UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY WASHINGTON, D.C. 20460

MEMORANDUM Date: March4, 2015 OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

SUBJECT: Momfluorothrin: Response to Registrant Comments from Sumitomo Chemical onthe Human Health Risk Assessment (December 9, 2014; DP Barcode: D409621). PC Code: 016331 Decision No.: 474816 Petition No.: NA DP Barcode: D425171 Registration No.: NA RiskAssessment Type: NA TXRNo.:NA Regulatory Action: Section 3 Registration CaseNo.: None CAS No.: NA MRID No.: NA 40 CFR: NewActive Ingredient

FROM: Monica Hawkins, Ph.D., M.P.H., Risk Ass Christopher Schlosser, Toxicologist Risk Assessment Branch VI THROUGH: DonnaDavis, Acting Branch Chief Risk Assessment Branch VI Health Effects Division TO: Julie Chao, Risk Management Team 1 Kahle Davis, Risk Management Team 25 Marietta Echeverria, Chief Insecticide Rodenticide Branch Registration Division (7505P) ental Health

## Scientist**~**

HED has received comments on the review ofthe human healthrisk assessment for Section 3 Registration December 9, 2014; DP Barcode: D409621. EPA's Response: HED acknowledges the submitted corrections from Sumitomo Chemical. Since the requested revisions do not impactthe risk calculations orconclusions from the December 9, 2014 risk assessment, no revision to the momfluorothrinrisk assessment was undertaken atthis time. Page 1of4However, HED will incorporate the recommended changes into the next momfluorothrinrisk assessment. Sumitomo's Comments: (1) 870.3100 90-day Oral Toxicity-Rat 870.3150 90-day Oral Toxicity-Dog 870.3700a Prenatal Developmental Toxicity Study

- Rat 870.4100 Chronic Toxicity-Rat 870.4300a Carcinogenicity-Rat (Typo; see commentNo. 10) 870.4300b Carcinogenicity-Mouse 870.6200 Acute Neurotoxicity Screening Battery-Rat 870.6200 Subchronic Neurotoxicity Screening Battery -Rat 870.7800 Immunotoxicity-Rat The descriptions of"lack ofstability data" in the lastparagraph were incorrect. In these studies, stability oftest substance was confirmed based onthe data ofexpiry date. (2) P13. Comment 1stparagraph L3 In addition to tremor, salivationbutnot impaired gait and muscularrigidity was observed in the acute neurotoxicity study. (3) P38-43. Typo Table A2.2 S-15632 => S-1563 (4) P40. Typo Table A.2.2. Carcinogenicity (rat), Guideline No. : 870.4300 => 870. 4200 (5) P40. Typo Table A.2.2. Carcinogenicity (rat), 

### F:O,

...,or 188 => 

### F:O,

...,or 182 (6) P42. Typo 4th paragraph Ll, almost entirely=> at almost constantrate (7) P42. Typo 5thparagraph L6, 3.4893% => 3.483% (8) P46. Typo 870.3200 28-day dermal toxicity 1st paragraph L3, 5days/week during a 28-day period=> 7days/weekduring a 28-dayperiod (9) P49. Comment 6thparagraph L3 However, delayed sexual maturation in females is considered treatment related as the effect was

...=>However, delayed sexual maturation in females is consideredtreatmentrelated although this was attribute to the retarded growth ofthe pups. As the effect was ... (10) P51. Typo A.4.5 Carcinogenicity, 870.4300a Combined Chronic Toxicity/Carcinogenicity -Rat=> 870.4200a Carcinogenicity-Rat Page 2of4

### (11) P5l. Comment Last paragraph L4, only reaching statistical significance in males. => not only males but also females. (12) P52. Typo Carcinogenicity-Mouse 1stparagraph L3, 673 => 639, 433 => 427, 934 ==> 

### 853 (13) P55. Typo 4thparagraph Ll, absorption=> plasma 14C concentration (14) P55. Typo Last paragraph L2, parent compound=> 14C (15) P55. Typo Lastparagraph L3, in male rats=> in both male and female rats (16) P56. Typo 6th paragraph L4, n=3 => n=4 (17) P56. Typo with comment 7th paragraph L6, 3.5% => 3%, The value should be rounded to 3% in accordance with the OECD guidance notes on dermal absorption to avoid afalse impression ofaccuracy. (18) P58. Typo A.4.10 Mode ofAction 3rdparagraph L4 and 8, CYP2Bl0 activity=> expression ofCYP2BI0 (19) P59. Typo 2nd paragraph L2,

... in the rat=> inthe mouse (20) P59. Typo 4th paragraph L3,

...in all rats=> in all mice (21) P59. Typo 4th paragraph LIO,

...for CYP2 =>forCYP2B (22) P60. Typo 3rd paragraph Ll3, Study Days 11-15 =>StudyDays 8-11 and 11-15 (23) P60. Typo 3rd paragraph LI9, gene expression=> delete please (not examined in this study) (24) P60. Typo 3rd paragraph L22-24,

... a marked and significant

... CYP2A10. =>delete please (not examined in this study) (25) P60. Typo 4th paragraph L3, (2.8- => (2.9- (26) P61. Typo 1stparagraph L1, for 14 days => for 7 days (27) P61. Typo 4thparagraph L8 and 11, CYP2Bl/2 activity=> expression ofCYP2Bl/2 (28) P62. Typo 4th paragraph L8, 300 ppm=> 3000 ppm (29) P62. Comment 4th paragraph L9, in all groups=> not conducted animals inrecovery group (30) P63. Typo 4th paragraph L7, UGP-glucuronosyltransferase =>UDPglucuronosyltransferase (31) P64. Typo 2nd paragraph L7, MRIDs

.. .490200602 => 49020062 (32) P64. Typo 3rd paragraph L8, CYP2B expression=> CYP2B (expression is not necessary) Page 3of4(33) P64. Typo 4thparagraph L7, 2-8 fold=> 2.8-fold (34) · P64. Typo 4thparagraph L8, CYP2B expression=> CYP2B activity (35) P64. Typo 5th paragraph L3, diffused=> centrilobular (36) P65. Typo 3rdparagraph L4, 30000 ppm=> 3000 ppm (37) P66

. Comment 2ndparagraph L3, Enlarged livers, diffuse hepatocellularhypertrophy and thyroid follicular cell hypertrophy were observed in 7/10 animals dosed with 10,000 ppm for 7 or 14 days.=> It is imprecise. Enlarged livers, diffuse hepatocellularhypertrophy and thyroid follicular cell hypertrophy were observed in 10 or 8/10, 10/10, and 7/10 animals dosed with 10,000 ppm for 7 or 14 days, respectively.

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