SAT Report

PMN Number: P-13-0267

SAT Date: 2/20/2013

Print Date: 4/1/2013

Related cases:

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1 3

 Persistence Bioaccum Toxicity Comments

2 31

Exposure Based Review:

Health: No

Ecotox: Yes

Routes of exposure: Health: Low Concern

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: NO SIG HLTH CNCRNS

AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-13-0267

FATE: 

with MP = 130 C (E)

log Kow = 6.33 (E) 

S = 0.06 mg/L at 25 C (E)

VP = 2.8E-6 torr at 25 C (E)

BP = 376 C (E)

H = 1.04E-6 (E)

log Koc = 4.37 (E)

log Fish BCF = 3.84 (E)
log Fish BAF = 2.23 (E) 

POTW removal (%) = 90 via sorption and biodeg; Analog: OECD 301B(Mod Sturm CO2 ev): 

 28d: 28%(10mg/L), 15%(20mg/L).

Time for complete ultimate aerobic biodeg = wk-mo

Sorption to soils/sediments = v.strong

Volatilization half-life from a standard river = 950 hrs

Volatilization half-life from a standard lake = 440 da

Atmospheric Oxidation Half-life = 4.56 hr via OH radical

PBT Potential: P2B3

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption of the neat material is nil through the skin, but 

poor through the skin for the material in solution, while absorption is poor through the lung and 

GI tract., based on physical/chemical properties. No significant health concerns.

 Test Data: Submitted with the PMN:

Negative in Salmonella with and without activation;

Rat (F) acute (15D) oral (gavage) LD50 > 2000 mg/kg

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 *

daphnid 48-h LC50 *

green algal 96-h EC50 *

fish _ chronic value 0.001 * Not Acceptable; Not a 

good analog

daphnid _ chronic 

value

0.006 * Not Acceptable; Not a 

good analog

algal _ chronic 

value

0.022

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: P-13-0267: 

Fish Ecotoxicity Test:

 conducted 28-day growth test in zebra fish 

(Brachydanio rerio) with an analog of the PMN substance (tested as 100% commercial product) 

under flow-through conditions. The study method was adapted from the growth-rate test for 

rainbow trout developed by Crossland (1986). This study closely follows OECD guideline 215. 
A single replicate of sixteen B. rerio were exposed to a dilution water control, a solvent control 

(methanol) or the test substance at nominal test concentrations of 33 or 100 μg/L. 

Corresponding mean measured concentrations of 32 and 105 μg/L were determined by GC 

analysis. To prepare stock solutions, 0.25 g of test substance was dissolved in 50 mL of 

methanol using sonication to give 5 g/L stock (stock A). A volume of 16.7 mL Stock A was 

diluted 1 in 3 with methanol to produce a 1.67 mg/L solution (stock B). Two dosing stocks (5 

liters each at 4.2 – 1.4 mg/L) were prepared by diluting the 5 mg/mL and 1.67 mg/mL stocks 

with distilled water. Dosing stocks were diluted 1 in 42 to produce nominal concentrations of 33 

and 100 μg/L. Each test solution was dosed at 67 mL/min giving about 10 volume replacements 

per day. Measured concentrations of test substance ranged from 56 – 160% of nominal values 

during the study. On day 3, a blockage occurred in the capillary dosing into the 100 μg/L test 

vessel. This stopped the dilution water-flow (but allowed some dosing stock through) raising the 

concentration to 218 μg/L. This result was not incorporated in the mean concentration over the 

test period as it was not representative. The blockage also caused the control vessel to become 

contaminated (78 μg/L). By day 4, concentrations in the control tank had fallen to 0.1 μg/L. 

Over the course of the study, temperature ranged from 22.5 – 23.5 ̊C, pH ranged from 7.1 – 7.8 

and dissolved oxygen ranged from 7.7 – 10.2 mg/L. Dilution water hardness ranged from 86 –

108 mg CaCO3/L. A loading of approximately 0.14 g fish/L was calculated. There was no 

effect on the average fish weight or specific growth rates at any of the concentrations tested. 

Based on mean measured concentrations, the NOEC is 105 μg/L. This study is not acceptable 

given the chemical’s estimated water solubility of 0.00045 mg/L and Log Kow of 8.4 is very 

different from the PMN test substance estimated water solubility and Log Kow values. It should 

be noted that the two measured concentrations are above the estimated water solubility limit for 

this analog. Also, the test should have used more dose concentrations to determine the chronic 

endpoint. According to OECD test guideline 215, at least five concentrations are required and 

only two were provided in this study. Also, the measured concentrations of the test substance 

varied between 56 and 160% of the nominal concentration during the course of the study. This 

percent difference far exceeds the test guideline’s ten percent difference. No effects were seen at 

either concentration. 

28-day NOEC = No effects at saturation.

Daphnid Ecotoxicity Test: 

 conducted a 21-day toxicity test in Daphnia magna 

with an acceptable analog of the PMN substance (tested as 100% commercial product) under 

static-renewal conditions with daily renewal. The study was reported to follow OECD test 

guideline 202. Ten replicates of one D. magna were exposed to a dilution water control (Elendt 

M7 medium), a solvent control (methanol) or the test substance at nominal test concentrations of 

33 or 100 μg/L. Corresponding mean measured concentrations of 23.2 and 79.7 μg/L were 

determined by GC analysis. The stock solution was prepared by dispersing 0.05 g test substance 

in 50 mL of methanol, using a sonic bath, to make a 1.0 g/L stock (Stock A). A volume of 1.67 

mL Stock A was then made up to 50 mL with methanol to form a 0.33 g/L stock (Stock B). Test 

solutions were prepared by adding known volumes of these stocks to 1.5 liters Elendt medium. 

Analysis of test solution concentrations indicated that concentrations of fresh solutions were on 

average 83.5% of nominal values and concentrations of old solutions were on average 65.2% of 

nominal values. Over the course of testing, temperature ranged from 14.5 – 25.0 ̊C, pH ranged

from 7.2 – 8.1 and dissolved oxygen ranged from 4.5 – 9.3 mg/L. Dilution water hardness 
ranged from 234 – 256 mg CaCO3/L. A loading rate of 10 daphnids/L was calculated. No 

inhibitory effects on daphnia were observed during the study. Based on mean measured 

concentrations, the 21-day NOEC was 79.7 μg/L. This study is not acceptable given the 

chemical’s estimated water solubility of 0.00045 mg/L and Log Kow of 8.4 is very different 

from the PMN test substance estimated water solubility and Log Kow values. However, the 

study should have been reported to have followed OECD Test guideline 211 instead of OECD 

202. Also, the water temperature variation range is well above the OECD 211 recommended 2 

degrees variation. Finally, the two measured concentrations are above the estimated water 

solubility limit for this analog. No effects were seen at either concentration. 

21-day NOEC = No effects at saturation.

The two studies are acceptable given the low water solubility and high Log Kow

Acute CoC = No effects at saturation

Chronic CoC = 1 pbb

Ecotox Study Reviewer: Amuel Kennedy

February 28, 2013

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

1

SARs Amides

SAR Class Amides

Ecotox Category None

Ecotox Factors Comments: 

 SAT Chair: J. Kwiat