SAT Report

PMN Number: P-13-0170

SAT Date: 1/11/2013

Print Date: 3/8/2013

Related cases:

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1 3

 Persistence Bioaccum Toxicity Comments

1 1 PMN

2

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: No exposures needed

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-13-0170

FATE: 

Solid with MP = 53-83.5 C (M)

log Kow = 5.50 (M) 

S < 0.001 mg/L at 25 C (E)

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

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = 90 via sorption; OECD 301C(MITI): 1%/28d NRB; OECD 
305(Bioconcentration): 4.9 (low), 12 (high)/28d.

Time for complete ultimate aerobic biodeg ≥ mo

Sorption to soils/sediments = v.strong

PBT Potential: P2B1

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption is nil all routes as the neat material and poor 

all routes when in solution based on physical/chemical properties. No significant health 

concerns. Low concern.

 Test Data: P13-170: (-) Salmonella with and without activation; (-) 

E. coli with and without activation; (-) for chromosome aberrations in CHL cells with and 

without activation; (-) in a mouse lymphoma assay with and without activation; rat oral LD0 = 

2000 mg/kg; rat dermal LD0 = 2000 mg/kg; no skin irritation in rabbits; no eye irritation in 

rabbits; (-) for skin sensitization in a mouse local lymph node assay up to 50% ai; rat 28-day oral 

NOEL = 1000 mg/kg (highest dose tested)

: negative in Salmonella and E coli with and without activation (analog)

negative for chromosome aberrations in CHL cells (analog)

acute dermal study in rats - no deaths or signs of toxicity at 5000 mg/kg

mild skin irritant in rabbits - all effects cleared by 48 hours

mild eye irritant in rabbits - all effects cleared by day 7

negative for dermal sensitization in the mouse local lymph node assay at concentrations up to 

50%

28-day oral study in rats - NOEL = 1000 mg/kg, highest dose tested 

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 * >0.02 or *, * P-13-0170

daphnid 48-h LC50 * > 0.02 or *, * P-13-0170

green algal 96-h EC50 * 0.0003, * P-13-0170

fish _ chronic value *

daphnid _ chronic 

value

*

algal _ chronic 

value

* 0.0002, * P-13-0170

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for Phosphate Esters; MW 651; 

solid with unknown mp (P); S < 0.00001 g/L (P); pH7; 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 for P-13-0170: Phosphoric acid, mixed esters 

Trade name: ADK STABILIZER 

FP-800, ADK STAB FP-800, T-1752, T-1317F).

Acute fish, acute daphnia, algae, earthworm, and activated sludge bacteria toxicity studies were 

conducted on the PMN P-13-0170; activated sludge bacteria toxicity test showed low toxicity 

(NOEC = 1000 mg/L) and was not considered in this hazard assessment. The aquatic toxicity 

studies were conducted in and the earthworm toxicity study was 

conducted in 

he sponsor of the PMN is AMFINE Chemical Company. The PMN is 

classified as a phosphate esters with a water solubility of <0.01 mg/L (experimental) and 0.03 

mg/L (predicted) and a Log P of 5.5 (experimental) and 9.2 (predicted).

Additional data have been provided for with reportedly the same proportions 

of as P-13-0170. Substances were referred to as mixtures or reaction products. 

The substances were identified with different CAS RN numbers for reasons unknown to EPA. 

Until further information is provided 

, these substance are considered to be the same substances for the purpose of 

characterizing hazard.

Fish Ecotoxicity Test: 

1) A 96-hour limit test in Medaka (Oryzias latipes) was conducted with P-13-0170 

 under static conditions 

according to OECD TG 203 (Fish Acute Toxicity Test) and OECD TG 23 (Guidance Document 

on Aquatic Toxicity Testing of Difficult Substances and Mixtures). A preliminary study 

concluded that the test substance solubility was below the determination limit (< 0.020 mg/L). 

Two replicates of eight O. latipes were exposed to a dilution water control (dechlorinated tap 

water) or the PMN substance at a nominal concentration of 100 mg/L. To prepare the 100 mg/L 

test solution, the test sample and dilution water were mixed and stirred by magnetic stirrer for 

about 48 hours. The test vessels were covered with a lid to prevent dust, and volatilization of the 

test solution. At the start of the exposure, the test solution was suspended to white with floating 

matter/precipitations observed. The appearance kept until the end of the exposure. The test 

solution in the control was clear and colorless at the start and the end of the exposure. HPLC 

analysis of the test substance in solution was conducted; however, the test substance 

concentration was below the determination limit (< 0.022 mg/L) at the start and end of testing. 

Over the course of testing, temperature was maintained at 23.9 – 24.8  ̊C, pH ranged from 7.9 –

8.1 and dissolved oxygen ranged from 8.1 – 8.4 mg/L. Dilution water hardness was 28 mg 

CaCO3/L and TOC was 0.6 mg/L. A loading rate of 0.24 g fish/L was calculated. No mortality 

or abnormal responses were observed during the exposure including any physical effects that 

may have resulted from the cloudy nature of the test solution. Therefore, the LC50 is greater than 

100 mg/L (nominal concentration) or ‘no effects at saturation’. The study was considered 

acceptable to characterize the fish acute toxicity endpoints even though test solutions were 

described as cloudy and methods were not employed to reduce the cloudiness (e.g., 

centrifugation or siphoning).
96-hour LC50 = No Effect at Saturation (NES) 

2) The following summary was excerpted from the ECOTOX Report. A 

96-hour acute fish toxicity test was conducted with Rainbow trout (Oncorhynchus mykiss) under 

semi-static conditions. For the definitive test, a control, a solvent control and 0.020 mg/L of the 

test material were tested. The 0.020 mg/L of the PMN test material was dissolved in DMF 

(dimethylformamide; 0.1 mg/L) to prepare the stock solution. Daily renewals were made for the 

test concentrations. The test material was centrifuged or not centrifuged to demonstrate the total 

amount of test material in the system v. the total amount of dissolved sample that could be 

bioavailable to the organism. Fish were exposed in three replicates of 10 fish each. Observations 

were done at 3, 6, 24, 48, 72, and 96 hours after the start of exposure. DO = 7.9 – 9.9 mg/L, pH = 

7.4 – 7.7, and temperature = 10.8 – 14.0 °C. Analysis of the test concentrations showed the test 

material to have mean, measured concentrations within 100 – 120 % of nominal taken from 

samples uncentrifuged before or after test concentration renewal. Centrifuged test samples prior 

to or after test material renewal showed measured values of 53 – 71 % of nominal. The test 

material measured concentrations in older solutions declined compared to the freshly prepared 

samples which was thought to be due to the adsorptive/accumulative properties of the PMN test 

material. No mortality was observed during the test. The test was considered valid [or 

acceptable].

96-hour LC50 > 0.020 mg/L or NES

NOEC = 0.020 mg/L

Daphnid Ecotoxicity Test: 

1) A 48-hour limit test in water fleas (Daphnia magna) was conducted with P-13-0170 

 under static conditions 

according to OECD TG 202 (Daphnia sp. Acute Immobilization Test) and OECD TG 23 

(Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures). A 

preliminary study concluded that the test substance solubility was below the determination limit 

(< 0.020 mg/L). Four replicates of five D. magna were exposed to a dilution water control 

(dechlorinated tap water) or the PMN substance at a nominal concentration of 100 mg/L. To 

prepare the 100 mg/L test solution, the test sample and dilution water were mixed and stirred by 

magnetic stirrer for about 48 hours under about 20 ̊C. The solution taken from the middle layer 

of the dispersed suspension was collected after settling for one hour. This solution was divided 

into each test vessel as the test solution. At the start of the exposure, the test solution was white 

and turbid, and precipitations and floating matter were observed. The appearance kept until the 

end of the exposure. The test solution in the control was clear and colorless at the start and the 

end of the exposure. HPLC analysis of the test substance in solution was conducted; however, 

the test substance concentration was below the determination limit (< 0.022 mg/L) at the start 

and end of testing. Over the course of testing, temperature was maintained at 20.1 ̊C, pH was 

7.9 and dissolved oxygen ranged from 8.8 – 8.9 mg/L. Dilution water hardness was 28 mg 

CaCO3/L and TOC was 0.6 mg/L. A loading rate of 50 daphnid/L was calculated, which is 

considered high according to OPPTS standards. No immobilization was observed at a nominal 

concentration of 100 mg/L and no effects were observed that could have been attributed to the 

cloudy test solutions. Therefore, the EC50 is greater than 100 mg/L (nominal concentration) or 

‘no effects at saturation’. The study was considered acceptable to characterize the daphnid acute 

toxicity endpoints even though test solutions were described as cloudy and methods were not 

employed to reduce the cloudiness (e.g., centrifugation or siphoning).
48-hour EC50 = NES 

2) The following summary was excerpted from the ECOTOX Report. The 

48-hour acute toxicity test for D. magna (four replicates per test concentration/ 10 daphnids per 

replicate) was a static test with solvent control (DMF; 0.1 mg/L), negative control, and a nominal 

concentration of 0.0060 mg/L. Analysis of the test material ranged from 0.00848 to 0.00974 

mg/L and no sign of loss of test material over the 48-hour period. The mean, measured value was 

0.0089 and although slightly higher than the nominal test concentration, this is thought to be due 

to variation associated with analysis of the sample being so close to the LOQ (see above). Water 

quality parameters were the following: temperature = 20.9 -21°C, pH = 7.9-8.0, and DO = 8.1 –

8.4 mg/L. No immobilization was observed during the test. The test was considered valid [or 

acceptable].

48-hour EC50 > 0.0089 mg/L or NES

NOEC = 0.0089 mg/L

Algal Ecotoxicity Test:

1) A 72-hour growth inhibition study in green algae (Pseudokirchneriella subcapitata) was 

conducted with P-13-0170 

under static conditions according to OECD TG 201 (Freshwater Alga and 

Cyanobacteria, Growth Inhibition Test) and OECD TG 23 (Guidance Document on Aquatic 

Toxicity Testing of Difficult Substances and Mixtures). A preliminary study concluded that the 

test substance solubility was below the determination limit (< 0.020 mg/L). Six replicates of P. 

subcapitata (104 cells/mL) were exposed to a dilution water (OECD medium) control or the 

PMN substance at a nominal concentration of 100 mg/L. Algae were illuminated at a light 

intensity ranging from 96 – 105 μE/m2/s with constant shaking. The test sample and medium 

were mixed and stirred by magnetic stirrer for about 48 hours to prepare 100 mg/L. At the start 

of the exposure a white suspension was observed in the 100 mg/L exposure level that remained 

at study termination in addition to a tint of green due to algae growth. Control solutions were 

colorless and clear at the start of the exposure, and those at the end of the exposure were green 

due to algae growth. HPLC analysis of the test substance in solution was conducted; however, 

the test substance concentration was below the determination limit (< 0.020 mg/L) at the start 

and end of testing. Over the course of testing, temperature ranged from 23.3 – 23.5 ̊ and pH 

ranged from 7.8 – 8.2. The cell density in the control cultures increased by a factor of ≥ 130 

after 72 hours. The test substance did not have a statistically significant effect on biomass or 

growth rate nor did cloudiness in treated cultures result in any apparent shading. The EC50 is 

greater than 100 mg/L (nominal) or ‘no effects at saturation’. Based on a NOEC of 100 mg/L 

(nominal), the ChV is considered to be ‘no effects at saturation’. The study was considered 

acceptable to characterize the algae toxicity endpoints even though test solutions were described 

as cloudy and methods were not employed to reduce the cloudiness (e.g., centrifugation or 

siphoning).

72-hour EC50 = NES

72-hour ChV = NES

2) The following summary was excerpted from the ECOTOX Report. The 

green algae (Pseudokirchneriella subcapitata) were exposed to the test material for 96 hours 

under static conditions with a solvent control (0.1 mg/L tetrahydrofuran), negative control, and 
0.00038, 0.00075, 0.0015, 0.0030, and 0.0060 mg/L of the test material. The algae were exposed 

in 3 replicates of each test concentration under constant illumination (7000 lux) and shaking (150 

rpm). The initial cell density was 1 X 104 cells/mL. Temperature was 24 °C, pH = 7.5 – 8.0. 

Samples of algae were removed at 0, 24, 48, 72, and 96 hours to determine biomass and growth. 

Some interference was observed in the controls after analytical measurements were taken. 

Therefore the response in the controls was corrected for in calculating the test material 

concentrations and thereby resulted in the range of the material concentration to be less than the 

LOQ to 137 % of the nominal concentrations. Inhibition of growth was determined at the 

0.00038 and the 0.00075 mg/L test concentrations to be 1 and 63 %, respectively. Test results are 

reported as geometric means due to requirements for reporting in this manner if there is an 

observed decline in the test concentrations or the determined concentrations are below the LOQ 

of the analytical method. The test was considered valid [or acceptable].

96-hour ErC50 = 0.0040 mg/L (95 % C.I. = ± 0.00038 – 0.00042 mg/L) (growth rate)

96-hour EbC50 = 0.00032 mg/L (95 % C.I. = ± 0.00031 – 0.00033 mg/L) (biomass)

NOEC = 0.000238 mg/L

Earthworm Ecotoxicity Test: 

A 14-day limit test in earthworms (Eisenia foetida) was conducted with P-13-0170 

according to the Guidelines for 

the Testing of Chemicals 

and OECD Test Guideline No. 207. Following a preliminary range-finding test, four replicates 

of 10 earthworms were exposed to either the control or the PMN substance at a nominal 

concentration of 1000 mg/kg (dry weight of artificial soil). According to the weight of the 

artificial soil, 10 g of a mixture of fine ground quartz and an appropriate amount of test 

substance corresponding to 740 g wet weight of artificial soil were mixed with 740 g wet 

artificial soil for each test container. No analysis was conducted to determine the homogeneity, 

concentration or stability of the test material formulation. The test vessels were covered with 

perforated plastic film to prevent the test medium from drying and maintained in a temperature 

controlled room under continuous illumination at 800 lux. Over the course of the study, soil 

temperature was 20 ± 0.2 ̊C, the water ratio ranged from 32-35% and soil pH ranged from 6.0 –

6.1. No mortalities were observed throughout the exposure period. The 14-day LC50, based on 

nominal concentrations, was > 1000 mg/kg dry soil weight. The study was acceptable to 

characterize the earthworm acute toxicity endpoint.

14-day LC50 > 1000 mg/kg

Aquatic toxicity studies submitted with the PMN and with were considered 

acceptable and indicated no effects at saturation following short-term exposure to fish and 

daphnid. Based on the results of the two algae studies, risk will be determined with a 96-hour 

EbC50 of 0.00032 mg/L and a ChV of 0.000238 mg/L (ChV=NOEC since LOEC>EC50). The 

acute earthworm toxicity study was also considered acceptable, but is not generally considered 

during the initial screen of a PMN. QSAR predictions using the phosphate esters class indicated 

no effects at saturation for all endpoints. The acute CoC of 1 ppb for P-13-0170 was calculated 

from the algae 96-hour EC50 of 0.00032 mg/L (0.32 ppb) by dividing an assessment factor of 4. 

The chronic CoC of 1 ppb for P-13-0170 was calculated from the algae ChV of 0.000238 mg/L 

(0.24 ppb) by dividing by an assessment factor of 10.
Acute CoC = 1 ppb

Chronic CoC = 1 ppb

Ecotox Study Reviewer: K. Moran 

Factors Values Comments

Assessment Factor

10

Concentration of Concern 

(ppb)

1

SARs Phosphate Esters

SAR Class Phosphate Esters

Ecotox Category None

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916