SAT Report

PMN Number: P-14-0800

SAT Date: 9/11/2014

Print Date: 9/30/2014

Related cases:

 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 3

 Persistence Bioaccum Toxicity Comments

2 11

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: IRR –E; SENSIT; KIDNEY; UNCERT BLOOD; UNCERT 

REPRO/DEVEL

Summary of Assessment:

 Fate:

Fate Summary: P-14-0800

FATE: 

Solid with MP = Dec. >224 C (M)

log Kow = 2.94 (M) 

S = 0.65 mg/L at 25 C (M)

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

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = 25-50 via sorption and biodeg; All Analogs: OECD111(Hydrolysis): 

t1/2(pH4,7,9 @ 25C, pH9 @ 50C): >1yr/>1yr/14d/25h; OECD 301D(Closed Btl): 23.6%/28d 
NRB.

Time for complete ultimate aerobic biodeg = mo

Sorption to soils/sediments = moderate

PBT Potential: P2B1

*CEB FATE: Migration to ground water = moderate

 Health:

 Health Summary: Absorption is nil all routes based on physical/chemical 

properties. Dissociation in GI tract is possible. Concern for irritation/corrosion to the eye, 

sensitization, kidney toxicity, uncertain concern for blood and repro/developmental toxicity, all 

based on submitted with PMN data.

 Test Data: Negative in Ames assay with and without activation.

Acute rat oral LD50 > 2000 mg/kg-bw

Rabbit eye irritation test result in serious damage to eyes.

OECD 407, 28 day oral with rats NOAEL=1000 mg/kg-bw/day (highest dose tested), NOEL = 

50 mg/kg-bw/day (blood pathology). 

OECD 421, Reproduction/Fertility test – NOAEL for parental effects and pup growth rate was 

350 mg/kg-bw/day, NOAEL for reproductive effect was 1000 mg/kg-bw/day.

OECD 429, Dermal Sensitization – positive, sensitization potential in the Local Lymph Node 

Assay (review in PMN Gold).

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 2.7 12.18 measured: analog

daphnid 48-h LC50 0.16 0.030 measured: analog

green algal 96-h EC50 <1 0.046 measured: analog

fish _ chronic value 0.27 1.218 measured: ACR

daphnid _ chronic 

value

0.016 0.0030 measured: ACR

algal _ chronic 

value

<1 0.014 measured: analog

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SAR nearest analog method for 

 SAR chemical class = MW 

1665; S = 0.65 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

Ecotoxicity Test Data Results for P-14-0800: 
Freshwater fish, freshwater invertebrate, and green algae toxicity studies were completed for a 

reaction product of 

The PMN material is used as a The PMN material is described as a 

 in neat form; as a 15% dispersion in during processing; and as a solid entrained 

in deposited on paper at end use. The molecular weight for a representative structure is 

1664.84 g/mol. The PMN substance has an estimated Henry’s Law Constant of <1 x 10-8 

atm-m3/mole and is expected to be nonvolatile. The water solubility of the tested analog is 0.65 

mg/L at 25°C. The acute freshwater fish fish study was reported to follow EU Method C.1 

(2008), OECD TG No. 203 (1992), USEPA OPPTS 850.1075 (1996), and OECD Series on 

Testing and Assessment No. 23 (2000). The acute freshwater invertebrate study was reported to 

follow EU Method C.2 (2008), OECD TG No. 202 (2004), USEPA OPPTS 850.1010 (1996), 

and OECD Series on Testing and Assessment No. 23 (2000). The green algae study was reported 

to follow Commission Directive 92/69/EEC, Part C, C.3 (1992), OECD No. 201, and 

International Organization for Standardization (1998) ISO/DIS 14442. All studies were 

conducted under GLP conditions.

The test substance information and study summaries below are for the following analogous 

chemical, not the actual PMN substance.

Fish Ecotoxicity Test:

 conducted a 96-hour fish toxicity test in zebrafish (Brachydanio rerio) with 

 98.3 % UVCB substance), an analog substance, under static conditions. 

This study was reported to follow EU Method C.1 (2008), OECD TG No. 203 (1992), USEPA 

OPPTS 850.1075 (1996), and OECD Series on Testing and Assessment No. 23 (2000). 

Following preliminary and supplementary tests, single replicates of seven B. rerio were exposed 

to a control (filtered tap water) or to the test substance at nominal concentrations of 5.535, 6.912, 

8.64, 10.8, and 13.5 mg/L. Corresponding geometric mean-measured concentrations of the test 

substance were 3.84, 4.79, 6.53, 8.49, and 10.62 mg/L, as determined via HPLC with UV-VIS 

detection (LOQ = 0.1 μg/mL; LOD = ~0.05 μg/mL). The analytically determined geometric 

mean test substance concentrations in the test media ranged from 87-92% of nominal at test 

initiation and from 54-67% of nominal at test termination. A single test substance stock solution 

was prepared according to the water accommodated fraction (WAF) method. A supersaturated 

test substance stock solution (nominally 1000 mg/L) was prepared by dispersing/dissolving the 

test substance amount without the use of any organic solvent into the test medium (filtered and 

aerated aquarium water) two days before the start of the study (day -2). This solution was shaken 

for 24 hours at ~30°C, and then was left settling for 24 hours at ~20°C. Thereafter, the solution 

was filtrated by paper filter (0.22 μm). The test solutions were prepared by the appropriate 
diluting of the stock solution on day 0. Over the course of the study, temperature ranged from 

22.8-23.1°C, pH ranged from 8.39-8.46, and dissolved oxygen ranged from 90-93%. Dilution 

water hardness was 238 mg/L as CaCO3. A loading rate of 0.630 g fish/L was reported. The 

cumulative percent mortalities at the geometric mean-measured test concentrations of 0 

(control), 3.84, 4.79, 6.53, 8.49, and 10.62 mg/L were 0, 0, 0, 0, 14, and 29%, respectively. At 

the test concentration of 8.49 mg/L, decreased activity and low locality in the aquarium were 

observed at 96 hours. Although the following concerns lend some uncertainty with respect to the 

exposure regime, the test is considered adequate:

· The study tested concentrations that are above the reported water solubility of the test 

substance (0.65 mg/L at 25°C).

· A single test substance stock solution was prepared according to the WAF method: the test 

substance was dispersed/dissolved in water, and the resulting stock solution was shaken, allowed 

to settle, filtered, and serially diluted to prepare the test solutions. According to OECD Series on 

Testing and Assessment No. 23 (2000), WAFs are prepared individually and not by serial 

dilution of a single stock WAF.

· Measured concentrations differed from the nominal values by greater than 20% at all 

concentrations at test termination.

Based on geometric mean-measured concentrations, the 96-hour LC50 (95% confidence interval) 

was 12.18 (8.21-18.08) mg/L.

96-hour LC50 = 12.18 mg/L

Daphnid Ecotoxicity Test:

conducted a 48-hour immobilization toxicity test in water fleas (Daphnia 

magna) with (100% purity; 98.3 % UVCB substance), an analog substance, under 

static conditions. This study was reported to follow EU Method C.2 (2008), OECD TG No. 202 

(2004), USEPA OPPTS 850.1010 (1996), and OECD Series on Testing and Assessment No. 23 

(2000). Following a preliminary study, four replicates of five daphnids were exposed to a control 

(ISO medium) or to the test substance at nominal concentrations of 0.016, 0.031, 0.063, 0.125 

and 0.25 mg/L. Corresponding geometric mean-measured concentrations of the test substance 

were 0.012, 0.025, 0.051, 0.103 and 0.25 mg/L, as determined via HPLC with UV-VIS detection 

(LOQ = 0.1 μg/mL; LOD = ~0.05 μg/mL). The analytically determined geometric mean test 

substance concentrations in the test media ranged from 102-119% of nominal at test initiation 

and from 52-97% of nominal at test termination. A single test substance stock solution was 

prepared according to the water accommodated fraction (WAF) method. A supersaturated test 

substance solution (1000 mg/L) was prepared by dispersing/dissolving the test substance amount 

without the use of any organic solvent into the test medium (ISO Medium) two days before the 

start of the study (on day -2). This solution was shaken for 24 hours at ~30°C, and then was left 

settling for 24 hours at ~30°C. Thereafter, the solution was filtrated by paper filter (0.22 μm). 

The test solutions were prepared by the appropriate diluting of the stock solution on day 0. Over 

the course of the study, temperature ranged from 19.9-20.2°C, pH ranged from 7.79-7.89, and 

dissolved oxygen ranged from 6.3-6.7 mg/L. Dilution water hardness was 144 mg/L as CaCO3. 

A loading rate of 125 daphnids/L, which exceeds the recommended loading of 40 daphnids/L 

(USEPA OPPTS 850.1010, 1996), was calculated. The cumulative percent immobility at 

geometric mean-measured test concentrations of 0 (control), 0.012, 0.025, 0.051, 0.103 and 0.25 

mg/L were 0, 0, 50, 75, 100 and 100%, respectively. Although the following concerns lend some 

uncertainty with respect to the exposure regime, the test is considered adequate:
· A single test substance stock solution was prepared according to the WAF method: the test 

substance was dispersed/dissolved in media, and the resulting stock solution was shaken, 

allowed to settle, filtered, and serially diluted to prepare the test solutions. According to OECD 

Series on Testing and Assessment No. 23 (2000), WAFs are prepared individually and not by 

serial dilution of a single stock WAF.

· Measured concentrations differed from the nominal values by greater than 20% at all test 

concentrations except the highest at test termination.

Based on geometric mean-measured concentrations, the 48-hour EC50 (95% confidence interval) 

was 0.030 (0.024-0.037) mg/L.

48-hour EC50 = 0.030 mg/L

Algal Ecotoxicity Test:

 conducted a 72-hour growth inhibition test in algae (Pseudokirchneriella 

subcapitata) with (100% purity; 98.3 % UVCB substance), an analog substance, 

under static conditions. This study was reported to follow Commission Directive 92/69/EEC, 

Part C, C.3 (1992), OECD No. 201, and International Organization for Standardization (1998) 

ISO/DIS 14442. Following two preliminary studies, six replicates of P. subcapitata (104 

cells/mL) were exposed to a control medium (algal mineral salts test medium) and three 

replicates of P. subcapitata (104 cells/mL) were exposed to the test substance at nominal 

concentrations of 0.008, 0.016, 0.031, 0.063, 0.125 and 0.25 mg/L. Corresponding geometric 

mean-measured concentrations of the test substance were 0.004, 0.006, 0.012, 0.017, 0.024 and 

0.052 mg/L, as determined via HPLC with UV-VIS detection (LOQ = 0.1 μg/mL; LOD = ~0.05 

μg/mL). The analytically determined geometric mean test substance concentrations in the test 

media ranged from 65-91% of nominal at test initiation and from 5-27% of nominal at test 

termination. The algae were illuminated with a light intensity of 8166 lux with constant shaking. 

A single test substance stock solution was prepared according to the water accommodated 

fraction (WAF) method. A supersaturated test substance stock solution (nominally 1000 mg/L) 

was prepared by dispersing/dissolving the test substance amount without the use of any organic 

solvent into the test medium (OECD medium) two days before the start of the study (on day -2). 

This solution was shaken for 24 hours at 30°C, and then was left settling for 24 hours at 

19.1-19.6°C. Thereafter, the solution was filtrated by paper filter (0.22 μm). The test solutions 

were prepared by the appropriate diluting of the stock solution on day 0. The test flasks were 

covered with air-permeable stoppers. Over the course of the study, temperature ranged from 

23.0-23.3°C, and pH ranged from 8.78-9.83. The cell density in the control cultures increased by 

a factor of 70 within 72 hours. Although the following concerns lend some uncertainty with 

respect to the exposure regime, the test is considered adequate:

· A single test substance stock solution was prepared according to the WAF method: the test 

substance was dispersed/dissolved in media, and the resulting stock solution was shaken, 

allowed to settle, filtered, and serially diluted to prepare the test solutions. According to OECD 

Series on Testing and Assessment No. 23 (2000), WAFs are prepared individually and not by 

serial dilution of a single stock WAF.

· Measured concentrations differed from the nominal values by greater than 20%.

Based on geometric mean-measured concentrations, the 72-hour EC50’s for biomass, growth 

rate and yield were 0.046, 0.143 and 0.046 mg/L, respectively. The 72-hour NOEC and LOEC 

were 0.012 and 0.017 mg/L, respectively. The 72-hour ChV was 0.014 mg/L.

72-hour EC50 (Biomass; Yield) = 0.046 mg/L
72-hour EC50 (Growth rate) = 0.143 mg/L

NOEC = 0.012 mg/L

LOEC = 0.017 mg/L

ChV = 0.014 mg/L

The 96-hour freshwater fish toxicity test (LC50 = 12.18 mg/L), the 48-hour freshwater 

invertebrate (daphnid) toxicity test (LC50 = 0.030 mg/L), and the 72-hour green algae toxicity 

test (EC50 = 0.046 mg/L; NOEC = 0.012 mg/L; LOEC = 0.017 mg/L; ChV = 0.014 mg/L) with 

an analog of P-14-0800 were adequate. Applying an acute-to-chronic (ACR) ratio of 10 to the 

acute experimental values yields chronic values of 1.218 mg/L (=12.18/10) for fish and 0.003 

mg/L (=0.030/10) for daphnids. For comparative purposes, the 96-hour fish LC50 of 2.7 mg/L, 

the 48-hour daphnid LC50 of 0.16 mg/L, the 96-hour green algae EC50 of <1 mg/L, and the fish, 

daphnid, and green algae chronic values (ChV) of 0.27, 0.016, and <1 mg/L, respectively, were 

predicted based on the SAR nearest analog method for 

The daphnid experimental results indicate that it is the most acutely sensitive species. Based on 

the daphnid experimental EC50 of 0.030 mg/L and application of an assessment factor of 5, the 

acute concentration of concern (CoC) for P-14-0800 is 0.006 mg/L (=0.030/5) or 6 ppb. Based 

on predicted and experimental ChV values, the daphnid is the most sensitive species on a chronic 

exposure basis. Applying an assessment factor of 10 to the daphnid ChV of 0.003 mg/L yields a 

chronic CoC of 0.0003 mg/L (=0.003/10) or 1 ppb rounded to one significant figure for 

P-14-0800.

Acute CoC = 6 ppb

Chronic CoC = 1 ppb 

Ecotox Study Reviewer: R. Sternberg

September 17, 2014

Factors Values Comments

Assessment Factor

10

Concentration of Concern 

(ppb)

1

SARs

SAR Class

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: Viktor Morozov