<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 (pchem). No 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 

NOAEL = 100 mg/kg/d, with changes in blood chemistry at higher doses; rat 90-day oral 

NOAEL = 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); pH7; 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: None

CASRN: 890406-75-4

18th, 

November 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. promelas 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, pH = 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. No details were 

given on the material the organisms were exposed to (purity, certificate of analysis, physical 

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 WAF 
48-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 

particles 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, pH = 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. No 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 (purity 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, pH = 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, purity 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 control 
and 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 = No effects at saturation.

Reviewer:

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb) 

Acute 

Concentration of Concern 

(ppb) Chronic

*

SARs esters

SAR Class esters

TSCA New Chemcial 

Category 

Esters

Ecotox Factors Comments: 

 SAT Chair: 

 Fate assessor: Ecotox assessor: Health assessor: