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: No

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 = Negl.

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

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*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption is nil all routes (pchem). 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 = polymer-cationic- pH7; 

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% purity) 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) No 440/2008, Annex Part C, C.1. Following a 

preliminary 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 is 

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that 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, part 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, pH 

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. No 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 

provided, 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 

(ppb)

59

SARs Cationic Polymer

SAR Class Cationic Polymer 

Ecotox Category Polycationic Polymers

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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