Document ID: EPA-HQ-OPP-2012-0128-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2012-10-16T04:00Z

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

MEMORANDUM

DATE:		October 3, 2012

SUBJECT:	Science Review in Support of Rode-Trol, Containing 90.0% Powdered Corn Cobs (33.3% Cellulose) As Its Active Ingredient.  

            Decision Number: 						447148
            DP Number: 							402046, 402312
            EPA File Symbol Number: 				84889-E
            Chemical Class: 							Biochemical
            PC Code: 								100154
            CAS Number:							9004-34-6 (cellulose)
            Active Ingredient Tolerance Exemptions: 		Nonfood-use
            MRID Numbers: 						48433501-48433503, 48433506, 48533801-48533802, 48824701*not all MRIDs are associated with the DP numbers.
                                                                  
FROM:		Angela L. Gonzales, Biologist	
            Biochemical Pesticides Branch
            Biopesticides & Pollution Prevention Division (7511P)

TO:			Leonard Cole, Senior Regulatory Specialist
            Biochemical Pesticides Branch
            Biopesticides & Pollution Prevention Division (7511P) 

ACTION REQUESTED

On behalf of Rode-Trol, LLC, E[x]ponent, Inc. requests registration of Rode-Trol, an end-use product (EP) containing powdered corn cobs (33.3% cellulose). The chemical is a new biochemical active ingredient. The proposed EP is intended for use as a rodenticide in commercial and residential indoor settings. In support of the proposed EP, the registrant submitted a proposed product label, Confidential Statement of Formulas (CSFs) dated 7/12/11, product chemistry data and information in MRIDs 48433501-48433402, 48533801 and 48824701 and mammalian toxicology data and information in MRIDs 48433503, 48433506 and 48533802. 

RECOMMENDATIONS AND CONCLUSION

1. The product chemistry submission is ACCEPTABLE pending resolution of the deficiencies discussed below.
	MRID 48433501-UPGRADEABLE					MRID 48433502-UPGRADEABLE
	MRID 48533801-ACCEPTABLE					MRID 48824701-ACCEPTABLE

a. Refer to the Confidential Appendix (CA) below.

b. Refer to the CA below.

c. The active ingredient statement on the label must be revised as follows:
		ACTIVE INGREDIENT:
		Powdered Corn Cobs*...............................90%
		OTHER INGREDIENT(S):...................... 10%
		TOTAL:									     100%		
			*Contains 33.3% w/w Cellulose 

d. Refer to the CA below.

e. The bulk density of the MP was provided to fulfill the density data requirement for the EP. Density data for the EP should be provided and listed in box 7 on the CSF.

f. The rationale provided to satisfy the storage stability (OCSPP 830.6317) and corrosion characteristics (OCSPP 830.6320) is inadequate. Additional scientifically-sound rationale supported by references must be submitted or studies must be conducted. 

2. The mammalian toxicology submission is ACCEPTABLE.
	MRID 48433503-UPGRADEABLE					MRID 48433506-ACCEPTABLE
	MRID 48533802-ACCEPTABLE

3. Nontarget toxicology data are not required for the EP at this time.

NOTE TO RAL:

1. In the "Ingredients" row on the data matrix dated 7/12/11, the applicant listed the active ingredient as mono- and di- potassium salts of phosphorous acid which must be revised.

2. Efficacy data were submitted to support registration of the EP but were reviewed by another science reviewer. Refer to the memoranda from C. Fuentes for more information.

STUDY SUMMARIES 

Product Chemistry (MRIDs 48433501-48433502, 48533801 and 48824701)

All data requirements have been satisfied with the exception of storage stability and corrosion characteristics. Physical and chemical properties data for the EP are summarized in Table 1 below. Data Evaluation Records (DERs) were not created for the submitted MRIDs. Refer to the CA below for more product chemistry information.

                                       
TABLE 1. Physical and Chemical Properties of Rode-Trol (40 CFR § 158.2030)
                               OCSPP Guideline 
                                   Property
                             Description of Result
                                   (PC 38-DD)
                                     MRID
830.6302
Color
Light-brown/beige
                                   48433502
830.6303
Physical State
Solid pellet
                                   48433502
830.6304
Odor
Characteristic of hay
                                   48433502
830.6313
Stability to Normal and Elevated Temperatures, Metals and Metal Ions
Not required for EP
                                       
830.6315
Flammability
Flash point: 388ºF (open cup); 396 ºF (closed cup)  (data are bridged from TGAI; inert components not expected to contribute significantly to flammability)
                                   48433502
830.6317
Storage Stability
Rationale is inadequate
                                   48433502
830.6319
Miscibility
N/A: not an emulsifiable liquid that will be diluted with petroleum solvents.
                                   48433502
830.6320
Corrosion Characteristics
Rationale is inadequate
                                   48433502
830.7000
pH
N/A: test substance is not soluble or dispersible in water
                                   48433502
830.7050
UV/Visible Light
Absorption
Not required for EP
                                       
830.7100
Viscosity
N/A: product is a solid
                                   48433502
830.7200
Melting Point/Range
Not required for EP
                                       
830.7220
Boiling Point/Range
Not required for EP
                                       
830.7300
Bulk Density
28.0 lb/ft[3] (data are for the MP and should be submitted for the EP)
                                   48433502
830.7520
Particle Size, Fiber Length and Diameter Distribution
Not required for EP
                                       
830.7550
830.7560
830.7570
Partition Coefficient (n-
Octanol/Water)
Not required for EP

                                       
830.7840
Water Solubility
Not required for EP
                                       
830.7950
Vapor Pressure
Not required for EP
                                       

Mammalian Toxicology (MRIDs 48433503, 48433506 and 48533802)