### SAT Report PMN Number: P-12-0437 SAT Date: 7/17/2012 Print Date: 11/7/2012

Related cases : Health related cases: Ecotox related cases:

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

Persistence Bioaccum Toxicity Comments 2 11

Exposure Based Review : Health: Yes Exposure based testing (health): Inhalation only Ecotox: Yes
Routes of exposure : Health: Dermal Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: LUNG, IRR-S,E, AQUATOX-A,C
Summary of Assessment :

Fate : Fate Summary: P-12-0437 FATE:

VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) POTW removal (%) = 50-90 via sorption and biodeg Time for complete ultimate aerobic biodeg = mo Sorption to soils/sediments = strong PBT Potential: P2B1*CEB FATE: Migration to ground water = slow

Health : Health Summary: Absorption is nil all routes based on physical/chemical p roperties. This material may be irritating to the skin and eyes. There is concern for lung effects if respirable particles are inhaled based on changes in the balance in the lungs and/or cationic binding to lung tissues. Low moderate concern.

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

fish 96-h LC50 2.0 daphnid 48-h LC50 2.1 green algal 96-h EC50 2.0 fish

_ chronic value 0.11 daphnid

_ chronic value 0.15

algal

_ chronic value 0.50

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for ; SAR chemical class = MW 2609; p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;
Ecotoxicity Test Data Results for P-12-0437:

An acute marine copepod toxicity study was conducted on PMN P-12-0437 The study was completed in 2012 The PMN is characterized as a . The study was conducted according to ‘ISO 14669 (1999) Water Quality -Determination of acute lethal toxicity to marine copepods (Copepoda; Crustacea)’; GLP compliance was not stated.
A 48-hour marine copepod acute toxicity study was conducted with the PMN under static testing conditions. Following a range-finding study, two replicates of ten Acartia tonsa per concentration were exposed to nominal concentrations of 0 (dilution water control), 1, 3.2, 10, 32, or 100 mg/L. Based on statements made in the study report, the definitive test was conducted twice since irregular results were observed in the first definitive test; however, detailed resultswere only presented for one of the tests. Methods for preparing test solutions were described as a water accommodated fraction (WAFs), which was considered acceptable since the PMN appears to be a mixture. However, since the submitter prepared a single stock solution that was subsequently diluted to achieve desired nominal test concentrations, the submitter did not follow methods for preparing WAFs (OECD guidelines, ASTM guidelines) that require individual p reparation of each test concentration. Thus, the submitter’s technique for test solution p reparation was considered unacceptable. In addition, no attempt was made to quantify the amount of PMN in solution compared to controls (e.g., TOC analysis). Test organisms were 19 days old at test initiation. Over the course of the study dissolved oxygen concentrations of 89-98%, p H levels of 8.05-8.16, and water temperatures of 20.7-21.5 °C were reported. Dilution water hardness was not provided. Percentage mortality was 0%, 9%, 0%, 20%, and 90% in the 0, 1, 3.2, 10, 32, and 100 mg/L exposure groups for the initial definitive test. In the second definitive test, 25% and 85% mortality was observed at nominal concentrations of 10 and 18 mg/L, respectively. The submitter provides a nominal 48-hour LC50 of 21.7 mg/L, which appears to be based on the initial definitive test that was considered by the submitter to have irregular results. Based on interpolation of the provided results for the follow-up definitive test, the 48-hour LC50 would be about 13 mg/L. Since the inadequate method for preparing WAFs may have resulted in lower concentrations than what was reported, the LC50 was considered to be ≤ 13 mg/L. The study was considered unacceptable based on the absence of test concentration analysis to confirm amount of substance achieved in each test concentration and the inadequate approach for preparing test solutions. 48-hr LC50 ≤ 13 mg/L
The submitted study was considered unacceptable. Predictions based on the QSAR will be used to determine risk are also no effects at saturation for all aquatic acute and chronic endpoints. The 96-hour fish LC50 was 2 mg/L, the 48-hour daphnid LC50 was 2.1, the 96-hour algae EC50 was 2 mg/L, the fish ChV was 0.11 mg/L, the daphnid ChV was 0.15 mg/L, and the green algae ChV was 0.5 mg/L. An acute CoC of 400 p pb was calculated based on the fish 96-hour LC50 (2 mg/L) divided by an assessment factor of 5. A chronic CoC of 11 p pb was calculated based on the fish ChV (0.11 mg/L) divided by an assessment factor of 10.

Acute CoC = 400 Chronic CoC = 11
Ecotox Study Reviewer: K. Moran QA/QC: L. N ewsome 7/19/2012

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 11

SARs SAR Class

Ecotox CategoryEcotox Factors Comments:

SAT Chair: Becky Jones