SAT Report

PMN Number: S-11-0001

SAT Date: 10/22/2010

Print Date: 10/3/2011

Related cases:

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 3

 Persistence Bioaccum Toxicity Comments

3 1 1 PMN

Exposure Based Review:

Health: Yes

Ecotox: Yes

Routes of exposure: Health: Dermal Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: CARDIO; DEVEL; LIVER; KIDNEY; SOLVENT-NEURO; ONCO 

(UNCERT); AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: S-11-0001

FATE: 

Liquid with MP = -122C (M)

log Kow = 3.72 (M); 

S < 50 / 62 mg/L at 25 C (M/EPI)

VP = 403 torr at 20 C (M)

BP = 34 C (M)

H = 0.187 (E)

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log Koc = 2.37 (E)

log Fish BCF = 2.12 (E)

log Fish BAF = 2.581 (E) 

POTW removal (%) = 90-99 via sorption and stripping

Time for complete ultimate aerobic biodeg > mo

Sorption to soils/sediments = low

Volatilization half-life from a standard river = 1.5 hrs

Volatilization half-life from a standard lake = 5.6 da

Atmospheric Oxidation Half-life = 4400 hr via OH radical

PBT Potential: P3B1

*CEB FATE: 

 Health:

 Health Summary: Absorbed all routes (analog). Concern for 

cardiosensitization and developmental toxicity based on analogs (PMN is lower MW than 

); liver and kidney toxicity based on test data, PMN appears to be more toxic than 

when rat 28-d inhalation LOAELs are compared; liver cancer (uncertain) based on the 

presence of peroxisome proliferation in the liver of both sexes in all doses in the rat 30-d 

inhalation study; and possible neurotoxicity, i.e., CNS, based on other solvents.

 Test Data: S11-0001: no eye irritation in rabbits; (-) for skin 

sensitization in a mouse local lymph node assay

: rat acute oral LD0 = 2.0 g/kg with no significant toxic signs; rat 30-d inhalation (6 h/d 

5 d/wk over 30 d) LOAEL (lowest dose tested) = 1000 ppm=1770 mg/kg/d with effects to liver 

(increases in absolute and relative [organ/body] liver weights in males in all treated groups, 

hepatocyte hypertrophy in males in all treated groups, and peroxisome proliferation in the liver 

of both sexes [strong response in males] in all treated groups), effects to kidneys, reduced body 

weight gain, reduced food intake, and effects to red blood cells (reviewed by RAD); mild and 

transient (1 d) eye irritation in rabbits; no skin irritation in rabbits; guinea pig 10-d inhalation 

metabolism study at 10 000 ppm, 6 h/d for 10 d showed metabolism of the PMN chemical via 

the presence of F ion in the blood

: rat acute oral LD0 = 5.0 g/kg with no toxic signs; rat acute inhalation (nose-only/4 h) 

LC0 = 10 100 ppm with no significant toxic signs; rat acute inhalation (nose-only/4 h) LC0 = 10 

450 ppm with rapid respiration and increased salivation; no skin irritation in rabbits; slight and 

transient (1 d) eye irritation in rabbits; no skin sensitization in guinea pigs (B); Ames test was 

negative; chromosome aberration test with CHL cells was negative; mouse micronucleus (ip) test 

was negative; rat 28-d inhalation (vapor, 6 h/d, 5 d/wk for 4 weeks) NOAEL = 1500 ppm = 2438 

mg/kg/d, LOAEL = 3000 ppm=4876 mg/kg/d based on liver toxicity; rat 90-d inhalation (vapor, 

6 h/d, 5 d/wk for 13 weeks) NOAEL = 7533 ppm = 76,867 mg/m3 = 21,413 mg/kg/d, LOAEL = 

15,159 ppm = 154,683 mg/m = 43,090 mg/kg/d based on liver toxicity; dog cardiac sensitization 

(gas-nose only) at 10% NOAEL = 1020 g/m3; rat developmental toxicity test via inhalation 

(vapor-6 h/d, GD 6 to 19) NOAEL (highest dose tested) = 30,000 ppm for fetal and maternal 

effects; rat developmental toxicity test via inhalation: fetal NOAEL = 7500 ppm, fetal LOAEL = 

15,000 ppm; maternal NOAEL = 15,000 ppm (highest dose tested)

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 Ecotox:

Test 

Organism

Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 24 > 1.5

daphnid 48-h LC50 15 0.74

green algal 96-h EC50 9.8 > 2.9

fish _ chronic value 2.2

daphnid _ chronic value 1.7

algal _ chronic value 4.2

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for neutral organic chemicals; 

SAR chemical class = ether; MW ; liquid with mp = -122 C (M); log Kow = 2.96 (EPI), 

3.72 (M); S < 50 mg/L at 20 C (P); pH7; effective concentrations based on 100% active 

ingredients and mean measured concentrations; DW hardness < 150.0 mg/L as CaCO3; and 

DW TOC <2.0 mg/L;

This S case came with ecotoxicity data. Attached document shows details. Below are 

conclusions:

Three acute ecotoxicity studies accompanied the submission, a 72-hour algal growth inhibition 

test, 48-hour semi-static acute toxicity to aquatic invertebrates test and a 96-hour acute toxicity 

static fish test. These studies complied with OECD guidelines 201, 202, and 203 for: 1) O2, pH, 

temperature, water hardness values and other water quality parameters; 2) species, age, number 

of organisms per replicate, and biomass loading rates; and, 3) replicate and overall variability. 

The tests were performed in a GLP laboratory and there was a quality assurance statement 

provided. The test substance was 99.83 % pure and described as highly volatile and poorly 

soluble. ECOSAR (v. 1.00a) predicted a chronic concern concentration of 170 ppb based on the 

chronic toxicity value for daphnia of 1.7 mg/L. The acute concern concentration predicted by 

ECOSAR (v. 1.00a) is 2,450 ppb.

I. 96-hour Zebra Fish (Danio rerio) Acute Toxicity Study with 

A saturated solution was prepared and maintained by applying a column generator system where 

the test medium was continuously circulated through a column with the test material and glass 

wool. Analytical verification of the test samples was performed at 0, 48 , and 96 hours of the test 

duration. A limit test was performed with a nominal concentration of 1 mg/L. Analytical 

measurement of the test substance showed mean measured concentrations at 0, 48, and 96 hours 

to be 1.46, 1.33, and 1.70, respectively. Sub-lethal effects were observed within 2 hours of the 

test and included discoloration, and hypoactive swimming and one immobile (not moving but 

not deceased) fish. After 24 hours, fish had difficulty swimming and were observed laying on 

their side but began to swim normally after this observation. From 48 hours to 72 hours of 

exposure, the fish recovered and no other sub-lethal effects were observed. During the time that 

sub-lethal effects were observed, a high number of gaseous bubbles were present at the bottom 

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of the vessel. These bubbles most likely originated from the test substance in the gaseous phase. 

No mortality was observed during the test.

96-hour LC50 = >1.5 mg/L 

NOEC = < 1.5 mg/L

II. 48-hour Acute Semi-static Toxicity Test for Daphnia magna with 

A saturated solution was prepared and maintained by applying a column generator system where 

the test medium was continuously circulated through a column with the test material in a 

closed-loop system with minimum head space. The acute daphnid test was conducted as a limit 

test with a saturated solution in addition to a 45 and 70 % saturated solution. Test solutions were 

renewed after 24 hours of exposure and analytical determination of the test item was done at 0, 

24, and 48 hours resulting in test concentrations of 0.29, 0.65, and 0.84 from the 45, 70 and 

100% saturated solutions, respectively. The following percentages of immobilization of the 

daphnids were observed: 0.29 mg/L (5 % immobilization), 0.65 mg/L (0% immobilization), 0.84 

mg/L (100 % immobilization). 

Some deviations from the guidelines were conducted:

(1) The amount of glass wool in the column was increased and the test substance amount 

decreased to 10 g and the pump flow was lowered from 5 to 4 mL/min. This change was 

necessary as it was observed that the test substance did not remain in the column when less glass 

wool and 12 g of test substance and a flow of 5 mL/min. was applied.

48-hour EC50 = 0.74 mg/L (95% c.l. 0.65 – 0.84 mg/L) 

NOEC = 0.65 mg/L

I. Fresh Water Algal (Pseudokirchneriella subcapitata) Growth Inhibition Test with 

The test substance solution was prepared in closed vessels and adjusted growth medium to 

compensate for the poorly soluble, highly volatile nature of the test material. Nominal 

concentrations of the test material were prepared in a 72-hour static test (10, 18, 32, 56, and 100 

mg/L). Each test vessel contained 1 X 104 algal cells per mL. Cell number was determined at 

24, and 48 hours. A mean measured concentration of 2.9 mg/L was determined for the 100 mg/L 

test concentration chamber at the start of the test. Despite the poor agreement with nominal 

values (average 3 %), there was agreement in terms of the dilution factor for all of the test 

concentrations. After 48 hours, no test substance could be measured except for 0.49 mg/L in 

samples taken from the nominal 56 mg/L test chamber at 24 hours. The test item did not have a 

significant inhibitory affect on growth rate or yield. 

Some deviations from the guidelines:

(1) Temperature slightly exceeded the optimum range : the highest measured temperature was 

0.2° C higher than the protocol indicates but did not affect the exposure or growth of algae.

(2) Temperature was measured using Testo measuring equipment instead of Rees measuring 

equipment because the test room did not have the latter.

(3) Only the 32 mg/L test concentration had duplicate samples : not enough test solution was 

available from this test chamber, duplicate measurement was however considered sufficient for 

evaluation.

48-hour ErC50 > 2.9 mg/L (growth rate) 

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NOEC = 2.9 mg/L

48-hour EyC50 > 2.9 mg/L (yield) 

NOEC = 2.9 mg/L

The measured value from the most conservative toxicity result will be used to determine a 

concentration of concern. To determine a concentration of concern, using the lowest of these 

values (0.74mg/L for daphnia), the 0.74 mg/L value is divided by the default acute to chronic 

ratio of 10 to simulate a chronic value (ChV) to yield 0.074 mg/L. Dividing this value (0.074 

mg/L) by an assessment (uncertainty) factor of 10, yields a concern concentration of 0.0074 

mg/L or 7.4 ug/L (ppb). 

Chronic CC = 7.4 ppb

Acute CC = 148 ppb

Eco Reviewer 

S. Pollack

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

7.4 ECOSAR predicted 170 ppb

SARs neutral organic chemicals

SAR Class ether

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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