UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

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: TroyChemicalCorporation

GUIDELINE: 830 Guidelines

COMMODITIES: Formulation

REVIEWER:

ORGANIZATION:

Chris Jiang 0

AD

APPROVER: Karen P. Hicks

APPROVED DATE:
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

K

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{'l

Thru: Karen P. Hicks,CT Team Leader ....

Chemistry and Toxicology Team

Product Science Branch Y f { 1 0( \ \

Antimicrobials Division (751OP) ' l

To: Jacqueline Campbeli-McFarlane PM 34\Stacey Grigsby

Regulatory Management Branch II 

Antimicrobials Division (751OP)

Applicant: Troy Chemical Corporation

FORMULATION FROM LABEL: 

Active 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°C.

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 °5.

16. The dissociation constant in water is acceptable as his value was determined to 

be 4.47 at 23.4 °C.

17. The octanol\water partition coefficient is acceptable as this value is independent 

of temperature and pH. The log Pow was found to be 3.7 at 20°C.

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 is unacceptable as this requirement was not addressed in the /

submission.

25. The miscibility is 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 submission.

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.