BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Oil of Mustard and 

Ally Isothiocyanate (AITC)

PC Code: 004901

U.S. Environmental Protection Agency 

 Office of Pesticide Programs 

Biopesticides and Pollution Prevention Division 

(last updated September 26, 2013) 

 
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Table of Contents

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

II. ACTIVE INGREDIENT OVERVIEW .............................................................................. 7

III. REGULATORY BACKGROUND...................................................................................... 7

A. Application for Pesticide Registration ............................................................................... 7

B. Food Clearances/Tolerances ............................................................................................... 8

IV. RISK ASSESSMENT ........................................................................................................... 8

A. Product Analysis Assessment (40 CFR § 158.2030) .......................................................... 8

B. Human Health Assessment.................................................................................................. 8

1. Tier I Toxicology ........................................................................................................................................... 8

2. Tier II and Tier III Toxicity Studies .......................................................................................................... 10

3. Effects on the Endocrine System ................................................................................................................ 10

4. Dose Response Assessment ......................................................................................................................... 11

5. Drinking Water Exposure and Risk Characterization ............................................................................ 11

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

a. Occupational Exposure and Risk Characterization ................................................................................. 11

b. Residential, School and Day Care Exposure and Risk Characterization ............................................... 12

7. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation ........................... 12

a. Food Exposure ............................................................................................................................................. 12

b. Drinking Water Exposure .......................................................................................................................... 12

c. Other Non-occupational Exposure ............................................................................................................ 12

8. Cumulative Effects from Substances with a Common Mechanism of Toxicity ..................................... 13

9. Determination of Safety for United States Population, Infants and Children ....................................... 13

10. Risk Characterization ................................................................................................................................. 13

C. Environmental Assessment ............................................................................................... 13

1. Ecological Hazards ...................................................................................................................................... 13

2. Environmental Fate and Ground Water Data .......................................................................................... 13

3. Ecological Exposure and Risk Characterization ...................................................................................... 13

4. Endangered Species Assessment ................................................................................................................ 14

D. Product Performance Data ............................................................................................... 14

V. RISK MANAGEMENT DECISION ................................................................................. 14
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A. Determination of Eligibility for Registration .................................................................. 14

B. Regulatory Decision ........................................................................................................... 14

C. Environmental Justice ....................................................................................................... 15

VI. ACTIONS REQUIRED BY REGISTRANTS.................................................................. 15

A. Reporting of Adverse Effects ............................................................................................ 15

B. Reporting of Hypersensitivity Incidents .......................................................................... 15

VII.  APPENDIX A. DATA REQUIREMENTS (40 CFR PART 158-SUBPART U) .......... 16

VIII.  APPENDIX B. REFERENCES ....................................................................................... 21

IX. GLOSSARY OF ACRONYMS AND ABBREVIATIONS ............................................. 22
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BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM 

Branch Chief 

Linda A. Hollis, M.S. 

Product Chemistry/Human Health Effects/Nontarget Organisms 

Russell Jones, Ph.D., Senior Scientist 

Regulatory Action Leader 

Gina Burnett, M.S. 

 
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I. EXECUTIVE SUMMARY 

Allyl isothiocyanate (AITC) is a naturally occurring component of Oil of Mustard, which was 

first registered by the Agency for pesticidal use in 1962. As part of Oil of Mustard, AITC has 

been determined by the Agency to be the residue of concern and, as such, has been well 

characterized in the Reregistration Eligibility Decision for Flower and Vegetable Oils (EPA, 

1993), the Biopesticides Registration Action Document for Oriental Mustard Seed (PC Code 

014921) (EPA, 2008), and the Vegetable and Flower Oil Summary Document for Registration 

Review (EPA, 2010). AITC is produced naturally when enzymes of the mustard plant, 

myrosinase and glucosolinate, are in the presence of water. In addition to its presence in mustard, 

AITC can be found in food commodities such as cooked cabbage, kale, and horseradish. It is 

synthetically produced from allyl iodide and potassium thiocyanate. In pesticidal products, AITC 

is used as an insect and animal repellent, feeding suppressant, insecticide, fungicide, herbicide 

and nematicide. 

The Agency has registered manufacturing-use product (MP), IR9804 (EPA Reg. No. 89285-1) 

and end-use product (EP), IRF135 (EPA Reg. No. 89285-2). These products contain synthetic 

AITC at 99.8% and 96.3%, respectively. IRF135 is intended for use as an insecticide, fungicide, 

herbicide and nematicide to be applied (1) by tractor mounted shank injection at a depth of 8 to 

15 inches, followed by tarp overlay, (2) by drip injection, also covered by tarp overlay, and (3) 

by deep injection to depths greater than 17 inches, with no tarp covering. This is the first 

proposed soil fumigant containing AITC as its active ingredient. IR9804 is intended for 

formulation into end-use products for soil treatment. The label application methods are for preplant applications, which would be considered a non-food use. No residual activity is expected 

and the active ingredient and its degredates will dissipate prior to crop seeding. 

The Agency has concluded that adequate mammalian toxicology data are available to support 

AITC (EPA, 1993; EPA 2010). The oral LD50 in rats is 339 mg/kg (EPA, 1993). Human 

exposure to AITC is expected to be minimal from the proposed MP and soil treatment EP, 

IR9804 (EPA Reg. No. 89285-1) and IRF135 (EPA Reg. No. 89285-2) (EPA, 2013). The active 

ingredient is not likely to result in adverse human health effects, based upon available reports 

and information. 

AITC rapidly degrades in the environment by normal biological, physical and/or chemical 

processes that can be reasonably expected to exist where the pesticide is applied (EPA, 2013). In 

each case of registration of products containing AITC, sufficient data or information has been 

submitted to demonstrate that there will be no toxicity or adverse effects to nontarget organisms 

with the exception of certain insects and honey bees (EPA, 2008). The Agency has concluded 

that the honey bee toxicity issue can be appropriately addressed thru end-use product label 

mitigation. 

On October 1, 2009, the U.S. Environmental Protection Agency (EPA or the Agency) announced 

a policy to provide a more meaningful opportunity for the public to participate in 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 uses; first outdoor uses; first residential uses; or any other 
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registration actions for which EPA believes there may be significant public interest. 

Consistent with the policy of making registration decisions more transparent, the public was 

provided 15 days in which to submit comments to the Agency regarding its pending decision to 

register products containing AITC for use as a pre-plant soil treatment. The following documents 

are available for comment in the docket, identification number EPA-HQ-OPP-2013-0658: a draft 

of this Biopesticides Registration Action Document (BRAD), the draft product labels for IR9804 

(EPA Reg. No. 89285-1) and IRF135 (EPA Reg. No. 89285-2), and the Agency science review 

memorandum for these products (EPA, 2013). The public participation comment period was 

open from September 11, 2013 – September 25, 2013. No comments were received during this 

period. 

Following the public participation comment period, the draft BRAD was updated to include 

additional information on AITC degredates and the draft product label for IRF135 (EPA Reg. 

No. 89285-2) was revised to include: 1) a five day entry restricted period, 2) directions on 

notification/sign posting before application, 3) clarification of methods to determine soil and 

weather conditions, and 4) a table of contents. 

It was determined that a fumigant management plan, as required for conventional pesticide soil 

fumigant, will not be required for IRF135 (EPA Reg. No. 89285-2). AITC is not a restricted use 

pesticide, and all hazards will be mitigated by the personal protective equipment, restricted entry 

period, and notification requirements included on the final version of the product label. 

Altogether, the Agency believes that, based on the existing information in the Agency’s database 

on AITC and the recent information submitted in support of the registration of pesticide products 

containing AITC for pre-plant soil treatment, it is in the best interest of the public to issue the 

registrations for IR9804 (EPA Reg. No. 89285-1) and IRF135 (EPA Reg. No. 89285-2). The 

basis for this decision can be found in the science review memorandums for these products 

(EPA, 2013a; EPA 2013b) and the existing information in the Agency’s database on AITC, all of 

which are characterized in this BRAD. 

For definitions of scientific terms, please refer to http://www.epa.gov/pesticides/glossary/. 
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II. ACTIVE INGREDIENT OVERVIEW 

Common Name: Oil of Mustard

Chemical Names: 1-Propene, 3-isothiocyanato- 

 2-Propenyl isothiochyanate 

 3-Isothiocyanato-1-propene 

 Allyl isosulfocyanate 

 Allyl isothiocyanate 

 Allyl mustard oil 

Trade & Other Names: Oil of Mustard 

 Allyl isothiocyanate (AITC) 

CAS Registry Number: 57-06-7 

OPP Chemical Code: 004901 

Type of Pesticide: Biochemical Pesticide – insect and animal repellent, 

feeding suppressant, insecticide, fungicide, herbicide and 

nematicide 

Biochemical Classification 

Oil of Mustard, containing the residue of concern AITC, was first approved by the Agency for 

use in a registered product as a biochemical insecticide in 1962. For more information regarding 

product chemistry data requirements, please refer to Tables 1 thru 4 in Appendix A for this 

document. 

III. REGULATORY BACKGROUND 

A. Application for Pesticide Registration 

On August 29, 2012, Technology Sciences Group, Inc., on behalf of Isagro USA, Inc. (hereafter 

referred to as “Isagro” or “applicant”), 430 Davis Drive, Suite 240, Morrisville, NC, 27560, 

submitted applications to register a new biochemical pesticide products, IR9804 (EPA Reg. No. 

89285-1) and IRF135 (EPA Reg. No. 89285-2), containing AITC as their active ingredient. 

IRF135 is intended for use as an insecticide, fungicide, herbicide and nematicide to be applied to 

be applied (1) by tractor mounted shank injection at a depth of 8 to 15 inches, followed by tarp 

overlay, (2) by drip injection, also covered by tarp overlay, and 3) by deep injection to depths 

greater than 17 inches, with no tarp covering. IR9804 is intended for formulation into end-use 

products for soil treatment. 
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B. Food Clearances/Tolerances 

AITC is exempt from the requirement of a tolerance as stated at 40 CFR § 180.1167: 

40 CFR § 180.1167 Allyl isothiocyanate as a component of food grade oil of mustard; exemption from 

the requirement of a tolerance. 

The insecticide and repellent Allyl isothiocyanate is exempt from the requirement of a tolerance for 

residues when used as a component of food grade oil of mustard, in or on all raw agricultural commodities, 

when applied according to approved labeling. 

 

The proposed end-use product, IRF135 (EPA Reg. No. 89285-2), is labeled for pre-plant soil 

application only. The active ingredient (synthetic AITC) and its degradates will dissipate prior to 

planting. The Agency considers this to be a non-food use and, therefore, a tolerance or 

exemption from the requirement of a tolerance is not required. 

IV. RISK ASSESSMENT 

A. Product Analysis Assessment (40 CFR § 158.2030) 

Biochemical pesticide product analysis data requirements include product chemistry and 

composition, analysis and certified limits, and physical and chemical characteristics. Product 

chemistry and composition data include information about the identity of the active ingredient, 

the manufacturing process, and discussion of the potential for formation of unintentional 

ingredients. Analysis and certified limits data include information on analysis of samples and 

certification of limits. Physical and chemical characteristics data describe basic characteristics of 

the registered pesticide products, including color, physical state, odor, stability, miscibility, pH, 

corrosion characteristics, viscosity and density. 

All product chemistry data requirements have been satisfied for the active ingredient (Oil of 

Mustard/AITC) and the proposed products, IR9804 (EPA Reg. No. 89285-1) and IRF135 (EPA 

Reg. No. 89285-2). Refer to Tables 1 thru 4 in Appendix A for a summary of product chemistry 

data specific to these products. Refer to the Vegetable and Flower Oil Summary Document for 

Registration Review (EPA, 2010) for a summary of product chemistry information for Oil of 

Mustard/AITC. 

B. Human Health Assessment 

1. Tier I Toxicology 

AITC has already been assessed by the Agency and the Agency has concluded that adequate 

mammalian toxicology data are available to support this biochemical pesticide (EPA, 1993; 

EPA, 2008; EPA 2010). In addition, adequate mammalian toxicology data and information are 

available to support registration of IR9804 (EPA Reg. No. 89285-1) and IRF135 (EPA Reg. No. 

89285-2). This information is summarized below and listed in Table 5 in Appendix A of this 

document. 
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Acute Toxicity for IR9804 (EPA Reg. No. 89285-1) and IRF135 (EPA Reg. No. 89285-2) 

(OCSPP Guideline Nos. 870.1100, 870.1200, 870.1300, 870.2400, 870.2500, and 870.2600; 

Master Record Identification (MRID) Nos. 488241-03 thru -07): 

The acute oral toxicity in rats for IF9804 (EPA Reg. No. 89285-1), containing 99.8% AITC, is 

LD50 = 425.4 mg/kg. Acute dermal toxicity (rat) is LD50 > 200 mg/kg, and acute inhalation 

toxicity (rat) is LC50 > 0.21 mg/L. Therefore, IR9804 (EPA Reg. No. 89285-1) is categorized as 

Toxicity Category II for acute oral toxicity, acute dermal toxicity, and acute inhalation toxicity. 

It is categorized as Toxicity Category I for primary eye irritation and primary dermal irritation 

due to its corrosivity, and is classified as a dermal sensitizer. No hypersensitivity incidents have 

been reported. 

Guideline studies for acute human health toxicity testing were not submitted for the EP, IRF135 

(EPA Reg. No. 89285-2). In lieu of Guideline studies, the applicant submitted a request to bridge 

the acute toxicity data submitted in support of the TGAI/MP (containing 99.8% AITC) to 

support the acute toxicity data requirements for the EP (containing 96.5% AITC). The Agency 

has determined this request to be acceptable based upon the substantial similar formulation 

between these two products. 

Subchronic Toxicity, Developmental Toxicity, and Mutagenicity Testing for IR9804 (EPA 

Reg. No. 89285-1) (Tier I) (OCSPP Guideline Nos. 870.3100, 870.3250, 870.3465; 870.3700, 

870.5100, 870.5300, 870.5375; MRID No. 48824108): 

A Guideline 90-day oral toxicity study was not submitted. In lieu of a study, the applicant cited a 

90-day oral toxicity study conducted by the National Toxicology Program (NTP, 1982) on 

F344/N rats dosed with 1.5 to 25 mg AITC/kg-body wgt/day, five days per week for 13 weeks 

which had a No Observed Adverse Effect Level (NOAEL) of 25 mg AITC/kg-body wgt/day, the 

highest level tested. No mortalities occurred during the course of the study and no treatmentrelated effects were observed on tissues obtained from the test animals when compared to nontreated controls. There were no differences in body weights between treated animals and nontreated controls (EPA, 2013a). 

A Guideline 90-day dermal toxicity study was not submitted. The applicant requested and was 

granted a waiver based on the fact that the product is not intended for application to human skin 

and prolonged or repeated dermal contact is not expected when EPs for pre-plant soil treatment 

are applied in accordance with Agency approved use directions and PPE (for handlers: coveralls 

worn over long sleeve shirt and long pants, chemical resistant footwear plus socks, chemical 

resistant gloves, protective eyewear, and an air purifying respirator). Similarly, a Guideline 90-

day inhalation toxicity study was not submitted. The applicant requested and was granted a 

waiver based on the fact that repeated inhalation exposure to AITC aerosol, vapor or gas is 

highly unlikely and not expected, when the EPs for pre-plant soil treatment is applied in 

accordance with EPA approved label use directions and PPE. 

A Guideline Prenatal Developmental Toxicity study was not submitted. In lieu of a study, the 

applicant cited a study in which AITC was one of 16 chemically-related compounds evaluated in 

order to correlate potential developmental toxicity with molecular structure. In this study, no 
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difference in the percentage of abnormal fetuses in AITC-treated offspring were detected 

compared to control, and no difference between treated and control in the percentage of dead 

fetuses was detected. The authors concluded that AITC did not display any teratogenic potential 

at the NOAEL of 60 mg/kg. The 60 mg/kg dose would be equivalent to 4.2 g AITC for a 

standard 70 kg human (EPA, 2013a). 

Guideline Mutagenicity studies were not submitted. In lieu of a study, the applicant cited a 

battery of mutagenicity studies on AITC conducted by the National Toxicology Program (NTP). 

In this battery, two reverse mutation studies confirmed that mutagenicity responses were 

negative in all strains tested with and without S9 activation. In three in vitro mammalian gene 

mutation studies, a negative response was observed in the first trial using mouse lymphoma cells 

without S9 activation at concentrations ranging from 0.05 to 0.8 mg/mL AITC. A second trial 

without S9 exhibited a significant increase in average mutant frequency and significant reduction 

in relative total growth at AITC concentrations of 0.4, 0.6, and 0.8 mg/mL; 1.0 mg/mL was 

cytotoxic. A third trial without S9 also exhibited a significant increase in average mutant 

frequency at concentrations of 0.6 to 1.4 mg/mL and a significant reduction in growth; a 

concentration of 1.6 mg/mL was cytotoxic. It is noted that the positive results were observed 

without S9 activation and in the presence of substantial cytotoxicity. An in vivo mammalian 

chromosome aberration study was conducted with mice dosed intraperitoneally with 0, 25, or 50 

mg/kg AITC and compared against mice dosed with a positive control, dimethylbenzanthracine 

(DMBA). Increases in chromosome aberrations were not observed in AITC treated mice when 

compared to non-treated (negative) controls, while a positive response was observed in DMBAtreated mice. The Agency has determined that the weight of evidence demonstrates that AITC is 

not likely to be a mutagen. In addition, the method of application and rapid degradation rate for 

the proposed pre-plant soil treatment, together with appropriate PPE, mitigates exposure to 

humans (EPA, 2013a). 

2. Tier II and Tier III Toxicity Studies 

The biochemical pesticide Human Health Assessment data requirements for Tier II and Tier III 

were not required due to the low toxicity of the active ingredient and the low levels of exposure 

expected from its intended uses in EP products. 

3. Effects on the Endocrine System 

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

 

Between October 2009 and February 2010, EPA issued test orders and data call-ins for the first 

group of 67 chemicals, which contains 58 pesticide active ingredients and nine 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. 

 

AITC (as contained in Oil of Mustard) is not among the group of 58 pesticide active ingredients 

on the initial list to be screened under the EDSP. Under FFDCA section 408(p), the Agency must 

screen all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP test orders and 

data call-ins for all pesticide active ingredients. 

 

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/. 

4. Dose Response Assessment 

No toxicological endpoints have been identified for Oil of Mustard or AITC; therefore, a doseresponse assessment was not required. 

5. Drinking Water Exposure and Risk Characterization 

No significant exposure from drinking water is expected when products containing Oil of 

Mustard or AITC are used according to the product label directions. AITC is a naturally 

occurring component of the human diet and degrades rapidly in the soil with a short half-life 

(T1⁄2) ranging from 20 to 60 hours. AITC transforms in sterilized soil at the same rate as intact 

soil, indicating that degredation is not dependent on soil microbial populations. Products 

containing AITC will not be directly applied to water. However, in an aqueous solution in the pH 

range between 6 and 8, AITC is proposed to degrade completely. Within this pH range, the 

primary decomposition products identified were: allyl thiocyanate (ATC); allylamine (AA); and 

carbon disulfide (CDS). ATC, an isomer of AITC, is expected to completely degrade in soil in 

approximately 4-5 days post application. The remaining two degradates, AA and CDS are 

expected to rapidly degrade by microbial activity in the soil in time frames that are much less 

than 5 days based on the weight of laboratory evidence. Should any amount of AITC or its 

degradates volatilize into the atmosphere, they will be rapidly diluted and degraded via reaction 

with photochemically produced hydroxyl radicals (EPA, 2013a; EPA, 2013b). 

6. Occupational, Residential, School and Day Care Exposure and Risk 

Characterization 

a. Occupational Exposure and Risk Characterization 

Occupational exposure to the proposed soil treatment EP, IRF135 (EPA Reg. No. 89285-2), is 

not expected due to mitigation through precautionary language and personal protective 
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equipment (PPE) on the label.For other products containing AITC, the Agency has required 

labels to include the appropriate signal word and precautionary statements, as PPE if applicable, 

to mitigate any risk of exposure. 

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

The proposed soil treatment EP, IRF135 (EPA Reg. No. 89285-2), is for agricultural use only. 

Previously approved AITC products for outdoor residential use have been approved by the 

Agency based on minimal exposure to AITC when used according to label directions. No indoor 

residential, school, or day care uses are currently approved for products containing AITC. 

7. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation 

There is reasonable certainty of no harm to U.S. populations, including infants and children, 

from aggregate exposures to residues of AITC when used as proposed. This includes all 

anticipated dietary exposures and all other exposures for which there is reliable information. 

Moreover, potential non-occupational inhalation and dermal exposure is not likely to pose any 

adverse effects to exposed populations via aggregate and cumulative exposure. 

a. Food Exposure 

Dietary exposure of AITC is already occurring, given that this substance can be found in many 

foods commonly consumed by humans such as cooked cabbage, kale, horseradish, and mustard. 

AITC is exempt from the requirement of a tolerance for residues when used as a component of 

food grade oil of mustard, in or on all raw agricultural commodities, when applied according to 

approved labeling. Furthermore, the proposed use of synthetic AITC as a pre-plant soil treatment 

will not result on residues on food as the AITC, and its degradates, will readily degrade prior to 

planting (EPA, 2013a). 

b. Drinking Water Exposure 

The proposed use of synthetic AITC as a pre-plant soil treatment will not result in water residues 

because this biochemical degrades rapidly in the soil with a short half-life (T1⁄2) ranging from 20 

to 60 hours. Products containing AITC will not be directly applied to water. However, in an 

aqueous solution in the pH range between 6 and 8, AITC is proposed to degrade completely. 

Therefore, drinking water exposure from the proposed used pattern is not expected to pose 

incremental risk to adults, infants and children via drinking water consumption. 

c. Other Non-occupational Exposure 

The proposed soil treatment EP, IRF135 (EPA Reg. No. 89285-2), is for agricultural use only. 

Previously approved AITC products for outdoor residential use have been approved by the 

Agency based on minimal exposure to AITC when used according to label directions. Other nonoccupational use is not expected for products containing this active ingredient. 
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8. Cumulative Effects from Substances with a Common Mechanism of Toxicity 

 

AITC has no demonstrated subchronic toxicity; thus, there is no reason to expect cumulative 

effects of exposure to Pear Ester and to other substances with common mechanism of toxicity. 

9. Determination of Safety for United States Population, Infants and Children 

AITC is exempt from the requirement of a tolerance for residues when used as a component of 

food grade oil of mustard, in or on all raw agricultural commodities, when applied according to 

approved labeling. Therefore, it is expected that no harm will result from aggregate exposure to 

the United States population, including infants and children, to the residues of AITC on food 

commodities. This includes all anticipated dietary exposures and all other exposures for which 

there is reliable information. Thus, there are not threshold effects of concern and consequently, 

provisions requiring additional margin of safety do not apply. Furthermore, the proposed use of 

synthetic AITC as a pre-plant soil treatment will not result on residues on food as the AITC, and 

its degradates, will readily degrade prior to planting (EPA, 2013a). 

10. Risk Characterization 

The Agency considered human exposure to AITC in light of the relevant safety factors in FQPA 

and 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 

products containing AITC when label instructions are followed. 

C. Environmental Assessment 

1. Ecological Hazards 

Oil of Mustard and AITC have already been assessed by the Agency and the Agency has 

concluded that adequate nontarget organism toxicology data and information are available to 

support these ingredients (EPA, 1993; EPA, 2008; EPA 2010). In addition, adequate nontarget 

organism toxicology data information were to support registration of IR9804 (EPA Reg. No. 

89285-1) and IRF135 (EPA Reg. No. 89285-2). This information is summarized in Table 6, in 

Appendix A of this document. 

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 

Exposure and risk from the registered and proposed (pre-plant soil treatment) uses of AITC are 

expected to be minimal for nontarget organisms, with the exception of honey bees (EPA, 2013a). 

Exposure to honey bees will be mitigated by appropriate label language on end-use products. 
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4. Endangered Species Assessment 

The Agency believes that Oil of Mustard and AITC will have “No Effect” on any currently listed 

threatened and endangered species, or any designated critical habitat, as listed by the U.S. Fish 

and Wildlife Service (USFWS) and the National Oceanic and Atmospheric Administration’s 

(NOAA) National Marine Fisheries Service (NMFS) (EPA, 2010). EPA anticipates conducting 

no further analysis of potential risks to endangered or threatened species unless public comments 

during the Registration Review process alter the Agency’s current position. The Registration 

Review for these active ingredients is ongoing as of the date of this document, September, 2013. 

D. Product Performance Data 

Product performance (efficacy) data must be developed for all pesticides to ensure that the 

products will perform as intended and that unnecessary pesticide exposure to the environment 

will not occur as a result of the use of ineffective products. The Agency reserves the right to 

require, on a case-by- case basis, the submission of efficacy data for any pesticide product 

registered or proposed for registration, but applications to register pesticide products intended to 

control a pest of significance public health importance, as defined in FIFRA section 28(d) and 

section 2(nn), must include such data. For further guidance on the product performance data 

requirement, refer to Pesticide Registration Notice (PR) Notices 96-7, 2002-1 and Explanation of 

Statutory Framework for Risk-Benefit Balancing for Public Health Pesticides 

(http://www.epa.gov/PR _Notices/pr1996-7.pdf) (http://www.ea.gov/PR_Notices/pr2002-1.pdf) 

and (http://www.epa.gov/pesticides/health/risk-benefit.htm). 

Oil of Mustard and AITC are not intended to be formulated into products to control public health 

pests as defined in FIFRA section 28(d) and section 2(nn), and product performance (efficacy) 

was not evaluated by the Agency. 

V. RISK MANAGEMENT DECISION 

A. Determination of Eligibility for Registration 

Section 3(c)(5) of FIFRA provides for pesticide product registration 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 eligibility criteria have been satisfied for the proposed pesticide products containing the 

active ingredient AITC (and for all previous registered pesticide products containing AITC and 

Oil of Mustard). 

B. Regulatory Decision 

The data submitted fulfill the requirements for the unconditional registration IR9804 (EPA Reg. 

No. 89285-1) as an MP to be formulated into soil treatment products and IRF135 (EPA Reg. No. 
Oil of Mustard and Allyl Isothiocyanate (AITC)

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89285-2) as an EP for pre-plant soil treatment. EPA is granting these unconditional registrations. 

For these product labels and for product-specific labels and information on other product 

containing Oil of Mustard and AITC, please refer to http://www.epa.gov/pesticides/pestlabels. 

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 products containing the active ingredients Oil of Mustard or AITC, or 

the use of AITC for pre-plant soil treatment will cause harm or a disproportionate impact on atrisk communities. For additional information regarding 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 AITC for pre-plant soil 

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

requirements. At this time, no additional data must be submitted to EPA for these particular 

products. For new uses and/or changes to existing uses, EPA may require additional data. 

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 

Under the provisions of 40 CFR Part 158.2050(d), all incidents of hypersensitivity (including 

both suspected and confirmed incidents) must be reported to the Agency. 

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

TABLE 1. Product Chemistry Data Requirements for IR9804 (99.8% AITC) (40 CFR § 158.2030) 

OPPTS 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. 

ACCEPTABLE 

48824101 

830.1700 Analysis of samples Submitted data satisfy the requirements 

for analysis of samples. 

ACCEPTABLE

48824102 

830.1750 Certification of limits Limits listed in the CSF are 

ACCEPTABLE

- 

830.1800 Analytical method ACCEPTABLE 48824102 
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TABLE 2. Physical and Chemical Properties of IR9804 (99.8% AITC) (40 CFR § 158.2030)

OPPTS Guideline 

No. 

Property Description of Result MRID 

830.6302 Color Colorless or pale yellow 

liquid 

48824101 

830.6303 Physical State Liquid 48824101 

830.6304 Odor Very pungent, irritating aroma 48824101 

830.6313 Stability to Normal and Elevated 

Temperatures, Metals and Metal Ions 

Reported stable. 48824101 

830.6315 Flammability Flashpoint = 46°C 48824101 

830.6317 Storage Stability Study in progress – 

anticipated completion date is 

the last quarter of 2013. 

48824101 

830.6319 Miscibility Not Applicable; TGAI/MP is 

not an emulsifiable liquid and 

is not diluted with petroleum 

solvents. 

- 

830.6320 Corrosion Characteristics Study in progress – 

anticipated completion date is 

the last quarter of 2013. 

48824101 

830.7000 pH 4-5 48824101 

830.7050 UV/Visible Light Absorption Refractive index 1.524-1.531; 

see 

http://www.fao.org/ag/agn/jef

ca-flav/img/img/1560.gif for 

the absorbance spectrum 

48824101 

830.7100 Viscosity Not Applicable for TGAI/MP - 

830.7200 Melting Point/Range -102.5°C 48824101 

830.7220 Boiling Point/Range 150-151°C; 148-154°C 48824101 

830.7300 Density 1.013-1.020; 1.0 48824101 

830.7520 Particle Size, Fiber Length and 

Diameter Distribution 

Not Applicable; TGAI/MP is 

not fibrous 

- 

830.7550 

830.7560 

830.7570 

Partition Coefficient 

 (n-Octanol/Water) Log P = 2.11 

48824101 

830.7840 Water Solubility Slightly soluble in water 48824101 

830.7950 Vapor Pressure 1.33 kPa @ 38.3°C 

0.493 kPa@ 20°C 

48824101 
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TABLE 3. Product Chemistry Data Requirements for IRF135 (96.3% AITC) (40 CFR § 158.2030) 

OPPTS Guideline No. Study Results MRID 

Method/Reference 

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. 

ACCEPTABLE

489194-01 

830.1700 Analysis of samples Not required for EP 489194-02 

830.1750 Certification of limits Limits listed in the CSF are 

ACCEPTABLE

489194-01 

830.1800 Analytical method Not required for EP 489194-02 

 
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TABLE 4. Physical and Chemical Properties of IRF135 (96.3% AITC) (40 CFR § 158.2030)

OPPTS Guideline 

No. 

Property Description of Result MRID 

830.6302 Color Not applicable per 40 CFR 

158.2030(e) – Product is an EP.

- 

830.6303 Physical State Liquid 489194-01 

830.6304 Odor Not applicable per 40 CFR 

158.2030(e) – Product is an EP. - 

830.6313 Stability to Normal and Elevated 

Temperatures, Metals and Metal Ions 

Not applicable per 40 CFR 

158.2030(e) – Product is an EP. - 

830.6315 Flammability (flashpoint) 47oC 489194-02 

830.6317 Storage Stability Study in progress–

anticipated completion 

date is the last quarter of 

2013.

489194-01

830.6319 Miscibility Not applicable per 40 CFR 

158.2030(e)(10) – EP is not 

an emulsifiable liquid and is 

not to be diluted with 

petroleum solvents.

- 

830.6320 Corrosion Characteristics Study in progress– 

anticipated completion 

date is the last quarter 

of 2013. 

489194-01 

830.7000 pH 4.87 (1% soln) 489194-02 

830.7050 UV/Visible Light Absorption Not applicable per 40 CFR 

158.2030(e) – Product is an 

EP.

- 

830.7100 Viscosity 0.6 centistokes @ 40°C 

0.8 centistokes @ 20°C 

489194-02 

830.7200 Melting Point/Range Not applicable per 40 CFR 

158.2030(e) – Product is an 

EP.

- 

830.7220 Boiling Point/Range Not applicable per 40 CFR 

158.2030(e) – Product is an 

EP.

- 

830.7300 Density 1.019 g/mL @ 20°C 489194-02 

830.7520 Particle Size, Fiber Length and 

Diameter Distribution 

Not applicable per 40 CFR 

158.2030(e) – Product is an 

EP.

- 

830.7550 

830.7560 

830.7570 

Partition Coefficient (nOctanol/Water) 

Not applicable per 40 CFR 

158.2030(e) – Product is an 

EP. 

- 

830.7840 Water Solubility Not applicable per 40 CFR 

158.2030(e) – Product is an 

EP.

- 

830.7950 Vapor Pressure Not applicable per 40 CFR 

158.2030(e) – Product is an 

EP.

- 
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Table 5. Mammalian Toxicology Data Requirements for IR9804 (EPA Reg. No. 89285-1) (40 CFR § 158.2050)

Study/OPPTS Guideline No. Results Toxicity 

Category/Description 

MRID 

Acute oral toxicity (rat) 

(870.1100) 

LD50 = 425.4 mg/kg 

ACCEPTABLE 

II 488241-03 

Acute dermal toxicity (rat) 

(870.1200) 

LD50 > 200 mg/kg 

ACCEPTABLE 

II 488241-04 

Acute inhalation toxicity (rat) 

(870.1300) 

LC50 > 0.21 mg/L 

ACCEPTABLE 

II 488241-05 

Primary eye irritation (rabbit) 

(870.2400) 

Waiver due to observed corrosiveness on skin 

ACCEPTABLE 

I 1 

Primary dermal irritation (rabbit) 

(870.2500) 

Corrosive 

ACCEPTABLE 

I 488241-06 

Dermal sensitization (guinea pig) 

(870.2600) 

Sensitizer 

ACCEPTABLE 

- 488241-07 

Hypersensitivity incidents 

(885.3400) 

- - - 

90-Day oral toxicity 

(870.3100) 

Rationale submitted 

ACCEPTABLE

 488241-08 

90-Day dermal toxicity 

(870.3250) 

Rationale submitted 

ACCEPTABLE

 488241-08 

90-Day inhalation toxicity 

(870.3465) 

Rationale submitted 

ACCEPTABLE

 488241-08 

Mutagenicity 

(870.5100, 5300 and 5375) 

Rationale submitted 

ACCEPTABLE

 488241-08 

Developmental toxicity 

 (870.3700) 

Rationale submitted 

ACCEPTABLE

 488241-08 

Table 6. Non-Target Organism Data Requirements for IR9804 (EPA Reg. No. 89285-1) (40 CFR § 158.2060)

Study/OPPTS Guideline No. Results Toxicity Category/Description MRID 

Avian Acute Oral/OPPTS 

850.2100 

Rationale submitted 

ACCEPTABLE 

No acute oral exposure based 

on application method and 

rapid environmental 

degradation 

48824108, p. 18 

Avian Dietary/OPPTS 850.2200 

Rationale submitted 

ACCEPTABLE 

No dietary exposure based on 

application method and rapid 

environmental degradation 

48824108, p. 20 

Freshwater Fish LC50/OPPTS 

850.1075 

Rationale submitted 

96-hr LC50 = 0.077 ppm 

ACCEPTABLE 

Very Highly Toxic, but no 

aquatic exposure based on 

application method and rapid 

environmental degradation 

48824108, pp. 22, 

37-47 

Freshwater Invertebrate/OPPTS 

850.1010 

Rationale submitted 

48-hr EC50 = 0.73 ppm 

ACCEPTABLE 

Very Highly Toxic, but no 

aquatic exposure based on 

application method and rapid 

environmental degradation 

48824108, pp. 23, 

216-221 

Non-target Plants/OPPTS 

850.4100 & 4150 

Rationale submitted 

ACCEPTABLE 

No non-target exposure based 

on application method and 

rapid environmental 

degradation 

48824108, pp. 24-

27 

Non-target Insects Rationale submitted

ACCEPTABLE 

No non-target exposure based 

on application method and 

rapid environmental 

degradation 

48824108, pp. 28, 

29 
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VIII. Appendix B. References 

1. U.S. EPA, 1993. Registration Eligibility Decision (RED). Flower and Vegetable Oils. Office 

of Pesticide Programs. U.S. Environmental Protection Agency (U.S. EPA). December 1, 

1993. Available at: 

http://www.epa.gov/opp00001/chem_search/reg_actions/reregistration/red_G-114_01-Dec93.pdf

2. U.S. EPA, 2008. Oriental Mustard Seed (PC Code 014921). Biopesticides Registration 

Action Document. Office of Pesticide Programs. U.S. Environmental Protection Agency 

(U.S. EPA). December 17, 2008. Available at: 

http://www.epa.gov/pesticides/chem_search/reg_actions/registration/decision_PC014921_17-Dec-08.pdf

3. U.S EPA, 2010. Vegetable and Flower Oils Summary Document. Registration Review: 

Initial Docket. Office of Pesticide Programs. U.S. Environmental Protection Agency (U.S. 

EPA). March 29, 2010. Available at: 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPP-2009-0904-0005

4. U.S. EPA, 2013a. Memorandum from Russell Jones, Ph.D. to Gina Burnett. Science Review 

in Support of the Registration of the TGAI/MP IR9804 and the EP, IRF 135, Respectively 

Containing 99.8% and 96.3% Allyl Isothiocyanate (AITC) As Their Active Ingredient. The 

TGAI/MP is an unregistered source of the active ingredient. Office of Pesticide Programs. 

U.S. Environmental Protection Agency (U.S. EPA). May 15, 2013. 

5. U.S EPA, 2013b. Memorandum from Russell Jones, Ph.D. to Gina Burnett. Revised Science 

Review in Support of the Registration of the TGAI/MP IR9804 and the EP, IRF 135, 

Respectively Containing 99.8% and 96.3% Allyl Isothiocyanate (AITC) As Their Active 

Ingredient. The TGAI/MP is an unregistered source of the active ingredient. Environmental 

Fate Addendum. Office of Pesticide Programs. U.S. Environmental Protection Agency (U.S. 

EPA). September 18, 2013. 

 
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IX. 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 

cm3 cubic 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 

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 
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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