### SAT Report PMN Number: P-15-0026 SAT Date: 10/24/2014

Print Date: 4/1/2015

Related cases : Yes Health related cases: Ecotox related cases:

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

Persistence Bioaccum Toxicity Comments 1 11

Exposure Based Review : Health: N o Ecotox: N o
Routes of exposure : Health: Ecotox: All releases to water Fate: ;
Keywords : Keywords: AQUATOX
Summary of Assessment :

Fate : Fate Summary: P-15-0026 FATE: Liquid with MP < 25 °C (E) log Kow = 15.8 (E) S < 0.001 mg/L at 25 °C (E) VP < 1.0E-6 torr at 25 °C (E) BP > 400 °C (E) H = 1.23E-3 (E) log Koc = 9.98 (E) log Fish BCF = 0.50 (E) log Fish BAF = 0.11 (E)POTW removal (%) = 90 via sorption and biodeg; Analog: N
, N -di(hydrogenated tallow-alkyl)- 1,3- p ropanediamine: ISO 11733, OECD 303A (CAS test): >99.999%/63d. Time for complete ultimate aerobic biodeg = wk-mo Sorption to soils/sediments = strong Volatilization half-life from a standard river = 4 hrs Volatilization half-life from a standard lake = 10 da Atmospheric Oxidation Half-life = 0.7 hr via OH radical PBT Potential: P1B1 *CEB FATE: Migration to ground water = slow

Health : Health Summary: Absorption is nil based on physical/chemical properties. N o concerns.

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 * 3.22 without humic acid 62.1 and 74.7 with humic acid daphnid 48-h LC50 * green algal 96-h EC50 * fish

_ chronic value * 0.322 ACR10 daphnid

_ chronic value *

algal

_ chronic value *

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for Aliphatic Amines; SAR chemical class = Aliphatic Amines; MW 579; liquid with BP >500 C (P); log Kow = 15.81 (E); S <0.000001 mg/L at 25 C (P); p H7; effective concentrations based on 100% active ingredients and nominal concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L; low concern for toxicity;

Ecotoxicity Data Results: Case Number: P-15-0026 The test substance information and study summaries below are for an analogous chemical, not the actual PMN substance. Chemical Name: N
, N -di(hydrogenated tallow-alkyl)-1,3- p ropanediamine Trade Name: Duomeen 2HT CAS RN: N ot assignedInitial Submission Review

Fish Ecotoxocity Tests: (1) c onducted a 96-hour acute toxicity test in zebra fish (Danio rerio) with an analog of the PMN substance (p urity: > 90%) under semi-static conditions with 48-hour renewal. This study was reported to follow OPPTS 850.1075 (1996). Following a range -finding test, two replicates of seven D. rerio were exposed to the test substance at nominal concentrations of 4.7, 8.5, 15.4, 27.7 and 50 mg/L. Due to the test animals displaying a higher sensitivity than expected based on the range finding test in the first 48 hours of testing, 2 additional concentrations, 1.45 and 2.61 mg/L, were tested separately to ensure all desired endpoints could be determined and excessive animal use with a repeat test be avoided. Therefore, a total of 7 concentrations were tested (1.45, 2.61, 4.7, 8.5, 15.4, 27.7 and 50 mg/L). The same fish batch and identical test procedures and conditions were used. Based on measurements at 0 and 48 hours (before renewal), corresponding time-weighted mean measured test concentrations were 1.0, 2.4, 3.7, 8.2, 14.2, 26.4 and 47.3 mg/L (66.2 – 97.0% of nominal values); concentrations of 14.2, 26.4 and 47.3 mg /L were based on 0-hour measurements only).

Based on measurements at 48 and 96 hours (after renewal), nominal concentrations of 1.45, 2.61 and 4.7 mg/L corresponded to time-weighted mean measured concentrations of 1.1, 2.2 and 6.4 mg/L (77.2

– 135.8% of nominal values). Analytical monitoring was conducted using an LC-MS/MS method (LOD = 0.34 μg/L; LOQ = 1.14 μg/L). Two replicates of seven D. rerio were exposed to the dilution water control (Dutch Standard Water; DSW) in each of the two
tests.

To prepare the 100 mg/L stock solutions (one for each test), the test substance (0.5 g) was first ultra sonicated in 150 mL of DSW for approximately 8 minutes. Care was taken to avoid excessive heating of the test substance. The stock solution formed was milk white in color. This was then added to 4.5 L of test media under agitation. The beaker used for preparation was filled and sonicated for a second and third time for one minute to remove residue on the glassware. All liquid was transferred to the stock solution flask in the normal manner. The pH of the stock solution was then reduced from 8.8 to 8.2 with HCl. The volume of the stock was then made up to 5 L with DSW to reach the desired concentration. An opaque solution without visible particles was obtained. The stock solutions were then used to prepare the test solutions. All preparation was conducted whilst agitating the media with magnetic stirrers. Aquaria were covered with glass plates and gently aerated during the test. When prepared, the test solutions were slightly turbid with no particles. Slight precipitate was observed in the higher concentrations at 48 hours.

Over the course of testing, temperature ranged from 20.4 – 21.1°C in control vessels, pH ranged from 8.0

– 8.3 and dissolved oxygen ranged from 8.1 – 9.4 mg/L. The dilution water hardness was 74.3 mg/L of CaCO 3; TOC was ≤ 2.0 mg/L. A mean biomass loading rate of 0.54 g fish/L was reported. Mortality was 100% at concentrations ≥ 4.7 mg/L. The percent mortality at 0 (control), 1.45 and 2.61 mg/L was 0, 0 and 7%, respectively. Reduced activity was observed at concentrations of 2.61, 4.7, 8.5 and 27.7 mg/L and loss of equilibrium was observed at 50 mg/L. At 2.61 mg/L, all surviving fish showed reduced activity. Based on nominal concentrations, the96-hour LC50 was 3.22 mg/L. 96-hour LC50 = 3.22 mg/L

(2) conducted a 96-hour acute toxicity test in zebra fish (Danio rerio) with an analog of the PMN substance (p urity: > 90%), mitigated with 20 mg/L humic acid, under semi-static conditions with 48-hour renewal. This study was reported to follow OPPTS 850.1085 (1996). Following a range-finding test, two replicates of seven D. rerio were exposed to a dilution water control (Dutch Standard Water [DSW] and 20 mg/L humic acid) or the test substance at nominal concentrations of 10, 18, 32.4, 58.3 and 104 mg/L. Corresponding initial measured concentrations (based on C16,C18 component) were 10.4, 17.2, 30.8, 60.5, 103.1 and 101.0 mg/L (95.0

– 104.0% of nominal). After the 48-hour renewal, the nominal concentration of 32.4 mg/L corresponded to a measured concentration of 30.1 mg/L. Analytical monitoring was conducted using an LC-MS/MS method. The LOD and LOQ were 0.14 and 0.45 μg/L for the C18,18 component; the LOD and LOQ were 0.15 and 0.52 μg/L for the C18,C16 component; the LOD and LOQ were 0.34 and 1.14 μg/L for the C16,C16 component.

To prepare the 104 mg/L stock solutions, the test substance (0.52 g) was ultra sonicated in 100 mL of DSW for approximately 8 minutes. Care was taken to avoid excessive heating of the test chemical. The stock solution formed was milk white in color. This was then added to 4.5 liters of test media containing 20 mg/L of humic acid under agitation. The beaker used for preparation was filled and sonicated for a second and third time for one minute to remove test substance residue on the glassware. All liquid was transferred to the stock solution flask in the normal manner. Visible reaction with the dissolved humic acid was observed forming a finely dispersed precipitate. The pH of the stock solutions was then reduced from 8.8 to 8.2 with HCl in line with the normal pH of the test media. The volume of the stock was then made up to 5 liters to reach the desired concentration . The stock was used as the highest concentration. Dilutions of the stock solution in freshly prepared DSW test medium containing 20 mg/L humic acid were used to prepare the desired nominal concentrations. All preparation was conducted whilst agitating the media with magnetic stirrers. Aquaria were covered with glass plates and gently aerated during the test. Interaction of the test substance with humic acid was clearly seen in all test replicates during the test period. A brown sediment was formed in all concentrations except the control.

Over the course of testing, temperature ranged from 20.4 – 21.1°C in control vessels, pH ranged from 8.1

– 8.4 and dissolved oxygen ranged from 7.9 – 9.1 mg/L. The dilution water hardness was 74 mg/L of CaCO 3; TOC was ≤ 2.0 mg/L. A loading rate of 0.5 g fish/L was reported. The
p ercent mortality at 0 (control), 10, 18, 32.4, 58.3 and 104 mg/L was 0, 0, 0, 0, 14 and 100%, respectively. Reduced activity was observed in 1 and 3 fish at 58.3 and 104 mg/L, respectively. Based on nominal concentrations, the 96-hour LC50 was 74.7 mg/L. 96-hour LC50 = 74.7 mg/L

(3) conducted a 96-hour acute toxicity test in the common carp (Cyprinus carpio) with an analog of the PMN substance (p urity: > 90%), mitigated by 20 mg/L humic acid, under semi-static conditions with 48-hour renewal. This study was reported to follow OPPTS 850.1085 (1996). Following arange-finding test, two replicates of ten C. carpio were exposed to a dilution water control (Dutch Standard Water [DSW] and 20 mg/L humic acid) or the test substance at nominal concentrations of 14.3, 25.7, 46.3, 83.3 and 150 mg/L. Corresponding initial measured concentrations were 12.5, 21.6, 38.8, 73.3 and 128 mg/L (83.9

– 88.0% of nominal). After the 48-hour renewal, the nominal concentration of 46.3 mg/L corresponded to a measured concentration of 39 mg/L. Analytical monitoring was conducted using an LC-MS/MS method (LOD = 0.26 μg/L, LOQ = 0.88 μg/L).

To prepare the 150 mg/L stock solutions, the test substance (0.750 g) was ultra sonicated in 150 mL of DSW for approximately 10 minutes. Care was taken to avoid excessive heating of the test chemical. After every minute of sonication, the stock was allowed to cool for around 30 seconds. When test substance particles were no longer visible, the power on the ultra sonic mixer was reduced to approximately 50% to prevent overheating. The stock solution formed was milk white in color. This was then added to 4.5 liters of test media containing 20 mg/L of humic acid whilst stirring. Visible reaction with the dissolved humic acid was observed forming a finely dispersed precipitate. The pH of the stock solutions was then reduced from 8.9 to 8.2 with HCl in line with the normal pH of the test media. The volume of the stock was then made up to 5 liters to reach the desired concentration. The stock was used as the highest concentration. Dilutions of the stock solution in freshly prepared DSW test medium containing 20 mg/L humic acid were used to prepare the desired concentration range in the aquaria prior to addition of the test animals. All preparation was conducted whilst agitating the media with magnetic stirrers. Aquaria were covered with glass plates and gently aerated during the test.

Over the course of testing, temperature ranged from 20.55 – 22.15°C in control vessels, p H ranged from 7.8

– 8.2 and dissolved oxygen ranged from 7.0 – 8.9 mg/L. The dilution water hardness was approximately 80 mg /L of CaCO3. A loading rate of 0.7 g fish/L was reported. The percent mortality at 0, 14.3, 25.7, 46.3, 83.3 and 150 mg/L was 0, 0, 0, 0, 100 and 100%, respectively. Sub-lethal effects (surfacing, lying on bottom) were observed at 83.3 and 150.0 mg/L. Based on nominal concentrations, the 96-hour LC50 was 62.1 mg/L. 96-hour LC50 = 62.1 mg/L

submitted three ecotoxicity studies on analog chemical for PMN substance, P-15-0026. EPA considers the submitted analog to be reasonable and acceptable for P-15-0026. Also, the submitted studies are considered to be acceptable. These test results will be used to calculate the concentrations of concern (CoC) for P-15-0026. QSAR values are not used because the values predicted were anomaly.

The acute CoC for P-15-0026 is 640 p pb (3220 p pb÷5(uncertainty factor)), based on the experimentally-derived 96-hour LC50 of zebra fish. The chronic CoC for P-15-0026 is 32 ppb (3220 ppb ÷ ACR of 10, and then another ÷ 10 (uncertainty factor)), based on the experimentally derived 96-h fish study value

. The reason for using this fish chronic value for calculating chronic CoC is that the zebra fish test without the humic acid, the pH level was stable and the values measured were still in environmentally relevant range.Acute CoC = 644 ppb Chronic CoC = 32 ppb

Ecotox Reviewer: October 30, 2014

Factors Values Comments Assessment Factor 10 Concentration of Concern (ppb) 32

SARs Aliphatic Amines SAR Class Aliphatic Amines Ecotox Category

Ecotox Factors Comments:

SAT Chair: