i

EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [Kable Bo Davis (PM-25) 703-306-0415]

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In 

cases where the outline element does not apply, please insert “NA-Remove” and 

maintain the outline. Please do not change the margins, font, or format in your 

pesticide petition. Simply replace the instructions that appear in green, i.e., “[insert 

company name],” with the information specific to your action.

TEMPLATE:

[BASF Corporation]

[Insert petition number]

EPA has received a pesticide petition ([insert petition number]) from [BASF 

Corporation], [26 Davis Drive, P.O. Box 13528, Research Triangle Park, North Carolina 

27709-3528] requesting, pursuant to section 408(d) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180

(Options (pick one)

1. by establishing a tolerance for residues of

[Quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid] in or on the raw 

agricultural commodity [canola] at [1.0] parts per million (ppm). No tolerances are 

proposed for the processed commodities, meal and refined oil, as no concentration of 

quinclorac residues is expected in these commodities. EPA has determined that the 

petition contains data or information regarding the elements set forth in section 408 (d)(2) 

of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data 

at this time or whether the data supports granting of the petition. Additional data may be 

needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism.

[Plant and livestock metabolism studies previously submitted for quinclorac are cited in 

support of this import tolerance petition for quinclorac on canola. A nature of the residue 

in canola included in this submission is summarized here.

Radiolabeled quinclorac was applied to canola plants 30 days after sowing at growth 

stage ES 15 at a targeted application rate of 0.178 lb a.i./A (200 g a.i./ha). The actual 
2

application rate was 0.16 lb a.i./A (181 g a.i./ha), about 1.8 times the maximum seasonal 

application rate. Green plants were sampled pre-treatment and at 1 day and 29 days after 

treatment (DAT). Seed and straw were harvested at 60 DAT, consistent with the 

proposed 60 day pre-harvest interval. The total radioactive residue (TRR) in seed was 

0.475 mg/kg. The samples were extracted with acetone:pH 7 phosphate buffer (1:1 v/v) 

followed by 0.1 N NaOH at ambient temperature and 0.1 N NaOH at 100°C. TRR 

extracted from the seed and straw was 96% and 88%, respectively. The non-extractable 

residues represented 2.7% and 12.2% of the TRR, respectively. Based on analysis of the 

seed extract by HPLC with radiometric detection, the main radioactive residues in the 

seed were quinclorac ((37.1% TRR, 0.176 ppm) and the methyl ester, BH 514-ME 

(37.1% TRR, 0.176 ppm). No other residue >5% TRR was observed.

To remain consistent with the current residue definition for quinclorac of parent only in 

the commodities of wheat, rice, sorghum and barley, the proposed tolerances in canola 

seed are based on the residues of parent quinclorac in canola seed. ]

2. Analytical method. [An adequate analytical method for enforcement of the 

tolerances exists. The analytical method used for quantitative determinations was 

designed to measure quinclorac residues present as the parent compound.]

3. Magnitude of residues. [Magnitude of the Residue - Raw Agricultural 

Commodities: Canola field trials are predominately from Canadian sites and were 

conducted using rates and timing intervals to represent the use patterns, conditions and 

areas of use for this product in Canada. These studies should be adequate to establish an 

import tolerance for canola seed at the proposed 1.0 ppm level based on parent only. 

Results from 19 field trials support the proposal that parent quinclorac can be used to 

monitor the safe use of ACCORD Herbicide in canola. The tolerance proposed was 

determined using the OECD calculator.

Based on the results of a processing study, residues of quinclorac do not concentrate in 

meal or refined oil. 

The use in canola does not result in a maximum reasonable feed burden for cattle, poultry

or swine in excess of that already determined for registered uses. No additional data were 

needed in support of residues in meat, milk, poultry and eggs.]

B. Toxicological Profile

1. Acute toxicity. [Based on available acute toxicity data quinclorac does not pose 

any acute toxicity risks. Several acute toxicology studies place technical-grade quinclorac 

in Toxicity Category III for acute oral, acute dermal, acute inhalation toxicity, and for eye 

irritation. Technical-grade quinclorac is in category IV for primary dermal irritation and 

is a skin sensitizer. The soluble liquid end use formulation of quinclorac (ACCORD SL) 

that is pending registration in Canada (registered as Paramount, Facet L, and Drive XLR8 

in US) has tested negative for skin sensitization.]

2. Genotoxicity. [Quinclorac was tested for its genotoxic potential in a battery of 
3

six in vitro or in vivo studies covering the required endpoints of point mutations, 

chromosomal damage and DNA damage and repair. Quinclorac did not demonstrate any 

genotoxic effects. Quinclorac was negative for inducing mutations in both an in vitro

Ames test and an in vitro forward mutation assay in mammalian cells (HGPRT test with 

and without metabolic activation). Both an in vitro and an in vivo chromosome 

aberration assay (with and without metabolic activation) showed no evidence of a 

clastogenic effect. Unscheduled DNA synthesis was not induced in the UDS assay. A 

mutagenicity evaluation with Bacillus subtilis (with and without metabolic activation)

was also negative. These studies demonstrate that Quinclorac is not genotoxic.]

3. Reproductive and developmental toxicity. [Teratology - Rats: A developmental 

study in rats fed dosages of 0, 24.4, 146, and 438 mg/kg/day (HDT) resulted in a 

developmental toxicity NOEL of 438 mg/kg/day and a maternal toxicity NOEL of 146 

mg/kg/day based on reduced food consumption, increased water intake, and mortality at 

438 mg/kg/day (HDT). Under the conditions of this study, quinclorac did not produce 

any sign of embryo/fetal toxicity and did not alter fetal morphological development. 

Teratology - Rabbits: A developmental study in rabbits fed dosages of 0, 70, 200, and 

600 mg/kg/day resulted in a developmental toxicity NOEL of 200 mg/kg/day based on an 

increase in resorptions and postimplantation loss; a decrease in the number of live fetuses 

and decreased fetal body weights at the 600 mg/kg/day dose level (HDT). At all other 

treatment levels no embryo/fetal toxicity was observed. The maternal toxicity NOEL is 

70 mg/kg/day based on decreased body weight gain and food consumption at 200 

mg/kg/day; and increased water consumption, increased mortality, and discoloration of 

the kidney at 600 mg/kg/day. 

Two-Generation Reproduction - Rats: [A two-generation reproduction study was 

conducted with rats dosed 0, 50, 200, and 600 mg/kg/day. The parental toxicity NOAEL 

is 200 mg/kg/day. The parental LOAEL is 600 mg/kg/day, based on reduced body

weight in both sexes during premating and lactating periods. The reproductive toxicity

NOAEL is equal to or greater than 600 mg/kg/day. The developmental toxicity NOAEL 

is 200 mg/kg/day. The developmental toxicity LOAEL is 600 mg/kg/day, based on 

decreased pup weight and viability, as well as developmental delays.]

4. Subchronic toxicity. [A 13-week feeding study in mice was conducted at 

doses of 0, 4,000, 8,000, or 16,000 ppm; equivalent to 0, 1,000, 2,202 or 4,555 mg/kg/day

for males and 0, 1,467, 2,735 or 5,953 mg/kg/day for females. The lowest observed 

adverse effect level (LOAEL) is 1,000 mg/kg/day for males and 1,467 mg/kg/day for 

females based on decreased body weight gains in males and females (17.6 and 18.7%, 

respectively).

A 13-week feeding study in mice was conducted at doses of 0 and 500 ppm (equivalent to 

0 and 75 mg/kg/ day). The NOAEL is 75 mg/kg/day.

A 3-month feeding study in rats was conducted at doses of 0, 1000, 4000, or 12000 ppm 

(0, 76.8, 302.3 or 929.9 mg/kg/day in males and 0, 86.7, 358, or 1,035.4 mg/kg/day in 

females). The NOAEL is 302 mg/kg/day (male); 358 mg/kg/day (female). The LOAEL is 
4

930 mg/kg/day (male); 1035 mg/kg/day (female) based on decreased body weight gain, 

food consumption, and increased water intake in males and females, increased SGOT, 

SGPT and focal chronic interstitial nephritis in males.]

5. Chronic toxicity. [Chronic Feeding - Nonrodent: A 1-year feeding study in 

dogs fed 0, 34, 142, and 513 (males) and 0, 35, 140, and 469 (females) 

milligrams/kilogram/day (mg/kg/day) resulted in a no-observed-effect level (NOEL) of 

140 mg/kg/day based on reduced body weight gains, adverse effect on food efficiency, 

hematological and clinical chemistry values, increased liver and kidney weights, and 

microscopic findings in liver and kidneys at 513 mg/kg/day (males) and 469 mg/kg/day

(females), the highest dosages tested (HDT).

Chronic Feeding/Oncogenicity - Rats: A chronic feeding/carcinogenicity study in rats 

fed dosages of 1, 56, 186, 385, and 487 mg/kg/day (males) and 0, 60, 235, 478, and 757 

mg/kg/day (females) resulted in a NOEL of 385 mg/kg/day (males) and 478 mg/kg/day

(females) based on an equivocal (uncertain) increase in acinar cell hyperplasia of the 

pancreas in males at 487 mg/kg/day (HDT) and a slight decreases in weight for females 

at 757 mg/kg/day (HDT). No carcinogenic effect was observed in rats.

Oncogenicity - Mice: A carcinogenic study in mice fed dosages of 0, 37.5, 150, 600, and 

1200 mg/kg/day resulted in no carcinogenic effects observed under the conditions of the 

study up to and including 1200 mg/kg/day (HDT) and a systemic NOEL of 37.5 

mg/kg/day based on a reduction of body weight at 150 mg/kg/day.]

6. Animal metabolism. [A metabolism study with rats receiving dosages of 15, 

100, 600 and 1200 mg/kg/day resulted in more than 90% of the administered 

radioactivity eliminated in the urine within 5 days (most within 24 hours) and 0.7%–3.7% 

in the feces. Radioactivity was mainly associated with the unchanged parent compound. 

The glucuronic acid conjugate of quinclorac was a minor (2%–5%) metabolite in urine.]

7. Metabolite toxicology. [Reg. No. 161555 (the methyl ester metabolite of 

Quinclorac found in plant) was studied in animal metabolism and pharmacokinetic 

studies as well as toxicology studies. 

Male bile catherterized Wistar rats received a single oral dose of 15 or 600 mg/kg bw. 

About 83% of dosed material was absorbed, rapidly metabolized and excreted via urine, 

bile and feces. Less than 1% of the dosed radioactivity remaining in the carcass after 72 

hours. The the primary metabolite was found in urine and identified as quinclorac (at 

46.71% and 15.34% of the dose for the low and high dose respectively). The unchanged 

Reg. No. 16155 was only found in in the feces (0.45% and 12.45% of the dose for the 

low and high dose respectively). The remaining characterized and identified residues 

were minor, none amounting to more than 10% of the applied dose.

An acute oral toxicity study was conducted with rats given a single oral gavage dose of 

Reg. No. 161555 at a dose level of 2000 mg/kg bw. With no resulting mortality, the oral 

LD50 was found to be greater than 2000 mg/kg bw.
5

A 90D feeding study was conducted in rats with Reg. No. 161555 at dose levels of 0, 

2000, 4000 and 8000 ppm (equal to 0, 128, 252, and 518 mg/kg bw/d for males and 0, 

145, 274 and 509 mg/kg bw/d for females). Treatment resulted in a no-observedadverse-effect level (NOAEL) of 2000 ppm for male (128 mg/kg bw/d) and 4000 ppm for 

female Wistar rats (274 mg/kg bw/d) based upon impaired body weight gain and effects 

observed in the liver and thyroid target organs.]

8. Endocrine disruption. [No specific scientific studies were conducted to 

determine endocrine effects. However, the toxicity testing described above and 

conducted on three different animal species demonstrates no apparent estrogenic effects 

or treatment-related effects of quinclorac on the endocrine system.]

C. Aggregate Exposure

1. Dietary exposure. [A dietary exposure assessment was conducted to evaluate 

the potential risk from exposure to quinclorac in food and drinking water. The exposure 

assessment was conducted using all currently established tolerances and the proposed 

new import tolerance for canola. ]

i. Food. [Acute Dietary Exposure Assessment: The US EPA has determined 

that an acute dietary assessment for quinclorac is only required for females ages 13–49. 

The exposure was calculated using tolerance level residues, 100% crop treatment factors, 

and default processing factors. The consumption data was from the USDA Continuing 

Survey of Food Intake by Individuals (CSFII 1994–1996, 1998) and the EPA Food 

Commodity Ingredient Database (FCID) using Exponent's Dietary Exposure Evaluation 

Module (DEEM-FCID) software. 

The acute NOAEL is 200 mg/kg bw/day and the FQPA safety factor is 1. The resulting 

acute Population Adjusted Dose (aPAD) is 2.0 mg/kg bw/day. The results from the acute 

assessment showed that the food and water exposure represents less than 1% of the 

aPAD.

Chronic Dietary Exposure Assessment: The exposure was calculated using tolerance 

level residues, 100% crop treatment factors, and default processing factors. The 

consumption data was from the USDA Continuing Survey of Food Intake by Individuals 

(CSFII 1994–1996, 1998) and the EPA Food Commodity Ingredient Database (FCID) 

using Exponent's Dietary Exposure Evaluation Module (DEEM-FCID) software. 

The chronic NOAEL is 37.5 mg/kg bw/day and the FQPA safety factor is 1. The 

resulting chronic Population Adjusted Dose (cPAD) is 0.375 mg/kg bw/day. The results 

from the chronic assessment showed that children ages 1–2 years old were the most 

highly exposed sub-population. The food and water exposure utilized 3.1% of the 

cPAD. Table 1 below shows the chronic exposure for all sub-populations. 
6

Table 1. Results for Quinclorac (BAS 514 H) Chronic Dietary Exposure 

Analysis Considering all Tolerances using DEEM-FCID (food and water)

Population Exposure Estimate %cPAD

Subgroups (mg/kg b.w./day)

U.S. Population 0.0054 1.44

All Infants (< 1 year old) 0.0099 2.65

Children (1-2 years old) 0.0117 3.13

Children (3-5 years old) 0.0100 2.68

Children (6-12 years old) 0.0066 1.75

Youth (13-19 years old) 0.0044 1.16

Adults (20-49 years old) 0.0050 1.32

Adults (50+ years old) 0.0042 1.13

Females (13-49 years old) 0.0043 1.16

]

ii. Drinking water. [The proposed import tolerances for canola will not result in 

water exposure. The use with the highest estimated drinking water concentration is a 

section 18 use on cranberry. The modeled acute and chronic surface water concentrations 

are 77 ug/L and 70 ug/L, respectively. These drinking water values were included in the 

acute and chronic dietary exposure assessment. The acute water exposure for females 

ages 13–49 utilized 0.19% aPAD. The chronic water exposure for the most highly

exposed population sub-group, all infants, utilized 1.3% cPAD.]

2. Non-dietary exposure. [Quinclorac is currently registered for use in turf. 

However, the US EPA has not selected a dermal endpoint for quinclorac because no 

dermal toxicity was observed at the limit dose of 1000 mg/kg bw/day in the 21-day

dermal toxicity study. Therefore, a dermal exposure assessment is not required. For the 

turf use, an oral exposure from hand-to-mouth and object-to-mouth for toddlers is 

required. The oral short- and intermediate-term NOAEL is 70 mg/kg bw/day. The 

toddler oral exposure and resulting MOE values from the use of quinclorac on turf is 

shown in Table 2 below. 

Table 2. Residential Exposure and Risk Estimates for Post-Application Incidental Oral

Exposure of Toddlers to Quinclorac on Turf. 

Scenario

Expsoure 

mg/kg bw/day

Short- and 

Intermediate - Term 

MOE

Hand-to-mouth 0.011 6364

Object-to-mouth 0.0028 25000

Total 0.0138 5072

Acute Aggregate Exposure (Food and Drinking Water)

The aggregate acute risk includes residues of quinclorac from food and water. Exposures 
7

from residential uses are not included in the acute aggregate assessment. The results 

demonstrate that there are no safety concerns for any subpopulation based on established 

and new uses, and that the results clearly meet the FQPA standard of reasonable certainty 

of no harm.

Short- and Intermediate-Term Aggregate Exposure and Risk (food, water, and 

residential)

Short-term aggregate risk from quinclorac takes into account exposures from dietary

consumption (food and water) and residential exposure from turf use. Short- and 

intermediate-term aggregate risk assessment is not required for adults because there is no 

dermal exposure assessment required. The aggregate MOE from food, water, and 

residential oral exposure for children 1–2 years old is 2700. This MOE is greater than the 

target MOE of 100 which indicates there is no safety concern. 

Chronic Aggregate Exposure and Risk (food and water)

The aggregate chronic risk includes residues of quinclorac from food and water.

Exposures from residential uses are not included in the chronic aggregate assessment. 

The results demonstrate there are no safety concerns for any subpopulation based on 

established and new uses, and that the results clearly meet the FQPA standard of 

reasonable certainty of no harm.]

D. Cumulative Effects

[BASF is not aware of any other EPA registered active ingredient that is 

structurally similar to quinclorac or has a common mechanism of toxicity.]

E. Safety Determination

1. U.S. population. [Based on this risk assessment, BASF concludes that there is a 

reasonable certainty that no harm will result to the general population from the aggregate 

exposure to quinclorac.]

2. Infants and children. [Based on this risk assessment, BASF concludes that 

there is a reasonable certainty that no harm will result to infants or children from the 

aggregate exposure to quinclorac.]

F. International Tolerances

[There are no CODEX or Mexican maximum residue limits established for 

quinclorac on canola.]