Document ID: EPA-HQ-OPP-2009-0276-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-08-19T04:00Z

<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  >

<EPA Registration Division contact: [Shaja Joyner, PM-20 703-308-3194]>

 

<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], [PO Box 13528, Research Triangle Park, NC
27709-3528] 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.>

<(Options (pick one)>

<	1. by establishing a tolerance for residues of>

	

<	[Triticonazole] in or on the raw agricultural commodity [Crop group
15, cereal grains(except rice) and crop group 16 , forage fodder and hay
of the cereal grains group(except rice)] at [0.05 and 0.10] parts per
million (ppm) respectively.  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. The metabolism of triticonazole in cereal grains
is understood the residue of concern is the parent compound,
triticonazole.>

<	2. Analytical method. [The method of analysis included extraction and
LC/MS/MS quantitation.  ]>

<	3. Magnitude of residues. [Residue trials were conducted on corn,
rice, sorghum and wheat.  Seed was treated at the maximum label rate of
50g triticonazole per 100 kg of seed.  Grain, forage fodder and hay
samples were collected for analysis and analysed by LC/MS/MS.  No
residues greater than the limit of quantitation (0.01 ppm) were found in
wheat, corn or sorghum grain samples.  Ten of 12 rice grain samples
showed no residue (<0.01 ppm).  Two of 12 rice grain samples showed
residues of 0.02 ppm).  The maximum residue found in the crop group 16
(forage fodder and hay) were found in wheat forage at 0.1 ppm.  The
maximum residue in rice straw was 0.04 ppm.  No residue (<0.01 ppm) was
found in any crop group 16 matrix from corn or sorghum.]>

<B. Toxicological Profile>

<	1. Acute toxicity.  [The Agency reviewed the toxicity database for
triticonazole and published their assessment in the Federal Register on
September 27, 2002.  FR Vol. 67, No. 188 pages 60950 through 60960.  The
Agency determined that triticonazole is of low acute toxicity.  All
tests showed the compound to toxicity category III or IV

Acute neurotoxicity in the rat:  NOAEL = 400 mg/kg/day LOAEL = 2,000
mg/kg/day (limit dose) based on dose-related increases in motor activity
in both sexes.

]>

<	2. Genotoxicty. [Triticonazole is not genotoxic..]>

<	3. Reproductive and developmental toxicity. [>

Prenatal development in rats:  Maternal NOAEL = 200 mg/kg/day,LOAEL =
1,000 mg/kg/day based on reduction in mean body weight gain from GD
12–16.  Developmental NOAEL = 200 mg/kg/day.  LOAEL = 1,000 mg/kg/day
based on treatment-related increases in unilateral and bilateral
supernumerary ribs.

Prenatal development in rabbits:  Maternal NOAEL = 25 mg/kg/day, LOAEL =
50 mg/kg/day based on decreased body weight gain, reduced food
consumption,

and mortality.  Developmental NOAEL = 50 mg/kg/day LOAEL = 75 mg/kg/day
based on cranial variations, abortion, and increased pre and
post-implantation losses.

Two generation reproduction study in rats:  Parental/Systemic NOAEL =
37.5 mg/kg/day.  LOAEL = 250 mg/kg/day based on reduced body weights of
the F0 females and the F1 males and females, F0 maternal mortality, and
microscopic lesions in the adrenal gland of F0 and F1 males and females.
 Reproductive NOAEL = 37.5 mg/kg/day LOAEL = 250 mg/kg/day based on
decreased fertility of the F1 animals, reduced F1 and F2 pup survival,
and reduced F1 and F2 pup body weight.

 ]

<	4. Subchronic toxicity. [

28 day dermal toxicity study:  NOAEL = Dermal and systemic: 1,000
mg/kg/day (limit dose).  

90 day oral toxicity in the rat:  NOAEL = M: 2, F: 22.3 mg/kg/day LOAEL
= M: 19.8, F: 1183.5 mg/kg/day based on M: Increases in the incidence of
adrenocortical fatty vacuolation in males receiving ≥ 250 ppm, F: Hair
loss, decreased food efficiencies, adrenocortical fatty vacuolation,
zona reticularis degeneration,

centriacinar hepatocytic fatty vacuolation, and more severe anisocytosis

and spherocytosis in females receiving ≥12,500 ppm.

Subchronic neurotoxicity:  NOAEL = M: 695; F: 820 mg/kg/day.

]>

<	5. Chronic toxicity. [

One year oral toxicitystudy in the dog:  NOAEL = 25 mg/kg/day LOAEL =
150 mg/kg/day based on decreased absolute body weights of females,
decreased weight gain by males and females, and treatment-related
toxicity to the eye, liver, and adrenals.

Chronic (lifetime) toxicity and carcinogenicity in the rat:  NOAEL = M:
≥ 203.6, F: 38.3 mg/kg/day LOAEL = M: Adverse effects were not
observed, F: 286.6 mg/kg/day based on decreased body weight and body
weight gain, adrenal cortical and liver toxicity.  Since the publication
of the triticonazole tolerances in 2002, the Agency has considered
additional information regarding the adequacy of the dosing in this
study and determined that the dosing was adequate and that there was no
evidence of compound induced carcinogenicity.

Carcinogenicity in the mouse:  NOAEL = M: 17.4; F: 20.1 mg/kg/day LOAEL
= M: 202.2, F: 209.5 mg/kg/day based on decreased body weight gain and
liver toxicity. No significant increase in the incidence of neoplastic
lesions. No evidence of compound-induced carcinogenicity.

]>

<	6. Animal metabolism. [Excretion is rapid.  The parent is metabolized
to at least 12 different metabolites in the rat the most abundant being
the acid metabolite of the parent and the hydroxylated acid metabolite
of the parent molecule.  In the cow triticonazole is rapidly eliminated
in both the urine and faeces.  Approximately 0.2% of the administered
dose remains in tissue, mostly in the liver and kidneys.  The parent
molecule and the hydroxylated parent were the most abundant materials
identified in tissue.  In the hen, triticonazole is rapidly eliminated
with less than 0.1% of the dose remaining in tissue.  Less than 0.2% of
the dose was found in the egg.  Parent and hydroxylated parent
metabolites were identified as the major components in eggs and tissue.
]>

<	7. Metabolite toxicology. [The Agency has considered the impact of
1,2,4-triazole and its metabolites (common metabolites of most triazole
fungicides) in numerous tolerance decisions.  The Agency’s complete
risk assessment is found in the propiconazole reregistration docket at
http://www.regulations.gov, docket ID

number EPA–HQ–OPP–2005–0497.

 ]>

<	8. Endocrine disruption. [No studies have been conducted to
specifically assess the potential of triticonazole to induce estrogenic
or other endocrine effects.  The Agency is currently developing
methodology to assess the impact of chemicals on the endocrine system.]>

<C. Aggregate Exposure>

<	1. Dietary exposure. [Dietary exposure was estimated by BASF using the
DEEM model]>

<	i. Food. [The XXX model combines exposure from food and water.  BASF
estimates acute exposure to be <1% of the aPAD in women of childbearing
age (the most exposed population).  BASF estimates the chronic exposure
to be <1% in the general population and 1.4% in infants < 1 year, the
most exposed sub population.]>

<	ii. Drinking water. [The Agency has calculated drinking water exposure
values using the Index Rerservoir model based on the FL: turf scenario. 
The acute (1 in 10 year annual concentration) value calculated was 75.5
parts per billion.  The chronic (1 in 10 year average annual
concentration) was calculated to be 32.8 parts per billion.  Ground
water concentrations were calculated using the SCI-GRO model as 5.7
parts per billion.  These levels were used in the DEEM calculation.]>

<	2. Non-dietary exposure. [The Agency has calculated (margins of
exposure MOEs) for residential exposures resulting from the registered
turf uses of triticonazole.  The MOEs are much higher than the
Agency’s level of concern of 100.]>

<D. Cumulative Effects>

<	[The Agency has considered the impact of the common metabolites
1,2,4-triazole and its metabolites in numerous tolerance decisions.  The
Agency’s complete risk assessment is found in the propiconazole
reregistration docket at http://www.regulations.gov, docket ID number
EPA–HQ–OPP–2005–0497.

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<E. Safety Determination>

<	1. U.S. population. [Based on the risk assessment above there is a
reasonable certainty of no harm to the US population]>

<	2. Infants and children. [Based on the risk assessment above there is
a reasonable certainty of no harm to the infants and children.]>

<F. International Tolerances>

<	[There are no CODEX tolerances established for triticonazole.]>

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