SAT ReportPMN Number:P-13-0722SAT Date:7/26/2013Print Date:8/30/2013Related cases:Concern levels:Type of Concern:HealthEcoCommentsLevel of Concern:1-23PersistenceBioaccumToxicityComments312Anion211CationExposure Based Review:Health:Ecotox:NoRoutes of exposure:Health:Drinking Water InhalationEcotox:All releases to waterFate:;Anion rapid; Cation slowP2Rec Comments:Comment:P2REC: SAT: ForwardKeywords:Keywords:LUNG; LIVER; ACUTE; AQUATOXSummary of Assessment:Fate:Fate Summary:P-13-0722FATE: Estimations for anion MW 281log Koc = 1.24 (E)log Fish BCF = 1.03 (E)log Fish BAF = 1.08 (E)FATE: Estimations for typical cation, n=1 MW 202log Koc = 1.88 (E)log Fish BCF = 0.50 (E)log Fish BAF = -0.05 (E)PMN Substance: Liquid with MP< 25 C (E)S = 1.9 g/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 (%) = Anion 0-25; Cation 0-25 via biodeg; MTDID 10112:OECD301D(Closed Btl): 6% (low), 1% (high)/28d NRB.Time for complete ultimate aerobic biodeg = Anion >mo; Cation wkSorption to soils/sediments = Anion low; Cation strongPBT Potential: Anion P3B1; Cation P2B1*CEB FATE: Migration to ground water = Anion rapid; Cation slowHealth:Health Summary:Not absorbed from the skin, absorbed from the lung (pchem), moderate absorption from the GItract (Test data). Concern for liver toxicity for the anion based on (rat 28-day NOEL = 1.67 mg/kg); lung toxicity frominterference with the natural surfactant balance of the lungs and acute toxicity based on submitted test data.Test Data:PMN: oral ADME study: 51% (M), 74% (F) excreted in urine over 14 days, half-life = 1 day: (-) Salmonella with and without activation; (-) E. coli with and without activation; (-) for chromosome aberrations in ahuman lymphocyte assay with and without activation; oral ADME study: 62% excreted in urine in 96 h; rat oral LD50 >300 <2000mg/kg; no skin irritation in rabbits; no eye irritation in rabbits; (-) for skin sensitization in a mouse local lymph node assay up to 50%aiEcotox:Test OrganismTest TypeTest End PointPredictedMeasuredCommentsfish96-hLC5035.4daphnid48-hLC501.2green algal96-hEC500.48fish_chronic value3.5daphnid_chronic value0.12algal_chronic value0.088Sewage Sludge3-hEC50_Sewage Sludge_Chronic Value_Ecotox Values Comments:Predictions are based on SAR nearest analog for; SAR chemical classMW 483 with 100% < 1000 and 90% < 500; liquid; S = 1,900 mg/L at 25 C (P);pH7; effectiveconcentrations based on 100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as CaCO3; and TOC<2.0 mg/L;*Based on the presence ofsubstitution, substitutions, and a longer alkyl substitution on the nitrogen of theEPA identified analog that is most similar to the PMN, EPA concluded that data for is the most appropriateanalog. Submitted analog data are summarized below, but not incorporated into the ecotoxicity profile for P-13-0722.-----------------------------------------------------------------------------------------------------------------------------------Ecotoxicity Test Data Results for P-13-0722:Three acute ecotoxicity studies were conducted on an analog of PMN (P-13-0722) inlaboratories with fish, daphnia,and algae. EPA classified the PMN as a. Submitter provided analog data was foralsoclassified as aEPA identifiedas the SAR Nearest Analog; this substance is also a. Based on thepresence ofsubstitution, substitutions, and a longer alkyl substitution on the nitrogen of the EPA identifiedanalog that is most similar to the PMN, EPA concluded that data for is the most appropriate analog. Submitted analog dataare summarized below, but not incorporated into the ecotoxicity profile for P-13-0722.Fish Ecotoxicity Test:conducted a 96-hour limit fish toxicity study in Zebra fish (Danio rerio) with the analog substance (99.91%purity)under static conditions. This study was reported to follow OECD guideline No. 203, “Fish Acute Toxicity Test” (1992). Followingarange-finding study, singe replicates of seven D. rerio were exposed to adjusted ISO medium (control) and test substance at nominalconcentrations of 100 mg/L. To prepare the test solutions, a solution of 100 mg/L was stirred for 21-24 hours with a magnetic stirrerto accelerate the dissolving of the test substance in the test medium. The final test solutions were all clear and colorless. Over thecourse of the study, temperature ranged from 21.1 to 22.5oC,pH ranged from7.4 to 7.9 and dissolved oxygen ranged from 7.7 to 9.5mg/L. Test medium hardness was 180 mg CaCO3/L. A loading rate of 0.25 g fish/L was calculated. Test samples collected at96-hours of anionic and cationic parts of the test substance were 105% relative to nominal, determined by HPLC-MS analysis (LOD=0.003 mg/L).No mortalities or clinical effects were observed during the test period. Based on measured concentrations, the 96-hourLC50 was greater than 100 mg/L.96-hour LC50 > 100 mg/LDaphnid Ecotoxicity Test:conducted a 48-hour acute toxicity study in water fleas (Daphnia magna) with analog substance (99.91%purity) understatic conditions. This study was reported to follow OECD guideline No. 202, “Daphnia sp., Acute Immobilisation Test” (2004).Following a range-finding study, four replicates of five D. magna were exposed to adjusted ISO medium (control) and test substanceat nominal concentrations of 0, 18, 32, 56 and 100 mg/L. To prepare the test solutions, a 100 mg/L solution was stirred for 21-23hours with a magnetic stirrer to accelerate the dissolving of the test substance in the test medium. The lower test concentrations wereprepared by subsequent dilutions of the test solution in test medium. The final test solutions were all clear and colorless. Over thecourse of the study, temperature ranged from 20.1 to 20.8oC,pH ranged from7.7 to 7.8 and dissolved oxygen was 9.0 mg/L. Testmedium hardness was 180 mg/L. A loading rate of 62.5 daphnids/L was calculated. Test samples collected at 48-hours of anionic andcationic parts of the test substance ranged 95% to 104% relative to the nominal, determined by HPLC-MS analysis (LOD = 0.003mg/L). After 48 hours of exposure, 95% of the daphnids exposed to 100 mg/L were immobilized. At 56 and 32 mg/L percentages ofimmobility was 60% and 65%, respectively.No immobility was observed at or below 18 mg/L. Based on mean measuredconcentrations, the 48-hour EC50 was 38 mg/L.48-hour EC50 = 38 mg/LAlgal Ecotoxicity Test:conducted a 72-hour growth inhibition test in green algae (Pseudokirchneriella subcapitata) with analog substance(99.91%purity) under static conditions. This study was reported to follow OECD guideline No. 201, “Freshwater Alga andCyanobacteria, Growth Inhibition Test” (2006). Following a range-finding study, three replicates of P. subcapitata (1x104 cells/mL)were exposed to test substance at nominal concentrations of 4.6, 10, 22, 46 and 100 mg/L. Concurrently, six replicates of P.subcapitata (1x104 cells/mL) were exposed to M2 medium (control). The algae were illuminated with a light intensity within therange of 73 to 94 μE.m-2.s-1 with constant shaking. To prepare the test solutions, a solution of 100 mg/L was stirred for 19-23hourswith a magnetic stirrer to accelerate the dissolving of the test substance in the test medium. After the stirring period, a floating layerand particles were observed. Therefore, the mixture was left to stabilize for 15 minutes where after the clear and colorless WaterSoluble Fraction (WSF) was taken out. The lower test concentrations were prepared by subsequent dilutions of the WSF in testmedium. The final test solutions were clear and colorless. Initial test concentrations were not expected to be in agreement with thenominal since a floating layer and particles were observed during preparation. However, analysis of the sample shows that theseobservations were not directly related to the test substance. Since no floating layer or particles were present in the control, this featuremay be cause by precipitation of salts in the M2 medium in the presence of the test substance.Note, test substance is also a saltconsisting of an anion and cation. Over the course of the study, temperature ranged from 21.8 to 22.0oC and pH ranged from 8.0to8.3. Dilution water hardness was 24 mg CaCO3/L. The cell density in the control cultures increased by a factor of 186x within 72hours. Test samples collected at 72-hours of anionic and cationic parts of the test substance ranged from 94% to 116% relativeto thenominal, determined by HPLC-MS analysis (LOD = 0.003 mg/L). Based on nominal concentrations, the 72-hour EC50 for growthrate and yield was greater than 100 mg/L and 100 mg/L, respectively. The 72-hour NOEC and LOEC were 46 mg/L and 100 mg/L,respectively. The 72-hour ChV was 67.8 mg/L.72-hour EC50 (growth rate reduction) = > 100 mg/L72-hour EC50 (yield inhibition) = 100 mg/LNOEC = 46 mg/LLOEC = 10072-hour ChV = 67.8 mg/LFactorsValuesCommentsAssessment Factor10Concentration of Concern (ppb)9SARsSAR ClassEcotox CategoryEcotox Factors Comments:SAT Chair:L Keifer 564-8916