SAT Report

PMN Number: P-12-0520

SAT Date: 8/31/2012

Print Date: 2/27/2015

Related cases: Yes

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 2

 Persistence Bioaccum Toxicity Comments

1 3 1 Anion

1 1 1 Cation

Exposure Based Review:

Health: Yes

Ecotox: Yes

Routes of exposure: Health: Dermal Inhalation 

Ecotox: All releases to water

Fate: ; Anion rapid; Cation rapid

Keywords:

 Keywords: LUNG, IRR, AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-12-0520

The properties of the individual may not be representative of the properties of the parent 

FATE: Estimations for typical 

log Kow = 7.64 (M)

log Koc = 4.07 (E)

log Fish BCF = 1.75 (E)

log Fish BAF = 5.18 (E)

FATE: Estimations for cation 

log Kow = 2.83 (M)
log Koc = 2.48 (E)

log Fish BCF = 1.53 (E)

log Fish BAF = 1.80 (E)

PMN Substance: Solid 

S = Dispersible (E)

VP < 1.0E-6 torr at 25 C (E)

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = Anion 90 via sorption and biodeg; Cation 0-90; OECD 

 301B(Mod Sturm 94.2% (avg.)/28d.

Time for complete ultimate aerobic biodeg = Anion wk; Cation wk-mo

Sorption to soils/sediments = Anion low; Cation low

PBT Potential: Anion P1B3; Cation P1B1

*CEB FATE: Migration to ground water = Anion rapid; Cation rapid

 Health:

 Health Summary: : Absorption is nil through the skin, poor through the GI 

tract, and moderate through the lungs based on analogs. The PMN compound is a surfactant and 

there is concern for irritation and lung effects if inhaled based on surfactant activity. Low 

moderate concern. 

 Test Data: TOXICITY DATA for analog tall oil fatty acid, 

compound with 

acute oral study in rats _ 2 of 3 died at 2000 mg/kg, no deaths at 300 mg/kg, 

acute dermal study in rats - no deaths at 2000 mg/kg, atonia, desquamation

Transcutaneous Electrical Resistance Assay (TER) - potential to be corrosive

EpiDERM - non corrosive

negative in Salmonella with and without activation

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 25 62

daphnid 48-h LC50 3.2 > 100

green algal 96-h EC50 2.2 19

fish _ chronic value 1.1

daphnid _ chronic 

value

0.29

algal _ chronic 

value

0.78 1.8

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_
Ecotox Values Comments: Predictions are based on SARs for with 

molecular weight adjustment; SAR chemical class = (PMN 

substance); log Kow = 2.77 (EPI, free ); solid with unknown mp; S = dispersible in water 

at 25 C (P, n=1); pH7; effective concentrations based on 100% active ingredients and mean 

measured concentrations; hardness <180.0 mg/L as CaCO3; and <2.0 mg/L;

Ecotoxicity Test Data Results for P-12-0520: compounds with 

(no CASRN; , 50 % PMN substance in 

Acute fish, acute daphnia, and algae toxicity studies were conducted on an analog for PMN 

P-12-0520. The studies on the analog were completed in 2005 by 

 The canola-oil fatty acid portion of the 

 The PMN material is characterized as a 

solid in its neat form and as a solution with 40 – 50 % PMN material in 

 during manufacturing. The molecular weight is 411.72 g/mol. Studies followed the 

respective guidelines of OECD 201 OECD 202 

(Daphnia sp., Acute Immobilization Test), OPPTS 850.1010 (Aquatic Invertebrate Acute 

Toxicity Test), OECD 203 (Fish Acute Toxicity Test), and OPPTS 850.1075 (Fish Acute 

Toxicity Test, Freshwater and Marine); study methods concurred with methods specified in the 

respective guidelines except where specified below.

The test substance information and study summaries below are for an analogous chemical, not 

the actual PMN substance.

Fish Ecotoxicity Test:

 conducted a 96-hour fish acute toxicity study with an analog of 

P-12-0520 (purity not provided) under static-renewal testing conditions, with renewal at 48 

hours. This study was reported to follow OECD test guideline 203, OPPTS 850.1075, and 

 Following a range-finding study, two replicates of 10 fathead minnow 

 were exposed to of test 

substance at nominal loading rates of 0 (negative control), 6.3, 13, 25, 50 or 100 mg/L. Two 

replicates of 10 were exposed to a dilution water control. Individual were 

prepared for each test concentration. Test solutions were prepared prior to test initiation on Day 

0. New test solutions were prepared in separate test chambers on Day 2, and all surviving fish 

were transferred from old to new solutions. The test substance was mixed directly with the 

dilution water on a weight:volume basis. Each was stirred for 24 hours, and the 

stirring speed created a vortex depth of approximately 30 % of the test solution height. After 

mixing, the were allowed to settle for approximately one hour. The test solutions were 
then drawn from spigots placed near the bottom of the mixing vessels and added to the 

appropriate test chamber. The test solutions ranged in appearance from slightly cloudy to cloudy 

white in the test chambers, increasing in intensity with increasing test substance concentration. 

There was visible particulate matter suspended in the solutions at the start of each renewal period 

and on the surface of the solutions at the end of each renewal period. Samples of the test 

solutions were collected from the preparation vessels at test initiation and at 48-hours and 

from pooled solution from each test chamber prior to renewal at 48-hours and at test terminations 

to measure concentrations of as a measurement of the test substance 

in solution. was measured using a Aeration was applied to 

each test chamber throughout exposure to maintain dissolved oxygen concentration above 60 % 

of saturation. Over the course of the study, the water temperature ranged from 21.1 - 22.6 °C, 

pH ranged from 8.1 - 8.6, and the dissolved oxygen ranged from 6.6 - 8.6 mg/L. Dilution water 

hardness was 132 mg/L and content increased with increasing test substance concentration, 

and was generally consistent over the test period. Measurements of in the newly prepared 

 solution on Day 0 and Day 2 ranged from < 1 to 39.7 mg C/L. Measurements of in 

the 48-hour old solutions collected from the test chambers on Day 2 and Day 4 ranged from < 1 

to 34.1 mg C/L. A fish loading of 0.165 g fish/L was calculated. Mortality in the 0, 6.3, 13, 25, 

50 and 100 mg/L treatment groups at test termination was 0, 0, 0, 0, 20 and 100 %, respectively. 

Adverse effects were only observed in the 50 mg/L group and included one fish lying on the 

bottom of the chamber and one fish swimming erratically. All other surviving fish appeared 

normal. Due to the cloudiness of solutions and the suspended particulate matter, the observed 

effects could be due to physical toxicity. The 96-hour LC50 based on nominal loading 

rates was 62 mg/L. The test was considered acceptable.

96-hour LC50 = 62 mg/L

Daphnid Ecotoxicity Test:

 conducted a 48-hour daphnid acute toxicity study with an analog of 

P-12-0520 (purity not provided) under static-renewal testing conditions, with renewal at 24 

hours. This study was reported to follow OECD test guideline 202 and OPPTS 850.1010, and 

 Following a range-finding study, two replicates of 10 daphnids were 

exposed to of test substance at nominal loading rates of 

0 (dilution water control), 6.3, 13, 25, 50, or100 mg/L. Individual were prepared for each 

test concentration. Test solutions were prepared prior to test initiation on Day 0. New test 

solutions were prepared in separate test chambers on Day 1, and all daphnids were transferred 

from old to new solutions. The test substance was mixed directly with the dilution water on a 

weight: volume basis. Each was stirred for 24 hours and the stirring speed created a 

vortex depth of approximately 30 % of the test solution height. After mixing, the were 

allowed to settle for approximately one hour. The test solutions were then drawn from spigots 

placed near the bottom of the mixing vessels and added to the appropriate test chamber. At test 

initiation, the test solutions were cloudy white in appearance, increasing in intensity with 

increasing test substance concentration, with visible particulate matter suspended in the 

solutions. At test termination, the test solutions ranged in appearance from slightly cloudy white 

to cloudy white, with particulate matter suspended in solution and on the bottom of the test 

chambers. Samples of the test solutions were collected from the preparation vessels at test 

initiation and at 24-hours and from pooled solution from each test chamber prior to renewal at 
24-hours and at test terminations to measure concentrations of as a 

measurement of the test substance in solution. was measured using a 

analyzer. Over the course of the study, water temperature ranged from 20.0 - 20.8 °C, pH ranged

from 8.2 - 8.4, and the dissolved oxygen ranged from 7.1 - 8.8 mg/L. Dilution water hardness 

was 136 mg/L and the dilution water was < 1 mg/L. Measurements of in the newly 

prepared solution on Day 0 and Day 1 ranged from 2.2 to 34.3 mg C/L. Measurements of 

 in the 24-hour old solutions collected from the test chambers on Day 1 and Day 2 ranged 

from < 1 to 33.1 mg C/L. content increased with increasing test substance concentration, 

and was generally consistent over the test period. A daphnid loading rate of 40 daphnids/L was 

calculated. Percent mortality/immobility in the 0, 6.3, 13, 25, 50 and 100 mg/L treatment groups 

was 0, 0, 5, 0, 25 and 35 %, respectively. Adverse effects observed at treatment levels ≥ 13 

mg/L included lethargy and particulate matter attached to appendages. Due to the cloudiness of 

the solutions and the particulate matter observed in solution and on daphnid appendages, the 

observed effects could be the result of physical toxicity. The 48-hour EC50, based on nominal 

 loading rates, was greater than 100 mg/L. The test was considered acceptable.

48-hour EC50 > 100 mg/L

Algae Ecotoxicity Test:

Following a range-finding study, conducted a 72-hour algal toxicity 

study with an analog P-12-0520 (purity not provided) under static testing conditions. This study 

was reported to follow OECD test guideline 201 and EU Directive 92/69EEC, Method C.3. 

Green algae ( at a nominal cell density of 104 cells/mL, were 

exposed to water accommodated fractions of the analog test substance at 0 (culture 

medium control), 1.8, 4.1, 10, 20, 45, or 100 mg/L. Three replicate vessels were prepared for 

each test level and six replicate vessels were prepared for the media control. The algae were 

illuminated with a light intensity ranging from 5030 to 7120 lux. The test solutions were 

prepared by adding the analog test substance to 4 L of algal growth medium in a 4-L Pyrex 

aspirator bottle with tubulation and stirred for 24 hours. Stirring speed was adjusted to produce a 

vortex depth of approximately 30 % of the test solution height. After mixing, the were 

allowed to settle for 1 hour. At test initiation, the 4.1, 10, 20, 45 and 100 mg/L test solutions 

appeared cloudy with increasing intensity corresponding with increasing concentration. The 

negative control and the 1.8 mg/L test solutions appeared clear and colorless. At test 

termination, the 100 mg/L treatment level had suspended material; remaining test solutions had 

no visible test material. The in test solutions ranged from 1.6 – 48 mg/L at test initiation 

and from 2.7 – 36.0 mg/L at test termination. At test initiation, samples of the test solutions 

were collected from the preparation vessels for each treatment and media control group. 

At test termination, the biological replicates from each respective treatment and media control 

group were pooled and then sampled to measure concentrations of as 

a measurement of the test substance in solution. was measured using a 

analyzer. content typically increased with increasing test substance concentration, and was 

generally consistent over the test period. However, there was measureable background in 

the media control treatment and the two lowest concentrations had almost equal 

concentrations. The test temperature ranged from 23.1 - 23.3 °C, and the pH ranged from 7.6 - 

8.1. The 72-hour EC50s for biomass and growth rate, based on nominal loading rates, 

were 19 and 72 mg/L, respectively. Based on nominal loading rates, the LOEC for 
biomass was 1.8 mg/L (lowest concentration tested); the NOEC was therefore < 1.8 mg/L. The 

chronic value (ChV) is considered to be 1.8 mg/L (LOEC) since a NOEC could not be defined 

and the LOEC is close the EC10 (2.7 mg/L). The LOEC and NOEC for growth rate were 4.1 and 

1.8 mg/L, respectively, which resulted in a ChV (geometric mean of the NOEC and LOEC) of 

2.72 mg/L, based on nominal loading rates. The test was considered acceptable. 

72-hour EbC50 (biomass) = 19 mg/L

72-hour LOEC (biomass) = 1.8 mg/L

72-hour NOEC (biomass) < 1.8 mg/L

ChV (biomass) = 1.8 mg/L

72-hour ErC50 (growth rate) = 72 mg/L

72-hour LOEC (growth rate) = 4.1 mg/L

72-hour NOEC (growth rate) = 1.8 mg/L

ChV (growth rate) = 2.72 mg/L

Based on nominal loading rates, the 96-hour acute fish (LC50 = 62 mg/L), 48-hour acute 

daphnid (EC50 > 100 mg/L), and 96-hour algal (EbC50 = 19 mg/L, ChV = 1.8 mg/L) toxicity 

tests for an analog to the PMN substance were acceptable. Fish and daphnid ChV values of 6.2 

and > 10 mg/L, respectively, were predicted from acceptable experimental studies using an 

acute-to-chronic ratio of 10. For comparative purposes, predictions for the PMN substance, 

based SARs for with a molecular weight adjustment, are a fish 96-hour LC50 of 

25 mg/L, a daphnid 48-hour LC50 of 3.2 mg/L, a green algae 96-hour EC50 of 2.2 mg/L, a fish 

ChV of 1.1 mg/L, a daphnid ChV of 0.29 mg/L, and a green algae ChV of 0.78 mg/L. However, 

the experimental data from the analog were based on concentrations and not the 

concentration. The algae experimental data for the analog were used to determine the acute and 

chronic hazard of the PMN substance as the data indicate algae as the most sensitive species. 

Based on a 72-hour algae study on an analog, an EbC50 of 19 mg/L (19000 ppb), and the 

application of an assessment factor of 4, the acute for P-12-0520 is 4750 ppb. The 

 for P-12-0520 is derived by dividing the experimental algae biomass ChV of 1.8 mg/L 

(1800 ppb) by a factor of 10 (uncertainty factor) yielding a of 180 ppb for

P-12-0520.

Acute = 4750 ppb

Chronic = 180 ppb

Ecotox Study Reviewer: K. Eisenreich

September 6, 2012

Factors Values Comments

Assessment Factor

10

Concentration of Concern 

(ppb)

180

SARs with molecular 

weight adjustment
SAR Class

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: Becky Jones