### SAT Report PMN Number: P-14-0341 SAT Date: 3/21/2014 Print Date: 6/4/2014

Related cases : Health related cases: Ecotox related cases :

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 1-2 1

Persistence Bioaccum Toxicity Comments 1 12

Exposure Based Review : Health: Yes Exposure based testing (health): Reproductive/developmental toxicity testing Ecotox: N o Routes of exposure : Health: Drinking Water Inhalation Ecotox: N o releases to water Fate: ; Keywords : Keywords: BLOOD; LIVER (UNCERT); KIDNEY (UNCERT) Summary of Assessment :
Fate : Fate Summary: P-14-0341 FATE: Estimations for typicalPOTW removal (%) = 0-90 via sorption Time for complete ultimate aerobic biodeg = wk-mo Sorption to soils/sediments = low - moderate PBT Potential: P1B1 *CEB FATE: Migration to ground water = slow - moderate

Health : Health Summary: N ot absorbed through the skin as the neat material poor absorption through the skin if in solution, p oor absorption from the GI tract and moderate absorption from the lung ( p che m ). Concern for blood toxicity and uncertain concern for liver and kidney toxicity based on submitted test data. Test Data: (-) Salmonella with and without activation; (-) E. coli with and without activation; (-) for chromosome aberrations in V79 cells with and without activation; rat oral LD0 = 2000 mg/kg; rat dermal LD0 = 2000 mg/kg; no eye irritation in rabbits; no skin irritation in rabbits; (-) for skin sensitization in a mouse local lymph node assay up to 25% ai; rat 28-day oral NOEL = 50 mg/kg, LOEL = 250 mg/kg with effects to the blood, and possibly to liver, and kidney

Ecotox : Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 >100 > 100 daphnid 48-h LC50 >100 > 100 green algal 96-h EC50 >100 > 100 fish

_ chronic value >10 daphnid

_ chronic value >10
algal

_ chronic value >10
Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for Aliphatic Amines-Acids; SAR chemical class = Aliphatic Amines-Acids; with an unknown MP (P); 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: P-14-0341

Fish Ecotoxicity Test :conducted a 96-hour limit test in zebra fish (Brachydanio rerio) with P-14-0341
removable water) under semi-static conditions with daily renewal. This study was reported to follow EU Commission Directive 92/69/EEC, Part C.1 (1992) and the OECD Guideline for Testing of Chemicals No. 203 (1992). Following a range-finding test, single replicates of 7 B. rerio were exposed to a dilution water control (reconstituted water) or the test substance at a nominal concentration of 100 mg/L. Different components of the PMN ( ) in the test medium were quantified and mean measured concentrations of the individual components ranged from 94

–104% of nominal values. The test medium was prepared before the start of the test and prior to each test medium renewal by mixing 501

–505 mg of the test item into 5000 mL test water using ultrasonic treatment and intense stirring at room temperature. Throughout the study period, the test medium appeared clear with no remarkable observations. Over the course of testing, temperature ranged from 21

–22  ̊ C, p H ranged fro m 7.5

–7.9 and dissolved oxygen ranged from 8.3

–8.7 mg/L. Dilution water hardness was 250 mg CaCO3/L. A loading rate of 0.38 g fish/L was reported. All fish survived and no visible abnormalities were observed during the exposure p eriod. Based on nominal concentrations, the 96-hour LC50 was greater than 100 mg/L. This is an acceptable test. 96-hour LC50 > 100 mg/L
Daphnid Ecotoxicity Test: conducted a 48-hour limit test in water fleas (Daphnia magna) with P-14-0341
removable water) under static conditions. This study was reported to follow EU Commission Directive 92/69/EEC, C.2, (1992) and OECD Guideline for Testing of Chemicals, N o. 202 (1984). Following a range-finding test, four replicates of 5 D. magna were exposed to a dilution water control (reconstituted water) or the test substance at a nominal concentration of 100 mg/L. Different components of the PMN ) in the test medium were quantified and mean measured concentrations of the individual components ranged from 88

–99% of nominal values. The test medium was prepared immediately before the start of the test by mixing 50.2 mg of the test item into 500 mL test water using ultrasonic treatment and intense stirring at room temperature. The beakers were covered with glass plates to reduce the loss of water and to avoid the entry of dust into the solutions. The test medium appeared to be a clear solution throughout the test duration. At the start of the test, a few fine particles were observed. Over the course of testing, temperature ranged from 20

–21  ̊ C, p H ranged fro m 7.4

–7.9 and dissolved oxygen ranged from 8.6

–9.2 mg/L. Dilution water hardness was 250 mg CaCO3/L. A loading rate of 100 daphnids/L was calculated. N o immobilization was observed during the test period. Based on nominal concentrations, the 48-hour EC50 was greater than 100 mg/L. This is an acceptable test. 48-hour EC50 > 100 mg/L
Algal Ecotoxicity Test: conducted a 72-hour limit test in green algae (Scenedesmus subspicatus) with P-14-0341 not removable water) under static conditions . This study was reported to follow EUCommission Directive 92/69/EEC, C.3 (1992) and OECD Guideline for Testing of Chemicals, N o. 201 (1984). Following a range-finding test, three replicates of S. subspicatus (1 x 104 cells/mL) were exposed to the test substance at a nominal concentration of 100 mg/L. Different components of the PMN ) in the test medium were quantified and mean measured concentrations of the individual components ranged from 82

–103% of nominal values. Additionally, six replicates of S. subspicatus were exposed to a dilution water control. The algae were illuminated at a light intensity ranging from 8010

–8910 lux with continuous stirring. The test medium was prepared immediately before the start of the test by mixing 60.3 mg of the test item into 600 mL test water using ultrasonic treatment and intense stirring at room temperature. The flasks were covered with glass dishes. The test medium appeared to be a clear solution throughout the test duration. Over the course of testing, temperature ranged from 22

–23  ̊ C and p H ranged fro m 7.7

–8.4. Dilution water hardness was 24 mg CaCO3/L. The cell density in control cultures increased by a factor of 57 within 72 hours. There was no inhibitory effect of the test substance on S. subspicatus during the exposure period. Based on nominal concentrations, the 72-hour EC50 was greater than 100 mg/L for both biomass and growth rate. The 72-hour NOEC and LOEC values were 100 mg/L and > 100 mg/L, respectively. This is an acceptable test. 72-hour EC50 (biomass and growth rate) > 100 mg/L 72-hour NOEC (biomass and growth rate) = 100 mg/L 72-hour LOEC (biomass and growth rate) > 100 mg/L
(sponsor) submitted three ecotoxicity studies on P-14-0341. The studies were considered acceptable and will be used to calculate the concentrations of concern (COC) for P-14-0341. For comparative purposes, the QSAR- p redicted acute fish, acute Daphnia, and algae L/EC50s for P-14-0341 are > 100 mg/L, > 100 mg/L, and > 100 mg/L, respectively. The p redicted chronic values for fish, Daphnia, and algae are > 10 mg/L, > 10 mg/L, and > 10 mg/L, respectively. The acute COC for P-14-0341 is 20,000 p pb (100,000 p pb / 5 (uncertainty factor)), based on the experimentally-derived 96-hour LC50 for fish. The chronic COC for P-14-0341 is 1,000 p pb (10,000 p pb / 10 (uncertainty factor)), based on the experimentally-derived 96-hour LC50 for fish and an acute to chronic ratio of 10.

Acute COC = 20,000 p pb Chronic COC = 1,000 p pb

Ecotox Reviewer: J. Gallagher Date: 3/24/2014
Factors Values Comments Assessment Factor Concentration of Concern ( p pb) 1000

SARs SAR ClassEcotox Category
Ecotox Factors Comments:
SAT Chair: L Keifer 564-8916