### 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, p oor 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) - p otential 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); p H7; 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 ( p urity 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
p repared for each test concentration. Test solutions were prepared prior to test initiation on Day 0. N ew 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 werethen 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,
p H ranged fro m 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 ( p urity 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. N ew 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
p laced 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 at24-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, p H range d 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
p repared 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 ( p urity 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
p repared 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 forbiomass 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, p redictions 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 p pb), and the application of an assessment factor of 4, the acute for P-12-0520 is 4750 p pb. The for P-12-0520 is derived by dividing the experimental algae biomass ChV of 1.8 mg/L (1800 p pb) by a factor of 10 (uncertainty factor) yielding a of 180 p pb fo r P-12-0520.

Acute = 4750 p pb Chronic = 180 p pb

Ecotox Study Reviewer: K. Eisenreich September 6, 2012

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 180

SARs with molecular weight adjustmentSAR Class Ecotox Category

Ecotox Factors Comments:

SAT Chair: Becky Jones