SAT Report

PMN Number: P-11-0526

SAT Date: 7/29/2011

Print Date: 8/30/2013

Related cases:

Health related cases: Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 2 Health: PMN substance ; Eco: intact material

2 3 Health: ; Eco: toxicity of incomplete incineration products to terre

organisms

 Persistence Bioaccum Toxicity Comments

1 2 1 PMN

3 3 2 Incin Pdt.

Exposure Based Review:

Ecotox: Yes

Routes of exposure: Health: Dermal Inhalation DW and Inh for 

prdt

Ecotox: All releases to water

Fate: ;

Keywords:
 Keywords: PMN: LUNG; IRR-E,S,MM; SENS-S (UNCERT); AQUATOX

 LIVER; BLOOD; MALE REPRO; IMMUNOTOX; ONCO; 

Summary of Assessment:

 Fate:

Fate Summary: P-11-0526

FATE: S = Dispersible (E)H < 1.00E-8 (E)POTW removal (%) = 50-90 via sorption and biodegTime for complete ultimate aerobic biodeg > moSorption to soils/sediments = moderatePBT Potential: PMN P1B2; Incin Pdt P3B3*CEB FATE: Migration to ground water = moderate

 Health: Health Summary: Not absorbed through the skin as the neat material poor absorption throug

solution (pchem); poor absorption from the GI tract and moderate absorption from the lung (analog). Concern fo

the lung; irritation to eye, skin (chronic), mucous membranes and lung based on properties of the comreported Uncertain concern for dermal sensitization based on the . For the p

incineration product, based on test data for concerns are liver toxicity, blood toxicity, and toxicity [rat 28-day oral NOAEL = 50 mg/kg, LOAEL = 150 mg/kg with liver toxicity; rat 90-day oral LOAEL = decreased body weight in males at all doses and liver toxicity and anemia at 200 mg/kg; there were toxic effects males in the 90-day oral study that were judged by the reviewer to be indicative of the potential for male reproduis also concern for immunosuppression and oncogenicity based on data for .

 Test Data: The following studies were listed in the PMN as on-going: skin irritation; 

assay; eye irritation; oral LD-50; bacterial reverse mutation; acute inhalation (TBD); cytogenicity study in mammALD; subchronic oral w/repro & devel screen (TBD); 48-hr Daphnia EC50; 21-d Daphnia chronic; 96-hr trout Lgrowth inhibition; activated sludge respiration inhibition; ready biodegradation; adsorption/desorption (TBD); ab
function of pH (TBD); 7-day oral toxicity range-finding and toxicokinetic behavior

 Ecotox:

Test Organism Test Type Test End Point Predicted Measured C

fish 96-h LC50 >86

daphnid 48-h LC50 >61

green algal 96-h EC50 >17

fish 

_

chronic value >13

daphnid

_

chronic value >9.4

algal 

_

chronic value >4.2

Sewage Sludge 3-h EC50

_

Sewage Sludge

_

Chronic Value

_

Ecotox Values Comments: Predictions are based on SARs for SAR chemical class = 

 with mp unknown; S

effective concentrations based on 100% active ingredients and nominal concentrations; hardness <150.0 mg/L a

<2.0 mg/L;high concern for toxicity of incomplete incineration products to terrestrial organismsThree acute ecotoxicity studies were conducted on this PMN (P-11-0526) in 2011 by 

with fish, daphnia, and algae. The PMN consi

at room temperature with a purity of 30% and an estimated vapor pressure of 1E-6 mmHg at 25°C. This PMN is dispersible. The sorption to sediments and soils from P-11-0526 is moderate. For the toxicity studies, the testing provided nominal test concentrations. 
Rainbow trout (Oncorhynchus mykiss) (7 fish/concentration of the test material) were exposed to P-11-0526 und

conditions. The nominal test concentrations were 0.12, 1.2, 12, and 120 mg a.i./L (

plus a dilution water control)

course of the study, water temperature ranged from 12.0 

– 12.2°C, 

pH ranged fro

m 7.2 - 8.0, and the O2 concent

10.8 mg/L. The 96-hour LC50 for fish with P-11-0526 is > 120 mg a.i./L.In a 48-hour immobilization test, water fleas (Daphnia magna) (10 daphnia/test concentration) were exposed to Pconditions. The nominal test concentrations were 0.12, 1.2, 12, and 120 mg a.i./L (

plus a dilution water control)

course of the study, water temperature ranged from 19.5

—21.2°C, , and the O2 concentrations ranged 

48-hour EC50 for water fleas with P-11-0526 is > 120 mg a.i./L.In a 72/96-hour acute toxicity test for algal biomass, yield, and growth rate, an initial cell concentration of 1E+4 replicates/control and 2 replicates/test concentration) of green algae (Pseudokirchneriella subcapitata) were expounder static conditions. The nominal test concentrations were 0.012, 0.12, 1.2, 12, and 120 mg a.i./L (

plus a dilu

Throughout the course of the study, water temperature was 23°C and the pH r The test occlight (5730 to 7080 lux) and continuous agitation (100 rpm). In the 96-hour algal test, cell density (biomass) resu

test termination (96-hours). Algal yield and growth rate were reported at 72-hours even though it was a 96-hour algal EC50 for biomass, yield (72-hour), and growth rate (72-hour) are all > 120 mg a.i./L. The 96-hour algal NOboth biomass and yield (72-hour) are 120 and > 120 mg a.i./L, respectively. The 72-hour algal NOEC and LOEC 12 and 120 mg a.i./L, respectively. The 96-hour algal EC50 (cell density) for green algae with P-11-0526 is 8.2 chronic value for P-11-0526, based on the geometric mean of the NOEC and LOEC (growth rate), is 37.9 mg a.iThe three submitted aquatic ecotoxicity studies are considered invalid for several reasons. According to 

for fish, an acute fish toxicity test should have a minimum of 5 test concentrations an

fish per test concentration. The submitted fish test had 7 fish per test concentration, but only had 4 test concentra

 and 

minimum of 20 organisms per test concentration and have at a minimum 5 test concentrations. The submitted Dorganisms per test concentration and only had a total of four test concentrations. Furthermore, according to 

for algae, a minimum of 3 replicates of algae per test concentration is required and 6 

recommended for the controls. The submitted algal toxicity test only used 2 algal replicates per test concentratiothe control. As a result, the chronic and acute concern concentrations for P-11-0526 will be based on ECOSAR 

The chronic and acute concern concentrations are respectively.
Ecotox Study Reviewer: J. Gallagher 3 August 2011

Factors Values Comments

Assessment Factor 10

Concentration of Concern (ppb) 420

SARs

SAR Class new chemicals category: no

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916