SAT Report

PMN Number: P-12-0551

SAT Date: 9/25/2012

Print Date: 3/4/2013

Related cases:

Health related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 2

 Persistence Bioaccum Toxicity Comments

2 12

Exposure Based Review:

Health: No

Ecotox: Yes

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: 

IRR-E,S

LIVER

KIDNEY

BLOOD

MUTA

ONCO

AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-12-0551

FATE: Estimations for typical 

Liquid/Solid with 
POTW removal (%) = 25 via sorption, stripping and biodeg

Time for complete ultimate aerobic biodeg = mo

Sorption to soils/sediments = moderate

Volatilization half-life from a standard river = 3 hrs

Volatilization half-life from a standard lake = 5 da

Atmospheric Oxidation Half-life = 5.9 hr via OH radical

PBT Potential: P2B1

*CEB FATE: Migration to ground water = moderate

 Health:

 Health Summary: Absorption is poor through the skin, and good through 

the lung and GI tract, based on analogs ( componds). There are concerns for 

irritation to the eye and skin, liver, kidney, and blood toxicities, mutagenicity, and oncogenicity, 

based on analogs, submitted test data, and information in the PMN MSDS.

 Test Data: Submitted with the PMN:

Salmonella assay positive with activation, and negative without activation

Rat acute (7 hr total exposure) inhalation LC50 > 1.6 mg/L;

Rat acute (15D) oral (gavage) toxicity LD50 = 5000 mg/kg;

Dermal irritant in rabbits;

Eye irritant in rabbits (signs cleared by Day 8)

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 9.4 4.9

daphnid 48-h LC50 5.9 2.4

green algal 96-h EC50 6.9 7.8

fish _ chronic value 1.0

daphnid _ chronic 

value

0.78

algal _ chronic 

value

2.3 3.3

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_
Ecotox Values Comments: Predictions are based on SARs for neutral organic chemicals; 

SAR chemical class = MW 128; liquid with mp unknown (P); log Kow = 3.17 

(EPI, ), 3.30 (M); S = 31 mg/L at 20 C (P); pH7; effective concentrations based on 

100% active ingredients and mean measured concentrations; hardness <150.0 mg/L as CaCO3; 

and TOC <2.0 mg/L;

Three acute ecotoxicity tests were conducted on from 

with fish, daphnia, and algae. The studies were conducted from 2005 to 2008 by the 

. The PMN material was tested as a liquid with

an estimated boiling point of 220 °C. The measured vapor pressure is 20 mmHg at 25 °C. The 

water solubility of the PMN material is 100 mg/L. These studies complied with OCSPP and 

OECD guidelines for: 1) O2, pH, temperature, water hardness values and other water quality 

parameters; 2) species, age, number of organisms per replicate, and biomass loading rates; and, 

3) replicates and overall variability. The test was performed in a GLP laboratory and there was a 

quality assurance statement provided.

In a 96-hour fish test with Danio rerio (7/one replicate/test concentration) were 

exposed to nominal concentrations of 0.5, 1.0, 2.2, 5.0, and 10 mg/L under a static-renewal test 

conditions for 96-hours. The reported mean measured concentrations were 0.30, 0.50, 1.10, and 

3.05 mg/L. The highest measured concentration was not determined. Due to the instability of the 

PMN substance in water, the exposure was carried out in a closed static-renewal (daily renewal) 

system. Over the course of the study, water temperature ranged from 22- 23 °C, pH ranged from

7.5 – 8.5, and the dissolved oxygen concentration was greater than 80% saturation. At 96 hours 

of duration, only three fish survived after being exposed to 5 mg/L (nominally) and no fish 

survived at the highest nominal test concentration of 10 mg/L. The mean measured 96-hour 

LC50 for was 2.52 mg/L and the nominal concentration was 4.9 mg/L. The test is 

acceptable.

96-h LC50 = 4.9 mg/L (nominal)

In a 48-hour immobilization toxicity test with , 20 Daphnia magna (4 daphnia/ 

replicates with 5 replicates/test concentration) were exposed to nominal concentrations of 0.5, 

1.0, 2.2, 5.0, and 10 mg/L under a static test conditions for 96-hours. The reported mean 

measured concentrations were 0.15, 0.31, 0.62, 1.55 and 3.35 mg/L. Over the course of the 

study, water temperature ranged from 18- 22 °C, pH ranged from 7.5 – 8.5, and the dissolved 

oxygen concentration was 3 mg/L in all tested replicates. The 48-hour EC50 was reported to be 

2.4 mg/L based on nominal concentrations. The test is acceptable.

48-h EC50 = 2.4 mg/L (nominal)

In a 72-hour algal growth inhibition test, Desmodesmus subspicatus (0.5 x 104 cells/mL with 3 

replicates/test concentration) were exposed to n a water accommodation fraction 

(WAF) test under static conditions. Nominal concentrations of 0.5, 1.0, 2.2, 5.0, 10, 22, 50, and 

100 mg/L were reported. Over the course of the study, the pH remained at 8.1. Throughout the 
algal study, temperature ranged from 21- 24 °C. The 72-hour ErC50 (growth rate) for D. 

subspicatus is 12.2 mg/L. The 72-hour EyC50 (yield) is 7.83 mg/L.. The test is acceptable

72-h EC50 = 12.2 mg/L (growth rate)

72-h EC50 = 7.83 mg/L (yield)

72-h NOEC = 2.2 mg/L (yield)

72-h LOEC = 5 mg/L (yield)

Algal ChV = 3.3 mg/L (based on yield)

All studies are acceptable. For comparative purposes, the ECOSAR (v. 1.1) predicted fish 

96-hour LC50, Daphnia 48-hour EC50 and algal 72- hour EC50 are 9.4, 5.9, and 6.9 mg/L for 

 respectively. As a result of the experimental toxicity data provided by the sponsor, 

revised acute concentrations of concern are calculated. The updated acute concentration of 

concern is calculated by dividing the 48-hour daphnia EC50 (2.4 mg/L or 2,400 ppb) by an 

uncertainty factor of 5 (for daphnia) to yield 480 ppb. The chronic concentration of concern is 

derived by dividing the most conservative chronic value (ECOSAR-predicted Daphnia chronic 

value of 0.78 mg/L) by an uncertainty factor of 10. The chronic concentration of concern is 

0.078 mg/L or 78 ppb.

The acute CoC = 480 ppb

The chronic CoC = 78 ppb

Ecotox Study Reviewer: Amuel Kennedy QA/QC: Jeff Gallagher 

18 July 2012

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

78

SARs neutral organic chemicals

SAR Class

Ecotox Category Neutral Organics

Ecotox Factors Comments: 

 SAT Chair: J. Kwiat