### SAT Report PMN Number: P-11-0135 SAT Date: 1/7/2011 Print Date: 7/30/2012

Related cases : Health related cases : Ecotox related cases:

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 1 2

Persistence Bioaccum Toxicity Comments 1 11

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-11-0135 FATE:

S = 17 mg/L at 25 C (E) VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H = 1.26E-8 (E) log Koc = 2.96 (E) log Fish BCF = 0.50 (E) log Fish BAF = 1.89 (E)POTW removal (%) = 75-90 via sorption and biodeg; OECD 301B(Mod Sturm CO2ev): 80%/28d. Time for complete ultimate aerobic biodeg = wk Sorption to soils/sediments = moderate PBT Potential: P1B1 *CEB FATE: Migration to ground water = slow

Health : Health Summary: N ot absorbed through the skin as the neat material ( p che m ), p oor absorption through the skin if in solution (analog), p oor absorption from the lung and GI tract ( p che m ). N o significant health concerns. Test Data: (-) Salmonella with and without activation; (-) E. coli with and without activation; rat oral LD0 = 2000 mg/kg; no eye irritation in rabbits; no skin irritation in rabbits; (-) for skin sensitization in a mouse local lymph node assay (50% ai); no skin sensitization in guinea pigs using the Magnusson-Kligman assay (50% ai)

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

fish 96-h LC50 4.5 >100 or * test considered invalid daphnid 48-h LC50 6.0 or * green algal 96-h EC50 1.8 fish

_ chronic value 0.18 daphnid

_ chronic value 1.6

algal

_ chronic value 1.4

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for esters with acid group; SAR chemical class = ester-acid; MW 292; solid with (M); S = 17 mg/L at 25 C (P); effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;

PMN P11-0135
A single fish acute ecotoxicity study, conducted accompanied this PMN submission. In this study, the test substance,designated was tested. This designation was found in the PMN submission as it is therefore concluded that the PMN and not an analog was tested. The PMN is an ester with an acid group. The substance was described as a colorless solid of >98.1% p urity with a water solubility estimated to be 17 mg/L (Chemistry Report). The PMN was not measured analytically and reported concentrations are nominal.
In an acute static limit toxicity test conducted with Zebrafish (Brachydanio rerio) (7 fish/replicate x 1 replicate) were exposed to test concentrations of 0 and a saturated solution (nominal loading rate of 100 mg ) for 96 hours. The test solutions were prepared by adding 100 mg/L of the PMN to water and shaking at 20 rpm for 24 hours, then passing this solution through a filter with pore size of 0.45 um. Whether the filter was pre-conditioned was not described. Because of this, the filter may have removed PMN (if not pre-conditioned), compromising the test. Over the course of the study, water temperature was 22.3-23.4°C, O2 levels (as % saturation) ranged from 94-100%, water hardness of the dilution water was 87 mg/L as CaCO3 and electrical conductivity was not reported. The aqueous test media was aerated during the 96-hour exposure period. Thus, study parameters complied with OCSPP and OECD guidelines for: 1) O2, p H, 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.

N o mortality was observed in the control or treated group. Thus, the fish 96-hour LC50 is greater than the nominal loading rate of 100 mg a.i./L with no 95% confidence limits determinable. The LOAEC was > 100 mg a.i./L and the NOAEC was 100 mg a.i./L.
Results from this acute fish aquatic ecotoxicity study show lower toxicity than the ECOSAR- p redicted daphnid acute value of 4.5 mg/L (note ECOSAR also designates this PMN as also having the alternative designation of “No Effects at Saturation” ( N ES) due to low water solubility). Fish were the only species tested. For this PMN, ECOSAR predicts that algae will have a 96-hr EC50 of 1.8 mg/L and that daphnia will have a 96-hr LC50 of 6.0 mg/L.

The fish test could have been considered valid if the test solutions had not been filtered, p ossibly removing PMN from the test media and if the test solutions had been measured analytically. If the latter criteria had been met, it could have been concluded that the PMN showed “No Effects at Saturation” also consistent with ECOSAR predictions for fish. As it is however, filtering and lack of analytical measurement of the PMN cause this assay to be considered invalid. Also, daphnia and algae were not tested with the PMN. Only this fish test was submitted. Because ECOSAR predicts higher toxicity for algae than for fish or daphnia, the fish data could not be used to set a concentration of concern (COC) in the absence of test data from the two other species.
Thus, the predictions from ECOSAR for algae will supersede this fish test results for setting the COC to err on the side of protecting the environment. Based on algae, the most sensitive species p redicted by ECOSAR, the existing COC of 18 p pb will not be changed based on the test results for fish.
Reviewer: S. Cragg26 January 2011

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 18

SARs esters with acid group SAR Class ester-acid new chemicals category: esters Ecotox Category

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916