**UNITED STATES**  **ENVIRONMENTAL PROTECTION**  **AGENCY WASHINGTON,**  **DC 20460**  OFFICE O F CH EM ICAL S A

FE TY AND PO L LU T I ON PREVENTION 

### February 1 0 , 2011 DPBARCOD E : **MRI D**  **:** 

### D367948 4781050 1 , 4781050 2, 4781050 3 , 47810504, 47810505,4781050 6, 4781050 7, 47810508, 47810509 SUBJECT: Terbutry n Technical RE G. NO. OR FILE SYMBO L : 5383 - RGI DOCUMENT TYPE: Product Chemistry Review Manufacturing -use [X] OR End-use Product [] INGREDIENTS (PC Co des ) : 080813 CAS Number : 886 - 50 - 0 TEST LAB : Syngenta Crop Protection, In c . SUBMITTER : Troy Chemical Corporation GUIDELINE : 830 Guidelines COMMODITIE S : Formulation REVIEWER: ORGANIZAT ION : Chris Jiang 

# 0 AD APPROVER: Karen P. Hicks APPROVED DAT E :**UNITED STATES**  **ENVIRONMENTAL PROTECTION**  **AGENCY WASHINGTON,**  **DC 20460** 



# K OfFICE O f

CH EM ICAL SAFETY AN D PO L L U T I O

N PR EV E NTION February 10, 2 0 1 1 **MEMORANDUM Subject:**  Review for 538 3 -RGI **From:** Chri s Jiang, Chemist

Chemistry and Toxicology Team Product Science Branch Antimicrobials Division (75 1 OP) 

# ll6{' 

# l **Thru:** Karen P . Hick s , CT Team Le ader . . . .

Chemistry and Toxicology Team Pr oduct Science Branch 

# Y 

# f { **1 0**  ( \ \ Antimicrobi al s Division ( 75 1 OP) ' 

### l **To:** Jacqueline Campbeli -McFarlane PM 34\ Stacey Grigsby

Regulatory Management Branch II Antimicrobials Division (75 1 OP) **Applicant:** Troy Chemical Corporation FORMULATION FROM LABEL: Acti ve Ingredient(s ) : 2 - (tert - butylamino ) - 4 - ethylamino) -6 - (methylthi o ) - s-triazine Inert Ingredients Total %by wt . 96.6% 3.4% 10 0 . 0%BACKGROUND: The registrant has submitted a product chemistry package in support of a new active ingredient. The package includes a label, Confidential Statements of Formula (CSF dated 7115/2009 for the basic formulation and CSF dated 217/2011 for alternate formulation 1), and MR.IDs 47810501 , 4781050 2 , 4781050 3 , 4781050 4 , 4781050 5 , 4781050 6 , 4781050 7, 4781050 8 , and 4781050 9 . These studies are intended to satisfy the product chemistry requirements. The contractor has conducted a primary review of this submission and Product Science Branch of Antimicrobials Division has conducted a secondary review which supersedes the primary review. FINDINGS: 1 . The concentration of the active ingredient on the Confidential Statement of Formula (CSF dated June 1 8 , 2008) is consistent with the label declaration . 2 . All ingredients are cleared for use in pesticidal product s . 3 . The product identity and composition is acceptabl e . 4 . The description of the starting materials is acceptabl e . 5 . The description of the formulation process is acceptabl e . 6 . The discussion of the formation of impurities is acceptable. 7. The preliminary analysis is acceptabl e . 8 . All certified limits are acceptabl e. 9. The enforcement analy tical method is acceptabl e . Although the registrant did not address this requirement , the consultant wishes to use the method employed in MRlD 47810504 for analysi s . l 0. The color, physical state, and odor are acceptable. Both the pure active ingredient and the product are white solids. The product has a weak sulfide odor and the pure active ingredient is odorles s . 11. The melting point is acceptable as the melting point was found to be 377 K. 12. The boiling point is acceptable as the boiling point was found to be 618 K. 1 3 . The density is acceptable as the density was determined to be 1.20 at 20° C . 14. The water solubility is acceptable. This property was found to vary with temperature but not with p H .15. The vapor pressure is acceptable as the extrapolated vapor pressure was

determined to be 1 . 68 x 10 - 6 mm Hg at 20 ° 5. 1 6 . The dissociation constant in water is acceptable as his value was determined to be 4.47 at 23.4 °C. 1 7 . The octanol\

water partition coefficient is acceptable as this value is independent of temperature and p H . The l o g 

### P o w was found to be 3 . 7 at 20°C. 1 8 . The pH is acceptable as the pH of a 1% solution was determined to be 5.91. 1 9 . The stability is unacceptabl e. No data was submitted for this requirement. Datav for stab ility is needed to register a technical grade active ingredient/manufacturing u se product. This guideline (83 0 . 6313) includes stability to normal and elevated temperatures and reaction to metal and metal ion s . 2 0 . The oxidation/reduction potential i s unacceptable. The study states that/ oxidizing properties are predicted to be negative; however, the study states nothing about reducing potential. 21. The flammability is acceptable as the product i s not potentially flammabl e . 2 2 . The explodability is acceptable as the product is not potentially explosiv e . 23 . The studies for storage stability and corrosion characteristics were not submitte d . These data are required for manufacturing -use product s / technical grade active ingredient s. These data are often conducted j ointly under GLP compli anc e . These data can be submitted as a condition of registration . 2 4 . The viscosity i s unacceptable as this requirement was not addressed in the / submission. 2 5 . The miscibilit y i s unacceptable as this requirement was not addressed in the / submission. 26. The dielectric breakdown voltage is unacceptable as this requirement was not 

## I addressed in the sub m i ssion . 2 7 . The UVN i sible Absorption data i s acceptabl e . 2 8 . Under the " Direction s for Use" section of the labe l , change "PBI" to read "p o lybenzimidazole ( PBI )." 2 9 . Under the " P es

ticide Storag e " section of the labe l , add instructions that specify what to do if the product l eaks or spills from the product container.**CONCLUSIONS:** Product S ci ence Branch of Antimicrobials Division finds the CSFs for 38 3 -RGI to be acceptable and the data for 5383 - RGI to be unacceptable for the reasons discussed in the finding s . The registrant must remedy the issues before successful registration may procee d .