SAT Report

PMN Number: P-13-0722

SAT Date: 7/26/2013

Print Date: 8/30/2013

Related cases:Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 3

 Persistence Bioaccum Toxicity Comments

3 1 2 Anion2 1 1 Cation

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ; Anion rapid; Cation slow

P2Rec Comments:

Comment: P2REC: SAT: Forward
Keywords:

 Keywords: LUNG; LIVER; ACUTE; AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-13-0722

FATE: 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 202 

log 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 slow

 Health:

 Health Summary: Not absorbed from the skin, absorbed from the lung (pchem), moderate ab

tract (Test data). Concern for liver toxicity for the anion based on (rat 28-day NOEL = 1.67 mg/kg); l
interference 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 da

: (-) Salmonella with and without activation; (-) E. coli with and without activation; (-) for chromosom

human lymphocyte assay with and without activation; oral ADME study: 62% excreted in urine in 96 h; rat oral mg/kg; no skin irritation in rabbits; no eye irritation in rabbits; (-) for skin sensitization in a mouse local lymph nai

 Ecotox:

Test Organism Test Type Test End Point Predicted Measured C

fish 96-h LC50 35.4

daphnid 48-h LC50 1.2

green algal 96-h EC50 0.48

fish 

_

chronic value 3.5

daphnid

_

chronic value 0.12

algal 

_

chronic value 0.088

Sewage Sludge 3-h EC50

_

Sewage Sludge

_

Chronic Value

_

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

 MW 483 with 100% < 1000 and 90% < 500; liquid; S = 1,900 mg/L at 25 C 

concentrations based on 100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as C<2.0 mg/L;*Based on the presence of substitution, substitutions, and a longer alkyl substitution oEPA identified analog that is most similar to the PMN, EPA concluded that data for is thanalog. Submitted analog data are summarized below, but not incorporated into the ecotoxicity profile for P-13-0-----------------------------------------------------------------------------------------------------------------------------------Ecotoxicity Test Data Results for P-13-0722: 
Three acute ecotoxicity studies were conducted on an analog of PMN (P-13-0722) in laborator

and algae. EPA classified the PMN as a . Submitter provided analog data was for

classified as a EPA identified 

as the SAR Nearest Analog; this substance is also a 

presence of substitution, substitutions, and a longer alkyl substitution on the nitrogen analog that is most similar to the PMN, EPA concluded that data for is the most appropriate analog. Sare 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 

under static conditions. This study was reported to follow OECD guideline No. 203, “Fish Acute Toxicity Test” range-finding study, singe replicates of seven D. rerio were exposed to adjusted ISO medium (control) and test sconcentrations of 100 mg/L. To prepare the test solutions, a solution of 100 mg/L was stirred for 21-24 hours witto accelerate the dissolving of the test substance in the test medium. The final test solutions were all clear and cocourse of the study, temperature ranged from 21.1 to 22.5oC, 

pH ranged fro

m 7.4 to 7.9 and dissolved oxygen ran

mg/L. Test medium hardness was 180 mg CaCO3/L. A loading rate of 0.25 g fish/L was calculated. Test sample96-hours of anionic and cationic parts of the test substance were 105% relative to nominal, determined by HPLC0.003 mg/L). 

No mortalities or clinical effects were observed during the test period. Based on measured concent

LC50 was greater than 100 mg/L.96-hour LC50 > 100 mg/L Daphnid Ecotoxicity Test:

conducted a 48-hour acute toxicity study in water fleas (Daphnia magna) with analog substance (9

static conditions. This study was reported to follow OECD guideline No. 202, “Daphnia sp., Acute ImmobilisatioFollowing a range-finding study, four replicates of five D. magna were exposed to adjusted ISO medium (controat nominal concentrations of 0, 18, 32, 56 and 100 mg/L. To prepare the test solutions, a 100 mg/L solution was hours with a magnetic stirrer to accelerate the dissolving of the test substance in the test medium. The lower test prepared by subsequent dilutions of the test solution in test medium. The final test solutions were all clear and cocourse of the study, temperature ranged from 20.1 to 20.8oC, 

pH ranged fro

m 7.7 to 7.8 and dissolved oxygen wa
medium hardness was 180 mg/L. A loading rate of 62.5 daphnids/L was calculated. Test samples collected at 48

cationic parts of the test substance ranged 95% to 104% relative to the nominal, determined by HPLC-MS analysmg/L). After 48 hours of exposure, 95% of the daphnids exposed to 100 mg/L were immobilized. At 56 and 32 mimmobility was 60% and 65%, respectively. 

No immobility was observed at or below 18 mg/L. Based on mean m

concentrations, 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 a

(99.91% 

purity) under static conditions. This study was reported to follow OECD guideline No. 201, “Freshwate

Cyanobacteria, Growth Inhibition Test” (2006). Following a range-finding study, three replicates of P. subcapita

were exposed to test substance at nominal concentrations of 4.6, 10, 22, 46 and 100 mg/L. Concurrently, six replsubcapitata (1x104 cells/mL) were exposed to M2 medium (control). The algae were illuminated with a light interange of 73 to 94 μE.m-2.s-1 with constant shaking. To prepare the test solutions, a solution of 100 mg/L was stiwith a magnetic stirrer to accelerate the dissolving of the test substance in the test medium. After the stirring periand particles were observed. Therefore, the mixture was left to stabilize for 15 minutes where after the clear and Soluble Fraction (WSF) was taken out. The lower test concentrations were prepared by subsequent dilutions of thmedium. The final test solutions were clear and colorless. Initial test concentrations were not expected to be in agnominal since a floating layer and particles were observed during preparation. However, analysis of the sample sobservations were not directly related to the test substance. Since no floating layer or particles were present in thmay be cause by precipitation of salts in the M2 medium in the presence of the test substance. 

Note, test substanc

consisting of an anion and cation. Over the course of the study, temperature ranged from 21.8 to 22.0oC and pH r8.3. Dilution water hardness was 24 mg CaCO3/L. The cell density in the control cultures increased by a factor hours. Test samples collected at 72-hours of anionic and cationic parts of the test substance ranged from 94% to nominal, determined by HPLC-MS analysis (LOD = 0.003 mg/L). Based on nominal concentrations, the 72-hour rate and yield was greater than 100 mg/L and 100 mg/L, respectively. The 72-hour NOEC and LOEC were 46 mrespectively. The 72-hour ChV was 67.8 mg/L.72-hour EC50 (growth rate reduction) = > 100 mg/L72-hour EC50 (yield inhibition) = 100 mg/L

NOEC = 46 mg/L

LOEC = 100
72-hour ChV = 67.8 mg/L 

Factors Values Comments

Assessment Factor 10

Concentration of Concern (ppb) 9

SARs

SAR Class

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916