Novaluron
CAS No. 116714-46-6
US Federal Register
 
 

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.


 
Fluoride Action Network | Pesticide Project | 315-379-9200 | pesticides@fluoridealert.org