BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Cellulose

 PC Code: 100154

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

October 15, 2012
Cellulose

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TABLE OF CONTENTS

I. EXECUTIVE SUMMARY .................................................................................................. 5

II. ACTIVE INGREDIENT OVERVIEW.............................................................................. 6

III. REGULATORY BACKGROUND.................................................................................... 6

A. Classification ........................................................................................................................ 6

B. Food Clearances/Tolerances............................................................................................... 7

IV. RISK ASSESSMENT ......................................................................................................... 7

A. Active Ingredient Characterization.................................................................................... 7

B. Human Health Assessment.................................................................................................. 7

1. Toxicology ......................................................................................................................................................7

2. Dose Response Assessment .........................................................................................................................10

 3. Drinking Water Exposure and Risk Assessment.................................................................10

4. Occupational, Residential, School and Day Care Exposure and Risk Characterization ......................11

5. Risk Characterization .................................................................................................................................11

C. Environmental Assessment ............................................................................................... 12

1. Ecological Hazards......................................................................................................................................11

2. Environmental Fate and Ground Water ..................................................................................................12

3. Ecological Exposure and Risk Characterization ......................................................................................12

4. Endangered Species Assesment..................................................................................................................12

D. Efficacy Data ..................................................................................................................... 12

V. RISK MANAGEMENT DECISION................................................................................. 13

A. Determination of Eligibility for Registration .................................................................. 13

B. Regulatory Decision........................................................................................................... 13

VI. ACTIONS REQUIRED BY REGISTRANTS................................................................. 14

A. Reporting of Adverse Effects............................................................................................ 14

B. Reporting of Hypersensitivity Incidents.......................................................................... 14

VII. APPENDIX A. Data Requirements (40 CFR Part 158) ................................................. 14

VIII. APPENDIX B. Product Specific Information................................................................. 18
Cellulose

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IX. APPENDIX C. References. ................................................................................................ 18
Cellulose

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BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

Branch Chief

Linda A. Hollis, M.S.

Product Chemistry/Human Health Effects/Nontarget Organisms

Angela L. Gonzales, Biologist

Efficacy

Clara Fuentes, Ph.D., Entomologist

Senior Regulatory Specialist

Leonard S. Cole, Jr., M.S.
Cellulose

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I. EXECUTIVE SUMMARY

Cellulose is a new biochemical pesticide active ingredient intended for use as a rodenticide for 

the control of mice in commercial and residential indoor settings. Cellulose is derived from corn 

cobs that have been dried and ground into coarse granules. Cellulose is a polysaccharide and the 

main constituent of plant cell walls. It is also produced by some algae, fungi and bacteria. 

Cellulose is used in a variety of products including paper, textiles and building materials (French, 

2003). Various derivatives of cellulose including powdered cellulose and microcrystalline 

cellulose are approved by the U.S. Food and Drug Administration (FDA) for use in food and 

pharmaceutical products under 21 CFR § 175.105 as a thickening agent. 

The Biopesticides and Pollution Prevention Division (BPPD) determined that the 

data/information submitted to address product chemistry and Tier I acute toxicity data 

requirements satisfy the current guideline requirements. Acceptable data and information were 

submitted for the subchronic 90-day oral (OCSPP 870.3100), 90-day dermal (OCSPP 870.3250), 

90-day inhalation (OCSPP 870.3465), mutagenicity in vitro mammalian cell assay (OCSPP 

870.5100), mutagenicity in vivo micronucleus assay (OCSPP 870.5395) and developmental 

toxicity (OCSPP 870.3700) data requirements. BPPD has evaluated the relevant data and 

information and concluded that, based on the use pattern for cellulose as proposed to be 

registered and reflected in the proposed registration label, significant exposure to humans is not 

anticipated from the use of cellulose. 

At the request of the applicant, non-target organism data requirements for this product were 

waived on the basis that the guideline studies were not applicable because the proposed 

registration will only permit indoor use. Thus, non-target toxicity is not anticipated because of 

lack of exposure. Based on its non-target assessment, EPA has determined that the proposed 

registered use of cellulose in end use products (EPs) should not result in adverse effects to birds, 

fish, aquatic invertebrates, plants, or non-target insects.

Based on the acute toxicity data for cellulose, the active ingredient is toxicity category III for 

primary dermal irritation. EPA has not identified any toxic endpoints for non-target mammals, 

birds, plants, aquatic, or soil organisms. EPA has no concerns for any non-target organisms 

exposed to cellulose when used in accordance with approved label directions. Given that 

cellulose has very low toxicity and presents little, if any, risk to non-target organisms, EPA has 

concluded that it is in the best interests of the public to issue the registration for the cellulose MP 

(EPA File Symbol 84889-R) and the EP (EPA File Symbol 84889-E). 

BPPD has reviewed the data/information in support of the requirements for granting registration 

under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). It has 

been determined that the data/information submitted adequately satisfy current guideline 

requirements (please refer to 40 CFR Subpart U § 158.2000). 

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for 

the public to participate on major registration decisions before they occur. According to this 

policy, EPA provides a public comment period prior to making a registration decision for the 

following types of applications: new active ingredients, first food use, first outdoor use, first 
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residential use; and any registration decisions for which the Agency believes there may be 

substantial public interest. 

Consistent with the policy of making registration actions more transparent, cellulose is subject to 

a 15 day comment period as a “new active ingredient”. The notice for this comment period 

includes a draft Biopesticides Registration Action Document (BRAD) and draft product labels 

for PCC 38-DD, the (MP) and Rode-Trol, the (EP) which contain the new active ingredient, 

cellulose. The docket identification (ID) number is EPA-HQ-OPP-2012-0128. The Agency

believes that based on the risk assessment and information submitted in support of the 

registration of the MP and the EP, it is in the best interests of the public to issue the registration 

for Rode-Trol as a rodenticide. The basis for this decision can be found in the risk assessment for 

cellulose, which is characterized in this BRAD. 

II. ACTIVE INGREDIENT OVERVIEW

Common Name: Cellulose

 Chemical Names: N/A

Trade & Other Names: Powdered Corn Cobs

 CAS Registry Number: 9004-34-6

OPP Chemical Code: 100154

Type of Pesticide: Biochemical Pesticide (Rodenticide) 

III. REGULATORY BACKGROUND

On July 12, 2011, EPA received an application filed by Exponent, 1150 Connecticut Avenue, 

NW, Suite 1100, Washington, DC 20036, on behalf of Rode-Trol, LLC, 35801 Road 132, 

Visalia, CA 93292, to register the products, PCC 38-DD (EPA File Symbol No. 84889-R) and 

Rode-Trol (EPA File Symbol No. 84889-E) containing the new biochemical active ingredient, 

cellulose. A notice of receipt (NOR) of this application, allowing for a 30-day comment period, 

was published in the Federal Register on February 29, 2012 (77 FR 12296). No comments were 

received following this publication.

A. Classification

On June 22, 2006, the biochemical classification committee determined that cellulose is a 

biochemical.
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B. Food Clearances/Tolerances 

This active ingredient is not registered for use on food or feed commodities. A tolerance or 

exemption from the requirement of a tolerance is not required for the current uses.

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

Powdered corn cobs are shelled corn cobs that have been dried and ground. Cellulose which is 

the actual pesticidal component in the cobs, comprises approximately 37% of the powdered corn 

cobs. The mode of action of cellulose as a rodenticide is believed to be interference with 

osmoregulation in the intestines of rats and mice which results in dehydration, malnutrition and 

consequently death. A second theory regarding the mode of action of the active ingredient is that 

because cellulose is indigestible by non-ruminant mammals, consumption of excessive amounts 

of the material may result in intestinal dysfunction. 

Cellulose, a polysaccharide, is one of the most abundant organic compounds on Earth. It is the 

main constituent of plant cell walls and is also produced by some algae, fungi and bacteria. It is 

consumed in its natural state (as a component of plants) by humans and animals and is used in a 

variety of products, such as paper, textiles and building materials. (French, 2003) Various 

derivatives of cellulose, including powdered cellulose and microcrystalline cellulose are 

approved by the FDA for use in food and pharmaceutical products as a thickening agent (21 

CFR). Under the Federal Food, Drug and Cosmetic Act (FFDCA), EPA has exempted the 

compound from the requirement of a tolerance as a minimum risk active and/or inert ingredient 

in food-use pesticide products (40 CFR 180.950(e)). The Agency has also approved cellulose as 

a nonfood-use inert ingredient in pesticide products. In 2007, cellulose from powdered corn cobs 

was approved for use as a rodenticide in Canada by the Pest Management Regulatory Agency

(PMRA). 

All product chemistry data requirements for the registration of cellulose have been satisfied.

For more information regarding product chemistry data requirements, refer to Tables 1 and 2 in 

Appendix A. 

B. Human Health Assessment

1. Toxicology

To satisfy the toxicology data requirements, data were provided from the open scientific 

literature. Reviews and analyses of these data by the World Health Organization (WHO) and 

PMRA were also submitted. For all data requirements adequate data on surrogate chemicals such 

as microcrystalline cellulose or refined-alpha cellulose were submitted. These chemicals are 

derivatives of cellulose. In lieu of submitting data on the toxicity for powdered corn cobs, data 
Cellulose

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were submitted on cellulose because the compound is considered to be the pesticidal component 

of the powdered corn cobs. The data submitted are acceptable to qualitatively assess the toxicity

of the active ingredient. 

All toxicology data requirements have been satisfied in accordance with 40 CFR § 158.2050. 

The data presented in Table 3 below are a summary of the toxicity data for powdered corn cobs 

(cellulose). Data evaluation records (DERs) were not created for the submitted MRIDs; however, 

the data and information from these MRIDs are summarized in Table 3 and in the subsequent 

sections.

Adequate mammalian toxicology data/information is available to support registration of

cellulose. All toxicology data requirements for cellulose have been satisfied.

a. Acute Toxicity

All data submitted to support the acute toxicology data requirements were collected from the 

open scientific literature and were obtained from studies conducted on acceptable surrogate 

chemicals for cellulose, such as microcrystalline cellulose. Microcrystalline cellulose is purified, 

partially depolymerized cellulose (MRID 48433405, p. 95 of 110). Based on the available data 

and information, the Agency has classified cellulose as having low acute oral, acute dermal and 

acute inhalation toxicity. It is minimally irritating to the eye, is not a dermal irritant and is not a 

dermal sensitizer. 

All of the acute toxicity data referenced above were also reviewed by the World Health 

Organization (WHO) and Canada’s Pest Management Regulatory Agency (PMRA) and found to 

be acceptable.

b. Subchronic Toxicity 

90-Day Oral

The 90-day oral data requirement is conditionally required for nonfood uses that are likely to 

result in repeat oral exposure to humans. The proposed product is intended for use to formulate 

EPs which will be used as rodenticides in indoor settings. Repeat human oral exposure is not 

expected based on the proposed use pattern of the product. The proposed product will be placed 

in bait stations and/or trays and left alone to attract rodents. Label instructions will include

precautionary statements to mitigate exposure to applicators and children. Any oral exposure is 

likely to be accidental; repeated oral exposure is not anticipated. In the case that accidental 

exposure should occur, hazard data indicate that ingestion of cellulose is not likely to result in 

toxic effects. Several subchronic and chronic oral toxicity studies were cited (actual studies were 

not provided) in MRID 48534106 for derivatives of cellulose. Most of the studies were 

conducted using microcrystalline cellulose. In their safety evaluation of microcrystalline 

cellulose, the WHO reviewed these studies and concluded that there is no evidence to indicate 

that consumption of microcrystalline cellulose in foods (when foods are produced according to 

good manufacturing processes) will result in toxic effects in humans (MRID 48433405, p. 25 of 
Cellulose

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100). Moreover, humans are already naturally exposed via the oral route to cellulose through 

consumption of plants and other foods.

90-Day Dermal

The 90-day dermal data requirement is conditionally required to support uses involving 

purposeful application to the human skin or uses that would result in prolonged dermal exposure 

and if data from a 90-day oral study are not required or the active ingredient is known or 

expected to be metabolized differently by the dermal route of exposure than by the oral route and 

the metabolite is of toxicological concern. Purposeful application and prolonged exposure to the 

human skin is not anticipated based on the use pattern of the proposed product (the product will 

be placed in bait stations and/or trays and left alone to attract rodents). Label instructions will 

include precautionary statements to mitigate exposure to children. Additionally, humans are 

already exposed via the dermal route to cellulose in paper products, textiles, foods and plants.

90-Day Inhalation

The 90-day inhalation data requirement is conditionally required if there is a likelihood of 

significant levels of repeated inhalation exposure to the pesticide as a gas, vapor or aerosol. 

Cellulose is lowly toxic via the inhalation route of exposure. For the proposed uses of powdered 

corn cobs (cellulose) as a pesticide, repeated inhalation exposure is unlikely based on the 

physical properties of the active ingredient, which is a solid. The proposed EP is formulated as a 

pellet that is not inhalable. Although dust may be generated from the product containing the 

active ingredient during shipping and/or handling, significant exposure is not anticipated. Should 

exposure occur however, it is expected to be brief in duration. Moreover, the use pattern of the 

product significantly limits exposure since the active ingredient is housed in bait stations and/or 

trays. 

c. Developmental Toxicity

Developmental toxicity data are conditionally required if significant exposure to female humans 

is expected from the proposed product’s use under widespread and commonly recognized 

practice. Significant exposure to females is unlikely based on the proposed use pattern of the 

product containing the active ingredient (the product will be placed in bait stations and/or trays 

and left alone to attract rodents). If used according to label instructions, significant oral, dermal 

and inhalation exposure to the active ingredient is not anticipated. No developmental toxicity

effects were observed in studies with microcrystalline cellulose reviewed by the WHO (MRID 

484334-05, p. 21 of 110). 

d. Mutagenicity

Mutagenicity data are conditionally required to support nonfood uses if the use is likely to result 

in significant human exposure or if the active ingredient or its metabolites are structurally related 

to a known mutagen or belong to any chemical class of compounds containing a known mutagen. 
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Significant human exposure is unlikely based on the use pattern (the proposed EP will be placed 

in bait stations or in trays and left alone to attract rodents). Additionally, the proposed EP is for 

nonfood-uses only. Moreover, in studies reviewed by the WHO, microcrystalline cellulose was 

not mutagenic in various in vitro mutagenicity assays in Salmonella typhimurium and 

Escherichia coli and it was not mutagenic in in vivo mouse erythrocyte micronucleus 

mutagenicity assays.

e. Companion Animal/Nontarget Animal Toxicity and Risk Characterization

To assess the potential for hazardous effects to various species, including pets, which may

encounter the product containing the active ingredient during use, several non-guideline toxicity

studies were conducted and submitted to the Agency (MRIDs 48433507-48433516). The species 

tested were: brushtail possum (Trichosurus vulpecula), rabbit (Oryctolagus cuniculus cuniculus), 

guinea pig (Cavia porcellus), cat (Felis catus), dog (Canis familiaris), ferret (Mustela furo), 

chicken (Gallus gallus), duck (Anas platyrhynchos) and goldfish (Carassius auratus). In each 

study, test species were deprived of their normal diet for 24 hours and then presented with the 

product containing the active ingredient and a half-ration of their normal food. The feeding 

schedule continued for up to 10 days. Animals were observed for daily consumption and changes 

in body weight and behavior. Animals that consumed at least 5g test substance/kg body weight 

were euthanized and examined for gross pathological effects. Possums, cats, chickens, dogs and 

ferrets typically refused the product after sampling small to moderate quantities. Guinea pigs, 

rabbits and male ducks consumed appreciable amounts of the product over the testing period. No 

changes in behavior were observed in any of these species during the test period. Gross 

pathology observations were normal for these species with the exception of observations of 

possible reduced urine production in possums, guinea pigs and rabbits and dry feces in some 

ducks. Goldfish mortality occurred between the first day and 19 days post-application (the 

product was applied to simulate an accidental spillage into a fish tank or pond). It was not 

determined if mortality occurred due to water contamination from the product or from 

consumption of the product. 

Based on the data provided, the product appears to be unpalatable to possums, cats, chickens, 

dogs and ferrets. Should accidental consumption occur, the available data indicate that accidental 

exposure should not result in toxic effects to these species. Although guinea pigs, rabbits and 

ducks may consume the product, the available data indicate that accidental exposure should not 

result in toxic effects. Accidental exposure to fish may result in mortality based on the data 

submitted; however, exposure is not expected based on the use pattern of the product. Risk to all 

of the above species is expected to be negligible based on minimal toxicity and lack of exposure 

if label instructions are followed. 

2. Dose Response Assessment

Because no toxicological endpoints were identified for this active ingredient, a dose response 

assessment was not required. 
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3. Drinking Water Exposure and Risk Characterization

Based on the proposed use pattern of powdered corn cobs (cellulose) as a rodenticide, pesticide 

residues in drinking water are not expected when products are used according to label 

instructions. Products containing the active ingredient will be used in indoor commercial and 

residential settings only; therefore, cellulose residues in drinking water are unlikely. 

4. Occupational, Residential, School and Day Care Exposure and Risk Characterization

a. Occupational Exposure and Risk Characterization

An occupational exposure assessment was not conducted for powdered corn cobs (cellulose) 

because significant exposure to workers, handlers and applicators is not anticipated given that the 

active ingredient is housed in bait stations or trays (which limits exposure) and is not likely to be 

directly handled when used in accordance with label directions. Cellulose is of low toxicity and 

should exposure occur, it is likely to be via the dermal and possibly the inhalation route and 

expected to be brief in duration. Once the bait stations or trays are placed in the areas, they are 

left alone to attract rodents. There is a likelihood of exposure from inhalation to dust generated 

during the life-cycle of the product. This exposure is not expected to be significant and again, 

brief in duration. Moreover, should dermal or inhalation exposure occur significant risks are not 

anticipated because the active ingredient is of low dermal and inhalation toxicity and therefore, 

the Agency believes that use of this product presents no unreasonable risks. Humans are already 

exposed to cellulose in the diet and through use of various products such as paper and textiles, 

with no reports of adverse effects. There were no relevant toxicological endpoints were identified 

in the data submitted. 

 b. Residential, School and Day Care Exposure and Risk Characterization

A residential, school and day care exposure assessment was not conducted for powdered corn 

cobs (cellulose). Based on the proposed use pattern and toxicity data available to the Agency, 

anticipated exposure is not likely to result in unreasonable risk to humans. No relevant 

toxicological endpoints were identified and significant exposure is not expected if label 

instructions are followed. Any exposure in residential, school and/or day care settings is likely to 

be accidental and data available to the Agency indicate that the active ingredient is of low 

toxicity. Additionally, humans are already exposed to cellulose in the diet and through use of 

various products such as paper and textiles. 

5. Risk Characterization

Risk to humans from pesticidal use of powdered corn cobs (cellulose) is expected to be 

negligible due to the low toxicity of the active ingredient and the anticipated lack of exposure to 

humans as a result of its use pattern. The proposed product is not used in or on food, and is not 

directly applied to humans. Appropriate precautionary language requirements on end-use product 

labels will further mitigate exposure. 
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The Agency has considered powdered corn cobs (cellulose) in light of the relevant safety factors 

in FIFRA. A determination has been made that no unreasonable adverse effects to the U. S. 

population in general, and to infants and children in particular, will result from the use of this 

chemical when label instructions are followed.

C. Environmental Assessment

1. Ecological Hazards 

All non-target toxicology data requirements have been satisfied in accordance with 40 CFR 

158.2060. The information presented in Table 4 below is a summary of the non-target 

toxicology data and information for powdered corn cobs (cellulose). DERs were not created for 

the submitted MRIDs; however, data and information from these MRIDs are summarized in 

Table 4 and in the subsequent sections. 

2. Environmental Fate and Ground Water Data 

Environmental fate and groundwater data are not required at this time because the results of the 

nontarget organism toxicity assessment (Tier I data requirements) did not trigger these Tier II 

data requirements. 

3. Ecological Exposure and Risk Characterization

A risk assessment was not conducted for nontarget organisms due to the unlikelihood of 

exposure to nontarget organisms through the use of this product. Unreasonable effects to 

nontarget organisms are not anticipated; however, products should be used according to label 

instructions. 

4. Endangered Species Assessment

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

determination. The ecological risk assessment planned during registration review will allow the 

Agency to determine whether powdered corn cobs’ (cellulose) use has “no effect” or “may

effect” 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. 

D. Efficacy Data

Data and information in MRIDs 48433517 to 48433524 demonstrate that the proposed product 

kills rats and mice when they are fed exclusively on the product for a period of approximately 7 

days for rats and 3 days for mice. The submitted efficacy data include a summary of laboratory

studies conducted on the same formulation under different trade names and support the 

conclusion that the product causes mortality in rats and mice. The product causes physical 

disruption of the feeding mechanism in rats and mice. Mortality is caused by dehydration and 
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malnutrition. Several postulated pathological pathways were investigated and none were 

established as the physiological mechanism leading to these lethal outcomes. It is unknown how 

normal food consumption in addition to Rode-Trol would have influenced product performance 

since the mortality effects of Rode-Trol were tested by feeding the rodents exclusively on the 

product. Given this uncertainty, not with respect to whether or not the product causes mortality, 

but how soon it would take the rats/mice to die as a result of feeding on the product in addition to 

alternative food sources, the product label must accurately reflect the conditions of testing. 

Product performance data directly impact the label, its claims and directions for use. For the 

Rodetrol end use product, which is a product for indoor use only, the directions use for use must 

state "when applying the bait stations or trays, remove all alternative food sources from the 

treated area."

V. RISK MANAGEMENT DECISION

A. Determination of Eligibility for Registration 

Section 3(c)(5) of FIFRA provides for the registration of a new active ingredient if it is 

determined that: (A) its composition warrants proposed claims; (B) its labeling and other 

materials comply with the requirements of FIFRA; (C) it will perform its intended function 

without unreasonable adverse effects on the environment; and (D) when used in accordance with 

widespread and commonly recognized practice, it will not generally cause unreasonable adverse 

effects on the environment. 

The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied by 

the science assessments supporting the end use product containing the manufacturing use 

product, cellulose. The end use product is not expected to cause unreasonable adverse effects. 

Therefore, cellulose as a manufacturing use product is eligible for registration for the labeled 

uses. 

B. Regulatory Decision

The data submitted fulfill the registration requirements of cellulose for use as a rodenticide.

Refer to Appendix B for product-specific information.

Conditional/Unconditional Registration

All data requirements are fulfilled, and EPA has determined that an unconditional registration of 

cellulose is appropriate.

C. 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—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. At this time, 

EPA does not believe that use of tagetes oil pesticide products will cause harm or a 

disproportionate impact on at-risk communities. For additional information regarding 
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environmental justice issues, please visit EPA’s website at

http://www.epa.gov/compliance/environmentaljustice/index.html.

VI. ACTIONS REQUIRED BY REGISTRANTS

EPA evaluated all data submitted in connection with the registration of the cellulose pesticide 

product and determined that these data are sufficient to satisfy current registration data 

requirements.

Notwithstanding the information stated in the previous paragraph, it should be clearly understood 

that certain specific data are required to be reported to EPA as a requirement for maintaining the 

Federal registration for a pesticide product. A brief summary of these types of data are listed 

below. 

A. Reporting of Adverse Effects

Pursuant to FIFRA section 6(a)(2), reports of all incidents of adverse effects to the environment 

must be submitted to EPA.

B. Reporting of Hypersensitivity Incidents

Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) 

must be reported to the Agency under the provisions of 40 CFR Part 158.2050(d).

VII. APPENDIX A. Data Requirements (40 CFR Part 158-Subpart U)

*NOTE: Master Record Identification (MRID) numbers listed in the following tables are 

representative of supporting data/information for the original registration of the product 

containing this active ingredient. Subsequent to this registration, there may be additional MRIDs 

that support registration of other products containing this active ingredient. 

TABLE 1. Product Chemistry Data Requirements for Powdered Corn Cobs (Cellulose) (40 CFR § 158.2030)

OSCPP Guideline No. Study Results MRID

830.1550

to

830.1670

Product identity;

Manufacturing process;

Discussion of formation of 

unintentional ingredients

Submitted data satisfy the requirements 

for product identity, manufacturing 

process, and discussion of formation of 

impurities

48433401

48534109

830.1700 Analysis of samples Submitted data satisfy the requirements 

for analysis of samples.

48924801

830.1750 Certification of limits Limits listed in the CSF are acceptable. 48433401

48534109

830.1800 Analytical method Acceptable. 48433401
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TABLE 2. Physical and Chemical Properties of Powdered Corn Cobs (Cellulose) (40 CFR § 

158.2030)

OCSPP 

Guideline Property Description of Result(PC 38-DD) MRID

830.6302 Color Yellow-brown 48433402

830.6303 Physical State Solid 48433402

830.6304 Odor Faintly sweet 48433402

830.6313 Stability to Normal and 

Elevated Temperatures, 

Metals and Metal Ions

Stable 48433402

830.6315 Flammability Flash point: 388oF (open cup); 396 oF (closed 

cup)

48433402

830.6317 Storage Stability Rationale is inadequate 48433402

830.6319 Miscibility N/A: product is not an emulsifiable liquid that 

will be diluted with petroleum solvents

48433402

830.6320 Corrosion Characteristics Rationale is inadequate 48433402

830.7000 pH N/A: TGAI/MP is not soluble or dispersible 

in water

48433402

830.7050 UV/Visible Light

Absorption

Data are not necessary to inform the risk 

assessment

48433402

830.7100 Viscosity N/A: product is a solid 48433402

830.7200 Melting Point/Range Not expected to melt 48433402

830.7220 Boiling Point/Range N/A: TGAI is a solid 48433402

830.7300 Bulk Density 28.0 lb/ft348433402

830.7520 Particle Size, Fiber Length 

and Diameter Distribution

Coarse dust index: 0.89

Coarse dust: 9.78 X 10-5 %

Crude fiber: 36.9%

48433402

830.7550

830.7560

830.7570

Partition Coefficient (nOctanol/Water)Data are not necessary to inform the risk 

assessment

48433402

830.7840 Water Solubility 6.3% in water 48433402

830.7950 Vapor Pressure N/A: TGAI/MP is a solid 48433402
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Table 3. Mammalian Toxicology Data for Powdered Corn Cobs (Cellulose) (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

Acute oral toxicity (rat)

(870.1100)

LD50 > 3160 mg/kg1,3 (males)

LD50 > 5000 mg/kg2,3 (females and males) IV 4843340548534101

Acute dermal toxicity (rat)

(870.1200) LD50 > 2000 mg/kg2,3 (females and males) III 4843340548534102

Acute inhalation toxicity (rat)

(870.1300) LC50 > 5.35 mg/L2,3 (females and males) IV 4843340548534103

Primary eye irritation (rabbit)

(870.2400) Minimally irritating2

IV 48433405

48534104

Primary dermal irritation (rabbit)

(870.2500) Nonirritating2

IV 48433405

Dermal sensitization (guinea pig)

(870.2600) Not a sensitizer2 N/A 4843340548534105

90-Day oral toxicity 

(870.3100)

The proposed EP is nonfood-use. Uses are not 

anticipated to result in repeat oral exposure to 

humans.

Based on the review of available toxicity

studies, the World Health Organization 

(WHO) has concluded that there is no 

evidence to indicate that consumption of 

microcrystalline cellulose in foods (when 

foods are produced according to good 

manufacturing processes) will result in toxic 

effects in humans. Humans are already 

naturally exposed to cellulose through 

consumption of plants and other foods.

48433405

48534106

90-Day dermal toxicity

(870.3250)

Purposeful application and prolonged 

exposure to the human skin is not anticipated 

based on the use pattern (the proposed EP will 

be placed in bait stations or in trays and left 

alone to attract rodents). Additionally, humans 

are already exposed to cellulose and cellulose 

derivatives in paper products, textiles, 

pharmaceuticals, foods and plants.

90-Day inhalation toxicity

(870.3465)

Significant repeat inhalation exposure to the 

active ingredient as a gas, vapor or aerosol is 

unlikely based on the physical properties of 

the active ingredient. Powdered corn cobs 

(cellulose) are a solid material and the 

proposed EP is formulated as a pellet which is

not inhalable. Although dust may be 

generated during the life-cycle of the product, 

significant exposure is not anticipated and the 

active ingredient is of low inhalation toxicity.

The use pattern also precludes exposure (the 

proposed EP will be placed in bait stations or 

in trays and left alone to attract rodents).
Cellulose

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Table 3. Mammalian Toxicology Data for Powdered Corn Cobs (Cellulose) (40 CFR § 158.2050)

Study/OCSPP Guideline No. Results Toxicity 

Category/Description MRID

Mutagenicity-in vitro studies

(870.5100)

Significant human exposure is unlikely based 

on use pattern (the proposed EP will be placed 

in bait stations or in trays and left alone to 

attract rodents). The proposed EP is for 

nonfood-uses only.

Various mutagenicity assays with 

microcrystalline cellulose in Salmonella 

typhimurium and Escherichia coli were 

reviewed by the WHO. All results were 

negative for genotoxicity.

48433405

48534108

Mutagenicity-in vivo micronucleus 

assay (870.5395)

Significant human exposure is unlikely based 

on use pattern (the proposed EP will be placed 

in bait stations or in trays and left alone to 

attract rodents). The proposed EP is for 

nonfood-uses only.

In vivo mouse erythrocyte micronucleus 

mutagenicity assays using microcrystalline 

cellulose were reviewed by the WHO. All 

results were negative for genotoxicity.

48433405

48534108

Developmental toxicity

(870.3700)

Significant female human exposure is unlikely 

based on use pattern (the proposed EP will be 

placed in bait stations or in trays and left 

alone to attract rodents). The proposed EP is 

for nonfood-uses only.

No developmental toxicity effects were 

observed in studies with microcrystalline 

cellulose reviewed by the WHO. 

48433405

48534107

1Test substance was refined alpha-cellulose.

2Test substance was 85% microcrystalline cellulose.

3Highest dose tested.
Cellulose

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VIII. APPENDIX B.

For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels.

IX. APPENDIX C. References

French, A. D., Bertoniere, N. R., Brown, R. M., Chanzy, H., Gray, D., Hattori, K. and Glasser, 

W. 2003. 

Cellulose. Kirk-Othmer Encyclopedia of Chemical Technology. Published Online: October 

17, 2003

REVIEWS AND OTHER REFERENCES

U.S. EPA. 2012. Memorandum from Clara Fuentes, Ph.D. to Leonard S. Cole, Jr. Science review 

of Rodetrol performance against rats and mice. The active ingredient in the product is powdered 

corn cobs, containing 45.1% w/w cellulose. April 25, 2012.

U.S. EPA. 2012. Memorandum from Angela L. Gonzales to Leonard S. Cole, Jr. Science Review 

in Support of PCC 38-DD, Containing 100% Powdered Corn Cobs (37% Cellulose) As Its 

Active Ingredient. October 3, 2012.

U.S. EPA. 2010. Memorandum from Angela L. Gonzales to Leonard S. Cole, Jr. Science Review

in Support of Rode-Trol, Containing 90.0% Powdered Corn Cobs (33.3% Cellulose) As Its 

Active Ingredient. October 3, 2012. 

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

a.i. active ingredient

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticide Registration Action Document

bw body weight

CBI Confidential Business Information

CFR Code of Federal Regulations

cm3cubic centimeter

CSF Confidential Statement of Formula

°C degrees Celsius

EC50 median effective concentration. A statistically derived single concentration in 

environmental medium that can be expected to cause an effect in 50% of the test 

animals when administrated by the route indicated (inhalation). It is expressed 

as a concentration in air or water (e.g. mg/L).

EDSP Endocrine Disruptor Screening Program

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee

EP end-use product

EPA Environmental Protection Agency (the “Agency”)

FDA Food and Drug Administration
Cellulose

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FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

g gram

ha hectare

kg kilogram

Kow octanol-water partition coefficient

L liter

LC50 median lethal concentration. A statistically derived single concentration in air or 

water that can be expected to cause death in 50% of the test animals when 

administrated by the route indicated (inhalation and environment). It is 

expressed as a concentration in air or water (e.g. mg/L).

LD50 median lethal dose. A statistically derived single dose that can be expected 

to cause death in 50% of the test animals when administered by the route 

indicated (oral and dermal). It is expressed as a weight of 

substance per unit weight of animal (e.g., mg/kg).

MRID No. Master Record Identification Number

mg milligram

mPa millipascal

mL milliliter

MP manufacturing-use product

N/A not applicable

NE “No Effect”

NIOSH National Institute for Occupational Safety and Health

nm nanometer

NOEL no-observed-effect-level

NOF notice of filing

NOR notice of receipt

OPP Office of Pesticide Programs

OCSPP Office of Chemical Safety and Pollution Prevention

pa pascal

PPE personal protective equipment

PR Notice Pesticide Registration Notice

 TGAI technical grade of the active ingredient

 ug microgram

 USDA United States Department of Agriculture

 UV ultra-violet