UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

DATE: December 11, 2014 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

SUBJECT: Lufenuron. Human Health Assessment Scoping Document in Support of Registration 

Review. 

PC Code: 118205 

Decision No.: 495971 

Petition No.: NA 

Risk Assessment Type: NA 

TXRNo.: NA 

MRIDNo.: NA 

DP Barcode: 0423180 

Registration No.: NA 

Regulatory Action: Registration Review 

Case No.: 7627 

CAS No.: 103055-07-8 

40CFR: NA 

FROM: Kristin Rury, Biologist 

Vincent Chen, Toxicologist 4..__l ?--:;'.~_: __ _ 

Risk Assessment Branch III 

Health Effects Division (7509P) 

Office of Pesticide Programs 

THROUGH: Christine Olinger, Branch Chieff 1//-~ Risk Assessment Branch III 

Health Effects Division (7509P 

Office of Pesticide Programs 

TO: Bonnie Adler, Chemical Review Manager 

And 

Jill Bloom, Team Leader 

Risk Management & Implementation Branch 5 

Pesticide Re-Evaluation Division (7508P) 

Office of Pesticide Programs 

Attached is the Health Effects Division's (HED) human health Registration Review scoping 

document for the insect growth regulator, lufenuron. 

Executive Summary 

HED has evaluated recent human health assessments for lufenuron to determine whether 

sufficient data are available and whether any updates are needed to support Registration Review. 

To determine the scope of work necessary to support Registration Review, HED has considered 

Page 1 of 12 
Page 2 of 12 

 

updates to Agency science policy and risk assessment methodologies and to the lufenuron 

toxicity, exposure, and usage databases. 

Lufenuron is a benzoylphenylurea insect growth regulator used as a termiticide in above- and 

below-ground delivery systems. Lufenuron prevents insect growth by inhibiting chitin synthesis 

(i.e., exoskeleton growth). Lufenuron is registered exclusively for use in integrated management 

systems or impregnated bait stations. The bait containing lufenuron is formulated in a cellulose 

bait matrix that is then always inserted into the bait station structure; limiting potential exposure 

to lufenuron. The labels specify that only pest management professionals licensed to apply 

termite control products by the state (pest control operators) may use lufenuron. 

The most recent risk assessment for lufenuron was conducted to support lufenuron’s initial 

registration and evaluated lufenuron use in a bait to control termites (K. O’Rourke, D293828, 

07/02/2004). The assessment concluded that occupational and residential exposure is expected 

to be negligible. 

 

The lufenuron toxicology database is adequate for the registered use pattern. Lufenuron has low 

acute toxicity via the oral, dermal, and inhalation routes of exposure. It is not an eye or skin 

irritant; however it is dermal sensitizer. Following repeated oral (dietary) exposure, toxicity 

manifested as clinical signs indicative of neurotoxicity and increased relative organ weights in a 

sex specific manner. There was no evidence of developmental toxicity in rats and rabbits and the 

available database does not indicate a concern for target-organ toxicity. 

Because of the limited use pattern, a new dietary exposure and risk assessment is not needed 

during Registration Review because lufenuron is considered a non-food use pesticide. A dietary 

exposure assessment has not previously been conducted for lufenuron. Additionally, there is no 

need to calculate estimated drinking water concentrations (EDWCs). There are no outstanding 

residue chemistry database deficiencies at this time. The occupational and residential exposure 

databases are considered complete for lufenuron. Thus, an updated aggregate risk assessment is 

not required to support Registration Review because residential and drinking water exposures are 

considered negligible. Furthermore, a new occupational and residential exposure assessment is 

not needed during Registration Review. 

HED does not believe that new data are needed for Registration Review. Because of the 

negligible exposure from the registered uses of lufenuron, a quantitative risk assessment will not 

be conducted during Registration Review. 

Introduction 

Lufenuron is a benzoylphenylurea insect growth regulator currently undergoing Registration 

Review. The most recent (semi-qualitative) risk assessment for lufenuron was conducted to 

evaluate the proposed use in bait to control termites (K. O’Rourke, D293828, 07/02/2004). 

Exposure to lufenuron is considered to be negligible via all routes. Lufenuron products are only 

formulated to be used in enclosed impregnated bait stations for above- and below-ground use 

around residences and commercial buildings/structures to control subterranean termites. The 

labels specify that only pest management professionals licensed by the state to apply termite 
Page 3 of 12 

 

control products may use lufenuron. For information on the chemical identity of lufenuron, see 

Attachment 1. 

Hazard Characterization 

The toxicology database for lufenuron is adequate for human health risk assessment of the 

current registered uses (i.e., in termite bait in enclosed bait stations) where human exposure is 

expected to be negligible. Lufenuron’s toxicology database includes an acute toxicity battery, a 

subchronic oral study in rats, prenatal developmental studies in rats and rabbits, a genotoxicity 

study, and mutagenicity studies. In accordance with the 2007 40 CFR Part 158 toxicology data 

requirements, the following studies are required for lufenuron: a 90-day oral toxicity in nonrodents, a 90-day dermal toxicity in rats; a 90-day inhalation toxicity in rats; a reproduction and 

fertility effects in rats; neurotoxicity battery (acute and subchronic studies); and an 

immunotoxicity in rats. Health Effects Division’s Hazard and Science Policy Council 

(HASPOC) reviewed the exposure and toxicology database based on a weight of evidence 

approach granted waivers for these studies at this time. Since lufenuron use is expected to result 

in negligible occupational and residential exposure based on the currently registered uses 

(included in termite baits in enclosed bait stations), the HASPOC further concluded that a 

qualitative, not a quantitative, risk assessment is adequate for lufenuron (TXR# 0052871). 

In the repeated dietary exposure study in rats, lufenuron exposure led to clinical signs (i.e., tonicclonic seizures) and increased relative organ weights with respect to body weight (in males: brain 

and kidney; and in females: liver and adrenal glands). 

In rat and rabbit developmental toxicity studies, test animals were dosed up to the limit dose 

(1000 mg/kg/day) with no evidence of developmental toxicity or susceptibility. In rats, maternal 

animals were observed to have decreased food consumption in the absence of any fetal effects. 

Lufenuron is not mutagenic or genotoxic in the in vivo and in vitro assays. Based on the use 

pattern, carcinogenicity studies are not required for lufenuron. 

An immunotoxicity study is not required for lufenuron because lufenuron does not target the 

immune system, and an immunotoxicity study available for a similar chemical (diflubenzuron) 

did not show signs of immunotoxicity (TXR# 0052871). 

Lufenuron has low acute toxicity via the oral, dermal, and inhalation routes of exposure 

(Toxicity Categories III-IV); it is not an eye or skin irritant (Toxicity Category IV); and it is 

dermal sensitizer.

Conclusion: The toxicology database is adequate to support existing registrations of lufenuron. 

Based on the exposure profile, several toxicity studies have been waived, and additional toxicity 

studies are not required at this time. However, if the use pattern changes, the toxicology data 

requirements will need to be reevaluated. 

Dietary Exposure
Page 4 of 12 

 

Lufenuron is considered a non-food use pesticide. HED considers protected baits as nonfood/non-feed uses per the Chemistry Science Advisory Council (ChemSAC). The non-food use 

designation criteria for bait stations applies if they: (1) will not leak or spill; (2) prevent (direct) 

contact with food/feed; and (3) are resistant to child tampering (ChemSAC Minutes, 

06/22/2005). Therefore, all existing uses of lufenuron are considered non-food/non-feed uses, 

and the residue chemistry database is complete. 

A dietary risk assessment is not required for lufenuron during Registration Review as lufenuron 

is considered a non-food use pesticide and given the limited use pattern, the Environmental Fate 

and Effects Division (EFED) does not anticipate calculating EDWCs. 

Conclusion: The dietary exposure database is adequate to support existing registrations of 

lufenuron. A dietary exposure assessment is not needed during Registration Review. 

Residential and Occupational Exposure 

The lufenuron labels specify that only pest management professionals licensed by the state to 

apply termite control products may use lufenuron. Occupational handlers must wear long 

sleeved shirts, long pants, shoes, and socks (EPA Reg. Nos. 100-1181, 100-1257, 279-9559, and 

100-1174). 

Based on the use pattern, occupational handler and occupational/residential post-application 

exposure to lufenuron is expected to be negligible. Lufenuron is registered exclusively for use in 

integrated management systems or impregnated bait stations. The bait containing lufenuron is 

formulated in a cellulose bait matrix that is then always inserted into the bait station structure; 

limiting potential exposure to lufenuron. A preliminary, highly conservative quantitative 

exposure assessment was completed previously for lufenuron using the short- and intermediateterm no observed adverse effect level (NOAEL) of 10 mg/kg/day based on the available 

subchronic oral toxicity study in rats and dermal exposure data from a proprietary dermal 

exposure study conducted during the production of a termiticide barrier product. The 

conservative assessment resulted in an occupational handler dermal margin of exposure (MOE) 

of 24,000, which is not of concern to the Agency (the level of concern (LOC) is an MOE < 100). 

The screening-level, highly conservative, preliminary risk assessment was conducted based on 

the following rationale for the registered bait stations (K. O’Rourke, D293828, 07/02/2004): 

 The device is enclosed in a plastic station, except when the pest management professional 

adds water for moisture and looks for termites; 

 The device contains impregnated material with 0.15% ai; 

 The vapor pressure is low (3 x 10-8 mm Hg at 25°C); 

 The acute toxicity categories for all routes of exposure were low; and 

 Based on the weight of evidence presented, there was little to no anticipated exposure for 

handlers. 

Based on current occupational and residential exposure assessment policies, the currently 

registered uses of lufenuron result in negligible exposure. Therefore, an occupational and 

residential exposure assessment will not be conducted during Registration Review. 
Page 5 of 12 

 

Residential bystander exposure and exposures resulting from spray drift are not expected because 

there are no registered agricultural uses of lufenuron or uses that would result in volatilization or 

drift. 

Conclusions: The occupational and residential exposure databases are adequate to support 

existing registrations of lufenuron. A quantitative exposure assessment is not needed for 

lufenuron during Registration Review. 

Aggregate Risk Assessment 

Aggregate assessments consider exposures from food, drinking water, and residential uses. 

Although lufenuron is used in residential settings, the exposure from the registered uses is 

expected to be negligible. Lufenuron is considered a non-food/non-feed use pesticide; therefore, 

a dietary (food and drinking water) exposure assessment is not required. 

Conclusions: An aggregate risk assessment is not required during Registration Review. 

Public Health and Pesticide Epidemiology Data 

Based on the low frequency and severity of incident cases reported for lufenuron in both the OPP 

Incident Data System (IDS) and Centers for Disease Control and Prevention/National Institute 

for Occupational Safety and Health (CDC/NIOSH) Sentinel Event Notification System for 

Occupational Risk (SENSOR)-Pesticides, there does not appear to be a concern at this time that 

would warrant further investigation. There were no incidents reported in the IDS. A query of 

SENSOR-Pesticides 1998-2010 did not identify any cases involving lufenuron. 

The Agency will continue to monitor the incident information and if a concern is triggered, 

additional analysis will be included in the risk assessment. 

Tolerance Assessment and International Harmonization 

Lufenuron is considered a non-food/non-feed pesticide; therefore, there are no existing lufenuron 

tolerances. There are no Codex or Canadian maximum residue limits (MRLs) established for 

lufenuron; therefore, there is no harmonization issue at this time. 

Environmental Justice 

Potential areas of environmental justice concerns, to the extent possible, were considered in this 

human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions 

to Address Environmental Justice in Minority Populations and Low-Income Populations," 

(http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf). As a part of every pesticide risk 

assessment, OPP considers a large variety of consumer subgroups according to well-established 

procedures. In line with OPP policy, HED estimates risks to population subgroups from 

pesticide exposures that are based on patterns of that subgroup’s food and water consumption, 

and activities in and around the home that involve pesticide use in a residential setting. 
Page 6 of 12 

 

Extensive data on food consumption patterns are compiled by the United States Department of 

Agriculture’s (USDA’s) National Health and Nutrition Examination Survey (NHANES), What 

We Eat in America (NHANES/WWEIA) and are used in pesticide risk assessments for all 

registered food uses of a pesticide. These data are analyzed and categorized by subgroups based 

on age and ethnic group. Additionally, OPP is able to assess dietary exposure to smaller, 

specialized subgroups and exposure assessments are performed when conditions or 

circumstances warrant. Whenever appropriate, non-dietary exposures based on home use of 

pesticide products and associated risks for adult applicators and for children <6 years old, youths, 

and adults entering or playing on treated areas following application are evaluated. Further 

considerations are currently in development as OPP has committed resources and expertise to the 

development of specialized software and models that consider exposure to bystanders and farm 

workers as well as lifestyle and traditional dietary patterns among specific subgroups. 

Cumulative Risk Assessments 

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a 

common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as 

to lufenuron and any other substances, and lufenuron does not appear to produce a toxic 

metabolite produced by other substances. For the purposes of this tolerance action, therefore, 

EPA has not assumed that lufenuron has a common mechanism of toxicity with other substances. 

For information regarding EPA’s efforts to determine which chemicals have a common 

mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy 

statements released by EPA’s OPP concerning common mechanism determinations and 

procedures for cumulating effects from substances found to have a common mechanism on 

EPA’s website at http://www.epa.gov/pesticides/cumulative/. 

Data Requirements 

None. 

References

Memoranda Relevant to Registration Review of Lufenuron. 

Author DP/TXR

# Date Title 

Occupational Residential Exposure 

A. Assaad and K. O’Rourke D293828 07/02/2004 Lufenuron: Occupational and Residential Risk Assessment 

of a New Termiticide 

Toxicology 

J. Leshin 0052871 01/07/2014 Lufenuron: Summary of Hazard and Science Policy 

Council (HASPOC) Meeting of 09 October 2014: 

Recommendations on the requirement for a 90-day oral 

toxicity in non-rodents study, a 90-day dermal toxicity 

study, a 90-day inhalation toxicity study, a reproduction 

and fertility effects study, a neurotoxicity battery (acute 

and subchronic studies), and an immunotoxicity study. 

Incident Report 

S. Recore and E. Evans D495971 11/13/2014 Lufenuron: Tier 1 Review of Human Incidents 
Page 7 of 12 

 

Attachments 

Attachment 1. Chemical Identity Table 

Attachment 2. Lufenuron Use Pattern 

Attachment 3. Lufenuron Toxicity Profiles
Page 8 of 12 

 

Attachment 1: Chemical Identity 

Table A.1. Lufenuron Nomenclature.

Chemical structure 

Common name lufenuron 

PC Code 118205 

Company experimental name CGA-184699 

IUPAC name (RS)-1-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea 

CAS name N-[[[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]amino]carbonyl]-2,6-

difluorobenzamide 

CAS registry number 103055-07-8 

End-use products (EPs) F9878-1 Termite Bait (0.15% Lufenuron); EPA Reg. No. 279-9559 

Lufenuron Termite Bait (0.15% Lufenuron); EPA Reg. No. 100-1257 

Zyrox® Plus Termite Baiting Technology (0.15% Lufenuron); EPA Reg. No. 100-1181 

ImpasseTM Termite Bait (0.15% Lufenuron); EPA Reg. No. 100-1174 

Table A1.2. Physicochemical Properties of the Technical Grade of Lufenuron.

Parameter Value Reference 

Melting point range of 165.7 - 167.7°C MRID 45839503 

pH 5-7 at 25°C MRID 45839503 

Density 1.66 x 103 kg/m3 at 23°C MRID 45839503 

Water solubility 48 mg/L at 25°C MRID 45839503 

Solvent solubility Acetone: 460 g/L; 

Ethyl Acetate: 330 g/L; 

Toluene: 66 g/L; 

Methanol” 52 g/L; 

n-octanol: 8.2 g/L; 

n-hexane: 100 g/L

MRID 45839503 

Vapor pressure <4 x 10 - 6 Pa at 25°C or 3 x 10-8 mm Hg at 

25°C 

MRID 45839503 

Dissociation constant, pKa pKa = 10.2 +0.1 at 20°C MRID 45839503 

Octanol/water partition coefficient, 

Log(KOW) 

Log Pow = 5.12 at 25oC MRID 45839503 
Page 9 of 12 

 

Attachment 2: Lufenuron Use Pattern 

Table A.2. Lufenuron: Use Pattern. 

Formulation Registration 

Number Target Pest Application Method(s) Application information 

F9878-1 Termite 

Bait 

 (0.15% Lufenuron) 

279-9559 Subterranean 

Termites 

Cellulose-based bait matrix. 

For use in enclosed bait 

delivery stations. 

Monitoring stations must be monitored 

at least once every 3 months. 

Minimize disturbance of termites. 

After installation, bait stations should 

be inspected at 2-4 week intervals. 

Lufenuron Termite 

Bait (0.15% 

Lufenuron) 

100-1257 Subterranean 

Termites 

Cellulose-based bait matrix. 

For use in enclosed bait 

delivery stations. 

Monitoring stations must be monitored 

at least once every 3 months. 

Minimize disturbance of termites. 

After installation, bait stations should 

be inspected at 2-4 week intervals. 

Zyrox® Plus 

(0.15% Lufenuron) 100-1181 Subterranean Termites 

Cellulose-based bait matrix. 

For use in enclosed bait 

delivery stations. 

Once installed, the stations should 

remain loaded as long as termites are 

actively feeding on the bait. Minimize 

disturbance of bait stations during 

installation and inspection. After 

installation, bait stations should be 

inspected at 2-4 week intervals. 

ImpasseTM Termite 

Bait (0.15% 

Lufenuron) 

100-1174 Subterranean 

Termites 

Cellulose-based bait matrix. 

For use in enclosed bait 

delivery stations. 

Monitoring stations must be monitored 

at least once every 3 months. 

Minimize disturbance of termites. 

After installation, bait stations should 

be inspected at 2-4 week intervals. 

 

 
Page 10 of 12 

 

Attachment 3: Toxicology Data Requirements and Profile Table 

The requirements (40 CFR 158.500) for non-food uses are in the table below. Use of the new 

guideline numbers does not imply that the new (1998) guideline protocols were used. 

Table A.3.1: Toxicology Data Requirements 

Guideline Study Type Required Submitted Satisfied 

870.1100 Acute Oral Toxicity Yes Yes Yes 

870.1200 Acute Dermal Toxicity Yes Yes Yes 

870.1300 Acute Inhalation Toxicity Yes Yes Yes 

870.2400 Acute Eye Irritation Yes Yes Yes 

870.2500 Acute Dermal Irritation Yes Yes Yes 

870.2600 Skin Sensitization Yes Yes Yes 

870.3100 90-Day Oral Toxicity in Rodents CR Yes NA 

870.3150 90-Day Oral Toxicity in Non-Rodents CR No Waived2

870.3200 21/28-Day Dermal Toxicity No No NA 

870.3250 90-Day Dermal Toxicity Yes No Waived2

870.3465 90-Day Inhalation Toxicity CR No Waived2

870.3700 Prenatal Developmental Toxicity Study (Rodent) Yes Yes Yes 

Prenatal Developmental Toxicity Study (Non-Rodent) Yes Yes Yes 

870.3800 Reproduction and Fertility Effects Yes No Waived2

870.4100 Chronic Toxicity (Rodent) CR No NA 

Chronic Toxicity (Non-Rodent) CR No NA 

870.4200 Carcinogenicity (Rat) CR No NA 

Carcinogenicity (Mouse) CR No NA 

870.5100 Bacterial Reverse Mutation Test Yes Yes Yes 

870.5300 

870.5375 

in vitro Mammalian Cell Gene Mutation Test 

in vitro Mammalian Chromosome Aberration Test Yes1 Yes 

Yes Yes 

870.5385 

870.5395 

Mammalian Bone Marrow Chromosomal Aberration Test 

Mammalian Erythrocyte Micronucleus Test Yes1 No Yes Yes 

870.6100 Delayed Neurotoxicity of Organophosphorus Substances (Acute, Hen) CR No NA 

Delayed Neurotoxicity of Organophosphorus Substances (28-Day, Hen) CR No NA 

870.6200 Neurotoxicity Screening Battery (Acute, Rat) Yes No Waived2

Neurotoxicity Screening Battery (90-Day, Rat) Yes No Waived2

870.6300 Developmental Neurotoxicity Study CR No NA 

870.7200 Companion Animal Safety CR No NA 

870.7485 Metabolism and Pharmacokinetics CR No NA 

870.7600 Dermal Penetration CR No NA 

870.7800 Immunotoxicity Yes No Waived2

CR: Conditionally Required 

NA: Not Applicable 

1 Either guideline study type may be used to satisfy the data requirement (e.g., 870.5300 or 870.5375) 2 Waived by HASPOC on 09 October 2014 (TXR0052871) 
Page 11 of 12 

 

Toxicity Profiles 

Table A.3.2: Acute Toxicity Profile 

Guideline Study Type MRID Results 

Toxicity 

Category 

870.1100 Acute Oral Toxicity 45810301 LD50 > 2000 mg/kg III 

45853216 LD50 > 2000 mg/kg III 

870.1200 Acute Dermal Toxicity 45810302 LD50 > 2000 mg/kg III 

870.1300 Acute Inhalation Toxicity 45810303 LC50 > 2.350  0.1 mg/L IV 

870.2400 Primary Eye Irritation 45810304

All animals exhibited corneal opacity and iritis at 1 hr post 

instillation, but these were gone at 24 hrs. There were no 

positive signs of conjunctivitis exhibited at any time. 

IV 

870.2500 Primary Dermal Irritation 45810305

Primary Dermal Irritation Index (PDII) = 0.0083 

Very slight erythema (grade = 1) was noted in 1 female at 1 

hours, resolving within 24 hours. The remaining 2 animals did 

not exhibit any signs of erythema, nor was edema observed at 

any time. 

IV 

870.2600 Dermal Sensitization 45810306

Dermal sensitizer. Positive reactions were observed on the 

test flanks of 2/10 test males and 2/10 test females at the 24 

hour challenge examination and in 4/10 test males and 5/10 

test females at the 48 hr examination. No positive reactions 

were observed in the vehicle control group. 

N/A 

Table A.3.3: Subchronic, Chronic, and Other Toxicity Profiles 

Guideline Study Type MRID (year) / Doses / Classification Results 

870.3100 90-Day Oral 

Toxicity in Rodents 

(Rat) 

45853217 (1989) 

ppm: 

 0, 25, 150, 1500, 15000 

mg/kg/day: 

M: 0, 1.60, 9.68, 101, 998 

F: 0, 1.70, 10.2, 103, 1050 

Acceptable / Guideline 

NOAEL (mg/kg/day): M = 9.68 F = 10.2 

LOAEL (mg/kg/day): M = 101 F = 103 

Based on clinical signs of neurotoxicity, 

characterized tonic-clonic seizures in 1 female, 

increased brain & kidneys/BW ratios in males, 

liver & adrenal glands/BW ratios in females.

870.3150 90-Day Oral 

Toxicity in NonRodents (Dog) 

NA Waived by HASPOC on 09 October 2014 (TXR# 

0052871) 

870.3250 90-Day Dermal 

Toxicity (NA) 

NA Waived by HASPOC on 09 October 2014 (TXR# 

0052871) 

870.3465 90-Day Inhalation 

Toxicity (Rat) 

NA Waived by HASPOC on 09 October 2014 (TXR# 

0052871) 

870.3700 Prenatal 

Developmental 

Toxicity Study (Rat) 

45853219 (1989) 

mg/kg/day: 

F: 0, 100, 500, 1000 

Acceptable / Guideline 

Maternal 

NOAEL (mg/kg/day) = 500 

LOAEL (mg/kg/day) = 1000 

Based on decreased food consumption. 

Developmental 

NOAEL (mg/kg/day) = 1000 

LOAEL (mg/kg/day) > 1000 

Prenatal 

Developmental 

Toxicity Study 

(Rabbit) 

45853218 (1989) 

mg/kg/day: 

F: 0, 100, 500, 1000 

Acceptable / Guideline 

Maternal 

NOAEL (mg/kg/day) = 1000 

LOAEL (mg/kg/day) > 1000 

Developmental 

NOAEL (mg/kg/day) = 1000 

LOAEL (mg/kg/day) > 1000 

870.3800 Reproduction and 

Fertility Effects 

(Rat) 

NA Waived by HASPOC on 09 October 2014 (TXR# 

0052871) 
Page 12 of 12 

 

870.5100 Bacterial Reverse 

Mutation Test 

(Salmonella 

typhimurium) 

45853220 (1988) 

μg/plate: 

S9: 20, 78, 313, 1250, 5000 

Acceptable / Guideline 

CGA 184699 is not mutagenic in the standard 

battery of S. typhimurium strains exposed up to 

5000 μg/plate ± S9 

870.5300 in vitro Mammalian 

Cell Gene Mutation 

Test (Chinese 

Hamster Lung (V9) 

Cells) 

45853221 (1988) 

μg/plate: 

-S9: 25, 50, 100, 200, 300, 400, 500 

+S9: 37.5, 45, 75, 90, 150, 180, 300, 

360, 450, 540, 600, 720, 750, 

900 

Acceptable / Guideline 

CGA 184699 technical was non-mutagenic for 

forward mutation at the HGPRT locus of Chinese 

hamster lung (V79) cells treated up to cytotoxic 

concentration levels. 

870.5375 in vitro Mammalian 

Chromosome 

Aberration Test 

(Chinese Hamster 

Ovary Cells) 

45853222 (1989) 

μg/mL: 

S9: 25, 50, 100, 200, 400, 800, 1600 

Acceptable / Guideline 

CGA 184699 (lufenuron) is not cytogenetically 

active (structurally or numerically) in Chinese 

hamster ovary cells treated up to cytotoxic levels 

and reduced mitotic indices. 

870.5395 Mammalian 

Erythrocyte 

Micronucleus Test 

(Mouse) 

45853223 (1989) 

mg/kg/day: 

M: 1250, 2500, 5000 

Acceptable / Guideline 

CGA 184699 technical is considered negative for 

the induction of micronuclei in mice treated orally 

up to 5000 mg/kg 

NA In Vivo/In Vitro 

Unscheduled DNA 

Synthesis (Rat 

Hepatocytes) 

45853224 (2000) 

mg/kg/day: 

F: 1000, 2000 

Acceptable / Non-Guideline 

Acute oral administration of CGA 184699 

(lufenuron) to male rats up to the acceptable acute 

limit dose (2000 mg/kg) did not induce UDS in 

primary rat hepatocytes drawn from these animals 

2 or 16 hours post-dose. 

The negative UDS response in hepatocytes from 

test article-treated rats is considered valid, since it 

was demonstrated that genotoxic damage and 

repair (UDS) by the two mutagens (DMN, AAF) 

used as positive controls occurred in the absence of 

cytotoxicity. 

870.6200 Acute Neurotoxicity 

Screening Battery 

(Rat) 

NA Waived by HASPOC on 09 October 2014 (TXR# 

0052871) 

90-Day 

Neurotoxicity 

Screening Battery 

(Rat) 

NA Waived by HASPOC on 09 October 2014 (TXR# 

0052871) 

870.7800 Immunotoxicity 

(NA) 

NA Waived by HASPOC on 09 October 2014 (TXR# 

0052871)