<5%/10d, <8%/14d, <15%/28d. Time for complete ultimate aerobic biodeg = PMN ≥ mo Sorption to soils/sediments = PMN moderate; PBT Potential: PMN P3B1; *CEB FATE: Migration to ground water = PMN moderate;

Health : Health Summary: Absorption is nil all routes ( p che m ). N o significant health concerns for the PMN substance. Concerns for the are liver toxicity, blood toxicity (anemia), kidney toxicity, and developmental toxicity based on studies with submitted for a PMN analog (Rat 10-day oral NOAEL = 300 mg/kg/d, some evidence of liver toxicity; rat 28-day oral N OAEL = 100 mg/kg/d, with changes in blood chemistry at higher doses; rat 90-day oral N OAEL = 60 mg/kg/d with hematological findings consistent with anemia at 200 mg/kg/d and higher; rat oral reproductive toxicity NOAEL = 1000 mg/kg/d for reproductive toxicity, 100 mg/kg/d for systemic toxicity with effects to the liver and kidney at 1000 mg/kg/d; rat oral developmental toxicity NOAEL = 300 mg/kg/d for both developmental effects (decreased fetal weight) and maternal toxicity). Test Data: Analog: (-) Salmonella with and without activation; (-) E. coli with and without activation; (-) for chromosome aberrations in a human lymphocyte assay with and without activation; rat dermal LD0 = 2000 mg/kg; rat oral LD0 = 2000 mg/kg; no skin irritation in rabbits; no eye irritation in rabbits; no skin sensitization in guinea pigs using the Buehler assay; rat 28-day oral NOEL = 1000 mg/kg (highest dose tested)

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 * 96-hour LL50 > 100 mg/L WAF; not acceptable

daphnid 48-h LC50 * 48-hour EL50 >100 mg/L WAF; not acceptable

green algal 96-h EC50 * 96-hour EL50 > 100 mg/L WAF; not acceptable

fish

_ chronic value *

daphnid

_ chronic value *

algal

_ chronic value *

Sewage Sludge 3-h EC50

_ 14-d earthworm
tests > 1000 mg/kg dw

Sewage Sludge _ Chronic Value _Ecotox Values Comments: Predictions are based on SARs for esters; SAR chemical class = esters; MW solid with mp = 107 C (M); log Kow = 14.2 (EPI); S < 0.001 mg/L at 20 C (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 Data Review for: P-14-0067 Chemical Name: Octadecanedioic acid, 1,18-bis[2-[methyl[(1,1,2,2,3,3,4,4,4-nonafluorobutyl)sulfonyl]amino]ethyl] ester Trade Name: N one CASRN: 890406-75-4 18th, N ovembe r 2013

Four ecotoxicity studies were submitted for the PMN P14-0067 from ; a 96-hour acute fish toxicity test, a 48-hour aquatic invertebrate test, a 96-hour aquatic plant toxicity test, and an acute earthworm toxicity test. The aquatic studies were conducted by in 2005 on an analog of the PMN substance, Fatty acids, C>14, 2- [methyl [ (nonafluorobutyl) sulfonyl ] amino ] ethyl esters. The actual PMN substance is described as Octadecanedioic acid, 1,18-bis[2-[methyl[(1,1,2,2,3,3,4,4,4-nonafluorobutyl)sulfonyl]amino]ethyl] ester.

The earthworm study was conducted in 2011 by . The PMN has an estimated Log P value of 14.20 and an estimated water solubility estimate of < 1.0 X 10-6 mg/L.

The studies were performed under GLP conditions with a signed quality assurance statement and certificate of analysis also provided. All three aquatic tests allegedly followed OECD Guidelines for Testing of Chemicals 203, 202, 201, but not enough detail was provided in each data review summary. The earthworm test followed the SEPA Guideline 207, Earthworm Acute Toxicity Test.

96-hour Acute Fish Toxicity Test Two replicates of ten P. p romelas were exposed to a control (well water) and the test substance, an analog of the PMN substance, as water accommodated fractions (WAFs) at a nominal concentration of 100 mg/L. The solutions were mixed overnight and then allowed to settle for approximately one hour after mixing. All test solutions had particles floating on the surface, suspended throughout solution and on the bottom of the bottles. The negative control appeared clear and colorless and the test solution appeared slightly cloudy throughout the entire exposure. Analytical monitoring was not conducted. Over the course of the study, the temperature = 22±2°C, p H = 8.2-8.5 and DO = 6.5-8.0 mg/L. Dilution water hardness = 133 mg CaCO3/L. Animals in control and test group appeared normal throughout the exposure. N o details were given on the material the organisms were exposed to ( p urity, certificate of analysis, p hysical state, etc.) and the mortality table summary does not provide a key to show the effects on the organisms exposed. 96-hour LL50 > 100 mg/L WAF48-hour Aquatic Invertebrate Toxicity Test: Two replicates of ten D. magna were exposed to a control (well water) and the test substance, an analog of the PMN substance, as water accommodated fractions (WAFs) at nominal concentrations of 6.3, 13, 25, 50 and 100 mg/L. Analytical monitoring was not conducted. Test solutions were prepared in well water as individual WAFs. The solutions were mixed overnight and then allowed to settle for approximately one hour after mixing. All test solutions had
p articles floating on the surface, suspended throughout solution and on the bottom of the bottles. The negative control appeared clear and colorless throughout the exposure. Test solutions appeared clear and colorless throughout the exposure, except the 50 and 100 mg/L test solutions had visible test material on the bottom of the test chambers. Over the course of the study, temperature = 19.5-20.0oC, p H = 8.1-8.5 and DO = 8.4-8.8 mg/L. Dilution water hardness = 134 mg CaCO3/L. A loading rate of 50 daphnids/L was calculated. Animals in the control and test groups appeared normal throughout the exposure. N o mortalities were observed during testing. 48-hour EL50 > 100 mg/L

Algal Ecotoxicity Test: A 96-hour growth inhibition test in freshwater algae (Selenastrum capricornutum) was conducted with with the test substance, an analog of the PMN substance ( p urity not provided) under static conditions. The test substance was prepared as a water accommodated fraction (WAF) at nominal concentrations of 6.3, 13, 25, 50 and 100 mg/L. Analytical monitoring was not conducted. The algae were illuminated with a light intensity ranging from 3940 to 4650 lux with constant shaking. The solutions were mixed overnight and then allowed to settle for one hour after mixing. All test solutions had particles floating on the surface and laying on the bottom of the bottles. The flasks were sealed with vented caps. Over the course of the study, temperature = 22.7-23.1oC, p H = 7.5-8.6. The cell density in the control cultures increased by a factor of 244x within 96 hours. The percent inhibition for growth rate at 96-hours for nominal concentrations 6.3, 13, 25, 50 and 100 mg/L was 1.2%, 4.9%, 0.9%, -1.0% and -0.3%, respectively. The corresponding percent inhibition for cell density at 96-hours was 6.6%, 23%, 4.2%, -5.7% and -1.8%, respectively. 96-hour EL50 (cell density and growth rate) > 100 mg/L

Acute Toxicity to the Earthworm (Eisenia foetida) A 14-day toxicity study in the earthworm (Eisenia foetida) was conducted with an analog of the PMN substance (MTDID181(E10-0727) PM-870, p urity not provided). Following a range-finding test, four replicates of ten earthworms were exposed to a control (artificial soil) and the test substance at a nominal concentration of 1,000 mg/kg dry soil weight. Analytical monitoring was not conducted. Due to the insolubility of the test substance in water, the test substance was weighed with a balance and mixed with silica sand. The mixture was mixed thoroughly with basic test substrates and then with deionized water to obtain an even distribution of the test substance in the test substrates. Moisture of the test substrate was adjusted to 35% of dry weight with deionized water. The exposure vessels were covered with film to prevent the substrate from drying. Beakers were refilled with substrate on day 7. Over the course of the study, the moisture (% dry soil weight) = 33.55-37.93% and temperature = 20.1-20.2oC. The pH of the artificial soil in controls was 8.77 at the beginning of the test. A loading rate of 541.67 mg Earthworms/kg dry soil weight was calculated. The percent mortality on day 14 for the controland treatment group was 5% and 2.5%, respectively. At the end of the test, the average body weight of the surviving earthworms in the control group was not significantly decreased ( p >0.05); however, it was not significantly higher than the treatment group ( p >0.05). 14-day LC50 > 1000 mg/kg dry soil weight

Conclusion While the analog material that was tested is appropriate for PMN P-14-0067, due to the lack of any measured values for the WAF solution preparations for any of the aquatic tests or for the earthworm toxicity test, the ecotoxicity data for P-14-0067 is unacceptable.

The predictions from the ECOSAR model (v. 1.11) will be used for the category esters. For both the acute and chronic concern concentrations, the result is no effects at saturation. Acute CC,Chronic CC = N o effects at saturation.

Reviewer:

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) Acute Concentration of Concern ( p pb) Chronic *

SARs esters SAR Class esters TSCA New Chemcial Category Esters

Ecotox Factors Comments:

SAT Chair: Fate assessor: Ecotox assessor: Health assessor: