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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: William Cutchin, 703

- 305

- 7990

INSTRUCTIONS: Please uti lize this outline in preparing the pesticide petition. In cases where the outline element does not apply, please insert “NA

- Remove” and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green , i.e., “ [ insert

company name ] ,” with the information specific to your action.

TEMPLATE:

SNF, Inc.

I N

- 10750

EPA has received a pesticide petition ( IN

- 10750 ) from Scientific & Regulatory Solutions, L.L.C.

, 3450 Old Washington Rd # 303, Waldorf, MD 20602 on behalf of SNF, Inc., 1 Che mical Plant Road, Riceboro, GA 31321

, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the re quirement of a

tolerance for 2

- p ropen

- 1

- aminiu m, N,N

- dimethyl

- N

- propenyl

- , chloride, homopolymer ( “PolyDADMAC”, CAS Reg. No. 26062

- 79

- 3) under 40 CFR 180.940(a) when used as an inert ingredient ( dispersing aid ) in pesticide formulations.

EPA has determined that the petition contains data or informa tion regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted d a ta at this time or whether the data supports granting of the petition. Additional data may be needed before EPA r ules on the petition.

A. Residue Chemistry NA

B. Toxicological Profile

1. Acute toxicity.

A total of seven acute (oral, ski n, eye, sensitization) toxicity studies were submitted with the registration petition. A single does feeding study with rats was performed with PolyDADMAC. The results of the study classify PolyDADMAC as “slightly toxic” at a dose level of 5 ml/kg (approx . 2000 mg/kg).

The results of 2 skin irritation studies performed with rabbits indicate that PolyDADMAC is not a skin irritant. The results of a single skin irritation study2

performed on human test subjects indicates that PolyDADMAC is mildly irritating, causing mild redness at the area of exposure.

In a modified Draize study performed with PolyDADMAC on human test subjects, the results indicated that PolyDADMAC was likely not a skin sensitizer.

In two eye irritation studies performed with PolyDADMAC on rabbits, the results indicate that the product was slightly irritating to the eyes and that the effects were totally reversed within 72 hours following exposure. In an eye study performed with PolyDADMAC on cultured fibroblasts, the results indicate thea t PolyDADMAC is slightly irritating.

A total of six acute aquatic toxicity studies were performed with PolyDADMAC.

In a test to evaluate the acute toxicity of PolyDADMAC to the freshwater zebra fish ( Brach

y danio rerio ) with 5 ppm of humic acid, the 96 ho ur EC 50 was determined to be 7.8 mg/l

.

In a growth inhibition study on PolyDADMAC using the unicellular freshwater alga Chlorella vulgaris , the following results were obtained: EC A (I) 50 = 5.4 mg/L, EC μ (I) 50 = 7.7 mg/L, and the NOEC = 1.0 mg/L.

Three studies to determine the acute toxicity of PolyDADMAC on Daphnia

magna were performed using natural river waters from 3 rivers in France. The

results of the studies are as follows: the 48 hour EC 50 values from each study were 12.3, 13.4, and 14.5 mg/L.

A fourth study to evaluate the acute toxicity of PolyDADMAC on Daphnia

magna (under static conditions) was also performed using 5 ppm of humic acid. Based on the results of the study, the 48 hour EC 50 was determined to be 28.5 mg/L.

2. Genotoxicty.

Tw o genotoxicity studies were performed with PolyDADMAC. In the first study, an Ames test, PolyDADMAC was negative in all strains tested in the presence and absence of metabolic activation. In the second study, a mouse micronucleus assay, PolyDADMAC did no t induce a significant increase in micronucleated polychromatic erythrocytes in the male or female mice and was therefore concluded to be negative in the mice micronucleus assay.

3. Reproductive and developmental toxicity.

In a teratology study perfo rmed with Sprague

- Dawley rats, the test animals were dosed with 50, 150, 450, and 600 mg/kg/day of PolyDADMAC (oral gavage) from days six (6) to fifteen (15) of pregnancy, inclusive. Based on the results of the study, the administration of 600 mg/kg/day o f PolyDADMAC, and to a lesser3

extent, at the 450 and 150 mg/kg/day test groups, elicited a significant reduction in maternal food consumption during the first half of the dosing period. However, there was no effect of treatment at any of these three dose levels on maternal bodyweight, clinical condition, or on the incidence of macroscopic abnormalities at necropsy. There was also no evidence of maternal toxicity at the 50 mg/kg/day dose group and no evidence of embryolethality, teratogenicity, or embryoni c growth retardation at any of the dose groups investigated. Therefore, the no observed effect level (“NOEL”) for PolyDADMAC on embryonic development is 600 mg/kg/day

A multi

- generational study was also performed with PolyDADMAC using Sprague

- Dawley rats. The test groups were dosed with 0.375, 12.5, and 125 mg/kg/day (oral gavage) during the study. Based on the results of the study, PolyDADMAC caused no increase in reproductive failure compared to the control groups when dosed with PolyDADMAC at the level s used during the study. Nor were there any PolyDADMAC related effects upon the fertility index or any other

F 1 or F 2 generation parameters evaluated during the study (e.g., litter size, pup weight, fertility and parturition, reproductive indices such as mating index, fecundity index, male or female fertility indices, etc.). Finally, there was no remarkable pathology noted upon necropsy of any of the test animals. In conclusion, the inferred NOEL from the study was 125 mg/kg/day

4. Subchronic toxicit

y. NA

5. Chronic toxicity. NA

6. Animal metabolism. NA

7. Metabolite toxicology

. NA

8. Endocrine disruption

. NA

C. Aggregate E

xposure NA

D. Cumulative Effects NA

E. Safety Determination NA

F. International Tolerances NA

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