1 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

 

 Date: February 26, 2015 

 PC Code: 124002 

MEMORANDUM DP Barcode: D422123 

SUBJECT: Registration Review: Preliminary Problem Formulation for Environmental Fate, 

Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments 

for Novaluron 

FROM: Ryan Mroz, Biologist 

 He Zhong, Ph.D., Biologist 

 Environmental Risk Branch I 

Environmental Fate and Effects Division (7507P) 

THROUGH: Sujatha Sankula, Ph.D., Branch Chief 

Environmental Risk Branch I 

 Environmental Fate and Effects Division (7507P) 

 

TO: Meg Hathaway, Chemical Review Manager 

 Tom Myers, Team Leader 

 Kevin Costello, Branch Chief 

 Risk Management and Implementation Branch II 

Pesticide Re-Evaluation Division (7508P) 

 
2 

Table	of	Contents

1. Executive Summary ................................................................................................................ 3

2. Introduction ............................................................................................................................. 3

3. Use Characterization ............................................................................................................... 5

4. Conclusions from Previous Risk Assessments ....................................................................... 6

a. Ecological Risk Assessment .................................................................................................. 6

b. Drinking Water Exposure Assessments ................................................................................. 7

c. Clean Water Act Programs .................................................................................................... 7

5. Environmental Fate and Transport.......................................................................................... 7

a. Transformation Products ...................................................................................................... 10

6. Receptors............................................................................................................................... 11

a. Effects to Aquatic Organisms .............................................................................................. 11

b. Effects to Terrestrial Organisms .......................................................................................... 16

c. Degradates ............................................................................................................................ 19

d. Ecological Incidents ............................................................................................................. 21

7. Exposure Pathways of Concern ............................................................................................ 21

8. Analysis Plan ........................................................................................................................ 22

a. Stressors of Concern ............................................................................................................ 22

b. Measures of Exposure .......................................................................................................... 23

c. Measures of Effect ............................................................................................................... 23

9. Endangered Species Assessments ......................................................................................... 23

10.    Endocrine Disruptor Screening Program .............................................................................. 23

11.    Preliminary Identification of Data Gaps ............................................................................... 24

a. Environmental Fate .............................................................................................................. 24

b. Ecological Effects ................................................................................................................ 25

12. References .......................................................................................................................... 36

Appendix 1. Novaluron Uses and Application Rates ................................................................ 46

Appendix 2. Previous Actions for Uses of Novaluron .............................................................. 50

Appendix 3. Structures of Novaluron and its Degradates .......................................................... 55

Appendix 4. Major Degradates Chlorophenyl Urea and Chloroaniline .................................... 56

Appendix 5. Screening Level Models to Evaluate Potential Importance of Drinking Water and 

Inhalation Exposure Pathways .................................................................................................... 58
3 

1. Executive Summary 

The Environmental Fate and Effects Division (EFED) has completed the problem formulation for 

the ecological risk, environmental fate, endangered species, and drinking water assessments to be 

conducted as part of the registration review of novaluron (PC Code 124002). The problem 

formulation describes the methods planned to be used during the completion of the drinking water 

and ecological risk assessments in support of registration review and provides an overview of the 

environmental fate, ecological effects, and potential risks associated with the use of novaluron as 

well as uncertainties unique to the risk assessment of novaluron. This document also identifies 

additional studies that would be beneficial to conducting an ecological risk assessment. Major 

findings include: 

The following environmental fate data gaps were identified: 

 850.6100- ECM/ILV (soil and water) for parent and two metabolites (TGAI) 

The following ecotoxicity data gaps and uncertainties were identified for the parent 

novaluron (see Section 11b for details): 

 850.1400 - Saltwater fish early-life stage 

 850.1740 - Whole sediment – chronic freshwater invertebrates – TGAI with 

Leptocheirus plumulosus 

 Non-guideline - Whole sediment – chronic freshwater invertebrates – TGAI with 

Hyalella azteca

 850.4100 - Seedling Emergence and Seedling Growth 

 850.4150 - Vegetative Vigor850.4500/850.4550 - Non-vascular plant toxicity – 

Study with both a freshwater diatom, and estuarine/marine diatom 

 Non-guideline - Honeybee larval chronic toxicity (including acute endpoints) 

The following ecotoxicity data gaps and uncertainties were identified for the degradates 

chlorphenyl urea and chloroaniline (see Section 11b for details): 

 850.1075 - Freshwater fish acute toxicity – Chlorphenyl urea 

 850.1300 - Freshwater invertebrate life cycle - Chloroaniline 

 850.1350 - Saltwater invertebrates life cycle - Chlorphenyl urea and chloroaniline 

 850.1400 - Freshwater fish early-life stage – Chlorophenyl urea 

 850.4400 - Aquatic plant Toxicity Test using Lemna spp. – Chlorophenyl urea 

 850.4500/850.4550 - Non-vascular plant toxicity – Chlorphenyl urea (freshwater 

diatom, and estuarine/marine diatom) and Chloraniline (algae) 

Many of the labels for non-agricultural uses did not provide information on the maximum 

number of applications allowed per year, the maximum annual rate (in terms of lbs ai/A), 

or the minimum re-application interval. If the labels are not clarified, assumptions will be 

made based on the missing interval(s) for these uses as outlined in Appendix 1. 

2. Introduction 

Novaluron is a non-systemic insecticide insect growth regulator (IGR) in the benzoylphenyl urea 

family of chemicals. Novaluron inhibits chitin biosynthesis and cuticle formation in 

molting/developing insects and leads to abnormal endocuticular deposition, abortive molting, and 

adverse effects on insect growth and development. Novaluron has no effect on adult insects which 

have completed all successive molts. Novaluron acts primarily by ingestion, but also has some 
4 

contact activity. Novaluron is a chiral compound containing a racemic mixture of two 

enantiomers (R,S). 

Novaluron is formulated as an emulsifiable concentrate, suspension concentrate, flowable, water 

dispersible granule, bait cartridge, pellet, granule, and ready to use solution depending on the use. 

Applications are made manually (bait, spot/crack crevice, spot-on, cattle and poultry operations), 

aerially (broadcast), by ground (broadcast, band, direct spray, chemigation, and spot treatment), 

and directly to water (granule for mosquito control). Some pellets/tablets are applied directly to 

standing water that is disconnected from natural water ways (bird baths, swimming pool covers, 

boat covers, etc.) for mosquito control. The maximum single application rate for non-agricultural 

uses is 0.872 lb ai/A (14.83 lb ai/A yearly) as a dry scattering treatment for beetles in poultry 

operations, while the maximum agriculture use is a single application of 0.32 lb ai/A for pome 

fruits, excluding pears (0.97 lb ai/A yearly). (Appendix 1). 

Novaluron has a variety of both agricultural crops and non-agricultural crop uses. Agricultural 

crop uses include: alfalfa, apples, blueberries, cabbage, cauliflower, cotton, dry beans/peas, pears, 

peppers, potatoes, strawberries, and tomatoes. Non-agricultural uses include ornamental shrubs 

and bushes, turf as well as residential use for control of crickets and mosquitoes in small water 

bodies. According to the Biological and Economics Analysis Division (BEAD), application to 

cotton at an average rate of 20,000 lbs per year is the highest use followed by apples at 9,000 lbs 

per year on average (USEPA 2014a). Table 2.1 shows the agricultural uses in terms of average 

annual application (data from 2004 through 2012). 

Table 2.1. Average Annual Novaluron Agricultural Uses (data from 2004 through 2012). 

 Percent Crop Treated 

Crop Average Lbs. 

ai Average Maximum 

1 Alfalfa <500 <1 <2.5 

2 Apples 9,000 10 20 

3 Blueberries <500 <1 <2.5 

4 Cabbage <500 5 15 

5 Cauliflower <500 <2.5 5 

6 Cotton 20,000 <2.5 10 

7 Dry Beans/Peas <500 <1 <2.5 

8 Pears 3,000 15 25 

9 Peppers <500 <2.5 <2.5 

10 Potatoes 1,000 <2.5 5 

11 Strawberries 3,000 35 55 

12 Tomatoes <500 <2.5 <2.5 

 

In addition to novaluron-only products, novaluron is also formulated with other insecticides 

including: pyriproxyfen (also an insect growth regulator) and bifenthrin (a pyrethroid insecticide 

(Appendix 2). 
5 

EFED evaluated the most recent ecological risk assessments for novaluron in association with 

updated toxicity, exposure, and usage information to determine if sufficient data are available and 

if further updates are needed to support registration review. The most recent risk assessment is 

from 2013 for the use of novaluron as spot and perimeter treatments in animal husbandry or 

residential scenarios and included: outdoor flea control, outdoor cockroach perimeter treatment, 

outdoor control of litter beetles in chicken houses, outdoor control of ants, outdoor control of flying 

insect pests, indoor control of litter beetles in chicken houses, cattle and horse operations (flies), and

poultry operations (beetles) (D409223 and D412299). In addition, EFED considered the latest 

Agency science policies and risk assessment methodologies. The structure of novaluron and its 

degradates, as well as the chemical names and other identifiers, can be found in the chemical 

identity table attached to this document (Appendix 3).

3. Use Characterization 

Novaluron is a non-systemic benzoylphenyl urea insect growth regulator (IGR) used to control 

insects belonging to the orders Coleoptera, Diptera, Hemiptera, and Lepidoptera via inhibition of 

cuticle formation. It is registered for use on a variety of row crops, vegetables, tree crops, 

ornamentals, turf, and animal husbandry practices (see Appendix 1 for a full list). There is one 

active technical registration for novaluron, which is formulated into 17 active registered end-use 

products as emulsifiable concentrate, suspension concentrate, flowable, water dispersible granule, 

bait cartridge, pellet, granule, and ready to use solution. The chemical profile produced by 

BEAD, located on Regulations.gov in the registration review docket for novaluron, lists the use 

patterns of maximum exposures for the current uses of novaluron. EFED will use application 

scenarios that result in maximum exposure scenarios for a given use for the risk assessment. 

Failure of the label to specify the maximum single application rate, the application interval, the 

annual maximum rate (lb ai/A/year), and application method may result in conservative 

assumptions. 

For novaluron, several label issues were identified. Appendix 1 has more details on missing 

information and assumptions which may be made based on missing information: 

 Seasonal, rather than yearly application information is provided for many of the uses on 

registration numbers 499-557, 53883-306, 53883-344, 66222-217, 66222-231, 66222-

232). The number of applications and the maximum application rate should be reported 

on an annual basis. In the absence of yearly information, multiple seasons or crop cycles 

may be assumed for some crops when performing the risk assessment, based on input 

from the Biological and Economics Analysis Division (BEAD). 

 Several uses for insect control did not provide a clear maximum annual rate or retreatment interval between applications. Assumptions will be made on the maximum 

yearly rate based on how long the label language states insects are controlled for and how 

many reapplications at those intervals would fit into a year. 

 Registrations 53883-306, 53883-344, and 53883-355 do not list the number of 

applications per year. The number will be calculated based on the minimum re-treatment 

interval. 
6 

 Several registrations are granular formulations. Information on the size of the granule 

and the amount of novaluron contained within the granule is needed for the risk 

assessment. 

4. Conclusions from Previous Risk Assessments

a. Ecological Risk Assessment 

The Agency has conducted multiple ecological risk assessments on novaluron that serve as a basis 

for this problem formulation. The most recent comprehensive risk assessment was completed on 

August 14, 2013 (USEPA, 2013b; D409223 and 412299) for the following uses: Outdoor flea 

control, outdoor cockroach perimeter treatment, outdoor control of litter beetles in chicken 

houses, outdoor control of ants, outdoor control of flying insect pests, indoor control of litter beetles 

in chicken houses, cattle and horse operations (flies), and poultry operations (beetles). Data used in 

that assessment indicated that novaluron’s degradates, chlorophenyl urea and chloroaniline, are 

more toxic to both freshwater fish and aquatic non-vascular plants than the parent novaluron. It is 

uncertain if chlorophenyl urea or chloraniline is more toxic, so the previous assessment assumed the 

degradates had equal toxicity when compared to the other. Potential direct risk concerns from that 

assessment were identified for the taxa below: 

 

 Birds (chronic and dietary [Bioconcentration Factor (BCF) based]) 

 Terrestrial invertebrates (presumed) 

 Terrestrial and semi-aquatic plants (presumed from lack of data) 

 Benthic invertebrates (acute and chronic) 

 Estuarine/marine fish (chronic assumed from lack of data) 

 Aquatic vascular plants (not precluded for degradates only) 

Data gaps from the 2013 assessment were identified for novaluron below: 

 850.4100 - Seedling Emergence 

 850.4150 - Vegetative Vigor 

 Non-guideline Honeybee Larval Toxicity Test 

 850.1400 - Estuarine/Marine Fish Life-Cycle 

In addition, co-formulations with additional insecticides could pose additional risks/stress, either 

additive or synergistic, to both larval and adult honeybees. For example, novaluron is coformulated with both pyriproxyfen and bifenthrin. Pyriproxyfen, also an IGR, and could adversely 

affect larval honeybees/non-target insects and bifenthrin has been identified as highly toxic (LD50

of 0.015 mg a.i./bee) to adult honeybees. A Reregistration Eligibility Decision (RED) was not 

completed for novaluron. Table 4.1 below identifies risk concerns and issues from all previous 

assessments of novaluron. 

Table 4.1. Summary of Risk Concerns and Issues Identified for Novaluron in Previous 

Assessments

Birds Mammals Terr. 

Plants 

Terr. 

Inverts Fish BCF 

Aquatic 

Inverts 

Aquatic 

Plants 

Groundwater 

Contamination Persistence Degradates 

of Concern 

Yes1 Yes1 Yes2 Yes2 Yes2 Yes Yes Yes3 Yes Yes Yes4

“Yes” = Risk concerns or issues were identified or presumed from lack of data in previous assessments; 
7 

1 = Chronic

2 = Presumed due to lack of data. Fish encompasses estuarine/marine only 3 = Not precluded (for degradates only) 

4 = Two degradates of concern chlorphenyl urea and chloroaniline exist for novaluron. For aquatic uses these 

degradates were modeled separately from the parent novaluron in previous ecological risk assessments. 

b. Drinking Water Exposure Assessments 

The most recent drinking water assessment for novaluron was conducted to support the IR-4 

petition for the proposed new uses on various agricultural crops and residential ornamentals 

(USEPA 2014b; D418740). In this assessment, EFED recommended the surface water upper 

bound the estimated drinking water concentrations (EDWC) for novaluron, chlorophenyl urea and 

chloroaniline from the previous assessments (USEPA 2013a, D412441; USEPA 2009b; 

D363989+). The surface water upper bound EDWCs are listed in Table 4.2. 

Table 4.2. The Upper Bound EDWCs for Novaluron, Chlorophenyl Urea and Chloroaniline 

 Acute 

(μg/L) 

Non-cancer Chronic 

(μg/L) 

Cancer Chronic 

(μg/L) 

Novaluron 

(PA Apples) 

3* 0.76 0.62 

Chlorophenyl Urea 

(Poultry litter use)

8.77 6.01 3.21 

Chloroaniline 

(Poultry litter use)

12.59 10.05 6.05 

* Novaluron solubility limit 

In addition, EFED recommended the estimated concentrations of novaluron and two degradates in 

ground water sources with the peak EDWCs not to exceed 8.72 x 10-2 μg/L, 0.43 μg/L and 84.2 

μg/L for novaluron, chlorophenyl urea, and chloroaniline, respectively. 

c. Clean Water Act Programs 

Novaluron is not identified as a cause of impairment for any water bodies listed as impaired under 

section 303(d) of the Clean Water Act1. No Total Maximum Daily Load (TMDL) criteria have 

been developed for novaluron. Aquatic benchmarks have been established for novaluron and are 

available at http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm. Any data 

submitted or otherwise located as part of the registration review process may be used to update 

aquatic life benchmarks if applicable. 

5. Environmental Fate and Transport 

Novaluron is a chiral compound containing a racemic mixture of two enantiomers (R,S). The 

available environmental fate and ecological effects data on novaluron represents only the racemic 

mixture. Based on submitted environmental fate data and reported physical-chemical properties 

novaluron is not mobile and stable to hydrolysis and photolysis (Table 5.1). 

Novaluron has low vapor pressure (1.2 x 10-7 mm Hg), low water solubility (3 ppb), and high soil 

adsorption coefficient (Koc = 6,680 - 11,813). The low water solubility plus high soil adsorption 

 

1

 http://water.epa.gov/lawsregs/lawsguidance/cwa/tmdl/ 
8 

coefficient indicates novaluron's strong adsorption to soil and its limited ability to leach into 

groundwater. Novaluron is stable to hydrolysis (T1/2 = 101 days), soil photolysis (T1/2 = 257 

days), and aqueous photolysis (T1/2 = 187 days). The extrapolated degradation half-lives (DT50)

are well beyond the duration of study periods (hydrolysis 30 days and photolysis 15 days). 

Novaluron degradation in soil and water is controlled by microbial-mediated processes. Soil 

degradation half-lives range from 7-32 days to form chlorophenyl urea (275-352I) and 

chloroaniline (275-309I) (MRIDs: 44961009 and 44961010). Aqueous degradation half-lives 

range 10-51 days (MRIDs: 45638205, 45638206 and 45789203). Laboratory and field studies 

indicate runoff of entrained sediments is the most likely dissipation pathway for off-site 

movement of novaluron. During surface runoff conditions, novaluron may reach water bodies 

bound to soil particles and will likely partition into sediments once in surface water. In a field 

dissipation study conducted in North America, novaluron residues were not detected above 0.09 

ppm (Nova Scotia) in the 15-30 cm soil depth and above 0.06ppm (Ontario) in the 30-45 cm soil 

depths (MRID 45789204). Novaluron (RIMON® SUPRA 10EC ) was not detected above the 

LOQ (10 ppb) at any sampling interval or in any replicate sample in the 10-20 cm soil depth when 

applied to bare soil in Spain and Germany (MRID 45638403). In a microcosm study, novaluron 

exhibited water column DT90 values ranging from 12 to 20 days for three different test 

concentrations (i.e., 5, 15, and 50 g ai/ha treatment level and the main degradate, chlorophenyl 

urea (275-352I) was found in the water column (MRID 45785801). 

Novaluron (log Kow = 5.26) appears to accumulate in edible and non-edible fish tissues. In a 

standard bioconcentration study using the bluegill sunfish, the highest bioconcentration factor 

(BCF) in whole fish was 14,431x. The half-life for clearance of residues in the bluegill was 3.9 to 

7.3 days for whole fish (MRID 45638215). 

Table 5.1. Environmental Fate and Transport Properties of Novaluron

Parameters Value and Unit Reference 

PC Code 124002 

CAS Number 116714-46-6 Toxnet 

Chemical (CAS) Name 3-Chloro-4-[I, 1,2-

trifluoro-2- 

(trifluoromethoxy)ethoxy]p

henyl] -amino]carbonyl]-

2,6- 

difluorobenzamide 

IUPAC Name RS)-1-[3-Chloro-4 (1,1,2-

trifluoromethoxyethoxy)ph

enyl]-3-(2,6-

difluorobenzoy1) urea 

Molecular Formula C17H9ClF8N2O4 Product Chemistry, MRID 44961006 

Molecular Weight 492.7 Product Chemistry, MRID 44961006 
9 

Parameters Value and Unit Reference 

Molecular Structure MRID 45638206 

Smiles Fc1cccc(F)c1C(=O)NC(=O

)Nc2cc(Cl)c(OC(F)(F)C(F)

OC(F)(F)F)cc2 

EPI Suite 4.1 

Solubility (at 25 oC) 3 μg/L Product Chemistry, MRID 44961006 

Vapor Pressure 1.2 x 10-7 mm Hg Product Chemistry, MRID 44961006 

Henry’s Constant at 25 oC 2 x10-5 atm•m3/mol Product Chemistry, MRID 44961006 

Log Kow 5.26 EPI Suite 4.1 

Soil Partition Coefficient (Kd) 133, 247, 184, and 95 ml/g MRID 44961012 

Soil Partition Coefficient (Koc) 10271, 6650, 9658 and 

11813 ml/g 

MRID 44961012 

Aerobic Soil Metabolism T1/2

Degradates: 

chlorophenyl urea (maximum of 

26.6%@7 days) 

chloroaniline (maximum of 

8.5%@120 days) 

11.8 days, 14.5 days, 

13.7days and 7 days 

MRIDs: 44961009 and 44961010 

Anaerobic Soil Metabolism T1/2

Degradates: 

chlorophenyl urea (maximum of 

13.7%@59 days) 

chlorophenyl aniline 

(maximum of 5.8%@181 days) 

2,6-difluorobenzoic acid 

(maximum of 48.3%@59 days) 

2,6-difluorobenzamide 

(maximum of 2.5%@181days) 

65.8 days, 53.7 days, 42.2 

days and 44.7 days 

MRID 45638205 

Aqueous Photolysis (pH 5) T1/2

Degradates: 

187 days MRID 45638203 

Photodegradation on Soil 257 days MRID 45638204 

Hydrolysis T1/2 (pH7) stable MRID 44961008 

Aerobic Aquatic Metabolism 15.7 days, 23.7 days, 9.72 MRID 45638206 
10 

Parameters Value and Unit Reference 

Half-life 

chlorophenyl urea (maximum of 

21.7%@14 days) 

chlorophenyl aniline 

(maximum of 4.4%@30 days) 

2,6-difluorobenzoic acid 

(maximum of 0.8%@30 days) 

2,6-difluorobenzamide 

(maximum of 1.4%@30days) 

days and 9.06 days 

Anaerobic Aquatic Metabolism 

Half-life 

chlorophenyl urea (maximum of 

32.3%@267 days) 

chlorophenyl aniline 

(maximum of 49.2%@363 days) 

2,6-difluorobenzoic acid 

(maximum of 93.9%@363 days) 

2,6-difluorobenzamide 

(maximum of 1.7%@91days) 

50.6 and <91 days MRIDs: 45638207 and 45789203 

Terrestrial field dissipation 

(US, Canada, Spain, and 

Germany) 

20 - 178 days MRID 45638403 

Bioaccumulation in fish BCF = 14,431 MRID 45638215 

a. Transformation Products 

Novaluron degrades to form chlorophenyl urea and 2,6-difluorobenzoic acid. Hydrolysis of 

degradation products leads to the formation of chloroaniline from chlorophenyl urea and 2,6 

difluorobenzamide from 2,6-difluorobenzoic acid. The major degradates of chlorophenyl urea 

(275-352I) and chloroaniline (275-309I) are metabolites of concerns for ecological risk 

assessment and were also identified by the Health Effects Division (HED) to be of human 

drinking water concern (USEPA 2004a, MARC). The chloroaniline moiety may be characterized 

as a semi-volatile compound base on the vapor pressure (3.49 x 10-3 mm Hg) and is thought to be 

associated with the most pronounced toxicological effects of novaluron to mammals. 

Chlorophenyl urea occurred in aerobic soil metabolism at the maximum of 26.6% of the applied 

parent at 7 days post-treatment. Chlorophenyl urea appears to have low to slight mobility in soil 

(Koc values range from 1,950 to 2,563) (FAO 2000). Chloroaniline occurred at a maximum of 

8.5% of applied in the aerobic soil metabolism study at 120 days post treatment, the last sampling 

interval (MRID 44961009). Additionally, it is expected that chloroaniline is formed from the 

further degradation of the major degradate, chlorophenyl urea (275-352I) (MRIDs: 45638205 and 

45789203). In the anaerobic aquatic metabolism study, at the last sampling interval, i.e., 363 days 

post treatment, a maximum of 32% of the applied occurred in the soil and 49.8% in the total 
11 

system. A summary of fate and transport properties of these two major degradates can found in 

Appendix 4. 

6. Receptors 

Table 6.1 and 6.2 provide a summary of the aquatic and terrestrial taxonomic groups, 

respectively, and the available endpoints for the most sensitive surrogate species tested to 

characterize the potential acute and chronic ecological effects of novaluron. The Agency does not 

routinely include an evaluation of mixtures of active ingredients (either those mixtures of multiple 

active ingredients in product formulations or those in the applicator’s tank) in its risk assessments. 

Each active ingredient is subject to an individual risk assessment for a regulatory decision regarding 

the active ingredient on a particular use site (USEPA 2004b). However, novaluron is also formulated 

with pyriproxyfen (also an IGR) for insect control in animal husbandry practices and bifenthrin (a 

pyrethroid) for use on cotton. The most recent assessment (D409223) qualitatively discusses the 

incorporation of this pyriproxyfen mixture data and a qualitative discussion of implications of the 

available pesticide mixture effects data regarding the confidence of risk assessment conclusions 

will be addressed as part of the uncertainty analysis for the bifenthrin formulation. EFED will 

consider open literature, currently available models and other lines-of-evidence (e.g., monitoring 

data), as available to address the potential for cumulative effects of formulations in the risk 

description of the ecological assessment for novaluron. 

Additionally, although EFED does not normally assess indoor uses, there are some uses, e.g.

manure spread in poultry operations, which present a potential complete environmental exposure 

pathway and require special analyses. Specifically, it is expected that the indoor poultry house 

treatments will result in outdoor exposures to non-target organisms when the poultry litter is removed 

during sanitization. Similarly, the hay and manure that are cleaned from horse barns represent a 

complete exposure pathway. 

In general, novaluron is highly toxic to aquatic invertebrates, especially benthic invertebrates, 

which is unsurprising given its mode of action of affecting molting juvenile insects. It generally 

only affects vertebrates (birds and mammals) on a chronic basis. Honeybee data suggest 

novaluron is practically non-toxic to adult honeybees on both an oral and contact basis; however, 

as adult bees do not molt once they reach maturity and novaluron’s mode of action targets 

molting insects, the effect on molting juveniles and larvae is still uncertain. 

a. Effects to Aquatic Organisms 

Table 6.1. Summary of the Most Sensitive Endpoints from Aquatic Toxicity Studies for 

Novaluron 

Taxonomic Group Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification 

Freshwater fish1 Acute Bluegill sunfish 

(Lepomis macrochirus) 

LC50 > 0.96 mg 

ai/L 

NOAEC = 0.96 

mg ai/L 

No effects 

--^ 45499005 

Supplemental 
12 

Taxonomic Group Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification 

Acute Rainbow trout 

(Oncorhynchus mykiss) 

LC50 > 0.98 mg 

ai/L 

NOAEC = 0.98 

mg ai/L 

No effects 

--^ 45499004 

Supplemental 

Acute 

(formulation 

9.1% ai) 

Rainbow trout 

(Oncorhnychus mykiss) 

LC50 = 5.68 mg 

ai/L 

NOAEC = 0.49 

mg ai/L 

LOAEC = 1.00 

mg ai/L 

Sublethal effects: 

hyperventilation, 

loss of 

coordination, 

coughing, 

darkened 

pigmentation, 

reduced opercular 

movement 

Slightly toxic 45638314 

Acceptable 

Sub-chronic Rainbow trout 

(Oncorhynchus mykiss) 

28-day LC50 > 

0.00616 mg ai/L 

28-day LOAEC > 

0.00616 mg ai/L 

28-day NOAEC = 

0.00616 mg ai/L 

No effects 

-- 45638216 

Supplemental 

Sub-chronic 

(formulation 

9.2% ai) 

Rainbow trout 

(Oncorhynchus mykiss) 

28-day survival 

LC50 = 0.657 mg 

ai/L 

NOAEC = 0.310 

mg ai/L 

LOAEC = 0.640 

mg ai/L 

Toxic effects 

NOAEC = 0.111 

mg ai/L 

LOAEC = 0.310 

mg ai/L 

28-day wet weight 

and length 

NOAEC = 0.640 

mg ai/L 

LOAEC = 0.640 

mg ai/L 

Effects: lethargy, 

reduced response 

-- 45638406 

Supplemental 
13 

Taxonomic Group Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification 

to food, loss of 

coordination 

Estuarine/marine 

fish 

Acute Sheepshead minnow 

(Cyprinodon 

variegatus) 

LC50 > 0.002 mg 

ai/L 

NOAEC = 0.002 

mg ai/L 

No effects 

--^ 45638210 

Supplemental 

Freshwater 

invertebrates 

Acute 

(formulation 

9.1% ai) 

Waterflea 

(Daphnia magna) 

EC50 = 0.39 μg 

ai/L 

NOAEC = 0.11 

μg ai/L 

No sub-lethal 

effects 

Very highly toxic 45638413 

Acceptable 

Chronic Waterflea 

(Daphnia magna) 

NOAEC = 0.0299 

μg ai/L 

LOAEC = 0.0628 

μg ai/L 

Based on parental 

survival, length, 

and offspring 

production) 

-- 46581401 

Acceptable 

Estuarine/marine 

invertebrates 

Acute Eastern oyster 

(Crassostrea virginica) 

EC50 = 1.5 μg ai/L 

NOAEC = 0.28 

μg ai/L 

No sub-lethal 

effects 

Very highly toxic 45638208 

Acceptable 

Acute Mysid shrimp 

(Americamysis bahia) 

LC50 = 0.13 μg 

ai/L 

NOAEC = 0.087 

μg ai/L 

Sub-lethal effects: 

lethargy, erratic 

swimming 

Very highly toxic 45638209 

Acceptable 

 Chronic Mysid shrimp 

(Americamysis bahia) 

Survival (28 days) 

LC50 = 0.103 μg 

ai/L 

NOAEC = 0.06 

μg ai/L 

Reproduction 

(number of 

young/female/day) 

LOAEC > 0.12 μg 

ai/L 

NOAEC = 0.12 

μg ai/L 

Male Length 

-- 45638212 

Supplemental 
14 

Taxonomic Group Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification 

LOAEC = 0.06 

μg ai/L 

NOAEC = 0.026 

μg ai/L 

Female Length 

LOAEC > 0.12 μg 

ai/L 

NOAEC = 0.12 

μg ai/L 

Male and Female 

Dry Weight 

LOAEC > 0.12 μg 

ai/L 

NOAEC = 0.12 

μg ai/L 

Benthic 

invertebrates 

Sub-acute Midge 

(Chironomus tentans) 

Sediment 

Concentrations: 

28-day LC50 = 24 

μg ai/kg 

28-day EC50 = 34 

μg ai/kg 

28-day NOAEC = 

15 μg ai/kg 

28-day LOAEC = 

30 μg ai/kg 

Pore Water 

Concentrations: 

28-day LC50 = 

0.21 μg ai/L 

28-day EC50 = 

0.30 μg ai/L 

28-day NOAEC = 

0.13 μg ai/L 

28-day LOAEC = 

0.26 μg ai/L 

Most sensitive 

endpoints: 

survival and 

emergence ratio 

-- 47621902 

Supplemental 

Benthic 

invertebrates 

Aquatic plants 

and algae 

Sub-acute Midge 

(Chironomus tentans) 

Mean-measured 

sediment 

concentrations: 

Survival: 

EC50 >20 μg 

ai/kg 

95% C.I.: N/A 

NOAEC = 9.2 μg 

ai/kg 

Very highly toxic 48690101 

Supplemental 
15 

Taxonomic Group Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification 

LOAEC = 20 μg 

ai/kg 

Growth (AFDW): 

EC50 = 13 μg 

ai/kg 

95% C.I. = 12 to 

14 μg /kg 

NOAEC = 4.7 μg 

ai/kg 

LOAEC = 9.2 μg 

ai/kg 

Mean-measured 

pore water 

concentrations: 

Survival: 

EC50 >2.29 μg 

ai/L 

95% C.I.: N/A 

NOAEC = 1.38 

μg ai/L 

LOAEC = 2.29 μg 

ai/L 

Growth (AFDW): 

EC50 = 1.7 μg 

ai/L 

95% C.I.: 1.6 to 

1.8 μg /kg 

NOAEC = 0.574 

μg ai/L 

LOAEC = 1.38 μg 

ai/L 

Nonvascular Green algae 

(Pseudokircherniella 

subcapitata) 

Cell Density, 

Growth Rate, and 

Biomass 

EC50 > 9.68 mg 

ai/L 

NOAEC = 9.68 

mg ai/L 

No effects 

-- 45638221 

Supplemental 

Aquatic plants Vascular Duckweed 

(Lemna gibba) 

Number of fronds 

and plant biomass 

EC50 > 0.075 mg 

ai/L 

NOAEC = 0.075 

mg ai/L 

-- 45638223 

Acceptable 
16 

Taxonomic Group Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification 

No effects 

--^Toxicity classification not given based on no effects seen for only one concentration tested and a non-definitive endpoint. 

-- Toxicity classification not applicable 

1 Freshwater fish are surrogates for aquatic-phase amphibians. 

b. Effects to Terrestrial Organisms 

Table 6.2. Summary of the Most Sensitive Endpoints from Terrestrial Toxicity Studies for 

Novaluron 

Taxonomic 

Group 

Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification 

Birds 

Acute oral 

Zebra finch 

(Taeniopygia 

guttata) 

LD50 > 2250 mg ai/kg-bw 

NOAEC = 2250 mg 

ai/kg-bw 

No effects 

Practically nontoxic 

48690102 

Acceptable 

Acute oral 

Bobwhite quail 

(Colinus 

virginianus) 

LD50 > 2000 mg ai/kg-bw 

NOAEC = 2000 mg 

ai/kg-bw 

No effects 

Practically nontoxic 

45476801 

Acceptable 

Acute oral 

Mallard duck 

(Anas 

platyrhynchos)

LD50 > 2000 mg ai/kg-bw 

NOAEC = 2000 mg 

ai/kg-bw 

No effects 

Practically nontoxic 

45499001 

Supplemental 

Acute dietary 

Bobwhite quail 

(Colinus 

virginianus) 

LC50 > 5200 mg ai/kg-diet 

NOAEC = 2610 mg 

ai/kg-diet 

NOAEC based on 

mortality; no other 

effects. 

Practically nontoxic 

45499002 

Acceptable 

Acute dietary 

Mallard duck 

(Anas 

platyrhynchos)

LC50 > 5310 mg ai/kg-diet 

NOAEC = 5310 mg 

ai/kg-diet 

No effects 

Practically nontoxic 

45499003 

Acceptable 
17 

Taxonomic 

Group 

Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification 

Chronic 

reproduction 

Bobwhite quail 

(Colinus 

virginianus) 

NOAEC = 301 mg ai/kgdiet 

LOAEC = 1013 mg ai/kgdiet 

Based on reductions in 

number of eggs laid and 

set, viable embryos, live 

embryos, number of 

hatchlings, and hatching 

survival 

-- 

45638218 

Acceptable 

Chronic 

reproduction 

Mallard duck 

(Anas 

platyrhynchos)

NOAEC = 9.8 mg ai/kgdiet 

LOAEC = 30 mg ai/kgdiet 

Based on reductions in 

number of viable 

embryos, ratio of viable 

embryos to eggs set, and 

live embryos 

-- 

45638219 

Acceptable 

Mammals 

Acute oral 

Laboratory rat 

(Rattus norvegicus) 

LD50 > 5000 mg ai/kg-bw 

No effects 

Practically nontoxic 

44961001 

Acceptable 

Chronic 

Reproduction 

Laboratory rat 

(Rattus norvegicus) 

NOAEC = 1000 mg 

ai/kg-diet 

LOAEC = 4000 mg ai/kgdiet 

Based on decreased sperm 

counts in male F1

generation 

-- 

45651505 

Acceptable 

Terrestrial 

insects 

Acute 

contact 

Honeybee 

(Apis mellifera) 

LD50 > 100 μg ai/bee 

NOAEC = 100 μg ai/bee 

No effects 

Practically nontoxic 

45638220 

Acceptable 

Acute oral 

Honeybee 

(Apis mellifera) 

LD50 > 100 μg ai/bee 

NOAEC = 100 μg ai/bee 

No effects 

Practically nontoxic 

45638220 

Supplemental 

Acute oral 

(formulation 

9.1% ai) 

Honeybee 

(Apis mellifera) 

LD50 > 200 μg ai/bee 

NOAEC = 200 μg ai/bee 

No effects 

Practically nontoxic 

45638408 

Acceptable 
18 

Taxonomic 

Group 

Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification 

Field-testing 

for 

pollinators 

Honeybee 

(Apis mellifera) 

LC50 = Not determined 

Adverse effects observed 

on brood development in 

egg, young, and old larval 

stages in the 3.3 ml 

formulation/L treatment 

group. 

-- 

45638407 

Supplemental 

Field-testing 

for 

pollinators 

Honeybee 

(Apis mellifera) 

LC50 = Not determined 

Adverse effects observed 

on brood development in 

egg, young, and old larval 

stages in the 225 g ai/ha 

treatment group. 

-- 

45638409 

Supplemental 

Terrestrial 

invertebrates Sub-chronic 

Earthworm 

(Eisenia foetida) 

LC50 > 1000 mg ai/kg-soil 

NOAEC = 1000 mg 

ai/kg-soil 

No effects 

-- 

45638224 

Supplemental 

Terrestrial 

plants 

Vegetative 

vigor 

Monocot 

Onion (Allium 

cepa), corn (Zea 

mays), ryegrass 

(Lolium perenne), 

wheat (Triticum 

aestivum) 

Dicot 

Oilseed rape 

(Brassica napus), 

cabbage (Brassica 

oleracea), soybean 

(Glycine max), 

lettuce (Lactuca 

sativa), tomato 

(Lycopersicum 

esculentum), bean 

(Phaseolus 

vulgaris) 

Monocot (all) 

EC25 > 0.896 lb ai/A 

NOAEC = 0.896 lb ai/A 

Dicot (bean) 

EC25 > 0.896 lb ai/A 

NOAEC < 0.896 lb ai/A 

Based on 14% reduction 

in dry weight of bean. 

Phytotoxic effects in all 

species included 

chlorosis, necrosis, leaf 

wilt 

-- 

48690103 

Acceptable 
19 

Taxonomic 

Group 

Study Type Surrogate Species Toxicity Value Acute 

Toxicity 

Classification 

Source and 

Classification 

Seedling 

emergence 

Monocot 

Onion (Allium 

cepa), corn (Zea 

mays), ryegrass 

(Lolium perenne), 

wheat (Triticum 

aestivum) 

Dicot 

Oilseed rape 

(Brassica napus), 

cabbage (Brassica 

oleracea), soybean 

(Glycine max), 

lettuce (Lactuca 

sativa), tomato 

(Lycopersicum 

esculentum), bean 

(Phaseolus 

vulgaris) 

Monocot (all) 

EC25 > 0.972 lb ai/A 

NOAEC = 0.972 lb ai/A 

Dicot (bean) 

EC25 > 0.972 lb ai/A 

NOAEC < 0.972 lb ai/A 

Based on reduction in dry 

weight of bean. 

Phytotoxic effects in all 

species included 

chlorosis, necrosis, leaf 

wilt 

-- 

48690104 

Under Review* 

*This study is still under review. Results suggest a non-definitive (less than) NOAEC for dicots (bean) tested at the 

application rate of 0.972 lb ai/A. 

c. Degradates 

Table 6.3 provides aquatic taxa toxicity information for one major degradate of novaluron: 

chlorophenyl urea. Toxicity data are not available for the other major degradate of concern, 

chloroaniline. The degradate 2,6-difluorobenzoic acid is considered minor and will not be 

considered further because it has lost the chloroanaline toxic moiety and much less toxic than 

novaluron and its major degradates. Given the similarity in chemical structure between 

chloroaniline and chlorophenyl urea, it is assumed that the former will be more similar in its 

toxicity to chlorophenyl urea than to the parent, novaluron. ECOSAR methods will be used to 

predict aquatic toxicity for the degradates, when data are not available, based on their structural 

similarity to chemicals for which aquatic toxicity data are known (ECOSAR predictive software 

is available publically though the Epi SuiteTM program2

). While no toxicity data exist for 

chloroaniline, toxicity data for the degradate chlorophenyl urea suggest it is more toxic to 

freshwater fish, and algae than novaluron. Sub-chronic studies on earthworms suggest the 

chlorophenyl urea is more toxic to terrestrial invertebrates (earthworms) than parent novaluron. 

The toxicity of these degradates has previously been assumed to be equal and was previously 

modeled separately from the parent in a residue summation of total toxic residues (TTR) for both 

degradates. Since degradate data indicates chlorphenyl urea may be more toxic to some aquatic 

organisms than the parent novaluron, moving forward the toxic equivalency (TEQ) approach will 

be used assess the parent (novaluron) and degradates (chlorphenyl urea and chloroaniline). An 

 

1

 http://www.epa.gov/oppt/exposure/pubs/episuite.htm 
20 

RQ calculated using the TEQ approach represents risk from combined exposure to parent 

novaluron and degradates chlorphenyl urea and chloroaniline. 

Table 6.3. Summary of the Most Sensitive Endpoints from Aquatic Toxicity Studies for Novaluron 

Degradate Chlorphenyl Urea 

Taxonomic 

Group 

Study Type Surrogate Species Toxicity Value 

(all units in terms of the 

degradate) 

Acute 

Toxicity 

Classification 

Source and 

Classification

Freshwater 

invertebrates 

Acute 

Metabolite 

chlorophenyl 

urea 275-

352 I 

(96.2%) 

Waterflea 

(Daphnia magna) 

EC50 = 1910 μg ai/L 

NOAEC = 690 μg ai/L 

No sub-lethal effects 

Moderately 

toxic 

45499007 

Supplemental 

Freshwater fish 

Acute 

Metabolite 

chlorophenyl 

urea 275-

352 I 

(96.2%) 

Rainbow trout 

(Oncorhynchus 

mykiss) 

LC50 = 0.530 mg ai/L 

NOAEC (sub-lethal 

effects) = 0.144 mg ai/L 

Sub-lethal effects: 

darkened eye orbits, 

hyperventilation, loss of 

coordination, nervous 

behavior, lethargy, 

darkened 

Highly toxic 45499006 

Acceptable 

Aquatic plants 

and algae 

Metabolite 

chlorophenyl 

urea 275-

352 I 

(96.2%) 

Non-vascular plant 

Green algae 

(Pseudokircherniella 

subcapitata) 

Cell Density 

EC50 = 0.33 mg ai/L 

NOAEC = 0.105 mg ai/L 

Growth Rate 

EC50 > 0.890 mg ai/L 

NOAEC = 0.105 mg ai/L 

Biomass 

EC50 = 0.32 mg ai/L 

NOAEC = 0.105 mg ai/L 

-- 

45638222 

Supplemental 

Terrestrial 

invertebrates 

Sub-chronic 

chlorophenyl 

urea (99.3%) 

Earthworm 

(Eisenia foetida) 

LC50 = 447 mg ai/kg-soil 

NOAEC = 171 mg ai/kgsoil 

LOAEC = 309 mg ai/kgsoil 

Mortality and reduction in 

body weight 

-- 

45638225 

Supplemental 

ECOSAR run estimates for chlorphenyl urea and chloraniline are presented in table 6.4 below. 

To verify the reliability of the ECOSAR predictions, the results are compared to known novaluron 

and chlorphenyl urea toxicity endpoints. As previously mentioned, no toxicity data are available 

for chloroaniline so only the ECOSAR estimate is included. The results suggest that ECOSAR 

generally under-estimates toxicity. Consequently, degradate data are necessary to properly evaluate 

the risks of this chemical.
21 

Table 6.4. ECOSAR Estimates for Chlorphenyl Urea and Chloraniline compared to known toxicity 

endpoints 

Toxicity 

Novaluron 

(effects 

studies) 

Novaluron 

 (ECOSAR 

estimate) 

Chlorophenyl urea 

(effects studies) 

Chlorophenyl 

urea (ECOSAR 

estimate) 

Chloroaniline 

(ECOSAR 

estimate) 

Concentration (μg ai/L) 

Acute 

freshwater fish LC50 > 960 LC50 = 919 LC50 = 530 LC50 = 14355 LC50 = 4790 

Acute 

freshwater 

invertebrate 

LC50 = 4.31 LC50 = 9.0 LC50 = 1910 LC50 = 4021 LC50 = 2146 

Non-vascular 

aquatic plant EC50 > 9680 EC50 = 37.0 EC50 = 320 EC50 = 184 EC50 = 1649 

d. Ecological Incidents 

The ecological incident information system (EIIS) is an Office of Pesticide Programs database 

that houses ecological incidents that have been reported to the Agency. When available, EIIS 

includes the date and location of an incident, type and magnitude of effects observed in various 

species, use(s) of pesticides known or suspected of contributing to the incident, and results of any 

chemical residue analysis or other analyses conducted during incident investigation. EIIS 

incidents are categorized according to the certainty that the incident resulted from pesticide 

exposure. The Avian Incident Monitoring System (AIMS) is a database administered by the 

American Bird Conservancy that contains publicly available data on reported avian incidents 

involving pesticides. Incidents listed in this database may also be in the EIIS. 

Searches of the Ecological Incident Information System (EIIS v. 2.1.1), Avian Incident 

Monitoring System (AIMS), and the aggregate Incident Data System were performed on 12/4/14. 

No ecological incidents were reported in any of the databases for novaluron or its degradates. 

Although incident reporting is required under FIFRA Section 6(a)(2), the absence of reports in 

EIIS does not indicate that the chemical has no effects on wildlife; rather, it is possible that 

incidents have gone unreported. 

7. Exposure Pathways of Concern 

The environmental fate properties and use patterns of novaluron indicate that direct spray, spray 

drift, leaching to ground water, and runoff represent potential transport mechanisms to aquatic 

and terrestrial organisms. Drinking water and inhalation exposure pathways were screened using 

the SIP (Screening Imbibition Program) and STIR (Screening Tool for Inhalation Risk) screening 

methods and were found to be exposure pathways of low concern (no LOC exceedances are 

expected) (Appendix 5). SIP and STIR are described in detail at: 

http://www.epa.gov/oppefed1/models/terrestrial/index.htm. 
22 

8. Analysis Plan 

a. Stressors of Concern 

i. Ecological Risk Assessment 

The stressors of ecological concern for terrestrial organisms are novaluron and its degradates. 

Novaluron regulates insect growth by interfering with the molting process. Consequently, 

endpoints based on effects to adults or non-molting juveniles do not accurately reflect the toxicity 

of the compound for molting organisms. Toxicity endpoints derived from chronic studies will be 

used to more appropriately assess the risks of this type of chemical because the endpoints capture 

a molting stage; critical to evaluating effects of an insect growth regulator. No observed adverse 

effects concentrations (NOAECs) from the chronic guideline tests will be used to evaluate both 

acute and chronic risk for terrestrial invertebrates. Acute toxicity data will still be used to assess 

acute risk concerns for birds and mammals. While adult honeybees have not displayed much 

sensitivity to novaluron, larval studies are not available and will be necessary to proceed with 

assessing risk to bees. Additionally, terrestrial invertebrates (earthworms) have also displayed a 

greater sensitivity to the degradate chlorophenyl urea than the parent novaluron. 

The stressors of concern for aquatic organisms are novaluron and its major degradates 

chlorophenyl urea and chloroaniline. As with the terrestrial assessment, endpoints based on 

effects to adults or non-molting juveniles do not accurately reflect the toxicity of the compound 

for molting organisms. Toxicity endpoints derived from chronic studies, in addition to acute 

studies, will be used to more appropriately assess the risks of this type of chemical because they 

endpoints capture a molting stage; critical to evaluating effects of an insect growth regulator. No 

observed adverse effects concentrations (NOAECs) from the chronic guideline tests will be used 

with acute endpoints to assess risk for aquatic invertebrates. Risk concerns for aquatic fish and 

aquatic plants will be also assessed with acute and chronic endpoints. In addition, available 

toxicity data shows that aquatic plants, freshwater invertebrates and freshwater fish have some 

sensitivity to the degradate chlorophenyl urea. No data are available for chloroaniline. Both 

degradates will be considered stressors of concern for the risk assessment of aquatic organisms 

(i.e. aquatic plants, aquatic invertebrates, and fish) and modeled using the toxic equivalency 

(TEQ) approach to assess both the parent and degradates when data are available. For 

chloroaniline, without toxicity data ECOSAR estimates of toxicity endpoints will be used in this 

approach. 

ii. Drinking Water 

If a new drinking water assessment is needed, it will include the parent novaluron and degradates 

chlorophenyl urea (275-352I) and chloroaniline (275-309I) based on the MARC memorandum of 

the HED (USEPA 2004c, D278044). The assessment will be performed based on EFED’s current 

guidance using appropriate surface and groundwater models. Descriptions of all executable 

versions of current models for drinking water exposure can be obtained from URL link: 

http://www.epa.gov/oppefed1/models/water/. 
23 

b. Measures of Exposure 

EFED will use the latest standard available models to evaluate potential exposures to aquatic and 

terrestrial organisms as described at http://www.epa.gov/pesticides/science/models_db.htm. The 

parent novaluron only will be assessed for terrestrial exposures independently and where data are 

available a TEQ approach will be used for the parent and degradates chlorophenyl urea (275-

352I)/chloroaniline (275-309I) for aquatic exposures. 

i. Available Monitoring Data 

The Agency is aware of monitoring conducted by federal and state agencies such as U.S. 

Geological Survey (USGS) National Water Quality Assessment (NAWQA) Data Warehouse and 

California Environmental Data Exchange Network (CEDEN). This exposure data will be 

considered in the assessment to the extent that data on novaluron and/or its degradates are 

available. 

c. Measures of Effect 

Toxicity data presented in Section 6 of this problem formulation will be used to calculate risk 

quotients. Any additional information submitted by the registrant or found in the open literature 

prior to conducting the risk assessment will also be considered. The open literature studies are 

identified using EPA’s ECOTOXicology database (ECOTOX), which employs a literature search 

engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. The 

evaluation of both sources of data can also provide insight into the direct and indirect effects of 

pesticides on biotic communities from loss of species that are sensitive to the chemicals and from 

changes in structure and functional characteristics of the affected communities. 

9. Endangered Species Assessments 

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the 

Agency will evaluate risks to federally listed, threatened, and/or endangered (listed) species from 

registered uses of pesticides in registration review. The process for evaluating potential risks to 

listed species is further described at 

http://www.epa.gov/oppfead1/endanger/litstatus/riskasses.htm. 

 

10. Endocrine Disruptor Screening Program 

Novaluron was not included in the first group of 67 chemicals nor the second group of 109 

chemicals that will or have been issued an order to conduct Tier 1 Endocrine Disruptor Screening 

Program (EDSP) testing. For additional information the EDSP program, visit 

http://www.epa.gov/endo/. 
24 

11. Preliminary Identification of Data Gaps 

a. Environmental Fate 

Table 11.1 identifies environmental fate studies by MRID that offer data for each guideline 

requirement, as well as study classifications and whether or not further data are needed to support 

the risk assessment. There are no environmental fate studies available for either major degradates 

of novaluron (i.e., chlorophenyl urea and chloroaniline). Since EFED is using the TEQ approach 

to assess risk to aquatic organisms (i.e., plants, fish and aquatic invertebrates) in the Registration 

Review ecological risk assessment, environmental fate input parameter data for chlorophenyl urea 

and chloroaniline would facilitate the modeling of EECs. In the absence of data, EFED will 

assume these degradates are stable and use QSAR modeling (EPISuite ver. 4.0) to estimate the 

physical and chemical properties needed for modeling inputs. Additional environmental fate and 

physicochemical properties of major degradates can reduce the uncertainties in the aquatic 

exposure assessment. 

Table 11.1. Submitted Environmental Fate Data for Novaluron 

OCSPP 

Guideline 

Data 

Requirement 

Source 

MRID 

Classification Are data 

needed to 

conduct 

risk 

assessment?

Justification and Assumptions EPA Will 

Make in the Absence of Data 

835.2120 Hydrolysis 44961008 Acceptable No --- 

835.2240 Aqueous 

Photolysis 45638203 Supplemental No --- 

835.2410 Soil Photolysis 45638204 Acceptable No --- 

835.4100 Aerobic Soil 

Metabolism 

44961009 

44961010 

Acceptable 

Supplemental No --- 

835.4200 Anaerobic Soil 

Metabolism 

45638205 Supplemental No --- 

835.4300 Aerobic Aquatic 

Metabolism 45638206 Supplemental No ---

835.4400 Anaerobic 

Aquatic 

Metabolism 

45638207 

45789203

Partially 

Acceptable1 No ---

835.1230 

835.1240 

Adsorption/ 

Desorption and 

Leaching 

44961011 

44961012 

45638201 

45638202 

Supplemental No --- 

835.6100 

164-1 

Terrestrial Field 

Dissipation 

45638403 

45638404 

45789204 

Supplemental 

Acceptable 

Acceptable 

No --- 

850.6100 

ECM/ILV (soil 

and water) --- --- Yes 

ECM/ILV (soil and water) for parent and 

metabolites: chlorophenyl urea (275-352I) 

and chloroaniline (275-309I) 
25 

OCSPP 

Guideline 

Data 

Requirement 

Source 

MRID 

Classification Are data 

needed to 

conduct 

risk 

assessment?

Justification and Assumptions EPA Will 

Make in the Absence of Data 

850.1730 

165-4 

Fish 

bioconcentration 

45638215 

45785802 Supplemental No --- 

NonGuideline 

Study 

Biological 

effects on fresh 

water aquatic 

ecosystems -

microcosm 

study 

45785801 Supplemental No --- 

1

The portion of this study, conducted with [chlorophenyl-U-14C]-labeled novaluron, is classified acceptable

b. Ecological Effects 

Table 11.2 and Table 11.3 identify ecological effects studies by MRID that offer data for each 

guideline requirement, as well as study classifications and whether or not further data are needed 

to support risk assessment. Rationale for the additional data requested is presented below the 

tables. No chronic data are available for estuarine/marine fish and the acute estuarine/marine fish 

toxicity endpoint was non-definitive (greater than). Two acute studies with TGAIs for freshwater 

fish and one for estuarine/marine fish all produced non-definitive endpoints with no effects. 

Without a definitive acute toxicity value the chronic toxicity cannot be estimated and it remains 

unclear if chronic risks are possible for estuarine/marine fish or which group (freshwater or 

estuarine/marine fish) is more sensitive to novaluron. A definitive acute toxicity value using 

TGAI for freshwater fish using the rainbow trout would make it possible to calculate a 

conservative chronic endpoint estimate for estuarine/marine fish by comparing the freshwater 

definitive endpoints to the estuarine/marine endpoints. Terrestrial plant toxicity endpoints used to 

evaluate risks to listed and non-listed species were non-definitive for dicots. While both Tier I 

seedling emergence and vegetative vigor tests, yielded LC50 endpoints greater than the highest 

concentration tested, effects were observed in dicots (statistically significant 14% reduction in dry 

weight with some signs of phytotoxicity that appeared to be treatment-related) in both the vegetative 

vigor, and the seedling emergence (under review at the Agency). Additional data or a study to 

establish a NOAEC for dicots is required to assess risk to plants. 
26 

Table 11.2. Aquatic Ecological Effects Data for Novaluron and Remaining Data Gaps

OCSPP 

Guideline 

Data 

Requirement 

Submitted 

Studies (MRID) 

Study 

Classifications 

Are data 

needed to 

conduct risk 

assessment? 

Justification and 

Assumptions EPA will 

Make in Absence of 

Data 

 850.1010 Freshwater 

invertebrate 

acute toxicity 

45638413 

(water flea) 

Acceptable No No acceptable TGAI1 

studies exist for 

freshwater invertebrates. 

A definitive endpoint 

only exists for MRID 

45638314 using a 

formulation. Chronic 

toxicity tests whose 

duration covers a molting 

stage better characterize 

the risk from this type of 

chemical due to the mode 

of action as in IGR. 

Acute risks will be 

evaluated using chronic 

toxicity endpoints and 

may be further 

characterized using the 

available TEP2

 data. 

850.1025 

850.1035 

 

Saltwater 

invertebrate 

acute toxicity 

45638208 

(mollusk) 

Acceptable No -- 

45638209 

(mysid) 

Acceptable 

 850.1075 Freshwater fish 

acute toxicity 

45638314 

(rainbow trout) 

Acceptable No No acceptable TGAI1 

studies exist for 

freshwater fish. A 

definitive endpoint only 

exists for a study using 

the rainbow trout and a 

formulation (MRID 

45638314). The nondefinitive endpoints from 

the two listed studies are 

greater than the parent 

solubility limit and will 

be used to characterize 

risk based on a 

comparison with the 

definitive TEP2

 study 

endpoint. 

45499005 

(bluegill sunfish) 

Supplemental 

45499004 

(rainbow trout) 

 850.1075 Saltwater fish 

acute toxicity 

45638210 Supplemental No 

 850.1300 Freshwater 

invertebrate 

life cycle 

46581401 

(daphnid) 

Acceptable No 
27 

OCSPP 

Guideline 

Data 

Requirement 

Submitted 

Studies (MRID) 

Study 

Classifications 

Are data 

needed to 

conduct risk 

assessment? 

Justification and 

Assumptions EPA will 

Make in Absence of 

Data 

 850.1350 Saltwater 

invertebrates 

life cycle 

45638212 

(mysid) 

Supplemental No The supplemental study 

is considered 

scientifically sound for 

use in the risk 

assessment. 

 850.1400 Freshwater fish 

early-life stage 

(None) N/A No There is no 60 day 

chronic study using 

TGAI1 for freshwater 

fish. Chronic risks to fish 

will be estimated using a 

non-guideline 28 day 

sub-chronic study 

(MRID 45638216). The 

28 day study did not 

exhibit any effects, and is 

considered less 

conservative than the 60 

day endpoint. 
28 

OCSPP 

Guideline 

Data 

Requirement 

Submitted 

Studies (MRID) 

Study 

Classifications 

Are data 

needed to 

conduct risk 

assessment? 

Justification and 

Assumptions EPA will 

Make in Absence of 

Data 

 850.1400 Saltwater fish 

early-life stage 

(None) N/A Yes No chronic data are 

available for 

estuarine/marine fish. It 

is uncertain if 

estuarine/marine fish are 

more or less sensitive 

than freshwater fish to 

novaluron (the 

estuarine/marine and 

freshwater fish acute 

values were nondefinitive. In the 

absence of estuarine 

marine data, an acute 

freshwater fish test 

(TGAI1

) with the 

rainbow trout yielding 

a definitive endpoint 

would allow EFED to 

calculate a conservative 

chronic endpoint using 

an acute to chronic 

ration (ACR). Risks 

cannot be precluded 

without an endpoint to 

characterize risk.

 850.1500 Fish life cycle (None) N/A No -- 

850.1735 Whole sediment – 

sub-chronic 

freshwater 

invertebrates 

47621901 

(midge) 

Supplemental No The supplemental study 

is considered 

scientifically sound for 

use in the risk 

assessment 

Non-guideline Whole sediment – 

chronic freshwater 

invertebrates 

48690102 

(midge) 

Supplemental Yes Current testing for 

sediments requires 

additional species. 

Available data only 

addresses a single 

species. A TGAI1

 test 

with Hyalella azteca for 

potential differential 

sensitivity among 

sediment organisms is 

required. A protocol 

should be submitted in 

advance of conducting 

the study. 
29 

OCSPP 

Guideline 

Data 

Requirement 

Submitted 

Studies (MRID) 

Study 

Classifications 

Are data 

needed to 

conduct risk 

assessment? 

Justification and 

Assumptions EPA will 

Make in Absence of 

Data 

850.1740 Whole sediment – 

chronic freshwater 

invertebrates 

None N/A Yes An estuarine/marine 

organism is required for 

sediment testing. A 28 

day TGAI1

 test with 

additional Leptocheirus 

plumulosus should be 

performed to evaluate 

the potential 

differential sensitivity 

among sediment 

organisms. A protocol 

should be submitted in 

advance of conducting 

the study. 

850.4400 Aquatic vascular 

plant toxicity test 

using Lemna spp. 

45638223 Acceptable No -- 

850.4500 Non-vascular plant 

toxicity 

45638221 (green 

algae) 

Supplemental Yes Three species, a 

freshwater algae, 

freshwater diatom, and 

estuarine/marine diatom 

are required. Only data 

for green algae are 

available. Data to 

evaluate the relative 

sensitivities of vascular 

plant species are 

required for risk 

assessment.

850.4550 Non-vascular plant 

toxicity 

Cyanobacteria 

Freshwater 

diatom 

Estuarine/marine 

diatom 

N/A Yes 

1

TGAI = technical grade active ingredient 

2

TEP = typical end-use product 

Table 11.3 Terrestrial Ecological Effects Data for Novaluron and Remaining Data Gaps

OCSPP 

Guideline 

Data 

Requirement 

Submitted 

Studies 

(MRID) 

Study 

Classifications 

Are data 

needed for 

risk 

assessment? 

Justification and 

Assumptions EPA will 

Make in Absence of Data 

 850.2100 Avian oral 

toxicity 

45476801 

(bobwhite) 

Acceptable No -- 

45499001 

(mallard) 

Supplemental 

48690102 

(zebra finch) 

Acceptable 

 850.2200 Avian dietary 

toxicity 

45499002 

(bobwhite) 

Acceptable No -- 
30 

OCSPP 

Guideline 

Data 

Requirement 

Submitted 

Studies 

(MRID) 

Study 

Classifications 

Are data 

needed for 

risk 

assessment? 

Justification and 

Assumptions EPA will 

Make in Absence of Data 

45499003 

(mallard) 

Acceptable 

 850.2300 Avian 

reproduction 

45638218 

(bobwhite) 

Acceptable No -- 

45638219 

(mallard) 

Acceptable 

Non-guideline Avian 

inhalation 

(None) N/A No -- 

 850.3020 Honeybee 

adult acute 

contact 

toxicity 

45638220 Acceptable No -- 

Non-guideline 

(OECD 213) 

Honeybee 

adult acute 

oral toxicity 

45638220 Supplemental No The supplemental study is 

considered scientifically 

sound for use in the risk 

assessment 

Non-guideline4 Honeybee 

adult chronic 

toxicity 

(including 

acute 

endpoints) 

(none) N/A No Due to the mode of action 

affecting molting juvenile 

insects, adults are not 

expected to be sensitive to 

novaluron. 

Non-guideline4 Honeybee 

larval chronic 

toxicity 

(including 

acute 

endpoints) 

(none) N/A Yes A chronic larval test 

should be performed with 

novaluron (TGAI1

). In the 

absence of data, risks will 

be presumed to larval 

honeybees based on the 

expected increased toxicity 

to larvae versus adults. 

Non-guideline Residues in 

pollen and 

nectar 

(none) N/A Yes Additional studies may be 

necessary if risk concerns 

are identified for juvenile 

bees at the tier I level. 

Pollen/nectar residue data 

may be required to refine 

the risk assessment to bees. 

A protocol should be 

submitted in advance of 

conducting the study. 

 850.3040 45638407 Supplemental Yes 
31 

OCSPP 

Guideline 

Data 

Requirement 

Submitted 

Studies 

(MRID) 

Study 

Classifications 

Are data 

needed for 

risk 

assessment? 

Justification and 

Assumptions EPA will 

Make in Absence of Data 

Field testing 

for 

pollinators 

45638409 Supplemental Additional semi-field or 

field studies may be 

necessary if risk concerns 

are identified for juvenile 

bees at the tier I level. 

Pollen/nectar residue data 

may be required to refine 

the risk assessment to bees. 

A protocol should be 

submitted in advance of 

conducting the study. 

850.4100 Seedling 

Emergence 

and Seedling 

Growth 

48690103 Under review1 Yes This study is under review 

and a final determination 

has not been made. 

Results indicate a nondefinitive NOAEC for 

dicots (bean). Without a 

definitive NOAEC risks 

for listed plants cannot be 

precluded. 

850.4150 Vegetative 

Vigor 

48690103 Acceptable Yes A NOAEC was not 

established for dicots 

(bean). Without a 

definitive NOAEC risks 

for listed plants cannot be 

precluded. 1

TGAI = technical grade active ingredient 

2

TEP = typical end-use product 

3 The study is currently under review and a final determination has not yet been made.

Effects data and data gaps for the degradates are listed below in table 11.4. Since some 

chlorphenyl urea data indicate the degradate is more toxic than the parent to some aquatic taxa, 

aquatic guideline studies are requested below. Toxicity data are not available for the 

chloroaniline degradate; however, given the similarity in chemical structure between 

chloroaniline and chlorophenyl urea, it is assumed that the former will be more similar in its 

toxicity to chlorophenyl urea than to the parent, novaluron. Select studies are requested for this 

degradate (chloroaniline) to help establish if equal toxicity can be assumed, or if chloroaniline 

may actually be more toxic than the chlorophenyl urea. Additional data may be required pending 

results of the requested data based on the toxicity results. 

 
32 

Table 11.4. Ecological Effects Data for Degradates Chlorphenyl Urea/Chloroaniline and 

Remaining Data Gaps 

OCSPP 

Guideline 

Data 

Requirement 

Submitted 

Studies 

(MRID) 

Study 

Classifications 

Are data 

needed to 

conduct 

risk 

assessment? 

Justification and Assumptions 

EPA will Make in Absence of 

Data - Some Example texts are 

include 

 850.1010 Freshwater 

invertebrate 

acute toxicity 

45638413 

(Chlorphenyl 

urea) 

Supplemental No Comparisons to the parent study 

will be characterized based on the 

available data. The degradate 

study was done with a TGAI1

while the acceptable parent study 

is with a formulation (TEP2

). 

850.1025 

850.1035 

850.1045 

850.1055 

Saltwater 

invertebrate 

acute toxicity 

None (N/A) Yes No data are available for the 

chloroaniline or chlorphenyl urea. 

A study is requested to establish 

the toxicity of chlorphenyl urea 

to invertebrates, a group 

sensitive to the parent.

 850.1075 Freshwater 

fish acute 

toxicity 

45499006 

(Chlorophenyl 

urea) 

Acceptable Yes No data are available for the 

chloroaniline degradate. The 

chloroaniline degradate is 

expected to be equivalent or more 

toxic than the chlorophenyl urea 

degradate, based on similarity in 

chemical structure. A study with 

the chloroaniline degradate 

would reduce the uncertainty 

surrounding the actual toxicity 

of this degradate.

 850.1075 Saltwater fish 

acute toxicity 

None (N/A) No Additional data is not requested at 

this time but may be requested at a 

later date pending results of the 

requested toxicity studies. 

 850.1300 Freshwater 

invertebrate 

life cycle 

None (N/A) Yes Given that aquatic invertebrates 

are a group sensitive to the parent 

novaluron a toxicity study for 

both degradates would establish 

a reference point between 

novaluron and its degradates for 

this stage. 
33 

OCSPP 

Guideline 

Data 

Requirement 

Submitted 

Studies 

(MRID) 

Study 

Classifications 

Are data 

needed to 

conduct 

risk 

assessment? 

Justification and Assumptions 

EPA will Make in Absence of 

Data - Some Example texts are 

include 

 850.1350 Saltwater 

invertebrates 

life cycle 

None (N/A) Yes Given that aquatic invertebrates 

are a group sensitive to the parent 

novaluron, a toxicity study for 

chlorophenyl urea would reduce 

uncertainty of the actual 

degradate toxicity to 

estuarine/marine invertebrates.

 850.1400 Freshwater 

fish 

early-life 

stage 

None (N/A) Yes Chlorphenyl urea was considered 

very highly toxic to the rainbow 

trout on an acute basis. A chronic 

study with chlorophenyl urea 

would reduce uncertainty and 

make comparisons to see if these 

fish are more sensitive to the 

degradate than the parent on a 

chronic basis. 

 850.1400 Saltwater fish 

early-life 

stage 

None (N/A) No Additional data is not requested at 

this time but may be requested at a 

later date pending results of the 

requested toxicity studies. 

 850.1500 Fish life cycle None (N/A) No Additional data is not requested at 

this time but may be requested at a 

later date pending results of the 

requested toxicity studies. 

850.4400 Aquatic plant 

Toxicity Test 

using Lemna 

spp. 

None (N/A) Yes No toxicity data on the degradates 

are available for aquatic vascular 

plants. Because aquatic nonvascular plants were more 

sensitive to chlorphenyl urea than 

the parent novaluron additional 

data with chlorophenyl urea for 

vascular plants would help clear 

up uncertainty regarding the 

toxicity of this degradate to 

these plants.
34 

OCSPP 

Guideline 

Data 

Requirement 

Submitted 

Studies 

(MRID) 

Study 

Classifications 

Are data 

needed to 

conduct 

risk 

assessment? 

Justification and Assumptions 

EPA will Make in Absence of 

Data - Some Example texts are 

include 

850.4500 Algal toxicity 45638222 

(Chlorphenyl 

urea) 

Supplemental 

(algae) 

Yes No data are available for any 

additional species or the 

chloroaniline degradate. The 

chloroaniline degradate is 

expected to be equivalent or more 

toxic than the chlorophenyl urea 

degradate, based on similarity in 

chemical structure. Chlorphenyl 

urea data indicate that it is more 

toxic to green algae than 

novaluron. A green algal study 

with chloroaniline and another 

species of freshwater or 

saltwater diatom on chlorphenyl 

urea would establish the 

comparison of relative sensitives 

of this taxa.

850.4550 Cyanobacteria None (N/A) No Additional data is not requested at 

this time but may be requested at a 

later date pending results of the 

requested toxicity studies. 

1

TGAI = technical grade active ingredient 

2

TEP = typical end-use product 

Additional justification for non-guideline data requests: 

Study Title: Tier 1- Larval Honeybee Acute and Chronic Oral Exposure

Rationale for Requiring the Data

Developing bee brood (i.e., larvae and pupae) can be exposed to pesticides through residues 

brought back to the colony by worker bees foraging in areas where the pesticide has been 

applied. While larvae are typically fed royal or brood jelly during their early stages of 

development, worker bee (females) and drone (males) larvae are also fed pollen/honey (bee 

bread) directly by in-hive nurse bees. EPA guidance (USEPA 2014c) on assessing the risk of 

pesticides to bees identifies a suite of laboratory-based studies intended that serve as the 

foundation for screening chemical for potential acute and chronic effects to larval bees. 

Practical Utility of the Data 

How will the data be used? 

The 21-day larval toxicity study1 under development by OECD provides both acute and 

chronic toxicity data on developing bee brood and will yield a median lethal dose (LD50) for 

assessing acute toxicity during the early part of the study as well as a 21-day no-observed 

adverse effect level (NOAEL) and lowest-observed adverse effect level (LOAEL) for 

assessing chronic effects. Alternatively, registrants may submit a separate acute (single dose) 

larval toxicity study following OECD Guideline 2372 as well as the 21-day repeat dose 

chronic toxicity study to address both acute and chronic larval endpoints. Effects on survival 
35 

and development (adult bee emergence) from repeat exposures to the active ingredient will be 

used in estimating chronic risk to individual brood. A protocol for the 21-day larval toxicity 

test should be submitted to the Agency for review before commencing the study and should 

include provisions for measuring the concentration of novaluron in the actual diet of the 

honeybee. 

How could the data impact the Agency’s future decision-making? 

Effects on survival and development from repeat exposures to the active ingredient will be 

used in estimating acute and chronic risk to individual brood. Risk estimates based on these 

data will be considered along with other lines of evidence to determine whether higher-tier 

studies are needed at the whole colony level. 

[1] Draft guidance for the 21-day larval toxicity study is available 

at: http://www.oecd.org/env/ehs/testing/Draft_GD_honeybees_rep_exp_for_2nd_CR_25_November_2013.pdf [2] OECD Guideline 237 is available at: http://www.oecdilibrary.org/docserver/download/9713171e.pdf?expires=1407449911&id=id&accname=guest&checksum=E67BEDEB01DB12D815E858CB45A

989FB

Study Title: Tier II Semi-Field Testing with Honeybee Colonies

Rationale for Requiring the Data

Bees can be exposed to pesticides through multiple pathways including contact with sprays 

and dusts and through ingestion of residues in food/water (e.g., pollen/nectar and water used 

to maintain colony temperature). Worker bees foraging on flowers for pollen and nectar can 

be exposed to residues in pollen and nectar either through direct contamination of these 

matrices by foliar sprays and/or dusts. Residues can in turn be brought back to bee colonies 

where in-hive bees including young adult and developing brood (i.e., eggs, larvae and pupae) 

may be exposed. EPA guidance on assessing the risk of pesticides to bees identifies a tiered 

process where the initial screen is based on a suite of acute and chronic laboratory studies 

individual adult bees and larvae. If screening-level assessment indicates potential chronic 

risks to individual bees, then higher-tier, semi-field testing studies may be required to 

examine potential effects at the colony level. Novaluron is an insect growth regulator that is 

applied to a variety of crops that rely on insect pollination. Residues on these crops can 

provide a route of exposure to foraging pollinators. 

Practical Utility of the Data 

How will the data be used? 

If acute tests with larval bees indicate that the novaluron is toxic to juvenile bees on an acute 

contact exposure basis and further effects are observed in chronic tests to individual bees, or 

acute and chronic test on honeybee larva, tier II studies such as the semi-field tests are needed 

(and may be requested) to determine whether whole colonies can be affected. 

If tests indicate that novaluron is toxic to juvenile bees on an acute or chronic exposure basis 

and further effects are observed in chronic tests to individual bees, or acute and chronic test 

on honeybee larva, tier II studies such as the semi-field tests may be needed to determine 

whether whole colonies can be affected. Pollen/nectar residue data may be required to refine 

the risk assessment to bees 
36 

How could the data impact the Agency’s future decision-making? 

Risk estimates based on these data will be considered along with other lines of evidence to 

determine whether higher-tier studies are needed at the whole-colony level to more precisely 

characterize the effects of real-world application. 

Study Title: Whole sediment: Chronic invertebrates freshwater invertebrates – TGAI with

Hyalella azteca

Rationale for Requiring the Data

Chronic sediment toxicity tests for the freshwater invertebrate midge (Chironomus riparius 

and Chironomus tentans) have been submitted to satisfy the Agency’s updated data 

requirements for outdoor uses in 40 CFR Part 158 (October 26, 2007); however, an additional 

epibenthic species is required. Based on the current use patterns, benthic organisms may be 

exposed to run-off or spray drift from novaluron uses. Novaluron, an insect growth regulator 

which can be persistent, affects molting invertebrates, and available studies with the infaunal 

midge indicate it is highly toxic to benthic invertebrates. An additional chronic sediment test 

encompassing a molting period is requested on a freshwater amphipod (e.g., Hyalella azteca) 

to establish sensitivity differences between the two species. Both freshwater species, Hyalella

and Chironomus differ substantially in their ecological niche (i.e., epibenthic vs. infaunal 

species), life history and phylogeny. 

 

Practical Utility of the Data 

How will the data be used? 

Data from sediment toxicity studies will be used to estimate potential risks to benthic 

organisms associated with uses of novaluron. The data will reduce uncertainties associated 

with the current risk assessment for benthic species and will improve our understanding of the 

potential effects of novaluron on aquatic ecosystems. 

How could the data impact the Agency’s future decision-making? 

Available data indicates that registered novaluron uses pose a risk of adverse effects to nontarget benthic organisms above the Agency Level of Concern. With data for the additional 

species, the Agency may explore other decision options to mitigate this risk. The lack of these 

data will limit the flexibility the Agency and registrants have in coming into compliance with 

the Endangered Species Act, and could result in use restrictions for novaluron which may 

otherwise be avoided, or which are unnecessarily severe. 

12. References 

FAO. 2000. Appendix 2. Parameters of pesticides that influence processes in the soil. In FAO

Information Division Editorial Group (Ed.), Pesticide Disposal Series 8. Assessing Soil

Contamination. A Reference Manual. Rome: Food & Agriculture Organization of the

United Nations (FAO). Available at

http://www.fao.org/DOCREP/003/X2570E/X2570E06.htm (Accessed Nov 14, 2014).
37 

USEPA. 2004a. Novaluron Estimated Drinking Water Concentration for Use in the Human 

Health Drinking Water Risk Assessment. D285477 and D285479. 20pp. 

USEPA. 2004b. Overview of the Ecological Risk Assessment Process in the Office of Pesticide 

Programs. Office of Prevention, Pesticides, and Toxic Substances. Office of Pesticide 

Programs. Washington, D.C. January 23, 2004.

USEPA. 2004c. Novaluron. Report of the Metabolism Assessment Review Committee (MARC). 

D297646. 44pp. 

USEPA. 2007. Novaluron and Novaluron Degradates (Chlorophenyl urea and Chloroaniline) 

Drinking Water Assessment in Support of New Use Registration Action for Tomato, 

Sugarcane, and Increase in Application Rate to Brassica. D345672, D340579, D340581, 

and D340583. 3pp. 

USEPA. 2009a. Novaluron and Novaluron Degradates (Chlorophenyl urea and Chloroaniline) 

Drinking Water Assessment in Support of New Use Registration Action for Stone Fruit, 

Bushberries, Brassica Leafy Greens, and Turnip Greens. D357061. 17pp. 

 

USEPA. 2009. Novaluron and Novaluron Degradates (Chlorophenyl urea and Chloroaniline) 

Drinking Water Assessment in Support of New Use Registration Action for Sorghum, 

Fruiting Vegetables (Group 8, D364309), Cucurbit Vegetables (Group 9), Low-growing 

Berry Subgroup (13-07G), Snap and Dry Bean, and Swiss Chard. D363989 and 

D364309. 4pp. 

USEPA. 2010. Tier II Drinking Water Exposure Assessment for Novaluron and Novaluron 

Degradates (Chlorophenyl urea and Chloroaniline) in Support of the New Use 

Registration on Sweet Corn. D378389. 17pp. 

USEPA. 2011. Tier II Drinking Water Exposure Assessment for Novaluron and Novaluron 

Degradates Chlorophenyl Urea and Chloroaniline to Control German, Asian, and Brown 

Banded Cockroaches and Crickets in Residential Areas and Control Mosquito Larvae in 

Small Water Bodies. D387737, D387738 and sub-bean D388519 (parent bean D385667). 

3pp. 

USEPA. 2012. Drinking Water Assessment in Support of the New Use of Novaluron in Peanuts 

and Soybeans. D402324. 23pp. 

USEPA. 2013a. Drinking Water Assessment in Support of the New Indoor and Outdoor nonfood Use of Novaluron for Pest Control. D412441. 28pp. 

USEPA. 2013b. Ecological Risk Assessment for the Proposed New Uses of Novaluron on 

Indoor and Outdoor Control of Fleas, Roaches, Litter Beetles, Ants, and Flying Insect 

Pests; and Flies, Beetles, and Other Insect Pests in Cattle, Poultry, and Horse Operations. 

Environmental Fate and Effects Division, Office of Pesticide Programs, United States 

Environmental Protection Agency. 
38 

USEPA. 2014a. Novaluron screening level usage analysis. Biological and Economic Analysis 

Division, Office of Pesticide Programs, United States Environmental Protection Agency. 

USEPA. 2014b. Drinking Water Assessment in Support of IR-4 New and Revised Uses of 

Novaluron (RIMON® 0.83 EC) on Avocado; Beans, Berries (Low-Growing), 

Bushberries, Carrot; Cotton, Cucurbit Vegetables, Fruiting Vegetables, Head and Stem 

Brassica, Leafy Brassica Greens, Ornamentals (Container Grown Ornamentals in 

Greenhouses, Shadehouses, Outdoor Nurseries), Peanuts, Pears, Pome Fruits, Potatoes / 

Sweet Potatoes, Sorghum, Soybeans, Stonefruits, Sweet Corn, Sugarcane, Swiss Chard, 

and Turnip Greens. D418740. 3pp 

USEPA. 2014c. Guidance for Assessing Pesticide Risks to Bees. Environmental Fate and 

Effects Division, Office of Pesticide Programs, United States Environmental Protection 

Agency. 

Fate Bibliography 

MRID Citation Reference 

44961006 Comb, A.L. (1997). Rimon (Pure): Determination of the PhysicoChemical Properties. Report No: MAK418/970332. Unpublished 

study prepared by Makhteshim Chemical Works, Ltd. Huntingdon Life 

Sciences, Ltd. 106 p. 

44961008 Lahav, H. (1998) (Carbon-14)-Rimon: Hydrolysis Under Laboratory 

Conditions: Lab Project Number: 445/973392: R-9703. Unpublished 

study prepared by Makhteshim Chemical Works, Ltd. Huntingdon Life 

Sciences, Ltd. 123 p. 

45638203 Shaw, D. (1998) (Carbon-14)-"Rimon": Photolytic Degradation in 

Water: Lab Project Number: MAK/443: R-9705: MAK 443/973390. 

Unpublished study prepared by Huntingdon Life Sciences, Ltd. 112 p. 

45638204 Shaw, D. (1998) (Carbon-14)-"Rimon": Photodegradation on Soil: Lab 

Project Number: MAK 444/973391: R-9704: MAK/444. Unpublished 

study prepared by Huntingdon Life Sciences, Ltd. 89 p. 

44961009 Aikens, P. (1999) (Carbon-14)-Rimon: Aerobic Soil Rate of 

Degradation: Lab Project Number: R-10030: MAK483/984569: 

SSHQ/164/98. Unpublished study prepared by Makhteshim Chemical 

Works, Ltd. and Huntingdon Life Sciences, Ltd. 102 p. 

44961010 Aikens, P. (1998) (Carbon-14)-Rimon: Aerobic Soil Metabolism (Pilot 

Study): Lab Project Number: MAK 446: R-9415: MAK446/974308. 

Unpublished study prepared by Makhteshim Chemical Works, Ltd. and 

Huntingdon Life Sciences, Ltd. 88 p. 
39 

45638207 Shepler, K.; Schick, M. (2002) Anaerobic Aquatic Metabolism of 

(Carbon-14)-Novaluron: Lab Project Number: 1028W-1: 1028W. 

Unpublished study prepared by PTRL West, Inc. 174 p. 

45789203 Shepler, K.; Schick, M. (2002) Anaerobic Aquatic Metabolism of 

Carbon 14 Novaluron: Lab Project Number: 1028W-2: 1028W: UCC 

2002-024. Unpublished study prepared by PTRL West, Inc. 203 p. 

45638205 Shaw, D. (1999) (Carbon-14)-"Rimon": Anaerobic Soil Metabolism: 

Lab Project Number: MAK/497: MAK 497/982727: R-10231. 

Unpublished study prepared by Huntingdon Life Sciences, Ltd. 111 p. 

45638206 Aikens, P. (1999) (Carbon-14)-"Rimon": Degradability and Fate in the 

Water/Sediment System: Lab Project Number: MAK 484/984634: R10031: MAK/484. Unpublished study prepared by Huntingdon Life 

Sciences, Ltd. 160 p. {OPPTS 835.4300} 

44961011 Shaw, D. (1998) (Carbon-14)-Rimon: Soil Column Leaching: Lab 

Project Number: MAK/472: R-10005: MAK472/974399. Unpublished 

study prepared by Makhteshim Chemical Works, Ltd. and Huntingdon 

Life Sciences, Ltd. 87 p. 

44961012 Aikens, P. (1997) (Carbon-14)-Rimon: Adsorption/Desorption on Soil: 

Lab Project Number: R-9667: MAK424: MAK424/973308. 

Unpublished study prepared by Makhteshim Chemical Works, Ltd. and 

Huntingdon Life Sciences, Ltd. 68 p. 

45638201 Aikens, P. (1999) (Carbon-14)-275-352 I: Adsorption/Desorption on 

Soil: Lab Project Number: MAK/528/992496: R-10639: MAK/528. 

Unpublished study prepared by Huntingdon Life Sciences, Ltd. 119 p. 

45638202 Shaw, D. (1999) (Carbon-14)-"Rimon": Aged Residue Soil Column 

Leaching: Lab Project Number: MAK 496/982726: R-10232. 

Unpublished study prepared by Huntingdon Life Sciences, Ltd. 96 p. 

45638403 Wilson, A. (2001) Novaluron: Terrestrial Field Dissipation Study with 

"Rimon" 10EC Applied to Bare Soil in Spain and Germany, 1999: Lab 

Project Number: MAK/547/004242: MAK/547: R-10971. Unpublished 

study prepared by Huntingdon Life Sciences, Ltd. 175 p. 

45638404 Willard, T. (2002) Terrestrial Field Soil Dissipation of Novaluron: 

Interim Study Report: Lab Project Number: AA010702: R-13885: 

990W. Unpublished study prepared by American Agricultural Services, 

Inc. and PTRL West, Inc. 676 p. 

45789204 Willard, T. (2002) Terrestrial Field Study Dissipation of Novaluron: 

Final Study Report: Lab Project Number: AA010702: R-13885: 2001-

099. Unpublished study prepared by American Agricultural Services, 

Inc. and PTRL West, Inc. 678 p. 

45785801 Jenkins, W. (2002) Novaluron (Rimon 10EC): Assessment of its 

Potential Biological Effects on Freshwater Aquatic Ecosystems Based 
40 

on its Application to Outdoor Microcosms: Lab Project Number: 

MAK/531: R-10698. Unpublished study prepared by Huntingdon Life 

Sciences Ltd. 625 p. {OPPTS 850.1950} 

45638215 Jenkins, C.A. 2000. 14c "RIMON: Bioconcentration in bluegill sunfish. 

Unpublished study performed by Huntingdon Life Sciences Ltd., 

Suffolk, England; sponsored and submitted by-Makhteshim Chemical 

Works, Ltd., Beer-Sheva, Israel. Study No.: R-9414. Final report issued 

May 3, 2000. 

45785802 Jenkins, C.A. 2000, 14C Novaluron: Depuration in rainbow trout 

following exposure to the test substance for 24 hours. Unpublished 

study performed by Huntingdon Life Sciences Ltd., Cambridgeshire, 

England; sponsored and submitted by Makhteshim Chemical Works 

Ltd., Beer-Sheva, Israel. Study No.: PC- 14841. Experimental start date 

March 20, 2002, and completion date August 1, 2002 (p. 9). Final report 

issued September 12, 2002. 

Ecological Effects Bibliography 

MRID Citation Reference

45476801 Rodgers, M. (1998) "Rimon" Technical Acute Oral Toxicity (LD50) to 

Bobwhite Quail: Lab Project Number: MAK410/972113. Unpublished 

study prepared by Huntingdon Life Sciences, Ltd. 54 p. {OPPTS 

850.2100} 

45499001 Hakin, B.; Norman, A.; Anderson, A.; et al. (1989) The Acute Oral 

Toxicity (LD50) of GR 572 Technical to the Mallard Duck: Lab 

Project Number: AGR 68/89647. Unpublished study prepared by 

Huntingdon Research Centre Ltd. 44 p. {OPPTS 850.2100} 

48690102 Hubbard, P.; Beavers, J. (2011) Novaluron TGAI: An Acute Oral 

Toxicity Study with the Zebra Finch (Poephila gruttata). Project 

Number: 234/118, R/28269. Unpublished study prepared by Wildlife 

International, Ltd. 34p. 

45499002 Hakin, B.; Norman, A.; Anderson, A.; et al. (1989) The Dietary 

Toxicity (LD50) of GR 572 Technical to the Bobwhite Quail: Lab 

Project Number: AGR 69/89126. Unpublished study prepared by 

Huntingdon Research Centre Ltd. 46 p. {OPPTS 850.2200} 

45499003 Hakin, B.; Norman, A.; Anderson, A.; et al. (1988) The Dietary 

Toxicity (LD50) of GR 572 Technical to the Mallard Duck: Lab 

Project Number: AGR 67/89125. Unpublished study prepared by 

Huntingdon Research Centre Ltd. 45 p. {OPPTS 850.2200} 
41 

45638218 Rodgers, M. (1999) "Rimon" Technical: Reproduction in Bobwhite 

Quail: Lab Project Number: MAK411/972997: R-9417: MAK/411. 

Unpublished study prepared by Huntingdon Life Sciences Ltd. 291 p. 

45638219 Rodgers, M. (2001) "Rimon" Technical: Reproduction in Mallard 

Duck: Lab Project Number: MAK412/973000: R-9418: MAK 412. 

Unpublished study prepared by Huntingdon Life Sciences Ltd. 243 p. 

45499004 Douglas, M.; Bell, G.; Macdonald, I.; et al. (1989) The Acute Toxicity 

of GR 572 Technical to Rainbow Trout (Salmo gairdneri): Lab Project 

Number: AGR 63(C)/891282. Unpublished study prepared by 

Huntingdon Research Centre Ltd. 19 p. {OPPTS 850.1075} 

45499005 Douglas, M.; Sewell, I.; Macdonald, I.; et al. (1989) The Acute 

Toxicity of GR 572 Technical to Bluegill Sunfish (Lepomis 

macrochirus): Lab Project Number: AGR 63(D)/89960. Unpublished 

study prepared by Huntingdon Research Centre Ltd. 20 p. {OPPTS 

850.1075} 

45499006 Jenkins, C. (1999) 275-352 I Acute Toxicity to Rainbow Trout (GR 

572 Technical): Lab Project Number: MAK525/992450. Unpublished 

study prepared by Huntingdon Life Sciences Ltd. 43 p. {OPPTS 

850.1075} 

45638314 Jenkins, C. (1998) "Rimon" 10 EC: Acute Toxicity to Rainbow Trout: 

Final Report: Lab Project Number: MAK/462/982146: MAK/462: R9912. Unpublished study prepared by Huntingdon Life Sciences Ltd. 

46 p. 

45638406 Jenkins, C. (2000) "Rimon" 10EC: Prolonged Toxicity to Rainbow 

Trout Under Flow Through Conditions 28-Day Study: Final Report: 

Lab Project Number: MAK/537/993312: MAK/537: R-10933. 

Unpublished study prepared by Huntingdon Life Sciences Ltd. 49 p. 

45638216 Jenkins, C. (1998) "Rimon" Technical: Prolonged Toxicity to 

Rainbow Trout Under Flow-Through Conditions, 28-Day Study: Final 

Report: Lab Project Number: MAK/441: MAK441/974266: R-9840. 

Unpublished study prepared by Huntingdon Life Sciences Ltd. 44 p 

45476802 Jenkins, C. (1997) "Rimon" Technical: Acute Oral Toxicity to 

Daphnia magna: Final Report: Lab Project Number: MAK/404: 

MAK404/970470. Unpublished study prepared by Huntingdon Life 

Sciences, Ltd. 46 p. {OPPTS 850.1010} 

45499007 Jenkins, C. (1999) 275-352 I Acute Toxicity to Daphnia magna (GR 

572 Technical): Lab Project Number: MAK526/992451. Unpublished 

study prepared by Huntingdon Life Sciences Ltd. 40 p. {OPPTS 

850.1010} 

45638413 Jenkins, C. (1999) "Rimon" 10 EC: Acute Toxicity to Daphnia magna: 

Final Report: Lab Project Number: MAK/463/983514: R-9913: MAK 
42 

463. Unpublished study prepared by Huntingdon Life Sciences Ltd. 45 

p. 

45638208 Cafarella, M. (2002) Novaluron--Acute Toxicity to Eastern Oyster 

(Crassostrea virginica) Under Flow-Through Conditions: Lab Project 

Number: 11742.6141: R-14139: 011901/FIFRA/OPPTS/FT-OYSTER. 

Unpublished study prepared by Springborn Laboratories, Inc. 67 p. 

{OPPTS 850.1025} 

45638210 Machado, M. (2002) Novaluron--Acute Toxicity to Sheepshead 

Minnow (Cyprinodon variegatus) Under Flow-Through Conditions: 

Lab Project Number: 11742.6140: R-14138: 

020499/FIFRA/OPPTS/FT-SHM. Unpublished study prepared by 

Springborn Laboratories, Inc. 59 p. {OPPTS 850.1075} 

46086203 Albuquerque, R. (2003) Rimon 10 EC: Mysid Acute Toxicity Test. 

Project Number: MAK/783, MAK/783/032052. Unpublished study 

prepared by Huntingdon Life Sciences, Ltd. 58 p. 

45638209 Machado, M. (2002) Novaluron--Acute Toxicity to Mysids 

(Americamysis bahia) Under Flow-Through Conditions: Lab Project 

Number: 11742.6142: R-14136: 011901/FIFRA/OPPTS/FT-MYSIDS. 

Unpublished study prepared by Springborn Laboratories, Inc. 63 p. 

{OPPTS 850.1035} 

45638211 Jenkins, C. (1998) (Carbon-14)-"Rimon": Daphnia magna 

Reproduction Test: Final Report: Lab Project Number: MAK/405: 

MAK405/974265. Unpublished study prepared by Huntingdon Life 

Sciences Ltd. 59 p. 

45638212 Lima, W. (2002) Novaluron--Life-Cycle Toxicity Test with Mysids 

(Americamysis bahia): Lab Project Number: 11742.6143: R-14140. 

Unpublished study prepared by Springborn Laboratories, Inc. 80 p. 

45638213 Barrett, K. (2001) (Carbon-14)-"Rimon" Technical: Fish Early Life 

Stage Toxicity Test for Fathead Minnow (Pimephales promelas): Lab 

Project Number: MAK507: MAK507/994379: R-10281. Unpublished 

study prepared by Huntingdon Life Sciences Limited. 63 p. {OPPTS 

850.1400} 

46581401 Jenkins, C. (1998) (Carbon 14)-"Rimon": Daphnia magna 

Reproduction Test: Final Report. Project Number: MAK/405, 

MAK405/974265, R/9341. Unpublished study prepared by 

Huntingdon Life Sciences Ltd. 59 p. 

45785805 Caunter, J.; Williams, T. (2002) Novaluron Technical: Determination 

of Effects on the Life Cycle of the Fathead minnow (Pimephales 

promelas): Lab Project Number: AJ0047A. Unpublished study 

prepared by Brixham Environmental Laboratory. 65 p. 
43 

45638214 Caunter, J.; Williams, T. (2000) Novaluron: Determination of Effects 

on the Reproduction of Fathead Minnow (Pimephales promelas): Lab 

Project Number: BL6993/B: AH0411A: MAK630/012118. 

Unpublished study prepared by Brixham Environmental Laboratory. 

90 p. 

45638215 Jenkins, C. (2000) (Carbon-14)-"Rimon": Bioconcentration in Bluegill 

Sunfish: Final Report: Lab Project Number: MAK498/985004: R9414: MAK/498. Unpublished study prepared by Huntingdon Life 

Sciences Ltd. 173 p. 

45638405 Jenkins, C. (2001) "Rimon" 10EC: An Assessment of the 

Bioconcentration of "Rimon" in Rainbow Trout in a Mescosm: Final 

Report: Lab Project Number: MAK/575/003707: R-11307: MAK/575. 

Unpublished study prepared by Huntingdon Life Sciences Ltd. 109 p. 

{OPPTS 850.1730} 

45785802 Jenkins, W. (2002) (Carbon 14) Novaluron: Depuration in Rainbow 

Trout Following Exposure to the Test Substance for 24 Hours: Final 

Report: Lab Project Number: R-14841: MAK/775. Unpublished study 

prepared by Huntingdon Life Sciences Ltd. 65 p. {OPPTS 850.1730} 

45785803 Todd, M. (2002) Novaluron: Determination of Residues in the 

Carcass, Muscle and Viscera of Fathead Minnow (Pimephales 

promelas) Following Exposure for 315 Days: Lab Project Number: R14842: MAK 777/023873. Unpublished study prepared by Huntingdon 

Life Sciences Ltd. 41 p. {OPPTS 850.1730, 860.1400} 

45638216 Jenkins, C. (1998) "Rimon" Technical: Prolonged Toxicity to 

Rainbow Trout Under Flow-Through Conditions, 28-Day Study: Final 

Report: Lab Project Number: MAK/441: MAK441/974266: R-9840. 

Unpublished study prepared by Huntingdon Life Sciences Ltd. 44 p. 

45785801 Jenkins, W. R., et, al. 2002. "Novaluron ("Rimon" 10EC): Assessment 

of its Potential Biological Effects on Freshwater Aquatic Ecosystems 

Basedon its Applications to Outdoor Microcosms. 

45638221 Jenkins, C. (1998) "Rimon" Technical: Algal Growth Inhibition 

Assay: Final Report: Lab Project Number: MAK/449: 

MAK449/974268: R-9842. Unpublished study prepared by 

Huntingdon Life Sciences Ltd. 45 p. 

45638222 Jenkins, C. (1999) 275-352 I: Algal Growth Inhibition Assay: Lab 

Project Number: MAK527: R-10637: MAK527/992452. Unpublished 

study prepared by Huntingdon Life Sciences Ltd. 44 p. 

45638223 Jenkins, C. (2001) "Rimon": Higher Plant (Lemna) Growth Inhibition 

Test: Lab Project Number: MAK610/003705: R-11755: MAK610. 

Unpublished study prepared by Huntingdon Life Sciences Ltd. 64 p. 
44 

45638411 Jenkins, C. (1998) "Rimon" 10 EC: Algal Growth Inhibition Assay: 

Final Report: Lab Project Number: MAK/464/98147: R-9914: 

MAK/464. Unpublished study prepared by Huntingdon Life Sciences 

Ltd. 45 p. 

45638220 Gray, A. (1997) "Rimon" Technical: Acute Toxicity to Honey Bees 

(Apis mellifera): Lab Project Number: MAK433/973447: R-9801: 

MAK/433. Unpublished study prepared by Huntingdon Life Sciences 

Ltd. 37 p. 

45638407 Gray, A. (1998) "Rimon" 10EC: Evaluation of the Effects of Insect 

Growth-Regulating Insecticides on Honey Bee (Apis mellifera) 

Colony Brood Development: Lab Project Number: MAK 435/973449: 

MAK 435: R-9799. Unpublished study prepared by Huntingdon Life 

Sciences Ltd. 181 p. 

45638408 Gray, A. (1998) "Rimon" 10EC: Acute Toxicity to Honey Bees (Apis 

mellifera): Lab Project Number: MAK 434/973448: MAK 434: R9800. Unpublished study prepared by Huntingdon Life Sciences Ltd. 

37 p. 

45638407 Gray, A. (1998) "Rimon" 10EC: Evaluation of the Effects of Insect 

Growth-Regulating Insecticides on Honey Bee (Apis mellifera) 

Colony Brood Development: Lab Project Number: MAK 435/973449: 

MAK 435: R-9799. Unpublished study prepared by Huntingdon Life 

Sciences Ltd. 181 p. 

45638409 Barrett, K. (2001) Novaluron: To Assess the Effect of "Rimon" 10EC 

to Honeybee Brood when Used in Commercial Citrus Groves: Lab 

Project Number: MAK 542/993030: R-10990: MAK 542. 

Unpublished study prepared by Huntingdon Life Sciences Ltd. 295 p. 

{OPPTS 850.3040} 

47737801 Walsh, D. (2009) Pollinator Pesticide Safety Trials 2007: Flonicamid. 

Project Number: IB/2009/PH/002/01. Unpublished study prepared by 

Washington State University. 19 p. 

45638410 Sharples, A. (2001) Novaluron: Evaluation of the Effects of "Rimon" 

10 EC on Populations of Non-Target Arthropods in Citrus Groves: 

Lab Project Number: MAK 543: MAK543/003923: R-10991. 

Unpublished study prepared by Huntingdon Life Sciences Ltd. 409 p. 

48194901 Scott-Dupree, C.; Conroy, L.; Harris, C. (2009) Impact of Currently 

Used or Potentially Useful Insecticides for Canola Agroecosystems on 

Bombus impatiens (Hymenoptera: Apidae), Megachile rotundata 

(Hymentoptera: Megachilidae), and Osmia lignaria (Hymenoptera: 

Megachilidae). Journal of Economic Entomology 102(1): 177-182. 

48690104 Sindermann, A.; Porch, J.; Krueger, H.; et al. (2011) Novaluron TEP: 

A Tier 1 Toxicity Test to Determine the Effects of the Test Substance 

on Seedling Emergence of Ten Species of Plants. Project Number: 
45 

234/119, R/28251. Unpublished study prepared by Wildlife 

International, Ltd. 84p.

46581402 

Bell, G. (2000) (Carbon 14) "Rimon" to Assess the Toxicity to the 

Sediment Dwelling Phase of the Midge Chironomus riparius. Project 

Number: MAK/508, MAK/508/992185, R/10339. Unpublished study 

prepared by Huntingdon Life Sciences, Ltd. 85 p. 

47621902 

Krueger, H.; Thomas, S.; Kendall, T. ; et al. (2008) C14-Novaluron: A 

Prolonged Sediment Toxicity Test with Chironomus riparius Using 

Spiked Sediment: (Rimon 0.83 EC). Project Number: 234A/101, 

R/20568, 234/073/108/CHI/SED. Unpublished study prepared by 

Wildlife International, Ltd. 74 p. 

45638224 

Rodgers, M. 1998) "Rimon" Technical Acute Toxicity (LC50) to the 

Earthworm (Eisenia foetida): Lab Project Number: MAK 413/972973: 

R-9458: MAK 413. Unpublished study prepared by Huntingdon Life 

Sciences Ltd. 30 p. 

45638225 

Rodgers, M. (2001) Chlorophenyl Urea Acute Toxicity (LC50) to the 

Earthworm (Eisenia foetida): Lab Project Number: MAK 619/003779: 

R-11872: MAK/619. Unpublished study prepared by Huntingdon Life 

Sciences Ltd. 33 p. 

46185801 

Kane, T. (2004) (Carbon 14) - "Rimon": Residues in Laying Hens. 

Project Number: MAK/810/0331178, R/15767, MAK/810. 

Unpublished study prepared by Huntingdon Life Sciences, Ltd. 135 p. 

45638217 Carter, J.N. Rimon Technical Effects on Soil Non-target Microorganisms - also contract draft available 
46 

Appendix 1. Novaluron Uses and Application Rates 

Use 

Maximum 

Single 

Application 

Rate lb ai 

Maximum Number 

of Applications per 

year 

(minimum 

application interval 

in days unless 

specified) 

Maximum 

Yearly 

Application 

Rate in lbs of ai 

Method of 

Application 

Outdoor flea 

control 0.035 17* (21) 0.60 Liquid spray spot treatment 

Outdoor 

cockroach 

perimeter 

treatment 

0.07 2* 

(6 months) 0.14 

Liquid spray 

perimeter 

treatment 

Indoor 

control of 

litter beetles 

in chicken 

houses 

0.002 1 app of treated 

manure/year 0.002 Liquid spray 

Outdoor 

control of 

litter beetles 

in chicken 

houses 

0.035 8** 

(46) 0.28 

Liquid spray 

perimeter 

treatment 

Outdoor 

control of 

ants 

0.07 26* 

(14) 1.82 

Liquid spray 

perimeter 

treatment 

Outdoor 

control of 

flying insect 

pests 

0.023 26* 

(14) 0.60 Liquid spray spot treatment 

Flies in 

cattle and 

horse 

operations 

0.436 17* 

(21) 7.41 Granular spot treatment 

Beetles in 

poultry 

operations 

0.872 17* 

(21) 14.82 Granular broadcast 

Beetles in 

poultry 

operations 

0.232 1 app of treated 

manure/year 0.232 Spread manure 

as fertilizer 

Flies in 

horse 

operations 

0.024 1 app of treated 

manure/year 0.024 Spread manure 

as fertilizer 

Outdoor 

crickets, 

outdoor 

cockroaches 

0.91 NS (180)*** NS Ground 

application 
47 

Mosquitos in 

small water 

bodies 

0.0003a

 NS (90)  NS Manual 

Mosquitos in 

small water 

bodies 

0.0004b NS (90)** ** NS Manual 

Termites 0.00137 60 day inspection 

NS assume 

inspection every 

2 months for 

.00822 

Bait station 

Bean, 

LowGrowing 

Berries 

0.077 3 

(7) 0.23 

Ground 

Application, 

Aerial 

application 

Potatoes / 

Sweet 

Potatoes, 

Head and 

Stem 

Brassica 

0.08 2 

(7) 0.16 

Ground 

Application, 

Aerial 

application, 

Chemigation 

Cucurbit 

Vegetables 0.08 3 

(14) 0.23 

Ground 

Application, 

Aerial 

application, 

Chemigation 

Carrot 0.08 3 

(7) 0.24 

Ground 

Application, 

Aerial 

application, 

Chemigation 
48 

Fruiting 

Vegetables, 

Peanuts, 

Grain 

Sorghum, 

Leafy 

Brassica 

Greens, 

Swiss 

Chard, 

Strawberry, 

Turnip 

Greens 

0.08 3 

(7) 0.23 

Ground 

Application, 

Aerial 

application, 

Chemigation 

Soybeans 0.08 3 

(10) 0.23 

Ground 

Application, 

Aerial 

application, 

Chemigation 

Sugarcane 0.08 5 

(14) 0.39 

Ground 

Application, 

Aerial 

application, 

Chemigation 

Sweet Corn 0.08 5 

(7) 0.39 

Ground 

Application, 

Aerial 

application, 

Chemigation 

Cotton 0.09 3 

(7) 0.27 

Ground 

Application, 

Aerial 

application, 

Chemigation 

Cotton (premix with 

Bifenthrin) 

0.062 

5 

(corn borer/thrips 7 

days all other pests 14 

days) 

0.27 

Ground 

Application, 

Aerial 

application, 

Chemigation 

Avocado 0.13 3 

(14) 0.38 

Ground 

Application, 

Aerial 

application 

Ornamentals 0.17 2 

(30) 0.34 Ground Application 

Bushberries 0.193 3 

(10) 0.58 

Ground 

Application, 

Aerial 
49 

application, 

Chemigation 

Group 11-10 

Pear 0.21 3 

(10) 0.62 Orchard Spray 

Group 11-10 

Pome 0.323 3 

(10) 0.97 Orchard Spray 

Stone Fruit 0.323 3 

(7) 0.97 

Ground 

Application, 

Aerial 

application, 

Chemigation 

Apple, pear 0.33 4 (10) 0.96 

Ground 

Application, 

Airblast 

Apples 0.26 1 0.26 

Ground 

Application, 

Airblast 

Alfalfa, seed 

(spring when 

pets first 

appear) 

0.078 4 

(7) 0.31 

Ground 

Application, 

Aerial 

application, 

Chemigation 

Alfalfa, seed 

(spring prebloom) 0.078 4 

(7) 0.16 

Ground 

Application, 

Aerial 

application, 

Chemigation 

Tomatoes 

(greenhouse) 0.078 2(7) whiteflies/thrips 3(7) other pests 0.46 Ground 

Application 

*Assumed, based on the minimum re-application interval. 

**Assumed, based on typical number of chicken growth cycles per year (USEPA 2012a, 

D403654) 

***Assumed based on label claim controls pests for 180 days 

****Not specified (NS) 

a calculated based on 1 pellet containing 0.24 mg/ai per pellet. Label lists a maximum rate of 

500g of pellets in 330 gallons of water 

b calculated based on 1 control rod containing 21.6 mg/ai per rod. Label lists a maximum 

rate of 8 control rods in 200 gallons of water 
50 

Appendix 2. Previous Actions for Uses of Novaluron

Crop Single Application Rate 

(lb ai/A) 

Number of Annual 

Applications 

(Application Interval in 

Days) 

Action/DP 

Barcode/Date 

Risk Conclusions 

Ornamentals 

and 

Greenhouse 

0.17 2 (30) Section 3 New 

Chemical 

Registration 

D318619 

No risk concerns exist for acute 

or chronic direct effects to 

listed or non-listed fish in 

freshwater or estuarine/marine 

environments. However, 

greatest risk from novaluron 

use is to invertebrates in both 

media. No acute effects are 

expected on birds, mammals, 

and plants. Chronic effects are 

possible on birds and mammals. 

Adverse impacts are possible 

on developing insects due to the 

novaluron’s mode of action, 

which is targeted against chitin 

development and cuticle 

formation of insect larvae. 

Pome fruit 

Cotton 

Potato 

0.32 

0.09 

0.08 

3 (10 – 14) 

3 (7 – 14) 

3 (10 – 14) 

Tier II DWA 

D285477 and 

D285479 

2/11/04 

Section 3 New 

Use Registration 

DP285477, 

285479, 287624, 

297230 

6/14/04 

Head and 

Stem Brassica 

0.04 – 0.08 3 (up to 0.16 lb ai/A) 

(7 – 14) 

Section 3 New 

Use Registration 

DP321545 

2/2/06 

No risk concerns exist for acute 

or chronic direct effects to 

listed or non-listed fish in 

freshwater or estuarine/marine 

environments. However, 

greatest risk from novaluron 

use is to invertebrates in both 

media. No acute effects are 

expected on birds, mammals, 

and plants. Chronic effects are 

possible on birds and mammals. 

Adverse impacts are possible 

on developing insects due to the 

novaluron’s mode of action, 

which is targeted against chitin 

development and cuticle 

formation of insect larvae. 

Sugarcane 0.08 5 (10 – 14) Section 18 

Emergency Use 

Exemption 

DP329703 

6/27/06 

Head and 

Stem Brassica 

Tomato 

Sugarcane 

0.08 

0.08 

0.08 

(ground and aerial) 

3 

3 

5 

(7 – 10) 

DWA 

DP340579, 

340581, 340583, 

345672 

12/13/07 

Section 3 New 

Use Registration 

for tomato and 

sugarcane and 

increase in 

maximum use 

rates for brassica 

vegetables 
51 

Crop Single Application Rate 

(lb ai/A) 

Number of Annual 

Applications 

(Application Interval in 

Days) 

Action/DP 

Barcode/Date 

Risk Conclusions 

DP340579, 

340581, 340583, 

345672 

2/5/2008 

Strawberry 0.08 

(ground) 

3 

(7 – 10) 

Section 18 

Emergency Use 

Exemption in 

Florida 

D357484 

10/30/2008 

Stone Fruit 

Bushberry 

0.32 

0.20 

3 (7-14) 

3 (10-14) 

DWA 

D357061 

3/10/09 

Section3 New 

Use Registration 

D358376 

04/14/2009 

Brassica 

Leafy Greens 

Turnip Greens 

0.08 3 (7-14) 

Strawberry 0.078 3 (7-10) Section 18 

Emergency Use 

Exemption in 

California 

D364391 

06/02/2009 

Novaluron use on strawberry 

has the potential to cause 

adverse acute and chronic 

impacts to both listed and nonlisted freshwater and 

estuarine/marine invertebrates. 

No acute adverse effects 

expected for fish, birds, or 

mammals. No chronic adverse 

effects expected for fish or 

mammals. Chronic risk 

expected to birds. Novaluron is 

not expected to cause adverse 

effects to terrestrial aquatic 

plants. Adverse impacts are 

possible on developing insects. 

Sorghum 

Fruiting Veg. 

Curcurbit 

Veg. 

Low Growing 

Berry 

Subgroup 

Snap and Dry 

Bean 

Swiss Chard 

0.078 3 

(7-14) 

DWA 

D363989 and 

D364309 

7/16/09 

Section3 New 

Use Registration 

D364309 & 

D364313 

11/27/2009 

Novaluron use has the potential 

to cause adverse acute and 

chronic impacts to both listed 

and non-listed freshwater and 

estuarine/marine invertebrates. 

No acute adverse effects 

expected for fish, birds, or 

mammals. No chronic adverse 

effects expected for fish or 

mammals. Chronic risk 

expected to birds. Risk to 

terrestrial plants is assumed. 

Sweet Corn 0.078 5 

(7) 

Tier II DWA 

D378389 

9/29/2010 
52 

Crop Single Application Rate 

(lb ai/A) 

Number of Annual 

Applications 

(Application Interval in 

Days) 

Action/DP 

Barcode/Date 

Risk Conclusions 

Section3 New 

Use 

Registration 

D378620 

11/18/2010 

Novaluron use has the potential 

to cause adverse acute and 

chronic impacts to both listed 

and non-listed freshwater and 

estuarine/marine invertebrates. 

No acute adverse effects 

expected for fish, birds, or 

mammals. No chronic adverse 

effects expected for fish; 

chronic risk expected for birds 

and mammals. Risk to aquatic 

plants not expected; risk to 

terrestrial plants presumed due 

to lack of data. 

Crickets in 

residential 

areas and 

mosquito 

larvae in 

small water 

bodies 

0.32 3 Tier II DWA 

D387737, 

D387738, 

D388519, and 

D385667 

4/25/2011 

0.91 

3 μg ai/L (limit of 

solubility) 

1 Section3 New 

Use Registration 

D385667, 

D387408, 

D387407, and 

389832 

Novaluron has the potential to 

cause chronic adverse effects to 

birds, chronic adverse effects to 

mammals, adverse effects to 

terrestrial invertebrates, and 

adverse effects to aquatic 

invertebrates. 

Peanuts and 

soybean 

0.078 3 

(7) peanuts 

(10) soybean 

DWA 

D402324 

8/27/12 

Section 3 New 

Use Registration 

D401844 

Risk to birds, terrestrial plants, 

terrestrial invertebrates, and 

aquatic invertebrates/mollusks 

Outdoor Flea 

Control 

0.035 17 

(21) 

DWA 

D412441 

8/7/13 

Section 3 New 

Use Registration 

D409223, and 

D412299 

8/14/13 

The proposed new uses of 

novaluron may present risk to 

the following groups: Birds, 

reptiles, and land-phase 

amphibians (chronic), terrestrial 

plants, terrestrial invertebrates 

(contact and oral), 

estuarine/marine fish (chronic), 

benthic invertebrates (acute and 

chronic), aquatic vascular 

plants ( degradates only) 

Outdoor 

Cockroach 

0.07 2 

(180) 

Outdoor 

Chicken 

Houses 

0.035 8 

(45) 
53 

Crop Single Application Rate 

(lb ai/A) 

Number of Annual 

Applications 

(Application Interval in 

Days) 

Action/DP 

Barcode/Date 

Risk Conclusions 

Indoor 

Chicken Litter 

to Field 

0.002 1 

Outdoor Ants 0.07 26 

(14) 

Outdoor 

Flying Insect 

Pest 

0.023 26 

(14) 

Flies in Cattle 

Operation 

0.436 17 

(21) 

Poultry 

Operation 

0.872 17 

(21) 

Poultry 

Manure to 

Field 

0.232 1 

Horse Barns 0.436 17 

(21) 

Horse Manure 

to Field 

0.024 1 

Avocado 0.13 3 

(14) 

IR-4 

New/revised 

uses 

D419642 

11/21/14 

DW assessment 

D418740 

9/2/14 

Novaluron use has the potential 

to cause adverse acute and 

chronic impacts to both listed 

and non-listed freshwater and 

estuarine/marine invertebrates. 

Chronic risk expected to birds. 

Chronic risk to estuarine/marine 

fish and risk to terrestrial plants 

is assumed No acute adverse 

effects expected for fish, birds, 

or mammals. No chronic 

adverse effects expected for 

fish or mammals. 

Bean, 

Low-Growing 

Berries 

0.077 3 

(7) 

Bushberries 0.193 3 

(10) 

Carrot, 

Fruiting 

Vegetables, 

Leafy 

Brassica 

Greens, 

Peanuts, 

Grain 

Sorghum, 

Strawberry, 

Swiss Chard, 

Turnip Greens 

0.08 3 

(7) 

Cotton 0.09 3 

(7) 

Cucurbit 

Vegetables 

0.08 3 

(14) 

Head and 

Stem 

Brassica, 

Potatoes / 

Sweet 

Potatoes 

0.08 2 

(7) 
54 

Crop Single Application Rate 

(lb ai/A) 

Number of Annual 

Applications 

(Application Interval in 

Days) 

Action/DP 

Barcode/Date 

Risk Conclusions 

Ornamentals 0.17 2 

(30) 

Group 11-10 

Pear 

0.21 3 

(10) 

Group 11-10 

Pome 

0.323 3 

(10) 

Soybeans 0.08 3 

(10) 

Stone Fruit 0.323 3 

(7) 

Sugarcane 0.08 5 

(14) 

Sweet Corn 0.08 5 

(7) 
55 

Appendix 3. Structures of Novaluron and its Degradates

Chemical Name Structure 

Novaluron 

3-Chloro-4-[I, 1,2-trifluoro-2- 

(trifluoromethoxy)ethoxy]phenyl] -

amino]carbonyl]-2,6- 

difluorobenzamide

275-352I 

1-[3-chloro-4-(1,1,2-trifluoro-2-

trifluoromethoxyethoxy)phenyl urea

275-309I 

3-chloro-4-(1,1,2-trifluoro-2-

trifluoromethoxyethoxy)aniline 

275-158I, DFBA 

2,6-difluorobenzoic acid 

275-157I 

2,6-difluorobenzamide 

275-143I 

4-Amino-2-chlorophenol 

 
56 

Appendix 4. Major Degradates Chlorophenyl Urea and Chloroaniline

A4-1. Fate and transport properties for degradate chlorophenyl urea (275-352I or 1-

[3-Chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]urea

Parameters Value and Unit Reference 

Molecular Formula C10H7ClO3F6N2 MRID 45638201 

Molecular Weight 352.5 MRID 45638201 

Molecular Structure MRID 45638206 

Smiles NC(=O)Nc2cc(Cl)c(OC(F)(F)C

(F)OC(F)(F)F)cc2 

EPI Suite 4.1 

Solubility in water at 20 oC 33 ppm MRID 45638201 

Vapor Pressure 1.03 x 10-5 mm Hg EPI Suite 4.1 

Henry’s Constant at 25 oC 8.5x10-12 atm•m3/mol EPI Suite 4.1 

Soil Partition Coefficient (Koc)

 1 2277 

(average of 4 Koc value) 

MRID 45638201 

Sandy loam 1950 

Sandy loam 2088 

Loamy sand 2563 

Clay loam 2505 

Soil Adsorption Kd1 40.2 

(average of 4 Kd value)

MRID 45638201 

Sandy loam 35.1 

Sandy loam 16.7 

Loamy sand 61.5 

Clay loam 47.6 

Aerobic Soil Metabolism T1/21

 47.1 days MRID 44961009 

Sandy clay loam 46.5 days 

Clay loam 45.9 days 

Aerobic aquatic metabolism half-life1 184.36 days MRID 45638206 

Bury Pond water-clay loam 108.5 days 

Meadow water-loamy sand 35.5 days 

Aqueous Photolysis T1/2 stable No data 

1Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides; Oct. 22, 

2009 
57 

A4-2. Fate and transport properties for degradate chloroaniline (275-309I or 3-

chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)aniline) 

Parameters Input Value and Unit Source of Info/Reference 

Molecular Formula C9H6ClO2F6N EPI Suite 4.1 

Molecular Weight 309.6 EPI Suite 4.1 

Molecular Structure MRID 45638206 

Smiles NC1=CC=C(C(=C1)Cl)OC(F)(

F)C(F)OC(F)(F)F 

EPI Suite 4.1 

Vapor Pressure 3.49 x 10-3 mm Hg EPI Suite 4.1 

Henry’s Constant at 25 oC 8.04x10-8 atm•m3/mol EPI Suite 4.1 

Solubility in water at 25 oC 13.87 ppm EPI Suite 4.1 

Soil Partition Coefficient (Koc) 918.8 EPI Suite 4.1 

Aerobic Soil Metabolism T1/2 180 EPI Suite 4.1 

Aerobic aquatic metabolism half-life 360 days EPI Suite 4.1 

Anaerobic Aquatic Metabolism Half-life 1,620 days EPI Suite 4.1 

Hydrolysis T1/2 (pH7) stable No data 

Aqueous Photolysis T1/2 stable No data 

 
58 

Appendix 5. Screening Level Models to Evaluate Potential Importance 

of Drinking Water and Inhalation Exposure Pathways

SIP (Screening Imbibition Program, v1.0) was used to calculate an upper bound estimate 

of novaluron exposure via drinking water using solubility (0.003 mg/L), the most 

sensitive acute and chronic avian toxicity endpoints (bobwhite quail, LD50 > 2000 mg 

ai/kg-bw; bobwhite quail and mallard duck NOAEC = 301 and 9.8 mg ai/kg-diet 

respectively) and the most sensitive acute and chronic mammalian toxicity endpoints (rat 

LD50 >5000 mg ai/kg-bw and NOAEL = 50 mg ai/kg-bw). The model indicated that 

there are no acute or chronic concerns to birds and mammals through the drinking water 

exposure pathway (Tables XX and XX). 

Table A5.1. SIP Mammalian Results for Novaluron 

Parameter Acute Chronic 

Upper bound exposure (mg/kg-bw) 0.0005 0.0005 

Adjusted toxicity value (mg/kg-bw) 3845.8028 38.4580 

Ratio of exposure to toxicity 0.0000 0.0000 

Conclusion* 

Drinking water exposure 

alone is NOT a potential 

concern for mammals 

Drinking water exposure 

alone is NOT a potential 

concern for mammals 

Table A5.2. SIP Avian Results for Novaluron 

Parameter Acute Chronic 

Upper bound exposure (mg/kg-bw) 0.0024 0.0024 

Adjusted toxicity value (mg/kg-bw) 17800.0000 0.4862 

Ratio of exposure to acute toxicity 0.0000 0.0050 

Conclusion* 

Drinking water exposure 

alone is NOT a potential 

concern for birds 

Drinking water exposure 

alone is NOT a potential 

concern for birds 

*Conclusion is for drinking water exposure alone. This does not combine all routes of exposure. Therefore, when 

aggregated with other routes (i.e., diet, inhalation, dermal), pesticide exposure through drinking water may 

contribute to a total exposure that has potential for effects to non-target animals. 

STIR (Screening Tool for Inhalation Risk, v1.0) was used to calculate an upper bound 

estimate of novaluron exposure via inhalation using molecular weight (492.7 g/mole), 

vapor pressure (1.20 x 10-7 mmHg), high end application rates (ground: 0.91 lb ai/A; 

aerial: 0.33 lb ai/A), most sensitive acute avian toxicity endpoint (bobwhite quale, LD50

> 2000 mg ai/kg-bw), and most sensitive acute oral and inhalation mammalian toxicity 

endpoints (rat, LD50 = >5000. mg ai/kg-bw and 4-hr LC50 > 2.04 mg ai/L, respectively). 

The results indicated that inhalation alone is not a potential pathway of concern for birds 

or mammals. 
59 

Table A5.3. STIR Avian (0.020 kg) Results for Novaluron 

Maximum Vapor Concentration in Air at 

Saturation (mg/m3

) 

3.18E-03 

Maximum 1-hour Vapor Inhalation Dose (mg/kg) 4.00E-04 

Adjusted Inhalation LD50 4.55E+00 

Ratio of Vapor Dose to Adjusted Inhalation LD50 8.79E-05 Exposure not Likely Significant 

Maximum Post-treatment Spray Inhalation Dose 

(mg/kg) 

9.62E-02(g) 

3.17E-02(a) 

 

Ratio of Droplet Inhalation Dose to Adjusted 

Inhalation LD50 

2.11E-02(g) 

6.97E-03(a) 

Exposure not Likely Significant 

Table A5.4. STIR Mammalian (0.15 kg) Results for Novaluron 

Maximum Vapor Concentration in Air at 

Saturation (mg/m3

) 3.18E-03 

 

Maximum 1-hour Vapor Inhalation Dose (mg/kg) 5.03E-04 

Adjusted Inhalation LD50 1.21E+02 

Ratio of Vapor Dose to Adjusted Inhalation LD50 4.14E-06 Exposure not Likely Significant 

Maximum Post-treatment Spray Inhalation Dose 

(mg/kg) 

1.21E-01(g) 

3.98E-02(a) 

 

Ratio of Droplet Inhalation Dose to Adjusted 

Inhalation LD50 

9.95E-04(g) 

3.28E-02(a) 

Exposure not Likely Significant