SAT Report

PMN Number: P-13-0346

SAT Date: 3/29/2013

Print Date: 5/1/2013

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1 3 Health: ; Eco: chronic concerns only

 Persistence Bioaccum Toxicity Comments

1 31

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: No exposures needed

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: 

Summary of Assessment:

 Fate:

Fate Summary: P-13-0346

FATE: 

log Fish BCF = 3.47 (E)

log Fish BAF = 4.11(E) 
POTW removal (%) = 90 via sorption and biodeg

Time for complete ultimate aerobic biodeg = wk

Sorption to soils/sediments = strong

Volatilization half-life from a standard river = 1000 hrs

Volatilization half-life from a standard lake = 750 da

PBT Potential: P1B3

*CEB FATE: Migration to ground water = slow

 Health:

 Health Summary: Expect poor absorption via all routes (pchem). No 

significant health concerns.

 Test Data: (-) Salmonella with and without activation; (-) for 

chromosome aberrations in CHL cells with and without activation; (-) oral mouse micronucleus 

assay; rat (SPF Wistar) oral LD0 = 5000 mg/kg; rat (Sprague-Dawley SD) oral LD0 = 5000 

mg/kg; slight eye irritation in rabbits; slight skin irritation in rabbits following one application at 

100% ai; mild skin irritation in rabbits following two to five applications ranging from 3 - 30% 

ai; no skin sensitization in guinea pigs using the Buehler assay; rat 90-day oral NOEL = 1000 

mg/kg (highest dose tested)

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 *

daphnid 48-h LC50 *

green algal 96-h EC50 *

fish _ chronic value 0.001

daphnid _ chronic 

value

0.008 0.0076 LOEC

algal _ chronic 

value

0.12

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for esters; SAR chemical class = 

ester; MW 286; pH7; effective concentrations 

based on 100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as 

CaCO3; and TOC <2.0 mg/L;

Initial Submission Review Ecological Toxicity Data for P-13-0346

PMN Chemical Name: 

CAS RN: 
Trade Name: 

Synonyms: 

Acute fish, acute daphnid and algal toxicity studies provided by (the 

submitter) are available for P-13-0346 however, they are written in

German. A summary of the un-reviewed toxicity test values is provided in Table 1 along with 

SAR predicted values for comparison. also submitted a chronic daphnid 

toxicity test, and earthworm toxicity test and a terrestrial plant toxicity test, which were reviewed 

below. The earthworm and plant toxicity test reviews were provided for information purposes 

only. 

Table 1. ECOSAR (v. 1.1) Ecotoxicity Profile for Predicted and Measured Acute and 

 Chronic Aquatic Toxicity Values

Test Organism Test Type Test End Point Predicted Measured

Fish 96-h LC50 * >100 (1)

Daphnid 48-h EC50 * >100(1)

Green algae 96-h EC50 * >100(1)

Fish Ch V 0.001 --

Daphnid Ch V 0.008 0.0076 (21-day LOEC)

Green algae Ch V 0.12 --

 Predictions are based on SARs for esters; SAR chemical class = ester; * = No effects at 

saturation; (1) = Test result were not evaluated for acceptability.

Daphnid Ecotoxicity Test: 

conducted a 21-day limit test in Daphnia magna with the PMN substance (98% 

purity) under static-renewal conditions with daily renewal. The test substance was a 

 with a reported water solubility of The study was reported to follow OECD 

Test Guideline No. 211 and EU-Guideline C.20. Following preliminary tests, ten replicates of 

one D. magna were exposed to a dilution water control (reconstituted tap water), a solvent 

control (acetone) or the test substance at a nominal concentration of 30 μg/L. A corresponding 

mean measured concentration of 7.6 μg/L was determined by GC-MS analysis (LOD/LOQ = 

0.05 mg/L). Since the test substance is poorly soluble in water, a stock solution containing 300 

mg/L in acetone was prepared. The resulting stock solution was then used to prepare the test 

solution shortly before each medium renewal. A volume of 100 μL of stock solution was added 

to 1000 mL of dilution water and homogenized. This test solution was then filled into sterilized 

test vessels and left to stand for 30 minutes to achieve saturation of the glass surface (by 

adsorption of the test substance on glass). The vessels were emptied and immediately filled with 

freshly prepared test solution. The recovery rate between the old and the corresponding new test 

solution was 0% nearly always except at 4 renewals. In the mean, a recovery rate of 2 % between 
renewals could be stated. The mean measured concentration of test substance in the new and old 

test solutions was only 48% and 1% of the nominal concentration, respectively. It was assumed 

that the low recovery rate was caused by instability of the test substance (biological 

degradation), the high adsorption on the daphnia and the glass surfaces and bioaccumulation in 

the daphnia. Therefore, the mean of the measured concentrations from the new and the old 

solutions was used for the determination of the results. Over the course of testing, temperature 

ranged from 21.6 – 24.5 ̊C, pH ranged from 7.9 – 8.7, dissolved oxygen ranged from 5.4 – 9.7 

mg/L and hardness ranged from 234 – 273 mg CaCO3/L. A loading rate of 12.5 daphnids/L was 

calculated. Percent inhibition of reproduction in the dilution water control, solvent control and 

30 μg/L treatment groups were 0%, 0% and 16%, respectively. Based on mean measured 

concentrations, the 21-day EC50 was > 7.6 μg/L and the NOEC and LOEC values were < 7.6 

and 7.6 μg/L, respectively. This 21-day daphnid test is valid.

21-day EC50 > 7.6 μg/L

21-day NOEC < 7.6 μg/L

21-day LOEC = 7.6 μg/L

Earthworm Ecotoxicity Test:

 conducted a 14-day artificial 

soil test in earthworms (Eisenia foetida andrei) with the PMN substance (98% purity). This 

study was reported to follow OECD Test Guideline No. 207. The water solubility of the test 

substance was reported to be Four replicates of ten E. foetida were exposed to a 

blank control, a solvent (dichloromethane) control or the test substance at nominal 

concentrations of 1, 10, 100 or 1000 mg/kg (dry soil weight). Due to limited solubility in water, 

the test substance was dissolved in dichloromethane. Aliquots of the dichloromethane-solutions 

were transferred onto dry quartz sand and the solvent was evaporated while the mixture was 

gently agitated. After the solvent was evaporated, the test item was present as a fine layer on the 

sand particles. Aliquots of the quartz sand/test substance-mixture were then mixed thoroughly 

into the artificial soil using a household mixer at high speed. At the same time, 588 mL of 

deionized water was added in order to obtain a water content representing approximately 35% of 

the relative wetness of the soil. Approximately 750 g of test substrate was distributed into 1000 

mL plastic dishes. In order to avoid drying of the soil, the dishes were covered with transparent 

lids which contained small holes for respiration purposes. Over the course of testing, 

temperature ranged from 21 – 22°C, pH ranged from 5.62 – 5.90 and the moisture content ranged 

from 35.8 – 39.0%. No mortalities or effects on body weights were observed during the study 

period. The 14-day LC50, based on nominal concentrations, was greater than 1000 mg/kg dry 

soil weight. The earthworm test is valid.

14-day LC50 > 1000 mg/kg dry soil weight

Terrestrial Plant Ecotoxicity Test:

 conducted a 6-day growth 

inhibition test in three terrestrial plants (wheat [Triticum aestivum], mustard [Brassica alba] and 

cress [Lepidium sativum]) with the PMN substance (98% purity). This study was reported to 

follow OECD Test Guideline No. 208. Four replicates of ten seeds/plant were exposed to a 

blank control or the test substance at nominal test concentrations of 10, 100 or 1000 mg/kg (dry 
soil weight). The test was repeated for the wheat treatments, because there was not a satisfactory 

germination rate within the first test series. The plants were illuminated with a light intensity of 

130 – 160 μE/m2/s. Due to limited solubility in water, 1 g of the test substance was dissolved in 

10 mL of dichloromethane (final volume). Aliquots (4 mL) of this solution were transferred 

onto 39.6 g dry quartz sand and the solvent was evaporated under a hood. After the solvent was 

evaporated, the test item was homogenously distributed as a fine layer on the sand particles. 

Aliquots of the quartz sand/test substance-mixture were then mixed thoroughly into the artificial 

soil using a household mixer at high speed. At the same time, 338 mL of deionized water was 

added in order to obtain a water content representing approximately 50% of the maximum of 

water retaining capacity of the soil. The soil treatments were transferred loosely into clean 

plastic pots with a volume of ~ 250 mL. In order to avoid drying of the soil, within the first three 

days the pots were covered with petri dishes. Within that time the roots of the seedlings could 

penetrate the soil. The temperature of the incubation room was in the range of 21 to 22°C and 

the light intensity was 130 – 160 μE/m2/s. Percent inhibition of growth at 10, 100 and 1000 

mg/kg dry soil weight was 14.5%, 29.3% and 37.4% for wheat, -5.5%, 8.1% and 49.8% for 

mustard and -35.1%, -33.8% and 35.1% for cress, respectively. Percent inhibition of 

germination at 10, 100 and 1000 mg/kg dry soil weight was 12.5%, 3.1% and 0% for wheat, 0%, 

-2.6% and 0% for mustard and 3%, 9.1% and 21.2% for cress, respectively. Based on nominal 

concentrations, the 6-day EC50 for emergence and growth is > 1000 mg/kg dry soil weight. 

6-day EC50 > 1000 mg/kg dry soil weight

Conclusions: The acute fish and daphnid toxicity and toxicity to algae tests for the P-13-0346 

could not be reviewed because they were in German. However, the data values for the acute 

toxicity tests are comparable to SAR predictions, indicating no effects at saturation (NES) for 

P-13-0345. Therefore, the Acute CoC is NES for P-13-0346. The chronic daphnid toxicity test 

is acceptable and is also comparable to the SAR predicted value for chronic toxicity and supports 

concern for the chronic toxicity of P-13-0346. The most sensitive species, based on the 

predicted values, is fish. Therefore, the Chronic CoC is 1 ppb (0.001 mg/L / Assessment Factor 

of 10, then rounded up to 1 ppb). The earthworm ecotoxicity test was acceptable, and the 14-day 

LC50 is > 1000 mg/kg dry soil weight (the highest concentration tested). The terrestrial plant 

ecotoxicity test was acceptable. The light intensity was below the guideline 350 ± 50 μE/m2/s, 

however, this did not appear to affect the controls. Therefore, the 6-day EC50 is > 1000 mg/kg 

dry soil weight (the highest concentration tested).

Chronic CoC = 0.001 mg/L (1 ppb) 

Acute CoC = NES (No effects at saturation; No effects up to the water solubility limit)

Ecotox Study Reviewer: Tracy Wright April 08, 2013

Factors Values Comments

Assessment Factor

10

Concentration of Concern 

(ppb)

1

SARs esters

SAR Class ester

Ecotox Category Esters
Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916