### SAT Report PMN Number: P-13-0355 SAT Date: 4/9/2013 Print Date: 7/1/2013

Related cases :

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 1-2 3

Persistence Bioaccum Toxicity Comments 3 11

Exposure Based Review : Health: N o Ecotox: N o
Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: All releases to water Fate: ;
Keywords : Keywords: SENS-S,L MUTA ONCO DEVEL MALE REPRO LIVER KIDNEY
Summary of Assessment :

Fate : Fate Summary: P-13-0355 FATE: MW = 1200 with 1% < 500 and 34% < 1000 Solid with MP = 80 C (M) S = N egl. VP < 1.0E-6 torr at 25 C (E)BP > 400 C (E) H < 1.00E-8 (E) POTW removal (%) = 90 via sorption; Japanese Biodeg Test: 2%(BOD), 1%(HPLC)/28d; Japanese Bioconc. Test: Peak A,B,C: <32-<41,<15-< 20,<12-<16 low); <4-<5,<2-<3,<2(high). Time for complete ultimate aerobic biodeg > mo Sorption to soils/sediments = v.strong PBT Potential: P3B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption of the neat material is nil all routes, while absorption of the low molecular weight fraction (34% < 1000, 1% < 500) for the material in solution is poor all routes, based on physical/chemical properties. Due to low water solubility, expect very poor oxidation of the terminal double bond via an intermediate. There are uncertain concerns for skin and lung sensitization, mutagenicity, oncogenicity, and developmental, male reproductive, liver, and kidney toxicities, based on

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

fish 96-h LC50 * >0.0037 96-hour LC50 > 0.0037 mg/L daphnid 48-h LC50 * >0.00706 48-hour EC50 > 0.00706 mg/L green algal 96-h EC50 * 0.034 fish

_ chronic value * daphnid

_ chronic value *

algal

_ chronic value * 0.016 ChV = 0.0157 mg/L (Geometric Means) Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for nonionic polymers; SAR chemical class = p olyme r - nonionic - ether; MW 1200 with 34% < 1000 and 1% < 500; solid with mp = 80 C (M); S < 0.001 mg/L at 20 C (P); 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;

Fish Ecotoxicity Test: Mitsubishi Chemical Safety Institute Ltd. (M.S.I.) conducted a 96-hour limit test in medaka (Oryzias latipes) with P-13-0355 (> 99% p urity) under static-renewal conditions with 24 hour renewal. This study was reported to follow the test method relating to new chemical substances“Algal growth inhibition test, Daphnia sp. acute immobilization test, and fish acute toxicity test” (Yakushokuhatsu No. 1121002, Heisei 15.11.13 Seikyoku No. 2, Kanpokihatsu No. 031121002, 2003). Following a range-finding test, single replicates of ten O. latipes were exposed to a dilution water control (dechlorinated tap water) or the test substance as a water accommodated fraction (WAF) at a nominal loading rate of 100 mg/L. A corresponding time weighted mean measured concentration of 0.0037 mg/L was determined by HPLC analysis (LOD = 0.00008 mg/L). To prepare a stock solution, the test substance was mixed with the dilution water to give a 100 mg/L (loading rate) solution. This solution was sonicated for 1 hour, then mixed with a magnetic stirrer for 3 hours (24°C, room temperature) and filtrated through a filter (0.45 μm p ore-size). This filtrate was then used as the test solution. After preparation, the test solution was kept at 24±1°C in an incubator or incubation room. The appearance of all test solutions was colorless during exposure. Over the course of the study, temperature ranged from 23.9

–24.6  ̊ C, p H ranged fro m 7.4

–8.0 and dissolved oxygen ranged from 6.8

–7.6 mg/L. Dilution water hardness was 40 mg CaCO3/L. A loading rate of 0.306 g fish/L was calculated. Percent mortality at 96 hours was 10% in the control group and 0% in the test group. Based on time weighted mean measured concentrations, the 96-hour LC50 was > 0.0037 mg/L. This study is acceptable. 96-hour LC50 > 0.0037 mg/L

Daphnid Ecotoxicity Test: Mitsubishi Chemical Safety Institute Ltd. (M.S.I) conducted a 48-hour limit test in water fleas (Daphnia magna) with P-13-0355 (> 99% p urity) under static-renewal conditions with 24 hour renewal. This study was reported to follow the test method relating to new chemical substances “Algal growth inhibition test, Daphnia sp. acute immobilization test, and fish acute toxicity test” (Yakushokuhatsu No. 1121002, Heisei 15.11.13 Seikyoku No. 2, Kanpokihatsu No. 031121002, 2003). Following a range-finding test, four replicates of five D. magna were exposed to a dilution water control (dechlorinated tap water) or the test substance as a water accommodated fraction (WAF) at a nominal loading rate of 100 mg/L. A corresponding mean measured concentration of 0.00706 mg/L was determined by HPLC analysis (LOD = 0.00008 mg/L). To p repare a stock solution, the test substance was mixed with the dilution water to give a 100 mg/L (loading rate) solution. This solution was sonicated for 1 hour, then mixed with a magnetic stirrer for 3 hours (20°C, room temperature) and filtrated through a filter (0.45 μm pore-size). This filtrate was then used as the test solution. After preparation, the test solution was kept at 24±1°C in an incubator or incubation room. The appearance of all test solutions was colorless during exposure. Over the course of the study, temperature ranged from 19.9

–20.5  ̊ C, p H ranged from 7.9

–8.3 and dissolved oxygen ranged from 7.8

–8.8 mg/L. A loading rate of 50 daphnia/L was calculated. The water hardness was 40 mg/L. Percent immobilization in the control and 100 mg/L test group was 0% and 5%, respectively. Based on time weighted mean measured concentrations, the 48-hour EC50 was > 0.00706 mg/L. This study is acceptable. 48-hour EC50 > 0.00706 mg/L

Algal Ecotoxicity Test: Mitsubishi Chemical Safety Institute Ltd. (M.S.I) conducted a 72-hour toxicity study in green algae (Pseudokirchneriella subcapitata) with P-13-0355 (> 99% p urity) under static conditions. This study was reported to follow the test method relating to new chemical substances “Algal growth inhibition test, Daphnia sp. acute immobilization test, and fish acute toxicity test”(Yakushokuhatsu No. 1121002, Heisei 15.11.13 Seikyoku No. 2, Kanpokihatsu No. 031121002, 2003). Following a range-finding study, three replicates of P. subcapitata (5 x 103 cells/mL) were exposed to a medium control or the test substance as a water accommodated fraction (WAF) at nominal loading rates of 10, 18, 32, 56 and 100 mg/L. Corresponding time weighted mean measured concentrations of < 0.00008 (control), 0.00382, 0.00539, 0.0124, 0.0199 and 0.0521 mg/L were determined via HPLC analysis (LOD = 0.00008 mg/L). The algae were illuminated with a light intensity within the range of 63-72 μE/m2/s with constant shaking. To p repare the test solutions, the test substance was added to the medium to give 10, 18, 32, 56 and 100 mg/L loading rate samples; these samples were sonicated for 1 hour, mixed with a magnetic stirrer for 3 hours and filtrated through a filter (0.45 μm pore-size). All test solutions were clear and colorless. Over the course of the study, temperature ranged from 22.7

–23.4°C and pH ranged from 7.9

–9.7. The cell density in the control cultures increased by a factor of 633 within 72 hours. As the inhibition rate at the highest concentration (the average measured concentration: 0.0521 mg/L, loading rate: 100 mg/L) was less than 50%, the EC50 and the EL50 values were shown as the range, "> test concentration". In all test groups, color of test cultures observed with naked eye showed a tendency to get more greenish during the exposure period. By microscopic observation at the end of exposure, in all concentration groups neither unusual cell shape of algae (contraction, expansion, damaged cell etc.) nor agglutination was observed, and the algae looked normal compared with that in the control group. Based on time weighted mean measured concentrations, the 72- hour EC50 for biomass and growth rate was 0.0340 and > 0.0521 mg/L, respectively. The 72-hour NOEC and LOEC values are 0.0124 and 0.0199 mg/L, respectively, which corresponds to a ChV (geometric mean of the NOEC and LOEC values) of 0.0157 mg/L. This study is acceptable. 72-hour EC50 (growth rate) > 0.0521 mg/L 72-hour EC50 (biomass) = 0.0340 mg/L 72-hour NOEC = 0.0124 mg/L 72-hour LOEC = 0.0199 mg/L ChV = 0.0157 mg/L

The acute base set toxicity studies for the 96-hour fish, 48-hour Daphnia, and 72-hour algal studies are acceptable. For comparative purposes, p redictions based on nonionic polymers QSAR are No effects at saturation for all acute and chronic endpoints. The acute CoC for P-13-0355 is determined from the experimental 72-hour EC50 algal toxicity study of 0.034 mg/L. The acute CoC is derived by dividing the 72-hour algal EC50 of 0.034 mg/L (34 p pb) by an assessment factor of 4 yielding an acute CoC of 8.5 p pb. The chronic CoC is derived by dividing the experimental geometric means from the algal study of 0.0157 mg/L value by an uncertainty factor of 10, yielding 0.00157 mg/L or 1.57 p pb.

Acute CoC = 8.5 p pb Chronic CoC = 2 p pb

Ecotox Study Reviewer: Amuel Kennedy

Factors Values Comments Assessment Factor 10Concentration of Concern ( p pb) 2 *

SARs nonionic polymers SAR Class p olyme r -nonionic-ether Ecotox Category N onionic Polymers

Ecotox Factors Comments:

SAT Chair: J. Kwiat