SAT Report

PMN Number: P-14-0341

SAT Date: 3/21/2014

Print Date: 6/4/2014

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 1

 Persistence Bioaccum Toxicity Comments

1 12

Exposure Based Review:

Health: Yes Exposure based testing (health): Reproductive/developmental toxicity testing

Ecotox: No

Routes of exposure: Health: Drinking Water Inhalation 

Ecotox: No releases to water

Fate: ;

Keywords:

 Keywords: BLOOD; LIVER (UNCERT); KIDNEY (UNCERT)

Summary of Assessment:

 Fate:

Fate Summary: P-14-0341

FATE: Estimations for typical 

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POTW removal (%) = 0-90 via sorption

Time for complete ultimate aerobic biodeg = wk-mo

Sorption to soils/sediments = low - moderate

PBT Potential: P1B1

*CEB FATE: Migration to ground water = slow - moderate

 Health:

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

absorption through the skin if in solution, poor absorption from the GI tract and moderate 

absorption from the lung (pchem). Concern for blood toxicity and uncertain concern for liver 

and kidney toxicity based on submitted test data.

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

with and without activation; (-) for chromosome aberrations in V79 cells with and without 

activation; rat oral LD0 = 2000 mg/kg; rat dermal LD0 = 2000 mg/kg; no eye irritation in 

rabbits; no skin irritation in rabbits; (-) for skin sensitization in a mouse local lymph node assay 

up to 25% ai; rat 28-day oral NOEL = 50 mg/kg, LOEL = 250 mg/kg with effects to the blood, 

and possibly to liver, and kidney

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 >100 > 100

daphnid 48-h LC50 >100 > 100

green algal 96-h EC50 >100 > 100

fish _ chronic value >10

daphnid _ chronic 

value

>10

algal _ chronic 

value

>10

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for Aliphatic Amines-Acids; SAR 

chemical class = Aliphatic Amines-Acids; with an unknown MP (P); 

effective concentrations based on 100% active ingredients and measured concentrations; 

hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg /L;

Ecotoxicity Test Data Results: P-14-0341

Fish Ecotoxicity Test:

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 conducted a 96-hour limit test in zebra fish (Brachydanio rerio) with P-14-0341 

removable water) under semi-static conditions with daily renewal. This study was reported to

follow EU Commission Directive 92/69/EEC, Part C.1 (1992) and the OECD Guideline for 

Testing of Chemicals No. 203 (1992). Following a range-finding test, single replicates of 7 B. 

rerio were exposed to a dilution water control (reconstituted water) or the test substance at a 

nominal concentration of 100 mg/L. Different components of the PMN (

) in the test medium 

were quantified and mean measured concentrations of the individual components ranged from 94 

– 104% of nominal values. The test medium was prepared before the start of the test and prior to 

each test medium renewal by mixing 501 – 505 mg of the test item into 5000 mL test water using 

ultrasonic treatment and intense stirring at room temperature. Throughout the study period, the 

test medium appeared clear with no remarkable observations. Over the course of testing, 

temperature ranged from 21 – 22 ̊C, pH ranged from 7.5 – 7.9 and dissolved oxygen ranged from 

8.3 – 8.7 mg/L. Dilution water hardness was 250 mg CaCO3/L. A loading rate of 0.38 g fish/L 

was reported. All fish survived and no visible abnormalities were observed during the exposure 

period. Based on nominal concentrations, the 96-hour LC50 was greater than 100 mg/L. This is 

an acceptable test.

96-hour LC50 > 100 mg/L

Daphnid Ecotoxicity Test:

 conducted a 48-hour limit test in water fleas (Daphnia magna) with P-14-0341 

removable water) under static conditions. This study was reported to follow EU Commission 

Directive 92/69/EEC, C.2, (1992) and OECD Guideline for Testing of Chemicals, No. 202 

(1984). Following a range-finding test, four replicates of 5 D. magna were exposed to a dilution 

water control (reconstituted water) or the test substance at a nominal concentration of 100 mg/L. 

Different components of the PMN 

) in the test medium were quantified and mean measured 

concentrations of the individual components ranged from 88 – 99% of nominal values. The test 

medium was prepared immediately before the start of the test by mixing 50.2 mg of the test item 

into 500 mL test water using ultrasonic treatment and intense stirring at room temperature. The 

beakers were covered with glass plates to reduce the loss of water and to avoid the entry of dust 

into the solutions. The test medium appeared to be a clear solution throughout the test duration. 

At the start of the test, a few fine particles were observed. Over the course of testing, 

temperature ranged from 20 – 21 ̊C, pH ranged from 7.4 – 7.9 and dissolved oxygen ranged from 

8.6 – 9.2 mg/L. Dilution water hardness was 250 mg CaCO3/L. A loading rate of 100 

daphnids/L was calculated. No immobilization was observed during the test period. Based on 

nominal concentrations, the 48-hour EC50 was greater than 100 mg/L. This is an acceptable 

test.

48-hour EC50 > 100 mg/L

Algal Ecotoxicity Test:

 conducted a 72-hour limit test in green algae (Scenedesmus subspicatus) with 

P-14-0341 

not removable water) under static conditions. This study was reported to follow EU 

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Commission Directive 92/69/EEC, C.3 (1992) and OECD Guideline for Testing of Chemicals, 

No. 201 (1984). Following a range-finding test, three replicates of S. subspicatus (1 x 104 

cells/mL) were exposed to the test substance at a nominal concentration of 100 mg/L. Different 

components of the PMN 

) in the test medium were quantified and mean measured 

concentrations of the individual components ranged from 82 – 103% of nominal values. 

Additionally, six replicates of S. subspicatus were exposed to a dilution water control. The algae 

were illuminated at a light intensity ranging from 8010 – 8910 lux with continuous stirring. The 

test medium was prepared immediately before the start of the test by mixing 60.3 mg of the test 

item into 600 mL test water using ultrasonic treatment and intense stirring at room temperature. 

The flasks were covered with glass dishes. The test medium appeared to be a clear solution 

throughout the test duration. Over the course of testing, temperature ranged from 22 – 23 ̊C and 

pH ranged from 7.7 – 8.4. Dilution water hardness was 24 mg CaCO3/L. The cell density in 

control cultures increased by a factor of 57 within 72 hours. There was no inhibitory effect of 

the test substance on S. subspicatus during the exposure period. Based on nominal 

concentrations, the 72-hour EC50 was greater than 100 mg/L for both biomass and growth rate. 

The 72-hour NOEC and LOEC values were 100 mg/L and > 100 mg/L, respectively. This is an 

acceptable test.

72-hour EC50 (biomass and growth rate) > 100 mg/L

72-hour NOEC (biomass and growth rate) = 100 mg/L

72-hour LOEC (biomass and growth rate) > 100 mg/L

 (sponsor) submitted three ecotoxicity studies on P-14-0341. The studies were 

considered acceptable and will be used to calculate the concentrations of concern (COC) for 

P-14-0341. For comparative purposes, the QSAR-predicted acute fish, acute Daphnia, and algae 

L/EC50s for P-14-0341 are > 100 mg/L, > 100 mg/L, and > 100 mg/L, respectively. The 

predicted chronic values for fish, Daphnia, and algae are > 10 mg/L, > 10 mg/L, and > 10 mg/L, 

respectively. The acute COC for P-14-0341 is 20,000 ppb (100,000 ppb / 5 (uncertainty factor)), 

based on the experimentally-derived 96-hour LC50 for fish. The chronic COC for P-14-0341 is 

1,000 ppb (10,000 ppb / 10 (uncertainty factor)), based on the experimentally-derived 96-hour 

LC50 for fish and an acute to chronic ratio of 10.

Acute COC = 20,000 ppb

Chronic COC = 1,000 ppb

Ecotox Reviewer: J. Gallagher

Date: 3/24/2014

Factors Values Comments

Assessment Factor

Concentration of Concern 

(ppb)

1000

SARs

SAR Class

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Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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