### SAT Report PMN Number: P-12-0548 SAT Date: 9/21/2012 Print Date: 6/4/2013

Related cases :

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 2 3

Persistence Bioaccum Toxicity Comments 2 22

Exposure Based Review : Health: N o Ecotox: Yes

Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: All releases to water Fate: ;
Keywords : Keywords: LIVER; N EURO; LUNG; DEVEL; AQUATOX
Summary of Assessment :

Fate : Fate Summary: P-12-0548 FATE: Estimations for typicalPOTW removal (%) = 90 via sorption; OECD 301B(Mod Sturm CO2 ev): 13%,14%/28d NRB. Time for complete ultimate aerobic biodeg = mo Sorption to soils/sediments = v.strong Volatilization half-life from a standard river = 2 hrs Volatilization half-life from a standard lake = 6 da Atmospheric Oxidation Half-life = 9.9 hr via OH radical PBT Potential: P2B2 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Expect moderate absorption via all routes (analog). Concern for liver toxicity and developmental toxicity based on submitted test data. Also concern for solvent neurotoxicity and pneumonia. Test Data: (-) Salmonella with and without activation; (-) E. coli with and without activation; rat inhalation LC50 >1 <5 mg/L; (-) for skin sensitization in a mouse local lymph node assay up to 25% ai; rat 28-day oral NOEL = 50 mg/kg, liver toxicity at >= 250 mg/kg; rat 28-day oral NOEL = 15 mg/kg, liver toxicity at >=150 mg/kg; rat oral combined protocol (OECD 422) N OEL = 30 mg/kg ( p arental animals), liver toxicity at higher doses; reproductive toxicity NOEL = 100 mg/kg (highest dose tested); developmental toxicity N OEL = 10 mg/kg

Ecotox :
Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 0.61 daphnid 48-h LC50 0.44 0.29 mg/L (95% C.I. = ± 0.25

– 0.37) not valid

green algal 96-h EC50 0.93 fish

_ chronic value 0.080 daphnid

_ chronic value 0.087

algal

_ chronic value 0.42

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for neutral organic chemicals; SAR chemical class = MW 196; effective concentrations based on 100% active ingredients and mean measured concentrations ; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;Ecotoxicity Study Review for

P12-0548 24th September, 2012
A 48-hour daphnid (Daphnia magna) immobilization study was submitted for PMN P-12-0548 under GLP conditions according to OECD guideline 202 and the OECD series on testing and assessment number 23 aquatic toxicity of difficult substances and mixtures. A combined limit/range-finding study was conducted under static conditions with four replicates of five daphnids each. The organisms were exposed to 0 (control), 1.0, 2.2, 4.6, 10, 22, 46, and 100 % of a water soluble fraction (WSF). Analysis of the samples taken at the start of the final test showed measured concentrations of 0.050, 0.14, 0.27, 0.91, 1.5, 2.8 and 6.1 mg/L at 1.0, 2.2, 4.6, 10, 22, 46 and 100% of the WSF, respectively. During the exposure period the measured concentrations decreased to 33-44% of initial at the end of the test. Based on these results, the average exposure concentrations were calculated to be: 0.032, 0.078, 0.18, 0.55, 0.96, 1.9 and 3.9 mg/L. The PMN test material ( p urity > 95%) was measured using GC methods and was prepared in the following manner: 100 mg/L of the test material was stirred for 2 days to reach maximum solubility and then left to rest for 1 hour. The WSF was siphoned out and used as the highest test concentration and the lower test concentrations were prepared by subsequent dilutions of the WSF. Water quality parameters were the following: water temperature = 20.4 - 21.7  ̊ C; p H = 7.7 - 7.9, DO = 8.9 - 9.3 mg/L, and dilution water hardness = 180 mg/L. At the end of the exposure period, the replicates of the four lowest test concentrations were pooled at each concentration before sampling. Due to the p resence of a floating layer, the samples from the three highest test concentrations were taken from one replicate. During the exposure period the measured concentrations decreased to 33-44% of initial at the end of the test. Based on these results, the average exposure concentrations were calculated to be: 0.032, 0.078, 0.18, 0.55, 0.96, 1.9 and 3.9 mg/L. At 48 hours, there was 0, 0, 0, 5, 90, 100, 100, 100% immobility in the control and average exposure concentrations of 0.032, 0.078, 0.18, 0.55, 0.96, 1.9 and 3.9 mg/L treatments, respectively. N o significant immobilization was observed at average test concentrations less than 0.55 mg/L. 48-hour EC50 = 0.29 mg/L (95% C.I. = ± 0.25

– 0.37)

N o other studies were submitted for PMN material P-12-0548. This study is considered invalid for two reasons. (1) N o attempts were made to expose the test organisms at the measured water solubility. While the measured water solubility is low, some attempts by the testing facility could have been demonstrated to address testing at the solubility determined experimentally. (2) It is not appropriate to prepare water soluble fractions by serially diluting the concentrations from the stock solution. With difficult to test substances it is instead recommended to prepare individual test concentrations without serial dilution according to the OPPTS 850.1000 guideline as well as the OECD series on testing and assessment number 23 aquatic toxicity of difficult substances and mixtures. As a result, the ECOSAR (v. 1.10) p redictions for neutral organics will be used to determine hazard for P-12-0548. The predicted acute concern concentration is derived from the 48-hour daphnid EC50 value of 0.44 mg/L. This value is divided by an assessment factor of 5 for invertebrates to yield 88 μ g/L or 88 p pb. The chronic concern concentration is determined from the fish chronic value of 0.080 mg/L which isdivided by an assessment factor of 10 to yield 8 μ g/L or 8 p pb. Chronic CC = 8 p pb Acute CC = 88 p pb Reviewer: S. Pollack

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 8

SARs neutral organic chemicals SAR Class Ecotox Category N eutral Organics

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916