### SAT Report

PMN Number: P-14-0563

SAT Date: 5/28/2014

Print Date: 4/1/2015

Related cases : Yes
Health related cases: Ecotox related cases: Analogs: On TSCA: 61791-10-4, 68071-95-4

Concern levels :

Type of Concern: Health Eco Comments
Level of Concern: 1-2 3

Persistence Bioaccum Toxicity Comments

1 11

Exposure Based Review : Health:

Ecotox: N o

Routes of exposure : Health: Dermal Drinking Water Inhalation

Ecotox: All releases to water

Fate: ;

P 2 Rec Comments : Comment: Forward without comments

Keywords : Keywords: LUNG, IRR-MM/L/E/S, DEV, SENS-S, ACUTE; AQUATOX

Summary of Assessment :

Fate : Fate Summary: P-14-0563
FATE: MW = 877 with 14% < 500 and 91% < 1000 Liquid with MP < 25 C (E) S = Disp. VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E)H < 1.00E-8 (E) POTW removal (%) = 90 via sorption an biodeg; Analog: CAS 863679-20-3: OECD

N S(Closed Btl): 63%/28d; Analog: CAS 863679-20-3: OECD 303A(cont. activ. sludge test): < 30.3 mg/L. Time for complete ultimate aerobic biodeg = wk Sorption to soils/sediments = v.strong
PBT Potential: P1B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption is poor from the skin, moderate from the GI tract, and good from the lung (analog). Concern for surfactant effects on the lung; irritation to skin (chronic), mucous membranes and lung based on surfactant properties. Concerns for developmental toxicity based on quaternary amines and by analogy to C8-C10 alkyl (hydroxyethyl)dimethylammonium chloride which caused the death of 3 of 25 dams, reduced maternal weight gain and induced delayed ossification at 100 mg/kg with a NOEL of 50 mg/kg (8e-14928). There also are concerns for eye irritation and dermal sensitization based on submitted analogue test data, and for acute toxicity based on submitted analogue test data.

Test Data: Analogue Test Data for Ethoquad 1MCD/25:

LD50 ˃ 300 and ˂ 2000 mg/kg in female rats

Positive for eye irritation in rabbits.

Modified Local Lymph Node Assay (LLNA) Challenge Experiment– EPA reviewer concluded that this assay uses a non-guideline modified LLNA that has not been validated. These results cannot be used to make a conclusion concerning sensitization.

Local Lymph Node Assay (LLNA) in Mice (Identification of Contact Allergen): EPA reviewer concluded that assay results show that Ethoquad IMC/25 is a skin sensitizer.

Ecotox :

Test Organism Test Type Test End
Point Predicted Measured Comments

fish 96-h LC50 35.4 29 analog daphnid 48-h LC50 1.2 2.58 PMN green algal 96-h EC50 0.48 0.39 analog

fish

_ chronic value 3.5 daphnid

_ chronic

value 0.12 0.26 analog

algal

_ chronic

value 0.088 0.072 analog

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic

_Value

Ecotox Values Comments:

Predictions are based on SAR-nearest analog method for cationic surfactants-quaternary ammonium ( ); SAR chemical class = surfactant-cationic-quaternary ammonium-C13; MW302; liquid with unknown mp (P); S = dispersible (P); p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Ecotoxicity Test Data Results
Case Number: P-14-0563 Chemical Name: Quaternary ammonium compounds, C12-14-alkyl(hydroxyethyl)dimethyl, ethoxylated chlorides

CAS RN: 1554325-20-0
Trade Name: Berol R648 NG
Initial Data Review

Invertebrate Ecotoxicity Test : (1) conducted a 48-hour toxicity test in water fleas (Daphnia magna) with P-14-0563 (approx. 60% p urity) under static conditions. This study was reported to follow OECD guideline No. 202 (2004) and Method C.2 of Council Regulation (EC) N o. 440/2008. Following a preliminary test, four replicates of five D . magna were exposed to a dilution water control (Dutch Standard Water) and the test substance at nominal concentrations of 0.25, 0.56, 1.2, 2.7 and 6.0 mg/L. Chemical analysis demonstrated that test substance remained stable throughout the test. Corresponding mean measured concentrations of 0.22, 0.51, 1.1, 2.5, 5.6 mg/L were determined via LC-MS/MS analysis (LOD = 0.37 μg/L). A stock solution of 109 mg/L of the test substance was prepared by adding 0.0109 g of test substance to approximately 80 mL of test media. The solution was then sonicated for 1 minute. A clear homogeneous stock solution was achieved. This solution was then made up to 100 mL with the test media and used to generate the nominal test concentrations. The stock was continually stirred during use. All vessels were covered by glass plates during the test. Over the course of the study, temperature ranged from 19.7-21.05oC, pH ranged from 8.0-8.3 and dissolved oxygen ranged from 9.0-9.1 mg/L. Dilution water hardness was 212 mg CaCO3/L and TOC was ≤ 2.0 mg/L. A loading rate of 100 daphnids/L was calculated. Measured concentrations were 88-93% of nominal at 0 hours and 88-96% of nominal at 48 hours. Percent immobility at 0 (control), 0.25, 0.56, 1.2, 2.7 and 6.0 mg/L was 0, 0, 0, 0, 55 and 100%, respectively. Based on nominal concentrations, the 48-hour EC50 was 2.58 mg/L. 48-hour EC50 = 2.58 mg/L

(2) conducted a 10-day toxicity test in marine crustaceans (Corophium volutator) with P-14-0563 ( p urity not specified) under unspecified test conditions. This study was reported to follow OSPARCOM guidelines (2006) Part A: “A sediment bioassay using an amphipod Corophium sp.” Three replicates of twenty C. volutator were exposed to the testsubstance at nominal wet weight concentrations of 10, 100, 320, 1000 and 10000 mg/kg. Corresponding nominal dry weight concentrations were 13.96, 139.42, 446.23, 1394.68 and 13945.34 mg/kg, respectively. The wet to dry ratio of sediment used in this study was 1.39 and this was used to correct nominal wet sediment concentrations to nominal dry sediment concentrations. Additionally, five control replicates of twenty C. volutator were tested concurrently. The test substance was characterized as soluble and therefore dissolved in a small quantity of sea water (UV sterilized and filtered to 1 ìm) and added directly to the mixing container, containing the wet sediment. The mixing vessels were then placed on a platform shaker at approximately 150 rpm for 3 hours. After this period, the contents of each container were equally distributed between the replicate vessels. Tests were conducted in 1 liter capacity glass beakers each containing 2 cm depth (approximately 150 mL) of amended sediment and 850 mL of overlying seawater (1 ìm filtered ultra violet treated seawater). Test vessels were covered with a rectangular sheet of perspex perforated with a small hole above the center of each beaker. Aeration was provided and a stream of air bubbles was released at a depth of approximately 6 cm. Over the course of the study, temperature ranged from 13.8-15.5oC, pH ranged from 7.88-8.10, dissolved oxygen ranged from 90-99% and salinity ranged from 36-44 p pt. On day 5, salinities 5p pt above the day 0 level were recorded in multiple vessels (at the concentration of 320 mg/kg); however, as no unusual effects in the animals were observed at the time or at Day 10, this was deemed to have had no effect on the test result. Percent mortality at 0 (control), 13.96, 139.42, 446.23, 1394.68 and 13945.34 mg/kg was 7, 10, 15, 13, 78 and 100%, respectively. Based on nominal dry weight concentrations, the 10-day LC50 was 1027.62 mg/kg. The 10-day NOEC and LOEC values were 446.23 and 1394.68 mg/kg (dry weight), respectively. This study is considered to be unacceptable. 10-day LC50 = 1027.62 mg/kg (dry weight) 10-day NOEC = 446.23 mg/kg (dry weight) 10-day LOEC = 1394.68 mg/kg (dry weight)

The test substance information and study summaries below are for an analogous chemical, not
the actual PMN substance. Chemical Name: Quaternary ammonium compounds, coco alkyl (hydroxylethyl) dimethyl, ethoxylated, chlorides

CAS RN: 863679-20-3 Trade Name: Berol R648, Ethoquad IMC1214/25, Ethoquad MC 1214/25

Fish Ecotoxicity Test: (1) conducted a 96-hour toxicity test in zebra fish (Danio rerio) with an analog of the PMN substance (82% p urity) under static conditions. This study was reported to follow OECD guideline No. 203 (1992) and EEC Directive 79/831, Annex V, p art C.1 (1989). Following a range-finding study, single replicates of seven D. rerio were exposed to a dilution water control (Dutch Standard water (DSW) medium) or the test substance at nominal concentrations of 6.25, 12.5, 25, 50 and 100 mg/L. Mean measured concentrations at 0, 6.25, 25 and 100 mg/L were < 0.1, 6.3, 26.3 and 103.5 mg/L respectively, as determined by LCMS analysis (LOD = 0.02 mg/L). To prepare the stock solution, a measured amount of 0.9999 g of test substance was transferred into a 1 L volumetric flask which was filled with testmedium. The stock solution was then diluted into freshly prepared test medium in order to obtain the desired nominal concentrations. Test vessels were covered with glass plates during the test. Over the course of the study, temperature ranged from 22.9-23.1oC, pH ranged from 7.8-8.1 and oxygen saturation ranged from 8.1-8.6 mg /L. The TOC content of the dilution
medium was ≤2.0 mg/L. An average biomass load of 0.32 g/L was reported. The results of the chemical analyses showed that the concentration of the test compound during the test remained within 80% of the concentration at the beginning of the test. A decrease of < 4% of test substance concentration during the 96 hours of testing was observed. Percent mortality at 0 (control), 6.25, 12.5, 25, 50 and 100 mg/L was 0, 0, 0, 0, 100 and 100%, respectively. Animals exposed to test concentrations of 50 and 100 mg/L exhibited sublethal effects including surfacing and lying on the bottom of the test vessel. Based on nominal concentrations, the 96-hour LC50 was 35.36 mg/L. 96-hour LC50 = 35.36 mg/L (82% trimethylalkyl amine ammonium salt) 96-hour LC50 = 29 mg/L (After correction to 100% active ingredient (a.i.))

(2) conducted two 96-hour acute effluent toxicity bioassay tests in rainbow trout (Oncorhynchus mykiss) with an analog of the PMN substance ( purity not specified). The first test used effluent water collected from a fundraiser car wash event at a
commercial automotive service location. The second test used a simulated effluent solution containing a consumer car wash detergent. The simulated effluent solution was formulated according to the product label directions with dilution that mimicked a car wash effluent. These tests are termed “practical” fish toxicity tests because the effluent solutions for both were collected or prepared such that each represented the actual runoff water that would be expected to enter into storm water drains and, eventually, the streams and rivers of Puget Sound. Both tests were conducted according to standard protocols specified in “Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms” (EPA-821-R-02-012). In the first test (with car wash effluent), four replicates of ten O. mykiss were exposed to a standard 0.5 dilution series consisting of 6.25, 12.5, 25, 50 and 100% car wash effluent water diluted with potable water. Potable water was also used to run a laboratory control test. In the second test (with simulated effluent), four replicates of ten O. mykiss were exposed to a concentration series of 0.01, 0.05, 0.1, 0.5, 1 and 10% simulated effluent (laboratory- p repared effluent sample) solution diluted with potable water. Potable water was also used to run a laboratory control test. There were significant differences in the way the stock water solutions for the two tests were prepared. For the first test, runoff water was collected from the parking lot of an automotive service facility during a fund-raising event. This water ran across approximately 30 feet of asphalt before collection and likely included contact with petroleum hydrocarbons and the grit and grime typically associated with a heavily traveled asphalt lot. Approximately 15 gallons of this water was sampled and delivered “as collected” to the laboratory. For the second test, the same detergent concentrate that was used for the car wash event was used by the laboratory to prepare a simulated effluent for testing. This simulated effluent was mixed according to instructions on the product container and was further diluted to simulate addition of rinse water. All water used in the second test was potable. Over the course of study 1, temperature ranged from 14.1-16.0oC, pH ranged from 6.7-8.3 and dissolved oxygen saturation ranged from 5.2-8.4%. Dilution water hardness was 99 mg/L as CaCO3. Over the course of study 2, temperature ranged from 10.6-11.7oC, pH ranged from 7.6-9.3 and dissolved oxygen saturation ranged from 8.5-11.6%. Dilution water hardness was 62 mg/L as CaCO3. Intest 1, p ercent mortality at 0 (control), 6.25, 12.5, 25, 50 and 100% concentrations was 0, 100, 100, 100, 100 and 100%, respectively. In test 2, p ercent mortality at 0 (control), 0.01, 0.05, 0.1, 0.5, 1 and 10% concentrations was 0, 0, 0, 0, 0, 2.5 and 100%, respectively . Based on nominal concentrations, the 96-hour LC50 in test 1 was 3.125%. In test 2, the 96-hour LC50 was 3.046%, which equates to a detergent concentrate concentration of approximately 1.6 ppm. Because the car wash effluent used in the first toxicity test was generated in an uncontrolled manner it is not possible to make conclusive remarks about the LC 50 results of the toxicity test. This is because the amount of detergent and water used was not measured; hence, detergent concentrations in the dilution series were not known. Also, no chemical analyses were performed to determine petroleum hydrocarbon or metals concentrations in the effluent. Nevertheless, the effluent water sample was collected from an actual fund-raising car wash event and the effluent water represented an actual potential impact to a local stream. On the other hand, the laboratory- prepared simulated effluent solution used in the second fish toxicity test used measured quantities of detergent and water, which allowed exact calculation of detergent
concentrations in the dilution series water. Uncertainties associated with this test include lack of exposure to a petroleum-contaminated asphalt parking lot and lack of exposure to grime from a dirty car. This study is considered to be unacceptable. 96-hour LC50 (test 1) = 3.125% 96-hour LC50 (test 2) = 3.046% (~ 1.6 ppm)

Invertebrate Ecotoxicity Test: (1) conducted a 48-hour toxicity test in water fleas (Daphnia magna) with an analog of the PMN substance (82% p urity) under static conditions. This study was reported to follow OECD guideline No. 202 (2004) and Directive 67/548/EEC, Annex V, p art C.2 (1989). Following a range-finding test, four replicates of five D. magna were exposed to a dilution water control (Dutch Standard Water (DSW ) medium) and the test substance at nominal concentrations of 0.2, 0.4, 0.8, 1.6 and 3.22 mg/L. The mean measured concentrations at 0 (control), 0.2, 0.8 and 3.2 mg/L were < 0.1, 0.165, 0.783 and 3.25 mg/L, respectively, as determined by LCMS analysis (LOD = 0.02 mg/L). A stock solution of 1.004 g/L was prepared by loading 0.1004 g of test substance, weighed out on an analytical balance, in
a 100 mL volumetric flask. The flask was filled with test medium. The stock solution was then manually shaken until a homogenous solution was obtained. The stock solution was then diluted into freshly prepared test medium in order to obtain the desired nominal concentrations. Test vessels were covered by glass plates during the test. Over the course of the study, temperature ranged from 20.25-20.40oC, pH ranged from 7.7-8.2 and dissolved oxygen ranged from 8.9-9.2 mg/L. The NPOC (non purgable organic carbon) content in the dilution water was ≤ 2.0 mg/L. A loading rate of 100 daphnids/L was calculated. The results of the chemical analyses show that the concentration of the test compound during the test remained within 80% of the concentration at the beginning of the test. A decrease of < 6% of test substance concentration during the 48 hours of testing was observed. Sub-lethal effects, such as floating at the surface, were not observed in the test concentrations where no immobility was observed. Percent immobilization at 0 (control), 0.2, 0.4, 0.8, 1.6 and 3.2 mg/L was 0, 0, 0, 5, 85 and 100%, respectively. Based on nominal concentrations, the 48-hour EC50 was 1.21mg/L. 48-hour EC50 = 1.21 mg/L (82% trimethylalkyl amine ammonium salt) 48-hour EC50 = 1 mg/L (After correction to 100% a.i.)(2) conducted a 21-day reproduction test in water fleas (Daphnia magna) with an analog of the PMN substance (50.8% p urity) under semi-static conditions with renewal at least three times per week to ensure constant exposure to
the test chemical . This study was reported to follow OECD test guideline No. 211 (2008) and OPPTS guideline 850.1300 (1996). The test was carried out using natural surface water originating from a protected natural spring with a naturally low Dissolved Organic Carbon (DOC) and Total Suspended Solids (TSS) content, allowing a more environmentally realistic determination of the effects of the test chemical to be made. Following a preliminary range-finding study, ten replicates of one D. magna were exposed to a blank control (natural surface water with standard Elendt M4 media vitamins) or the test substance at nominal concentrations of 0.09, 0.19, 0.36, 0.75 and 1.5 mg/L. Corresponding time weighted mean measured concentrations of 0.07, 0.15, 0.29, 0.64 and 1.335 mg/L were determined via LC-MS/MS analysis.

To prepare the stock solutions for every water renewal, approximately 0.010 g of test substance was weighed on an analytical balance into a 100 ml volumetric flask. Then 100 mL of test media was added. The stock solution was stirred at a moderate speed (so as not to produce excessive foam) for at least 30 minutes. The test chemical was found to be readily soluble and a clear homogenous stock solution was achieved. A fresh stock solution was prepared in this manner for each solution change. The pH of each stock solution was checked and found to be consistently 7.85 – 8. 0 and was therefore not adjusted. Test solutions were prepared by further
dilution of the stock solution with the test medium to achieve the desired test concentrations. Beakers were covered by glass plates during the test

.

Over the course of the study, temperature ranged from 19.8-20.2oC, pH ranged from 7.4-9.2 and dissolved oxygen ranged from 7.6-11.9 mg/L. Dilution water hardness was < 17.8 mg CaCO3/L and NPOC (non purgable organic carbon) content was 2.5 mg/L. In the 0 (control), 0.09, 0.19, 0.36, 0.75 and 1.5 mg/L test groups, the number of parent daphnids that died during testing were 1, 0, 0, 1, 1 and 9, respectively.. The recommended guideline criteria for the coefficient of variation of control fecundity (less than 25% in the control based on the number of living neonates for each parent animal surviving at the end of the test) was achieved. There were no statistically significant effects on reproduction. On day 9 in the 0.75 mg/L replicate dead neonates were observed. This was limited to day 9 only and the dead neonates were not used in the neonate counts for the reproduction endpoint. This was likely to be a physical rather than toxic effect as the juveniles were observed stuck together at the bottom of the test vessel covered in algae debris. The same situation was observed on days 14 and 16 in the 1.5 mg/L replicate. The time to first brood occurred in all test concentrations between day 7 and 9. The test
substance is therefore considered to have had no effect on the time to first brood at all concentrations. Initial analytical recovery in the stock solutions and all test concentrations were consistently higher than 80% of the nominal values, demonstrating sufficient initial dosing of the test chemical. The old solutions prior to refreshment did fall in some cases to below 80% of the nominal concentrations. The parallel replicates demonstrated that this was not due lack of substance stability but due to adhesion to the algae and hence the associated difficulties with analysis. It was concluded that due to the stability of the test chemical and the fact the testsubstance associates strongly with the food eaten by the test organisms, that exposure to the test chemical was maximized as far as was possible. Nominal concentrations were therefore used for endpoint calculations. Based on nominal concentrations , the 21-day EC50 for reproduction was 1.64 mg/L. The 21-day NOEC and LOEC values for reproduction were 0.75 and 1.5 mg/L, respectively. The 21-day NOEC and LOEC values for length and weight were 0.36 and 0.75 mg/L, respectively. A ChV of 1.1 mg/L was calculated for reproduction and a ChV of 0.52 mg/L was calculated for adult length and weight. 21-day EC50 (reproduction) = 1.64 mg/L 21-day NOEC (reproduction) = 0.75 mg/L 21-day LOEC (reproduction) = 1.5 mg/L 21-day ChV (reproduction) = 1.1 mg/L

21-day NOEC (adult length and weight) = 0.36 mg/L 21-day LOEC (adult length and weight) = 0.75 mg/L 21-day ChV (adult length and weight) = 0.52 mg/L

Algal Ecotoxicity Test: conducted a 72-hour toxicity test in fresh water green algae (Pseudokirchneriella subcapitata) with an analog of the PMN substance (82% p urity) under static conditions. This study was reported to follow OECD guideline No . 201 (2006), EEC (1992) and ISO 8692 (1989). Following a preliminary range-finding study, three replicates of P. subcapitata (1 x 104 cells/mL) were exposed to the test substance at nominal concentrations of 0.0625, 0.125, 0.25, 0.5 and 1.0 mg/L. Mean measured concentrations at 0.0625, 0.25 and 1.0 mg/L were 0.03, 0.2 and 1.0 mg/L, respectively, as determined by LCMS analysis (LOD = 0.02 mg/L). Additionally, six replicates of P. subcapitata were exposed to a blank medium control under similar conditions. The algae were illuminated at a light intensity within the range of 102-103 μmol/m2/s with constant shaking. A stock solution of 1 g/L was prepared by loading 0.1022 g of test substance, weighed out on an analytical balance, into a 100 mL volumetric flask which was filled with deionized water. This solution was mechanically stirred until a homogenous solution of about 1 g/L was obtained. This stock solution was diluted 100 times by transferring 2.446 mL into a 250 mL volumetric flask using a pipette. The volumetric flask was filled up to about 75% with deionized water and then concentrated OECD medium salt solutions were added. The flask was then filled up with deionized water obtaining a 10 mg/L stock solution in OECD medium. Test solutions were prepared by further dilution of the stock
solution with the test medium to achieve the desired test concentrations. The test flasks were closed with cotton-wool stoppers. Over the course of the study, temperature ranged from 23.25-23.50oC and pH ranged from 8.0-8.8. Dilution water hardness was 212 mg CaCO3/L and

TOC was ≤ 2.0 mg/L. The results of the chemical analyses show a decrease of the test substance of 11-30% during the test. This decrease is most likely due to the adsorption of the test substance to the algae. The algae were thus fully exposed to the initial concentration during the whole test
and this initial concentration deviated less than 10% from the nominal test substance concentration at 0.25 and 1 mg/L. The mean cell density in the control cultures increased by a factor of 100 within 72 hours. Based on nominal concentrations, the 72-hour EC50 for biomass and growth rate was 0.48 and 1.90 mg/L, respectively. The 72-hour NOEC and LOEC values were 0.0625 and 0.125 mg/L, respectively, for biomass and growth rate. A ChV of 0.0884 mg/L
was calculated.72-hour EC50 (biomass) = 0.48 mg/L (82% a.i.) 72-hour EC50 (biomass) = 0.39 mg/L (100% a.i.)

72-hour EC50 (growth rate) = 1.90 mg/L (82% a.i.) 72-hour EC50 (growth rate) = 1.56 mg/L (100% a.i.)

72-hour NOEC (biomass and growth rate) = 0.0625 mg/L 72-hour NOEC (biomass and growth rate) = 0.051 mg/L (100% a.i.)

72-hour LOEC (biomass and growth rate) = 0.125 mg/L 72-hour LOEC (biomass and growth rate) = 0.103 mg/L (100% a.i.)

72-hour ChV (biomass and growth rate) = 0.088 mg/L 72-hour ChV (biomass and growth rate) = 0.072 mg/L (100% a.i.)

submitted several ecotoxicity studies (two on actual PMN substance, P-14-0423 and five on an analogous chemical: Quaternary ammonium compounds, coco alkyl (hydroxylethyl) dimethyl, ethoxylated, chlorides with CAS RN: 863679-20-3). The daphnia’s study on PMN (P-14-0563) is considered to be acceptable. However, a 10-day toxicity test in marine crustaceans (Corophium volutator) with PMN is not acceptable based on the following information: 1) chemical purity was not specified; 2) under unspecified test conditions; and 3) lack of study details reported.

For studies submitted on the analogous chemical with CASRN 863679-20-3 are: 1) This analog chemical is acceptable; 2) The studies are considered to be acceptable, except the “Practical” Fish Toxicity Test Report.

These test results will be used to calculate the concentrations of concern (COC) for P-14-563. For comparative purposes, the QSAR- predicted acute and chronic fish, Daphnia, and algae values for P-14-0563 are 35.4 mg/L, 1.2 mg /L, and 0.48 mg/L, respectively. The predicted chronic values for fish, Daphnia, and algae are 3.5 mg/L, 0.12 mg/L, and 0.088 mg/L, respectively. The acute COC for P-14-0563 is 98 p pb (390 p pb / 4 (uncertainty factor)), based on the experimentally-derived 72-hour EbC50 of green algae. The chronic COC for P-14-0563
is 2 p pb (22 p pb / 10 (uncertainty factor)), based on the experimentally-derived 72-hour chronic algal value.

Acute COC = 98 p pb
Chronic COC = 2 ppb

Ecotox Reviewer:
Date: 06/03/2014The objective of this memorandum is to address the differences of the concentrations of concerns (CoCs) between P-14-0563 and when both cases used the same ecotoxicity data
submitted to EPA from

Background In the PMN submission of P-14-0563, analog data were submitted to be used to assess the PMN along with PMN data. The analog, quarternary ammonium compound; coco alkyl (hydroxyethyl) dimethyl, ethoxylated, chloride (CASRN: 863679-20-3), was identified as

Concerns for ecotoxicity were determined from submitted acute aquatic invertebrate test data on P-14-0563. Additionally, a chronic CoC of 7 ppb was determined from a 72-hour algal study for the analog CASRN 863679-20-3. Surface water concentrations (7Q10 values) exceeded the CC for more than 20 days for several PDM ( p robabilistic dilution model) scenarios for processing and use indicating a chronic toxicity risk. Because the PMN material is predicted to sorb strongly to soil, the FOCUS decision was to request a fish acute test mitigated with humic acid (OPPTS 850.1085). In addition, the submitter was also requested to conduct a fish early-life stage test (OPPTS 850.1400) and the chronic daphnia test (850.1300). Below is the hazard profile generated from ECOSAR (v. 0.99g) and included P08-0418 toxicity:

Summary

For , it appears that the chronic green algae value was not available or included in its assessment. Thus, the value used for final concern concentration was the chronic daphnid’s value. A fish acute toxicity test mitigated by humic acid was submitted and evaluated for the submission, establishing a mitigation factor (MF) of 1.6.

The fish acute toxicity test mitigated by humic acid study did not accompany the P-14-0563 submission and was not factored into the original P-14-0563 assessment. The submitter sent in the finalized daphind’s study report that concluded the chronic toxicity value of 0.26 mg/L, and the chronic green algae value of 0.072 mg/L as the most sensitive and environmentally protective endpoint.

After further review and inclusion of the MF of 1.6 from , the acute and chronic
concern concentration values were recalculated.

Conclusion These test results will be used to calculate the CoC for P-14-563. For comparative purposes, the QSAR-p redicted acute and chronic fish, Daphnia, and algae values for P-14-0563 are 35.4 mg/L, 1.2 mg/L, and 0.48 mg/L, respectively. The predicted chronic values for fish, Daphnia, and algae are 3.5 mg/L, 0.12 mg/L, and 0.088 mg/L, respectively.

The acute CoC for P-14-0563 is 156 p pb (390 p pb / 4 (uncertainty factor), then multiplied by MF of 1.6, based on the experimentally-derived 72-hour EbC50 of green algae. The chronic CoC forP-14-0563 is 11 p pb (70 p pb / 10 (uncertainty factor), then multiplied by MF of 1.6), based on the experimentally-derived 72-hour chronic algal value.

Acute CoC = 156 ppb
Chronic CoC = 11 ppb

Ecotox Reviewer:
Date: 07/09/2014

Factors Values Comments

Assessment Factor

10

Concentration of Concern (ppb) 11

SARs cationic surfactants-quaternary
ammonium

SAR Class surfactant-cationic-quaternary
ammonium-C13 Ecotox Category Cationic (quaternary ammonium)
surfactants

Ecotox Factors Comments:

SAT Chair: