### SAT Report PMN Number: P-13-0267 SAT Date: 2/20/2013 Print Date: 4/1/2013

Related cases :

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 1 3

Persistence Bioaccum Toxicity Comments 2 31

Exposure Based Review : Health: N o Ecotox: Yes
Routes of exposure : Health: Low Concern Ecotox: All releases to water Fate: ; Keywords : Keywords: N O SIG HLTH CNCRNS AQUATOX-A,C
Summary of Assessment :

Fate : Fate Summary: P-13-0267 FATE: with MP = 130 C (E) log Kow = 6.33 (E) S = 0.06 mg/L at 25 C (E) VP = 2.8E-6 torr at 25 C (E) BP = 376 C (E) H = 1.04E-6 (E) log Koc = 4.37 (E) log Fish BCF = 3.84 (E)log Fish BAF = 2.23 (E) POTW removal (%) = 90 via sorption and biodeg; Analog: OECD 301B(Mod Sturm CO2 ev): 28d: 28%(10mg/L), 15%(20mg/L). Time for complete ultimate aerobic biodeg = wk-mo Sorption to soils/sediments = v.strong Volatilization half-life from a standard river = 950 hrs Volatilization half-life from a standard lake = 440 da Atmospheric Oxidation Half-life = 4.56 hr via OH radical PBT Potential: P2B3 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption of the neat material is nil through the skin, but p oor through the skin for the material in solution, while absorption is poor through the lung and GI tract., based on physical/chemical properties. N o significant health concerns. Test Data: Submitted with the PMN:

N egative in Salmonella with and without activation; Rat (F) acute (15D) oral (gavage) LD50 > 2000 mg/kg

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 * N ot Acceptable; N ot a good analog daphnid

_ chronic value 0.006 * N ot Acceptable; N ot a good analog algal

_ chronic value 0.022

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: P-13-0267:

Fish Ecotoxicity Test: conducted 28-day growth test in zebra fish (Brachydanio rerio) with an analog of the PMN substance (tested as 100% commercial product) under flow-through conditions. The study method was adapted from the growth-rate test for rainbow trout developed by Crossland (1986). This study closely follows OECD guideline 215.A single replicate of sixteen B. rerio were exposed to a dilution water control, a solvent control (methanol) or the test substance at nominal test concentrations of 33 or 100 μg/L. Corresponding mean measured concentrations of 32 and 105 μg/L were determined by GC analysis. To prepare stock solutions, 0.25 g of test substance was dissolved in 50 mL of methanol using sonication to give 5 g/L stock (stock A). A volume of 16.7 mL Stock A was diluted 1 in 3 with methanol to produce a 1.67 mg/L solution (stock B). Two dosing stocks (5 liters each at 4.2

–1.4 mg/L) were prepared by diluting the 5 mg/mL and 1.67 mg/mL stocks with distilled water. Dosing stocks were diluted 1 in 42 to produce nominal concentrations of 33 and 100 μg/L. Each test solution was dosed at 67 mL/min giving about 10 volume replacements p er day. Measured concentrations of test substance ranged from 56

–160% of nominal values during the study. On day 3, a blockage occurred in the capillary dosing into the 100 μg/L test vessel. This stopped the dilution water-flow (but allowed some dosing stock through) raising the concentration to 218 μg/L. This result was not incorporated in the mean concentration over the test period as it was not representative. The blockage also caused the control vessel to become contaminated (78 μg/L). By day 4, concentrations in the control tank had fallen to 0.1 μg/L. Over the course of the study, temperature ranged from 22.5

–23.5  ̊ C, p H ranged fro m 7.1

–7.8 and dissolved oxygen ranged from 7.7

–10.2 mg/L. Dilution water hardness ranged from 86

– 108 mg CaCO3/L. A loading of approximately 0.14 g fish/L was calculated. There was no effect on the average fish weight or specific growth rates at any of the concentrations tested. Based on mean measured concentrations, the NOEC is 105 μg/L. This study is not acceptable given the chemical’s estimated water solubility of 0.00045 mg/L and Log Kow of 8.4 is very different from the PMN test substance estimated water solubility and Log Kow values. It should be noted that the two measured concentrations are above the estimated water solubility limit for this analog. Also, the test should have used more dose concentrations to determine the chronic endpoint. According to OECD test guideline 215, at least five concentrations are required and only two were provided in this study. Also, the measured concentrations of the test substance varied between 56 and 160% of the nominal concentration during the course of the study. This p ercent difference far exceeds the test guideline’s ten percent difference. N o effects were seen at either concentration. 28-day NOEC = N o effects at saturation.
Daphnid Ecotoxicity Test: conducted a 21-day toxicity test in Daphnia magna with an acceptable analog of the PMN substance (tested as 100% commercial product) under static-renewal conditions with daily renewal. The study was reported to follow OECD test guideline 202. Ten replicates of one D. magna were exposed to a dilution water control (Elendt M7 medium), a solvent control (methanol) or the test substance at nominal test concentrations of 33 or 100 μg/L. Corresponding mean measured concentrations of 23.2 and 79.7 μg/L were determined by GC analysis. The stock solution was prepared by dispersing 0.05 g test substance in 50 mL of methanol, using a sonic bath, to make a 1.0 g/L stock (Stock A). A volume of 1.67 mL Stock A was then made up to 50 mL with methanol to form a 0.33 g/L stock (Stock B). Test solutions were prepared by adding known volumes of these stocks to 1.5 liters Elendt medium. Analysis of test solution concentrations indicated that concentrations of fresh solutions were on average 83.5% of nominal values and concentrations of old solutions were on average 65.2% of nominal values. Over the course of testing, temperature ranged from 14.5

–25.0  ̊ C, p H range d from 7.2

–8.1 and dissolved oxygen ranged from 4.5

–9.3 mg/L. Dilution water hardnessranged from 234

–256 mg CaCO3/L. A loading rate of 10 daphnids/L was calculated. N o inhibitory effects on daphnia were observed during the study. Based on mean measured concentrations, the 21-day NOEC was 79.7 μg/L. This study is not acceptable given the chemical’s estimated water solubility of 0.00045 mg/L and Log Kow of 8.4 is very different from the PMN test substance estimated water solubility and Log Kow values. However, the study should have been reported to have followed OECD Test guideline 211 instead of OECD 202. Also, the water temperature variation range is well above the OECD 211 recommended 2 degrees variation. Finally, the two measured concentrations are above the estimated water solubility limit for this analog. N o effects were seen at either concentration. 21-day NOEC = N o effects at saturation.
The two studies are acceptable given the low water solubility and high Log Kow

Acute CoC = N o effects at saturation Chronic CoC = 1 p bb

Ecotox Study Reviewer: Amuel Kennedy February 28, 2013

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

SARs Amides SAR Class Amides Ecotox Category N one

Ecotox Factors Comments:

SAT Chair: J. Kwiat