Return to
Index Page
Adverse
Effects
ACTIVITY:
Insecticide (Benzoylurea)
CAS Name:
N-[[[3-chloro-4-[1,1,2-trifluoro-2-(trifluoromethoxy)ethoxy]phenyl]amino]carbonyl]-2,6-
difluorobenzamide
Structure:
US
Federal Register |
Date
Published |
Docket
Identification Number |
Details |
July 25, 2007 |
EPA-HQ-OPP-2007-0438 |
IR-4
/ Makhteshim-Agan of North America..
Pesticide
Petition PP 7E7199. Proposal to establish a tolerance for
residues of the insecticide novaluron in or on food commodities:
Tomato at 0.40 ppm;
tomato, paste at 0.80 ppm
sugarcane, cane at 0.50 ppm.
Makhteshim-Agan of North America, Inc., 4515 Falls of Neuse
Road, Raleigh, NC 27609, the manufacturer and basic registrant
of novaluron, prepared and summarized the following information
in support of the pesticide petition for novaluron. An adequate
analytical method, gas chromatography/electron capture detector
(GC/ECD), is available for enforcing tolerances of novaluron
residues in or on tomatoes, sugarcane and its processed commodities,
as published in the Federal
Register of April 5, 2006 (71 FR 17009) (FRL-7756-8). Based
on the sample size and dilution factors, the limit of quantitation
(LOQ) in matrix was equal to the lowest concentration level
for the validation analyses. The method verification trial supports
a LOQ of 0.05 ppm in the different tomato and sugarcane matrices.
The LOQ = 0.05 ppm was taken as the lowest level validated by
this method. |
April 13, 2007 |
EPA-HQ-OPP-2007-0005 |
Notice
of Receipt of Requests to Voluntarily Cancel Certain Pesticide
Registrations.
Registration No. |
Product Name |
Registrant |
066222 WA-05-0003 |
Rimon 0.83 EC |
Makhteshim-Agan
of North America Inc.
4515 Falls of Neuse Rd Ste 300
Raleigh, NC 27609 |
|
October 20, 2006 |
EPA-HQ-OPP-2006-0815 |
Pesticide
Tolerance for Emergency Exemption. FINAL RULE.
A time-limited tolerance, up to 12/31/09, established for residues
of the fungicide in connection with use of the pesticide under
a section 18 emergency exemption granted by EPA.
-- Sugarcane, cane at 0.15 ppm. |
April
5, 2006 |
EPA-HQ-OPP-2005-0525 |
IR-4
/ Makhteshim-Agan of North America.
Pesticide tolerance.
FINAL RULE. (PP 4E6834).
Specific
information on the studies received and the nature of the
toxic effects caused by novaluron as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse
effect level (LOAEL) from the toxicity studies can be found
at http://www.epa.gov/EPA-PEST/2004/June/Day-02/p12316.htm.
Commodity |
Parts per million |
Brassica,
head and stem, subgroup 5A
This
subgroup includes 10 commodities.
• broccoli
• broccoli, cavalo
• broccoli, chinese
• brussels sprout
• cabbage
• cabbage, chinese mustard
• cabbage, chinese napa
• cauliflower
• cavalo broccolo
• kohlrabi
|
0.50 |
•
a quantitative acute dietary exposure assessment is unnecessary.
• A cancer dietary exposure assessment was not conducted
because novaluron was classified as ``not likely to be carcinogenic
to humans.''
•
EPA determined that the 10X SF (safety factor) to protect
infants and children should be reduced to 1X.
•
The Agency lacks sufficient monitoring exposure data to complete
a comprehensive dietary exposure analysis and risk assessment
for novaluron in drinking water. |
Jan
18, 2006 |
EPA-HQ-OPP-2005-0531
|
IR-4
/ MAKHTESHIM-AGAN.
Amendment
to Existing Tolerance. Pesticide
Petition (PP) 4E6834.
IR-4, 681 U.S. Highway #1 South, North Brunswick, NJ 08902,
proposes to amend 40 CFR 180.598 by establishing tolerances
for residues of the insecticide novaluron (1-[3-chloro-4-
(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]-3-[2,6-difluorobenzoyl]urea)
in or on the food commodities Brassica
vegetables, head and stem (Subgroup 5A )at 0.5 ppm.
Makhteshim-Agan of North America, Inc.,
551 Fifth Avenue, Suite 1100, New York, NY 10176
is the manufacturer and basic registrant of novaluron.
Makhteshim-Agan of North America, Inc. prepared and summarized
the information in support of this pesticide petition for
novaluron. An adequate analytical method, gas chromatography/electron
capture detector (GC/ECD), is available for enforcing tolerances
of novaluron residues in or on head and stem Brassica vegetables,
as recently published in the Federal Register of June 2, 2004.
The limit of quantitation (LOQ = 0.05
ppm) was taken as the lowest level validated by this method.
Subgroup
5A includes 10 commodities. |
Commodity |
PPM |
broccoli |
0.5 |
broccoli,
cavalo |
0.5 |
broccoli,
chinese |
0.5 |
brussels
sprout |
0.5 |
cabbage |
0.5 |
cabbage,
chinese mustard |
0.5 |
cabbage,
chinese napa |
0.5 |
cauliflower |
0.5 |
cavalo
broccolo |
0.5 |
kohlrabi |
0.5 |
|
June
2, 2004 |
OPP-2004-0125 |
MAKHTESHIM-AGAN.
First-time
Pesticide
Tolerance for use on raw agricultural commodities in the US.
FINAL RULE.
Excerpt from
Table 1.--Subchronic, Chronic, and Other Toxicity
-- Reproduction
and fertility- rat. NOAEL (M/F)= 74.2>=1009.8
mg/kg/day; LOAEL= 297.5 mg/kg/ day based on decreased
epididymal sperm counts and increased age of preputial separation
in the F1 generation, reproductive LOAEL for females
was not established
Excerpts
from Table 2.--Summary of Toxicological Dose and Endpoints
for novaluron for Use in Human Risk Assessment
--
Chronic
dietary (All populations);
Long-term inhalation (>6 months) and
Long-term dermal (>6months).
Combined chronic toxicity carcinogenicity feeding in rat LOAEL
= 30.6 mg/kg/day based on erythrocyte damage and turnover
resulting in a regenerative anemia
-- Short-term
incidental oral (1-30 days); Intermediate-term incidental
oral (1-6 months); and Intermediate-term
inhalation (1 to 6 months): 90-day feeding study in
rat. LOAEL = 8.64 mg/kg/day based on clinical chemistry (decreased
hemoglobin, hematocrit and RBC counts) and histopathology
(increased hematopoiesis and hemosiderosis in spleen and liver).
Commodity-
Final Rule |
PPM
-
Final Rule |
PPM -
Proposed Feb 25, 204 |
Apple, wet pomace |
8.0 |
6.0 |
Fat:
Cattle |
0.60 |
0.3 |
Fat: Goat, Hog, Horse, Sheep |
11 |
Not
listed * |
Kidney: Cattle |
1.0 |
0.4 |
Kidney: Goat, Hog, Horse, Sheep |
1.0 |
Not
listed * |
Liver: Cattle |
1.0 |
0.4 |
Liver: Goat, Hog, Horse, Sheep |
1.0 |
Not
listed * |
Meat:
Cattle |
0.60 |
0.3 |
Meat: Goat, Hog, Horse, Sheep |
0.60 |
Not
listed * |
Meat byproducts: Cattle |
0.60 |
6.0 |
Meat byproducts, except liver and kidney:
Goat, Hog, Horse, Sheep |
0.60 |
Not
listed * |
Cotton, gin byproducts |
30 |
17 |
Cotton, undelinted seed |
0.60 |
0.3 |
Eggs |
0.60 |
Not
listed * |
Fruit, pome, group 11
This group includes: apple
- apple, dried pomace - apple, juice - apple, wet pomace
- crabapple - fruit, pome - loquat - mayhaw - pear - pear,
oriental - quince |
2.0 |
Not
listed * |
Milk |
1.0 |
0.4 |
Milk, fat |
20 |
Not
listed * |
Poultry, fat |
0.40 |
Not
listed * |
Poultry, meat |
0.03 |
Not
listed * |
Poultry, meat byproducts |
0.04 |
Not
listed * |
Vegetables, tuberous and corn, subgroup
1C
This group includes:
arracacha - arrowroot - artichoke, chinese - artichoke,
jerusalem - canna, edible
- cassava - chayote root - chufa - dasheen - ginger -
leren - potato - potato culls - potato granules flakes
- potato peel, wet - potato processed potato waste - potato,
specialty - sweet potato - tanier - turmeric - yam bean
- yam, true |
0.05 |
0.05 |
Pome
fruits (excluding pears) |
Not
listed |
1.0 |
Pears |
Not
listed |
2 |
|
Feb
25, 2004 |
OPP-
2004-0030 |
MAKHTESHIM-AGAN.
Pesticide tolerance
petition PP 2F6430;
in or on the raw agricultural
commodity
pome fruits (excluding pears) at 1.0 parts ppm,
apple pomace at 6.0 ppm,
pears at 2 ppm,
cottonseed at 0.3 ppm,
cotton gin by-products at 17
ppm,
tuberous and corm vegetables (Crop Subgroup 1-C) at
0.05 ppm,
cattle meat at 0.3 ppm,
cattle meat-by-products at 6.0 ppm,
cattle fat at 6.0 ppm,
cattle liver at 0.4 ppm, cattle kidney at 0.4
milk at 0.4 ppm.
Chronic
toxicity-
Chronic toxicity and oncogenicity
was evaluated in the rat, mouse and dog. The rat
chronic toxicity and oncogenicity was conducted with
dose levels of 25, 700, 20,000 ppm (1.25, 35, 1,000 mg/kg/day).
The no observed effect level (NOEL)
was 25 ppm (1.25 mg/kg/day) based on
methemoglobin. A mouse chronic
toxicity study was conducted with dose levels of 30,
450, 7,000 ppm (4.5, 67.5, 1,050 mg/ kg/day). The
NOEL was 30 ppm (4.5 mg/kg/day) based on methemoglobin.
Chronic toxicity was investigated
in dogs using dose levels of 10, 100, 1,000 mg/kg/day.
The NOEL of 100 mg/kg/day was based
on methemoglobin.
A reference
dose (RfD) of 0.083 mg/kg/day has been established for novaluron.
The RfD is based on a subchronic rat
study with a NOAEL of 8.3 mg/kg/day, based on
histopathological parameters in the spleen.
An uncertainty factor (UF) of 100 is used. |
Dec
19, 2001 |
OPP-30510A |
MAKHTESHIM-AGAN.
Conditional
approval of two pesticide products:
Rimon Technical, EPA Reg. No.
11678-57, for the manufacturing of end-use product formulations;
and
Rimon 10 EC, EPA Reg. No. 66222-35,
for the control of insect pests on container grown ornamentals
in greenhouses.
Both products were approved on September
25, 2001. |
April
4, 2001 |
OPP-
30510 |
MAKHTESHIM-AGAN.
Registration
Application for 2 Insecticide Products:
Rimon Technical. Proposed classification/Use: For manufacturing
of end-use product formulations.
Rimon 10 EC. Proposed classification/Use: General. For the
control of insect pests on container grown ornamentals in
greenhouses, shade houses, and outdoor nurseries. |
|