### SAT Report PMN Number: P-13-0175 SAT Date: 1/4/2013 Print Date: 3/4/2014

Related cases : Health related cases: Ecotox related cases:

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 1-2 2

Persistence Bioaccum Toxicity Comments 3 11

Exposure Based Review : Health: Ecotox: N o
Routes of exposure : Health: Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: LUNG OVERLOAD; LUNG; AQUATOX
Summary of Assessment :

Fate : Fate Summary: P-13-0175 FATE: Solid S = N egl. VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) POTW removal (%) = 90 via sorption Time for complete ultimate aerobic biodeg > mo Sorption to soils/sediments = v.strong PBT Potential: P3B1*CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption is nil all routes ( p che m ). Concern for lung toxicity if inhaled based on lung overload for high molecular weight polymers, and lung toxicity from cationic binding to lung membranes. Test Data: (-) Salmonella with and without activation; (-) E. coli with and without activation; rat oral LD0 = 2000 mg/kg; no skin irritation in rabbits; no eye irritation in rabbits

Ecotox :
Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 10.6 daphnid 48-h LC50 >100 green algal 96-h EC50 15.3 fish

_ chronic value 0.59 daphnid

_ chronic value >10

algal

_ chronic value 4.6
Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for polycationic polymers; SAR chemical class = p olyme r -cationic- p H7; effective concentrations based on 100% active ingredients and nominal concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Ecotoxicity Test Data Results for P-13-0175:

Fish Ecotoxicity Test: conducted a 96-hour limit test in zebrafish (Brachydanio rerio) with P-13-0175 (98.6% p urity) under flow-through conditions in 2011 for the sponsor The study was reported to follow OECD test guideline 203, OPPTS 850.1075 and Commission Regulation (EC) N o 440/2008, Annex Part C, C.1. Following a p reliminary range-finding test, a replicate of seven B. rerio were exposed to either a dilution water control (circulated and filtered tap water) or the PMN substance at a nominal test concentration of 100% v/v saturated solution. It is unclear what the nominal test concentration isthat was tested. Due to the extremely poor water solubility of the test substance, no analytical measurement was possible for the determination of concentration or stability in the test medium. Test solutions were prepared by mixing small particles of test substance (with a relatively high surface area) with glass beads. The mixture was poured into a glass column and then filled with aquarium water. It is unclear what mass of small particles were placed into the glass column. The column was connected to a circulating pump. The flow through the mixture-filled column was started approximately 10 hours before the introduction of the fish (to achieve the constant saturated solution) and run over the test period. The flow rate of the water pumped through the column filled with test item allowed a theoretical recirculation of the whole tank volume approximately every 12 minutes. Ten hours represented a recirculation of approximately 50 times. Throughout the entire 96-hour limit test, p art of the PMN/glass bead mixture continued to remain in the column. Over the course of testing, temperature ranged from 22.0

–22.3  ̊ C, p H ranged from 8.08

–8.20, and dissolved oxygen ranged from 91

–93% of the air saturation value at the temperature used. Dilution water hardness was 249 mg CaCO3/L. The loading of the test aquaria was 0.2 g fish/L test solution at the start of the experiment. N o lethal or sub-lethal effects were observed in the control or test group. It is reported in the submission that the fish 96-hour LC50- for P-13-0175 is > 100% v/v saturated solution. Once the sponsor provides what the nominal test concentration is that was tested, EPA can use that information for the purposes of acute concentration of concern determination. Until the nominal test concentration value is p rovided, this will be considered an un-acceptable test.
Reviewed by: Jeff Gallagher Date: January 10, 2013

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 59

SARs Cationic Polymer SAR Class Cationic Polymer Ecotox Category Polycationic Polymers

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916