









OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION





February 10, 2011



 DPBARCODE:



MRID:D367948



47810501, 47810502, 47810503, 47810504,47810505,47810506, 47810507,
47810508,47810509

SUBJECT:

Terbutryn Technical

REG. NO. OR FILE SYMBOL:

5383-RGI

DOCUMENT TYPE:

Product Chemistry Review

Manufacturing-use [X]

OR

End-use Product []

INGREDIENTS (PC Codes):

080813

CAS Number:

886-50-0

TEST LAB:

Syngenta Crop Protection, Inc.

SUBMITTER:

Troy Chemical Corporation

GUIDELINE:

830 Guidelines

COMMODITIES:

Formulation

REVIEWER:



ORGANIZATION:

Chris Jiang	0



AD

                                                  





APPROVER:	Karen P. Hicks



                                                  



APPROVED DATE:





OfFICE Of CHEMICAL SAFETY AND POLLUTION PREVENTION



February 10, 2011



MEMORANDUM



Subject: 	Review for 5383-RGI



From:

Chris Jiang, Chemist

Chemistry and Toxicology Team Product Science Branch Antimicrobials
Division (751OP)





ll6B'l



Thru:

Karen P. Hicks, CT Team Leader 	.... Chemistry and Toxicology Team

                                                  





Product Science Branch 	Y	f 	B 1	0 ( C C

Antimicrobials Division (751OP)	' l



To: 	Jacqueline Campbeli-McFarlane  PM 34CStacey Grigsby

Regulatory Management Branch II Antimicrobials Division (751OP)



Applicant: 	Troy Chemical Corporation



                                                  



FORMULATION FROM LABEL: Acti ve Ingredient(s):

2-(tert-butylamino)-4-ethylamino)-6-(methylthio)-s-triazine

Inert Ingredients

Total



 %by wt.

96.6%

3.4%

100.0%

 

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,
47810502, 47810503, 47810504, 47810505,

47810506, 47810507, 47810508, and 47810509.  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 18, 2008) is consistent with the label
declaration.



2. 	All ingredients are cleared for use in pesticidal products.



3. 	The product identity and composition is acceptable.



4. 	The description of the starting materials is acceptable.



5. 	The description of the formulation process is acceptable.



6. 	The discussion of the formation of impurities is acceptable.



7. 	The preliminary analysis is acceptable.



8. 	All certified limits are acceptable.



9. 	The enforcement analytical method is acceptable.  Although the
registrant did not address this requirement, the consultant wishes to
use the method employed in MRlD

47810504 for analysis.



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 odorless.



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.



13. 	The density is acceptable as the density was determined to be 1.20
at 20

14.	The water solubility is acceptable.  This property was found to vary
with temperature but not with pH.

 



15. 	The vapor pressure is acceptable as the extrapolated vapor pressure
was determined to be 1.68 x 10-6 mm Hg at 20 

16. 	The dissociation constant in water is acceptable as his value was
determined to be 4.47 at 23.4 

17. 	The octanolCwater  partition coefficient is acceptable as this
value is independent of temperature and pH.  The log Pow was found to be
3.7 at 20

18. 	The pH is acceptable as the pH of a 1% solution was determined to
be 5.91.



19. 	The stability is unacceptable.  No data was submitted for this
requirement.  Datav for stability is needed to register a technical
grade active ingredient/manufacturing use product.  This guideline
(830.6313)  includes stability to normal and elevated

temperatures and reaction to metal and metal ions.



20. 	The oxidation/reduction potential is 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 is not potentially
flammable.



22.	The explodability  is acceptable as the product is not potentially
explosive.



23. 	The studies for storage stability and corrosion characteristics
were not submitted. These data are required for manufacturing-use
products/technical  grade active ingredients.  These data are often
conducted jointly under GLP compliance.  These data can be submitted as
a condition of registration.



24. 	The viscosity i s unacceptable as this requirement was not
addressed in the /

submission.



25. 	The miscibility 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 subm i ssion.



27. 	The UVNisible Absorption data is acceptable.



28. 	Under the "Directions for Use" section of the label, change "PBI"
to read

"polybenzimidazole (PBI)."



29. 	Under the "Pesticide Storage" section of the label, add
instructions that specify what to do if the product leaks or spills from
the product container.

 



CONCLUSIONS:



Product Science Branch of Antimicrobials Division finds the CSFs for
383-RGI to be acceptable and the data for 5383-RGI to be unacceptable
for the reasons discussed in the findings.  The registrant must remedy
the issues before successful registration may proceed.

