EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [ P.V. Shah, 703

- 308

- 1846 ]

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 re place the instructions that appear in green , i.e., “ [ insert
company name ] ,” with the information specific to your action.

TEMPLATE:

[ Lighthouse Product Services on behalf of Winfield Solutions, LLC ]

[Insert petition number]

EPA has received a pesticide petition ( [insert petition number] ) from Lighthouse Product Services, 3937 Cedarwood Lane, Johnstown, Colorado 80534 on behalf of Winfield Solutions, LLC , 1080 County Road F West, Shoreview, Minnesota 55126

- 2910 proposing, 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. 920 to establish an exemption from the requirement of a tolerance for Kerosene/Fuel Oil #1, CAS #8008

- 20

- 6 or 64742

- 81

- 0

. EPA has determined that the p etition 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. [NA

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2. Analytical method. Because this petition is a request for an exemption from the requirement of a tolerance without numerical limitations, no analytical method is required.

3. Magnitude of residues. No specific crop residue information has been located for Kerosene/Fuel Oil #1 and this information is typically not available or required for the establishment of a tolerance exe mption for inert ingredients.

B. Toxicological Profile

a. Acute toxicity. Kerosene is a Toxicity Category III substance for acute oral, dermal, and inhalation toxicity and eye irritation

.2

2. Genotoxicty. In the only in vivo animal study located regarding genotoxic effects using inhalation as the route of exposure, male CD

- l mice (12/group) exposed to 100 or 400 ppm diesel fuel vapor (6 hours/day, 5 days/week, for 8 weeks) showed no adverse effects with respect to the frequen cy of domi nant lethal mutations

.

3. Reproductive and developmental toxicity. Oral Significant decreases in fetal body weight compared to controls were found

a f ter pregnant rats were treated orally during gestational days 6

- 15

. Der m al No der m al developmental or reproductive studies on kerosene were identified. There were no pathological changes in the reproductive organs of mice following chronic and/or intermediate dermal exposures to JP

- 5.

4. Subchronic toxicity. Oral Male Sprague

- Dawley rats were treated with 0, 750, 1,500 and 3,000 mg/kg/day of neat JP

- 8 by gavage for 90 days. A no

- observed

- adverse

- effect level (NOAEL) was not established with stomach irritation and decreased lymphocytes noted at doses of 750 mg/kg/day

. Dermal A 28

- day dermal toxicity study was conducted with New Zealand white rabbits i n which undiluted kerosene was applied dermally at 0, 200, 1000, and 2000 mg/kg/day. The LOAEL was 200 mg/kg/day based on skin irritation in males and females, decreased red blood cell count i n males and increased absolute and relative spleen weight in females. A NOAEL was not established. A 90

- day dermal toxicity study was conducted in which kerosene was dermally applied to Sprague

- Dawley rats In concentrations of 20%, 40% or 60% v/v at a rate o f 1 mL/kg/day which is equivalent to doses of 0, 165, 330, and 465 mg/kg/day. There were no test substance

- related effects on survival, clinical observations (apart from skin Irritation), neurobehavioral signs, or ophthalmological findings. The only clinic al observations were related to skin irritation at the application site. There was a dose

- related increase in the incidence and severity of erythema, edema, epidermal scaling, scab formation, thickening of the skin, and ulceration at the treated site. At necropsy, the only substance

- related observations made were the suggestion of a possible
treatment

- related effect consisting of skin crusts or ulceration at the site of application of the test material. Hematological, serum clinical parameters, and
organ w eights were unaffected by treatment. There were no treatment

- related microscopic changes In the tissues except for the skin findings.3

Inhalation Sprague

- Dawley rats were exposed to a nominal concentration of 25 mg/rn3 kerosene by inhalation for 28 days. Th ere were no treatment

- related effects on clinical condition, growth rate, organ weights, organ

- body weight ratios, or on any of the hematological or clinical chemistry determinations. No treatment

related microscopic changes were observed in any of the exa mined orga ns or in the respiratory tract. Hepatocellular fatty changes and vacuolization were observed in mice exposed to JP

- 5 vapor at 150 mg/rn3 continuously for 90 days. Similar effects on the liver were also observed In mice at 750 mg/rn3. A NOEAL was not reported.

5. Chronic toxicity. Dermal A two

- year study was conducted by administering JP

- 5 by dermal application to groups of 49 or 50 male and 50 female B6C3F mice at doses of 0, 250, or 500 mg/kg in an ace tone vehicle with a dose volume of 0.1 m L. There was a marked increase in the incidence of chronic dermatitis in both the low and high dose g r oups

. Neurotoxicity No histopathological changes were noted in the nervous system of mice following dermal application of 2,000 to 8,000 mg/kg/day of JP

- 5 fo r 13 weeks or of dermal application of 250 and 500 mg/kg day of JP

- 5 for 103 weeks

. Mutagenecity Standard Ames assays on two kerosene samples produced negative results with and without activation. Modified Ames assays on four kerosene(s) produced negative results (with and without activation) except for one positive assay that occurred with activation. A number of mouse lymphoma assays produced a mixture of negative and positive results. A sister chromatid exchange assay on hydrodesulfurized kerosene was ne gative with and without activation. Bone marrow cytogenetic tests on kerosene with Sprague

- Dawley rats were negative. A sister chromatid exchange assay on kerosene produced negative results in female mice and a positive response in male mice. A dominant le thal assay of kerosene produced negative results. Carcinogenicity Dermal A two

- year study of the administration of JP

- 5 navy fuel by dermal application to groups of 49 or 50 male and 50 female B6C3F1 mice at doses of 0,250. or 500 mg/kg in an acetone vehic le with a dose volume of 0.1 ml. Under the conditions of this 2

- year dermal study, JP

- 5 at doses of 250 and 500 mg/kg provided no evidence of carcinogenicity for male and female B 6C3F mice. Other studies of dermal carcinogenicity for kerosene and related

m aterials have shown some positive results but studies indicate that kerosene is a mouse skin tumor promoter rather than initiator and that this promotion4

required prolonged der m al irritation. The National Academy of Science (NAS) toxicological asse ssment o f JP

- 8 concluded that “ The carcinogenicity data available on mixtures similar to JP

- 8 (such as other jet fuels and middle distillates) indicate that most of these materials induce skin tumors in mice when topically applied in excessive amounts and under co nditions of excessive skin irritation”

.

6. Animal metabolism. In one animal study, fuel oil no. 2 applied to the skin of rats induced cutaneous aryl hydrocarbon hydroxylase activity in rat skin microsomal preparations by causing a three

- fold induction of benzo(a)pyrene (BaP) 3

- hydroxylase activity. In addition, BaP 3

- hydroxylase activity was selectively inhibited by a

- naphthoflavone, but not by metyrapone, suggesting that cytochrome P

- 448 enzymes are induced and may participate in the metabolism of this fu el oil Very limited animal data indicate that kerosene is absorbed and distributed to various tissues. Kerosene, labeled with 3H

- toluene or 14C

- hexadecane, was given to tracheotomized baboons (15 mL/kg) by nasogastric tube. Radioactivity was recovered from the brain, lung, liver, spleen, heart, and kidney after 6 hours. 3H

- Toluene was absorbed and taken up by most tissues to a greater extent than was 14C

- hexadecane; however, the amounts absorbed and distributed were very small

.

7. Metabolite toxicology

. [ NA

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8. Endocrine disruption

. S pecific s tudies pertaining to endocrine disruption from kerosene exposure have not been located.

C. Aggregate Exposure

1. Dietary exposure. Based on the volatility of kerosene, dietary exposures to kerosene are unlikely to occur as the result of the use of kerosene as an inert ingredient in pesticide formulations applied to growing crops. In general, environmental releases of kerosene will predominantly result in partitioning to air, given the volati lity of the individual hydrocarbon compounds that make up kerosene. In the air phase, photodegradation will be rapid.

i. Food. Based on the volatility of kerosene, exposures to kerosene on or in food are unlikely to occur as the result of the use of kerosene as an inert ingredient in pesticide formulations which were applied to growing crops. In general, environmental releases of kerosene will predominantly result in partitioning to air, given the volatility of the individual hydrocarbon compounds tha t make up kerosene. In the air phase, photodegradation will be rapid.

ii. Drinking water

. The minor fractions of kerosene that may partition to soil and water would likely undergo biodegradation. The API HPV Test Plan submission for the5

Kerosene/Jet Fu el Category Included biodegradation data (judged to be adequate by EPA) which concluded that kerosene(s) are inherently biodegradable, with a generally high degr ee of complete biodegradation”.

2. Non

- dietary exposure

. Kerosene is a complex mixture of various hydrocarbon fractions, and as such its transport and transformation in the environment is dependent on the environmental fate of the individual hydrocarbons that comprise it. In general, environmental releases o f kerosene will predominantly result in partitioning to air, given the volatility of the individual hydrocarbon compounds that make up kerosene. In the air phase, photodegradation will be rapid.

D. Cumulative Effects For the purposes of this tolerance action, it is not assumed that kerosene has common mechanism of toxicity with other substances.

E. Safety Determination 1. U.S. population. Kerosene is a Toxicity Category Ill substance for acute oral, dermal, and Inhalation toxicity and eye irritation and a Toxicity Category II substance for skin Irritation. Kerosene is not a skin sensitizer. Repeat dosing studies (oral, dermal) typically resulted in irritation and compensating responses to the Irritation (oral NOAEL 750 mg/kg/day. dermal NOAEL >165 mg/kg/day. A 28

- day rat inhalation toxicity study with kerosene resulted in no treatment

- related effects to rats exposed to a nominal concentration of 25mg /rn3 kerosene. A 90 day mouse inhalation study with JP

- 5 resulted in hepatocellular fatty changes and vacuolization being observed at dose levels of 150 mg/M3 a NOAEL was not reported. In vivo and in vitro genotoxicity studies with kerosene resulted in pri marily negative results. A dermal carcinogenicity study (2

- year) of JP

- 5 at doses of 250 and 500 mg/kg/day provided no evidence of carcinogenicity for male and female B6C3F1 mice. No quantitative or qualitative effects were observed in the fetuses from an oral developmental rat toxicity study. Decreases in fetal body weight were observed at 1,500 mg/kg/day JP

- 8 whereas decreases in maternal body weight gain were observed at 1.000 mg/kg/day. The NOAEL for maternal and developmental effects was 500 mg/kg. In general, environmental releases of kerosene will predominantly result in partitioning to air, given the volatility of the individual hydrocarbon compounds that make up kerosene. In the air phase, photodegradation will be rapid, and for those fractions of k erosene that will partition to soil and water, biodegradation will occur.

2. Infants and children

. The database for kerosene is sufficient for assessing the potential developmental effects from exposure to this substance. In a developmental toxicity st udy with mice, there was no incidence of developmental toxicity in the absence of maternal toxicity. No quantitative or qualitative susceptibility was observed from the availabl e developmental toxicity study i n mice.

F. International Tolerances

International tolerances for kerosene have not been located. As it is used as an inert ingredient, tolerances are not typically assigned.