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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 utilize 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.

IN-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 Chemical 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 requirement of a 

tolerance for 2-propen-1-aminium, 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 information regarding the 

elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully 

evaluated the sufficiency of the submitted data at this time or whether the data supports 

granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry NA

B. Toxicological Profile

1. Acute toxicity. 

A total of seven acute (oral, skin, 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 study 
2

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 theat 

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 (Brachydanio rerio) with 5 ppm of humic acid, the 96 hour EC50 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: ECA (I) 50 = 5.4 

mg/L, ECμ (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 EC50 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 EC50 was determined to be 28.5 

mg/L.

2. Genotoxicty.

Two 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 not 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 performed 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 of PolyDADMAC, and to a lesser 
3

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 embryonic 

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 levels used during the study. Nor 

were there any PolyDADMAC related effects upon the fertility index or any other 

F1 or F2 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 toxicity. NA

5. Chronic toxicity. NA

6. Animal metabolism. NA

7. Metabolite toxicology. NA

8. Endocrine disruption. NA

C. Aggregate Exposure NA

D. Cumulative Effects NA

E. Safety Determination NA

F. International Tolerances NA-Remove