### 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: N o
Routes of exposure : Health: N o 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 ( p che m ). N o 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; p H7; 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; * = N o 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% p urity) 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 % betweenrenewals 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, p H ranged fro m 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% p urity). 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, p H ranged fro m 5.62

– 5.90 and the moisture content ranged from 35.8

– 39.0%. N o mortalities or effects on body weights were observed during the study p eriod. 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% p urity). This study was reported to follow OECD Test Guideline No. 208. Four replicates of ten seeds/ p lant were exposed to a blank control or the test substance at nominal test concentrations of 10, 100 or 1000 mg/kg (drysoil 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 p lastic 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 p enetrate 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 ( N ES) 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 p redicted values, is fish. Therefore, the Chronic CoC is 1 p pb (0.001 mg/L / Assessment Factor of 10, then rounded up to 1 p pb). 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 p pb) Acute CoC = N ES ( N o effects at saturation; N o effects up to the water solubility limit)

Ecotox Study Reviewer: Tracy Wright April 08, 2013

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 1

SARs esters SAR Class ester Ecotox Category EstersEcotox Factors Comments:

SAT Chair: L Keifer 564-8916