SAT Report

PMN Number: P-12-0548

SAT Date: 9/21/2012

Print Date: 6/4/2013

Related cases:

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2 3

 Persistence Bioaccum Toxicity Comments

2 22

Exposure Based Review:

Health: No

Ecotox: Yes

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: LIVER; NEURO; LUNG; DEVEL; AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-12-0548

FATE: Estimations for typical 
POTW removal (%) = 90 via sorption; OECD 301B(Mod Sturm CO2 ev): 13%,14%/28d NRB.

Time for complete ultimate aerobic biodeg = mo

Sorption to soils/sediments = v.strong

Volatilization half-life from a standard river = 2 hrs

Volatilization half-life from a standard lake = 6 da

Atmospheric Oxidation Half-life = 9.9 hr via OH radical

PBT Potential: P2B2

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Expect moderate absorption via all routes (analog). 

Concern for liver toxicity and developmental toxicity based on submitted test data. Also concern 

for solvent neurotoxicity and pneumonia.

 Test Data: (-) Salmonella with and without activation; (-) E. coli 

with and without activation; rat inhalation LC50 >1 <5 mg/L; (-) for skin sensitization in a 

mouse local lymph node assay up to 25% ai; rat 28-day oral NOEL = 50 mg/kg, liver toxicity at 

>= 250 mg/kg; rat 28-day oral NOEL = 15 mg/kg, liver toxicity at >=150 mg/kg; rat oral 

combined protocol (OECD 422) NOEL = 30 mg/kg (parental animals), liver toxicity at higher 

doses; reproductive toxicity NOEL = 100 mg/kg (highest dose tested); developmental toxicity 

NOEL = 10 mg/kg

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 0.61

daphnid 48-h LC50 0.44 0.29 mg/L (95% 

C.I. = ± 0.25 –

0.37)

not valid

green algal 96-h EC50 0.93

fish _ chronic value 0.080

daphnid _ chronic 

value

0.087

algal _ chronic 

value

0.42

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 196; 

 effective concentrations based on 100% active 

ingredients and mean measured concentrations; hardness <180.0 mg/L as CaCO3; and TOC 

<2.0 mg/L;
Ecotoxicity Study Review for 

P12-0548 24th September, 2012

A 48-hour daphnid (Daphnia magna) immobilization study was submitted 

for PMN P-12-0548 under GLP conditions according 

to OECD guideline 202 and the OECD series on testing and assessment number 23 aquatic 

toxicity of difficult substances and mixtures. A combined limit/range-finding study was 

conducted under static conditions with four replicates of five daphnids each. The organisms were 

exposed to 0 (control), 1.0, 2.2, 4.6, 10, 22, 46, and 100 % of a water soluble fraction (WSF). 

Analysis of the samples taken at the start of the final test showed measured concentrations of 

0.050, 0.14, 0.27, 0.91, 1.5, 2.8 and 6.1 mg/L at 1.0, 2.2, 4.6, 10, 22, 46 and 100% of the WSF, 

respectively. During the exposure period the measured concentrations decreased to 33-44% of 

initial at the end of the test. Based on these results, the average exposure concentrations were 

calculated to be: 0.032, 0.078, 0.18, 0.55, 0.96, 1.9 and 3.9 mg/L. The PMN test material (purity 

> 95%) was measured using GC methods and was prepared in the following manner: 100 mg/L 

of the test material was stirred for 2 days to reach maximum solubility and then left to rest for 1 

hour. The WSF was siphoned out and used as the highest test concentration and the lower test 

concentrations were prepared by subsequent dilutions of the WSF. Water quality parameters 

were the following: water temperature = 20.4 - 21.7 ̊C; pH = 7.7 - 7.9, DO = 8.9 - 9.3 mg/L, and 

dilution water hardness = 180 mg/L. At the end of the exposure period, the replicates of the four 

lowest test concentrations were pooled at each concentration before sampling. Due to the 

presence of a floating layer, the samples from the three highest test concentrations were taken 

from one replicate. During the exposure period the measured concentrations decreased to 

33-44% of initial at the end of the test. Based on these results, the average exposure 

concentrations were calculated to be: 0.032, 0.078, 0.18, 0.55, 0.96, 1.9 and 3.9 mg/L. At 48 

hours, there was 0, 0, 0, 5, 90, 100, 100, 100% immobility in the control and average exposure 

concentrations of 0.032, 0.078, 0.18, 0.55, 0.96, 1.9 and 3.9 mg/L treatments, respectively. No 

significant immobilization was observed at average test concentrations less than 0.55 mg/L. 

48-hour EC50 = 0.29 mg/L (95% C.I. = ± 0.25 – 0.37)

No other studies were submitted for PMN material P-12-0548. This study is considered invalid 

for two reasons. (1) No attempts were made to expose the test organisms at the measured water 

solubility. While the measured water solubility is low, some attempts by the 

testing facility could have been demonstrated to address testing at the solubility determined 

experimentally. (2) It is not appropriate to prepare water soluble fractions by serially diluting the 

concentrations from the stock solution. With difficult to test substances it is instead 

recommended to prepare individual test concentrations without serial dilution according to the 

OPPTS 850.1000 guideline as well as the OECD series on testing and assessment number 23 

aquatic toxicity of difficult substances and mixtures. As a result, the ECOSAR (v. 1.10) 

predictions for neutral organics will be used to determine hazard for P-12-0548. The predicted 

acute concern concentration is derived from the 48-hour daphnid EC50 value of 0.44 mg/L. This 

value is divided by an assessment factor of 5 for invertebrates to yield 88 μg/L or 88 ppb. The 

chronic concern concentration is determined from the fish chronic value of 0.080 mg/L which is 
divided by an assessment factor of 10 to yield 8 μg/L or 8 ppb.

Chronic CC = 8 ppb Acute CC = 

88 ppb

Reviewer: S. Pollack

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

8

SARs neutral organic chemicals

SAR Class

Ecotox Category Neutral Organics

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916