Generally Recognized as 

Safe (GRAS) for use in foods with no limitations except good manufacturing practices. 
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

15

• Because calcium oxide is registered solely to treat medical waste and calcium hydroxide 

is required to state on the label “not for use in or on coating or other antimicrobial 

pesticides that will be used on food contact, food preparation or food processing 

surfaces,” dietary (food and water) exposure is not expected. Therefore, a dietary risk 

assessment has not been performed.

Residential:

• A residential risk assessment has not been conducted for calcium oxide or calcium 

hydroxide.

Aggregate:

• Because dietary exposure to calcium oxide is not of concern and a residential assessment 

was not performed, the Agency did not conduct an aggregate exposure assessment.

Occupational:

• An occupational risk assessment has not been conducted for calcium oxide or calcium 

hydroxide.

Cumulative:

• EPA does not have, at this time, available data to determine whether calcium oxide or 

calcium hydroxide have a common mechanism of toxicity with other substances or how 

to include these pesticides in a cumulative risk assessment. For the purposes of this 

Registration Review, EPA has assumed that calcium oxide and calcium hydroxide do not 

have a common mechanism of toxicity with other substances when used as an 

antimicrobial as registered.

Incidents:

• The Agency has reviewed the OPP Incident Data Systems (IDS) and one incident 

associated with calcium hydroxide exposure was reported in which dermal and eye 

irritation were the associated symptoms. No incidents associated with calcium oxide 

exposure have been reported. 

Tolerances and International Harmonization: 

• Calcium oxide is Generally Recognized as Safe (GRAS) as a direct food additive by the 

U.S. FDA (21 CFR 582.1210) and calcium hydroxide is Generally Recognized as Safe 

(GRAS) as a direct food additive by the U.S. FDA (21 CFR 582.1205) with “no 
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

16

limitation other than current good manufacturing practice.” 

• Calcium hydroxide is exempt from the requirement of a tolerance when used as an inert 

ingredient as a solid diluent or carrier in pesticide formulations applied to growing crops 

or to raw agricultural commodities (40 CFR 180.1001(c)). Calcium hydroxide is 

currently on EPA’s 4B list of Minimal Risk Inert Ingredients (those inert ingredients 

which have sufficient data to substantiate they can be used safely in pesticide products) 

while calcium oxide is on EPA’s 4A List of Inert Ingredients (inert ingredients generally 

regarded as safe).

• Calcium hydroxide is listed as an approved synthetic nonagricultural substance allowed 

as an ingredient in organic processed food by the USDA (205.605(b)(6)).

Data Call-In Status

• There are currently no outstanding Data Call-In data requirements for the calcium oxides 

case. 

Labels:

Registered active products, including EPA registration numbers, are provided in Table 1 below. 

For future reference, during registration review a list of product registration numbers will be 

included in the docket. Calcium oxide and calcium hydroxide product labels can be obtained 

from the Pesticide Product Label System (PPLS) website: 

http://oaspub.epa.gov/pestlabl/ppls.home

Table 1: Registered Active Products for Calcium Oxide and Calcium Hydroxide

EPA Reg. 

Number

Product Name Formulation 

Type

% Active 

Ingredient

Registrant

73696-2 Hydrated Lime

Technical 

Chemical 96.6 Alistagen Corporation

75661-1 Cold-Ster

Soluble 

Concentrate 86.8

Positive Impact 

Waste Solutions, LLC
Docket Number: EPA-HQ-OPP-2010-0693

www.regulations.gov

17

III. Summary of Anticipated Data Requirements –

Calcium Oxide and Calcium Hydroxide

The table below summarizes anticipated data needs for calcium oxide and calcium hydroxide 

listed in Section I of this document (Preliminary Work Plan), the Preliminary Plan for 

Registration Review of: Calcium Hydroxide/Oxide dated October 14, 2010, and Calcium Oxides 

(Calcium Oxide and Calcium Hydroxide): Human Health Assessment Scoping Document in 

Support of Registration Review dated October 27, 2010.

Active 

Ingredient

Guideline 

Number

Anticipated Data Requirement Test 

Material

Estimated 

Timeframe

(Measured 

from DCI 

Receipt)

075604 850.1075 Acute freshwater fish toxicity TGAI 12 months

075604 850.5400 Aquatic growth, Tier II green algae TGAI 12 months

075601 or 

075604

870.3200

21/28-day Dermal Toxicity

TGAI 24 months

075601 or 

075604

870.3465

28-day Inhalation Toxicity

TGAI 24 months

075601 or 

075604

870.5100

Bacterial Reverse Mutation Test

TGAI 8 months

075601 or 

075604

870.5300

and/or

870.5375

In vitro Mammalian Cell Gene Mutation Test

 or

In vitro Mammalian Chromosome Aberration Test 

TGAI 8 months

075601 or 

075604

870.5385

or

870.5395

Mammalian Bone Marrow Chromosomal 

Aberration Test

 or

Mammalian Erythrocyte Micronucleus Test

TGAI 8 months

075601 875.1300 Inhalation Exposure - Outdoor TGAI 24 months

075601 875.1400 Inhalation Exposure - Indoor TGAI 24 months

075601 875.1600 Data Reporting and Calculations TGAI 24 months

075601 875.1700 Product Use Information TGAI 12 months

075604 875.1100 Dermal Exposure - Outdoor TGAI 24 months
Docket Number: EPA-HQ-OPP-2010-0693 

www.regulations.gov 

18

Active 

Ingredient

Guideline 

Number

Anticipated Data Requirement Test 

Material

Estimated 

Timeframe

(Measured 

from DCI 

Receipt)

075604 875.1200 Dermal Exposure - Indoor TGAI 24 months

075604 875.1300 Inhalation Exposure - Outdoor TGAI 24 months

075604 875.1400 Inhalation Exposure - Indoor TGAI 24 months

075604 875.1600 Data Reporting and Calculations TGAI 24 months

075604 875.1700 Product Use Information TGAI 12 months
Docket Number: EPA-HQ-OPP-2010-0693

www.regulations.gov

19

IV. Appendix A: Registered Antimicrobial Uses of Calcium Oxide and Calcium Hydroxide

PC 

Code

EPA 

Reg 

Number 

used 

for Max. 

Appl. 

Rate

Formulation % 

Active 

Ingredi

ent in 

End 

Use 

Formul

ation

Use 

Category

Use Site Treatment Site/Surfaces Metho

d of 

Appli

cation

Max 

Application/

Use Rate

Use Limitations

075601 73696-2 

Technical 

Chemical 96.6

Use only for manufacture of or 

fabrication into antimicrobial 

pesticides to be used as 

coatings on, or components of, 

the following hard, inanimate 

surfaces and products: walls, 

floors, ceiling, tile, fixtures, tools 

appliance exteriors, pipe 

exteriors HVAC equipment, 

ductwork and related 

equipment (other than motors, 

fans and similar mechanical 

moving parts) interiors and 

exteriors, and concrete, stone, 

ceramic, plaster wood, and 

drywall substrates.

Formulations 

and 

antimicrobial 

coating 

products that 

incorporate 

hydrated lime 

are to be 

formulated to 

include 15-

25% of this 

product.

075604 75661-1 

Soluble 

Concentrate 86.8

Medical 

Premises and 

Equipment

Regulated 

Medical 

Waste

Cultures and stocks, human 

pathological waste, human 

blood and blood products, used 

and unused sharps and 

Isolation waste.

Open 

pour

7.5% by 

weight of the 

material 

treated

End use product 

is designed for 

use only in the 

PIWS-3000 

Treatment 

System.