### 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: N o Ecotox: N o

Routes of exposure : Health: N o 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; OECD305(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. N o 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 N OEL = 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 - N OEL = 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); p H7; 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 ( N OEC = 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 ( p redicted) and a Log P of 5.5 (experimental) and 9.2 ( p redicted).

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/ p recipitations 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, p H ranged fro m 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. N o 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 = N o Effect at Saturation (N ES) 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, p H = 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. N o mortality was observed during the test. The test was considered valid [or acceptable]. 96-hour LC50 > 0.020 mg/L or NES N OEC = 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
p reliminary 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
p repare 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, p H 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. N o 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 = N ES

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, p H = 7.9-8.0, and DO = 8.1

– 8.4 mg/L. N o immobilization was observed during the test. The test was considered valid [or acceptable]. 48-hour EC50 > 0.0089 mg/L or NES N OEC = 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 = N ES 72-hour ChV = N ES

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, and0.00038, 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, p H = 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) N OEC = 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. N o analysis was conducted to determine the homogeneity, concentration or stability of the test material formulation. The test vessels were covered with
p erforated 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. N o 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=N OEC 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 p pb for P-13-0170 was calculated from the algae 96-hour EC50 of 0.00032 mg/L (0.32 p pb) by dividing an assessment factor of 4. The chronic CoC of 1 p pb for P-13-0170 was calculated from the algae ChV of 0.000238 mg/L (0.24 p pb) by dividing by an assessment factor of 10.Acute CoC = 1 p pb Chronic CoC = 1 p pb

Ecotox Study Reviewer: K. Moran

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 1

SARs Phosphate Esters SAR Class Phosphate Esters Ecotox Category N one

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916