Document ID: EPA-HQ-OPP-2012-0939-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-03-27T04:00Z

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      	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
       		WASHINGTON, D.C. 20460
      
      
      
      
                                      1/1/2013
                                                                               
                             OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION
MEMORANDUM

SUBJECT:	Product Chemistry Scoping Document for the Registration Review of Chemical Name.  

            Registration Review Case #:		4110
            PC Code:						043801, 043802, 116902
            CAS Numbers:						77-06-5, 125-67-7, 8030-53-3
            Chemical Class:					Biochemical
                                                                  
FROM:		Sadaf Shaukat, Biologist /s/  1/1/13
            Biochemical Pesticides Branch
            Biopesticides & Pollution Prevention Division (7511P)

TO:			Menyon Adams, Regulatory Action Leader
            Biochemical Pesticides Branch
            Biopesticides & Pollution Prevention Division (7511P) 

ACTION REQUESTED

A preliminary assessment of available information on product chemistry data associated with the biopesticide gibberellins in support of the development of a Registration Review Work Plan.

Introduction

The EPA has made the determination that there is adequate information available on gibberellins, including Gibberellic Acid (GA3), Gibberellins (GA 4) and (GA 7), and
Potassium Gibberellate, and does not foresee the need for additional biochemical pesticide product chemistry data for products that currently contain gibberellins as the technical grade active ingredient.  Gibberellic Acids are naturally occurring plant hormones. They are used in agriculture as plant regulators to stimulate both cell division and cell elongation that affect leaves as well as stems (eventually affecting fruit development and fruit set). The plant regulator, Gibberellic Acid, was initially registered in the United States in 1947 as PROVIDE GROWTH REGULATOR SOLUTION (EPA Reg. No. 275-2) for applications to apple trees as a means of controlling fruit russet fungus. Currently there are eighty-one active registrations of products containing gibberellins. The Agency exempts gibberellins from the requirement of a tolerance when used as a plant regulator on plants, seeds, or cuttings and on all food commodities after harvest (see 40 CFR 180.1098). 

Concerning the product chemistry of gibberellins, all biochemical pesticide data requirements for the technical grade active ingredient have been satisfied and are summarized in Table 2. While no further product chemistry data are necessary for the products currently registered, future registrations must adequately address all of the biochemical pesticides product chemistry data requirements.

Table 1. Product Identity and Composition for Gibberellins
Case Number
                                                                           4110
Common Name
    Gibberellic Acid (GA3)/Gibberellins (GA4 & GA7)/Potassium Gibberellate 
Chemical Name, IUPAC
    Gibberellic Acid (GA3)/Gibberellins (GA4 & GA7)/Potassium Gibberellate 
Chemical Class
                                                                    Biochemical
Pesticide Type
                                                         Plant Growth Regulator
Year First Registered
                                                       1947 (USDA Registration)
Reregistration Eligibility Decision
(RED)
                                                                  December 1995
40 CFR Citation (Tolerance or  Exemption From Requirement of a Tolerance
40 CFR Citation (Tolerance or  Exemption From Requirement of  rance40 CFR § 180.1098
Pesticide Regulatory Action Leader
                                                                   Leonard Cole
PC Codes
                                                         043801, 043802, 116902
CAS Registry Numbers
                                                  77-06-5, 125-67-7, 8030-53-3 
Chemical Structure
                                       

Product Chemistry Summary
The Agency has conducted a review of the available product chemistry data and information.  These data are summarized below.

Table 2. Biochemical Pesticides Product Chemistry Data Requirements for Gibberellins 
                                 Guideline No.
                       Physical and Chemical Properties
                                   Status[1]
                                     Value
                                     MRID/
                                    Source
830.1100
Product Identity and Composition
                                       A
Refer to Table 1.
RED (Dec. 1995)
830.1200
Description of starting materials, production and formulation process
                                       A
CBI
47184703
830.1400
Discussion of formation of impurities
                                       A
CBI
47184703
830.1700
Preliminary analysis
                                       A
CBI
44448201
830.6302
Color
                                       A
White
45249702, 44448201
830.6303
Physical state
                                       A
Fine powder
45249702, 44448201
830.6304
Odor
                                       A
Odorless 
45249702, 44448201
830.6313
Stability to normal and elevated temperatures, metals and metal ions
                                       A
Stable at normal and elevated temperatures, and in contact with metals/metal ions; Chemically stable following storage @54oC for 14 days; Chemically stable on contact with aluminum, iron, and tin for 14 days; Chemically stable following exposure to artificial sunlight for 24 hrs
44081305, 44264704
830.7000
pH
                                       A
0.1% (w/v) = 3.14
0.5% (w/v) = 2.88
1.0% (w/v) = 2.82
44448201
830.7050
UV/Visible light absorption

                                       A
Neutral λ= 270.0 nm; ε= 19580
             λ= 209.4 nm; ε= 24385
Acid     λ= 278.7 nm; ε= 18998   
             λ= 206.8 nm; ε= 20800
Base     λ= 270.0 nm; ε= 19636
44710204
830.7200
Melting point/melting range
                                       A
205.6-224.5 [o]C
45249702
830.7220
Boiling point/boiling range
                                      N/A
Not a liquid at room temperature

830.7300
Density
                                       A
0.60 g/ml
44448201
830.7520
Particle size, fiber length, and diameter distribution
                                      N/A
Not a water insoluble or fibrous test substance

830.7550
830.7560
830.7570
Partition coefficient (n-Octanol/Water)
                                      N/A
Partially soluble in water

830.7840
Water solubility 
                                       A
70.4%
44448201
830.7950
Vapor pressure
                                       A
0.01 mPa (25[o]C)/ 1.3X10[-13] mm Hg
PPDB/Toxnet
   1. A=Acceptable. N/A=Not Applicable. N/D=Not Determined
                                  References

Bade. Product Identity, Manufacturing Process, Formation of Unintentional Ingredients, Gibberellic Acid (GA3). Private Study by Valent BioSciences Corp. Submitted to EPA. MRID 47184703.

Pesticide Properties Database, Online. 01/08/2013. http://sitem.herts.ac.uk/aeru/projects/ppdb/index.htm

Rojas. Physical and Chemical Properties Characterization of Gibberellin A4/A7 Code 12519, Technical Grade Active Ingredient. Private Study by Abbott Laboratories. Submitted to EPA. MRID 45249702.

Toxnet, Online. 01/08/2013. http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/~HsGGvC:1:vap 

United States EPA. Reregistration Eligibility Decision (RED): Gibberellic Acid. December 1995.

Zaletal. Product Chemistry-Physical and Chemical Properties of Kaltron Gibberellic Acid-Technical Grade Active Ingredient. Private Study by Zalco Laboratories, Inc. Submitted to EPA. MRID 44448201.