BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Oil of Mustard and 

Ally Isothiocyanate (ATIC)

PC Code: 004901

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

(last updated September 11, 2013)
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

2

Table of Contents

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

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

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

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

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

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

A. Product Analysis Assessment (40 CFR § 158.2030).......................................................... 7

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

5. Drinking Water Exposure and Risk Characterization ............................................................................10

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...............................................11

7. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation...........................11

a. Food Exposure .............................................................................................................................................11

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

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

8. Cumulative Effects from Substances with a Common Mechanism of Toxicity .....................................12

9. Determination of Safety for United States Population, Infants and Children .......................................12

10. Risk Characterization .................................................................................................................................12

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

D. Product Performance Data ............................................................................................... 13

V. RISK MANAGEMENT DECISION................................................................................. 14
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

3

A. Determination of Eligibility for Registration .................................................................. 14

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

C. Environmental Justice ....................................................................................................... 14

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

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
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

4

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.
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

5

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. 

Currently, pesticide product (MP), IR9804 (EPA File Symbol No. 89285-R) and end-use product 

(EP), IRF135 (EPA File Symbol 89285-E), are proposed to be registered. 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. 

IR9804 is intended for formulation into end-use products for soil treatment. The currently

proposed label application methods are for pre-plant 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 File Symbol No. 89285-R) and IRF135 (EPA File Symbol 89285-E) (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 
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

6

registration actions for which EPA believes there may be significant public interest. 

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

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 File Symbol 89285-R) and IRF135 (EPA File Symbol 89285-E), and the Agency science 

review memorandum for these products (EPA, 2013). Note: The draft EP label will be revised, 

during this period, to include additional mitigation measures in accordance with those seen 

for similar application methods (soil fumigants) but as appropriate for this biopesticide.

Intended revisions will include (1) an entry restricted period section on the label, (2) a 

fumigant management plan section, (3) clarification of restrictions for workers verses 

handlers, and (4) clarification of methods to determine soil and weather conditions. 

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 File Symbol 89285-R) and IRF135 (EPA File Symbol 89285-E). 

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

(EPA, 2013) and the existing information in the Agency’s database on AITC, both of which are 

characterized in this BRAD. 

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

II. ACTIVE INGREDIENT OVERVIEW

Common Name: Oil of Mustard

Chemical Names: 1-Propene, 3-isothiocyanato2-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
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

7

Biochemical Classification

Oil of Mustard, containing the residue of conern 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 File 

Symbol 89285-R) and IRF135 (EPA File Symbol 89285-E), 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.

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 File Symbol 89285-E), 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 
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

8

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 File Symbol 89285-R) and IRF135 

(EPA File Symbol 89285-E). 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 File Symbol No. 89285-R) and IRF135 (EPA 

File Symbol 89285-E). This information is summarized below and listed in Table 5 in Appendix 

A of this document.

Acute Toxicity for IR9804 (EPA File Symbol 89285-R) and IRF135 (EPA File Symbol 

89285-E) (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 File Symbol 89285-R), 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 File Symbol 89285-R) 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 File Symbol 89285-E). 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 

File Symbol No. 89285-R) (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 
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

9

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, 2013). 

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

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, 2013). 

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 
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

10

humans (EPA, 2013).

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 

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 
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

11

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, was identified at each pH and sampling 

interval; AA is expected to biodegrade quickly in the environment, and so if it is formed 

following AITC treatment of soil, human and animal exposure is unlikely. CDS is naturally

occurring in the environment, and is released from tree roots, tidal marshes and soil. CDS is 

considered ubiquitous in the environment, and so formation of carbon disulfide from treating soil 

with AITC would not increase exposure to non-target organisms over levels currently in the 

environment (EPA, 2013).

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 File Symbol 89285-E), 

is not expected due to mitigation through precautionary language and personal protective 

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 File Symbol 89285-E), 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 
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

12

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, 2013). 

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 File Symbol 89285-E), 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. 

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, 2013).

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. 
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

13

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 File Symbol 

No. 89285-R) and IRF135 (EPA File Symbol 89285-E). 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, 2013). 

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

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 Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

14

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 File 

Symbol No. 89285-R) as an MP to be formulated into soil treatment products and IRF135 (EPA 

File Symbol 89285-E) as an EP for pre-plant soil treatment. 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 
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

15

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.
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

16

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
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

17

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
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

18

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
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

19

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.

-
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

20

Table 5. Mammalian Toxicology Data Requirements for IR9804 (EPA File Symbol 89285-R) (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 File Symbol 89285-R) (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
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

21

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, 2013. Memorandum from Russel 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. 
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

22

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

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

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
Oil of Mustard and Allyl Isothiocyanate (AITC)

PC Code 004901

Biopesticides Registration Action Document

23

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