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: R egistrat ion 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 Pes t icide Programs



### THROUGH: Christine Olinger

, Branch Chieff

# 1//-~ Risk Assessment Branch III He alth Effec ts Division (7509P Office of Pesticide Programs

TO: Bonnie Ad l er, Chem i cal Review Manager And Jill Bloom, Team Leader Ri s k Management & Implementa t ion Branch 5 Pesticide Re-Evaluation Division (7508P) Office of Pesticide Programs

Attached is the Health Effects Division's (HED) human hea l th Regi st ra t ion Review scoping document for the insect growth regulator, lufenuron.



### Executive Summary

HED has eva l uated recent human health assessments for lufenuron to determine whether suffic i ent 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

Pag e 1 of 12

### Page 2 of 12 updates to Agency science policy and risk as sessment methodologies and to the lufenuron toxicity, exposure, and usage databases.

Lufenuron is a benzoylphenylur ea 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). Lufe nuron is registered exclusively for use in integrated management systems or impregnated bait stations. The bait co ntaining 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 pe st management professi onals licensed to apply termite control products by the state (pes t control operators) may use lufenuron.

The most recent risk assessment for lufenur on was conducted to support lufenuron’s initial registration and evaluated lufenuron use in a bait to control termite s (K. O’Rourke, D293828, 07/02/2004). The assessment concluded that occ upational and residential exposure is expected to be negligible.

The lufenuron toxicology database is adequate fo r 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. Follo wing repeated oral (dieta ry) exposure, toxicity manifested as clinical signs indicative of neur otoxicity and increased relative organ weights in a sex specific manner. There was no ev idence 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 c onsidered 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 con centrations (EDWCs). There are no outstanding residue chemistry database defici encies 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 Registra tion Review because residential and drinking water exposures are considered negligible. Furthermore, a new occu pational 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 ri sk assessment will not be conducted during Registration Review.

Introduction

Lufenuron is a benzoylphenylurea insect grow th regulator currently undergoing Registration Review . The most recent (semi-qualitative) risk assessment for lufenuron was conducted to evaluate the proposed use in bait to cont rol termites (K. O’R ourke, D293828, 07/02/2004). Exposure to lufenuron is considered to be neglig ible via all routes. Lu fenuron products are only formulated to be used in enclosed impregna ted bait stations for above- and below-ground use around residences and commercial bu ildings/structures to control subterranean termites. The labels specify that only pest management prof essionals 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 adequa te 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 toxicolo gy database includes an acu te toxicity battery, a subchronic oral study in rats, pren atal developmental st udies 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 batte ry (acute and subchronic studies); and an immunotoxicity in rats. H ealth Effects Division’s Hazar d and Science Policy Council (HASPOC) reviewed the exposur e and toxicology database ba sed 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 th e currently registered uses (included in termite baits in enclosed bait stations), the HA SPOC further concluded that a qualitative, not a quantitative, risk assessm ent is adequate for lufenuron (TXR# 0052871).

In the repeated dietary exposure study in rats, lu fenuron exposure led to c linical signs (i.e., tonicclonic seizures) and increased rela tive 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 studie s, test animals were dosed up to the limit dose (1000 mg/kg/day) with no evidence of developmental toxicity or sus ceptibility. In rats, maternal animals were observed to have decreased food consum ption 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 studi es are not required for l ufenuron.

An immunotoxicity study is not required for lufenuron because lufenuron does not target the immune system, and an immunotoxicity study ava ilable 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 studi es have been waived, and additional toxicity studies are not required at this time. However, if the use pattern change s, the toxicology data requirements will need to be reevaluated.

Dietary Exposure

### Page 4 of 12 Lufenuron is considered a non-food use pesticid e. HED considers protected baits as nonfood/non-feed uses per the Chemistry Science A dvisory 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 exis ting uses of lufenuron are cons idered 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 mana gement professionals licensed by the state to apply termite control products may use lufe nuron. Occupational ha ndlers 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/reside ntial post-application exposure to lufenuron is expected to be negligible. Lufenuron is re gistered exclusively for use in integrated management systems or impregnated bait stations. The bait containing lufenuron is formulated in a cellulose bait matr ix that is then always inserted into the bait station structure; limiting potential exposure to lufenuron. A prel iminary, highly conservative quantitative exposure assessment was completed previously for lufenuron using the shor t- 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 occupati onal handler dermal margin of exposure (MOE) of 24,000, which is not of concern to the Agency (t he level of concern (LOC) is an MOE < 100).

The screening-level, highly conservative, pr eliminary 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 impregnate d 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, th ere was little to no an ticipated exposure for handlers.
Based on current occupational a nd residential exposure assess ment policies, the currently registered uses of lufenuron resu lt 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 resulti ng from spray drift are not expected because there are no registered agricultural uses of lufenur on or uses that would re sult in volatilization or drift.

Conclusions: The occupational and residential exposur e databases are adequate to support existing registrations of lufenuron. A quantit ative 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 resi dential settings, the exposure fr om the registered uses is expected to be negligible. Lufenuron is consid ered a non-food/non-feed use pesticide; therefore, a dietary (food and drinking water) e xposure 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 inci dent cases reported for lufenuron in both the OPP Incident Data System (IDS) and Centers for Di sease Control and Preven tion/National Institute for Occupational Safety and H ealth (CDC/NIOSH) Sentinel Ev ent Notification System for Occupational Risk (SENSOR)-Pesticid es, there does not appear to be a concern at this time that would warrant further inve stigation. There were no incidents reported in the IDS. A query of SENSOR-Pesticides 1998-2010 did not iden tify any cases involving lufenuron.

The Agency will continue to monitor the incide nt information and if a concern is triggered, additional analysis will be incl uded in the risk assessment.

Tolerance Assessment and International Harmonization

Lufenuron is considered a non-food/non-feed pestic ide; therefore, there are no existing lufenuron tolerances. There are no Codex or Canadian maximum residue limits (MRLs) established for lufenuron; therefore, there is no harm onization issue at this time.

Environmental Justice

Potential areas of environmental ju stice concerns, to the extent possi ble, were considered in this human health risk assessment, in accordance w ith U.S. Executive Order 12898, "Federal Actions to Address Environmental Just ice in Minority Populations an d 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 c onsumer subgroups according to well-established procedures. In line with O PP policy, HED estimates risks to population subgroups from pesticide exposures that are ba sed on patterns of that subgrou p’s food and water consumption, and activities in and around th e 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 us ed in pesticide risk assessments for all registered food uses of a pesticide. These da ta 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 traditi onal dietary patterns among specific subgroups.

Cumulative Risk Assessments

Unlike other pesticides for which EPA has fo llowed 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 m echanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to ev aluate the cumulative effects of such chemicals, see the policy statements released by EPA’s OPP concer ning common mechanism determinations and procedures for cumulating effects from subs tances 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 Term ite 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% Lufe nuron); EPA Reg. No. 100-1174

Table A1.2. Physicochemical Propertie s 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/m 3 at 23°C MRID 45839503 Water solubility 48 mg/L at 25°C MRID 45839503 Solvent solubility A cetone: 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, pK a pKa = 10.2 +0.1 at 20°C MRID 45839503 Octanol/water partition coefficient, Log(K OW ) Log P ow = 5.12 at 25 o C 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, ba it 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, ba it 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, th e 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, ba it 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 pr otocols 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 T oxicity Yes Yes Yes 870.1300 Acute Inhalation Toxicity Yes Yes Yes 870.2400 Acute Eye Irri tation Yes Yes Yes 870.2500 Acute Dermal Ir ritation 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 Waived 2 870.3200 21/28-Day Dermal Toxicity No No NA 870.3250 90-Day Dermal T oxicity Yes No Waived 2 870.3465 90-Day Inhalation Toxicity CR No Waived 2

870.3700 Prenatal Developmental Toxici ty Study (Rodent ) Yes Yes Yes Prenatal Developmental Toxicity Study (Non-Rodent) Yes Yes Yes 870.3800 Reproduction and Ferti lity Effects Yes No Waived 2

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 Yes 1 Yes Yes Yes

870.5385 870.5395 Mammalian Bone Marrow Chro mosomal Aberration Test Mammalian Erythrocyte Micronucleus Test Yes 1 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 Waived 2 Neurotoxicity Screening Battery (90-Day, Rat) Yes No Waived 2 870.6300 Developmental Neurot oxicity Study CR No NA 870.7200 Companion Animal Safety CR No NA 870.7485 Metabolism and Phar macokinetics CR No NA 870.7600 Dermal Pene tration CR No NA 870.7800 Immunotoxicity Yes No Waived 2 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 LD 50 > 2000 mg/kg III 45853216 LD 50 > 2000 mg/kg III 870.1200 Acute Dermal Toxicity 45810302 LD 50 > 2000 mg/kg III 870.1300 Acute Inhalation Toxicity 45810303 LC 50 > 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 OralToxicity 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)