### SAT Report
PMN Number: P-14-0800
SAT Date: 9/11/2014 Print Date: 9/30/2014

Related cases :

Concern levels :

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

Persistence Bioaccum Toxicity Comments
2 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: IRR –E; SENSIT; KIDNEY; UNCERT BLOOD; UNCERT REPRO/DEVEL

Summary of Assessment :

Fate : Fate Summary: P-14-0800
FATE: Solid with MP = Dec. >224 C (M) log Kow = 2.94 (M) S = 0.65 mg/L at 25 C (M) VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) POTW removal (%) = 25-50 via sorption and biodeg; All Analogs: OECD111(Hydrolysis): t1/2( p H4,7,9 @ 25C, p H9 @ 50C): >1yr/>1yr/14d/25h; OECD 301D(Closed Btl): 23.6%/28dN RB. Time for complete ultimate aerobic biodeg = mo Sorption to soils/sediments = moderate PBT Potential: P2B1 *CEB FATE: Migration to ground water = moderate

Health : Health Summary: Absorption is nil all routes based on physical/chemical

p roperties. Dissociation in GI tract is possible. Concern for irritation/corrosion to the eye, sensitization, kidney toxicity, uncertain concern for blood and repro/developmental toxicity, all based on submitted with PMN data.
Test Data: N egative in Ames assay with and without activation. Acute rat oral LD50 > 2000 mg/kg-bw Rabbit eye irritation test result in serious damage to eyes. OECD 407, 28 day oral with rats NOAEL=1000 mg/kg-bw/day (highest dose tested), N OEL = 50 mg/kg-bw/day (blood pathology). OECD 421, Reproduction/Fertility test – NOAEL for parental effects and pup growth rate was 350 mg/kg-bw/day, N OAEL for reproductive effect was 1000 mg/kg-bw/day. OECD 429, Dermal Sensitization – positive, sensitization potential in the Local Lymph Node Assay (review in PMN Gold).

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 2.7 12.18 measured: analog daphnid 48-h LC50 0.16 0.030 measured: analog green algal 96-h EC50 <1 0.046 measured: analog
fish

_ chronic value 0.27 1.218 measured: ACR daphnid

_ chronic
value 0.016 0.0030 measured: ACR

algal

_ chronic
value <1 0.014 measured: analog

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic
Value _

Ecotox Values Comments: Predictions are based on SAR nearest analog method for SAR chemical class = MW 1665; S = 0.65 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

Ecotoxicity Test Data Results for P-14-0800:Freshwater fish , freshwater invertebrate, and green algae toxicity studies were completed for a reaction product of

The PMN material is used as a The PMN material is described as a in neat form; as a 15% dispersion in during processing; and as a solid entrained in deposited on paper at end use. The molecular weight for a representative structure is 1664.84 g/mol. The PMN substance has an estimated Henry’s Law Constant of <1 x 10-8 atm-m3/mole and is expected to be nonvolatile. The water solubility of the tested analog is 0.65 mg/L at 25°C. The acute freshwater fish fish study was reported to follow EU Method C.1 (2008), OECD TG No. 203 (1992), USEPA OPPTS 850.1075 (1996), and OECD Series on Testing and Assessment No. 23 (2000). The acute freshwater invertebrate study was reported to follow EU Method C.2 (2008), OECD TG No. 202 (2004), USEPA OPPTS 850.1010 (1996), and OECD Series on Testing and Assessment No. 23 (2000). The green algae study was reported to follow Commission Directive 92/69/EEC, Part C, C.3 (1992), OECD No. 201, and International Organization for Standardization (1998) ISO/DIS 14442. All studies were conducted under GLP conditions.

The test substance information and study summaries below are for the following analogous chemical, not the actual PMN substance.

Fish Ecotoxicity Test: conducted a 96-hour fish toxicity test in zebrafish (Brachydanio rerio) with 98.3 % UVCB substance), an analog substance, under static conditions. This study was reported to follow EU Method C .1 (2008), OECD TG No. 203 (1992), USEPA OPPTS 850.1075 (1996), and OECD Series on Testing and Assessment No. 23 (2000). Following preliminary and supplementary tests, single replicates of seven B. rerio were exposed to a control (filtered tap water) or to the test substance at nominal concentrations of 5.535, 6.912, 8.64, 10.8, and 13.5 mg/L. Corresponding geometric mean-measured concentrations of the test substance were 3.84, 4.79, 6.53, 8.49, and 10.62 mg/L, as determined via HPLC with UV-VIS detection (LOQ = 0.1 μg/mL; LOD = ~0.05 μg/mL). The analytically determined geometric mean test substance concentrations in the test media ranged from 87-92% of nominal at test initiation and from 54-67% of nominal at test termination. A single test substance stock solution was prepared according to the water accommodated fraction (WAF) method. A supersaturated test substance stock solution (nominally 1000 mg/L) was prepared by dispersing/dissolving the test substance amount without the use of any organic solvent into the test medium (filtered and aerated aquarium water) two days before the start of the study (day -2). This solution was shaken for 24 hours at ~30°C, and then was left settling for 24 hours at ~20°C. Thereafter, the solution was filtrated by paper filter (0.22 μ m). The test solutions were prepared by the appropriatediluting of the stock solution on day 0. Over the course of the study, temperature ranged from 22.8-23.1°C, p H ranged fro m 8.39-8.46, and dissolved oxygen ranged from 90-93%. Dilution water hardness was 238 mg/L as CaCO3. A loading rate of 0.630 g fish/L was reported. The cumulative percent mortalities at the geometric mean-measured test concentrations of 0 (control), 3.84, 4.79, 6.53, 8.49, and 10.62 mg/L were 0, 0, 0, 0, 14, and 29%, respectively. At the test concentration of 8.49 mg/L, decreased activity and low locality in the aquarium were observed at 96 hours. Although the following concerns lend some uncertainty with respect to the exposure regime, the test is considered adequate: · The study tested concentrations that are above the reported water solubility of the test substance (0.65 mg/L at 25°C). · A single test substance stock solution was prepared according to the WAF method: the test substance was dispersed/dissolved in water, and the resulting stock solution was shaken, allowed to settle, filtered, and serially diluted to prepare the test solutions. According to OECD Series on Testing and Assessment No. 23 (2000), WAFs are prepared individually and not by serial dilution of a single stock WAF. · Measured concentrations differed from the nominal values by greater than 20% at all concentrations at test termination. Based on geometric mean-measured concentrations, the 96-hour LC50 (95% confidence interval) was 12.18 (8.21-18.08) mg/L. 96-hour LC50 = 12.18 mg/L

Daphnid Ecotoxicity Test: conducted a 48-hour immobilization toxicity test in water fleas (Daphnia magna) with (100% p urity; 98.3 % UVCB substance), an analog substance, under static conditions. This study was reported to follow EU Method C.2 (2008), OECD TG No. 202 (2004), USEPA OPPTS 850.1010 (1996), and OECD Series on Testing and Assessment No. 23 (2000). Following a preliminary study, four replicates of five daphnids were exposed to a control (ISO medium) or to the test substance at nominal concentrations of 0.016, 0.031, 0.063, 0.125 and 0.25 mg/L. Corresponding geometric mean-measured concentrations of the test substance were 0.012, 0.025, 0.051, 0.103 and 0.25 mg/L, as determined via HPLC with UV-VIS detection (LOQ = 0.1 μg/mL; LOD = ~0.05 μg/mL). The analytically determined geometric mean test substance concentrations in the test media ranged from 102-119% of nominal at test initiation and from 52-97% of nominal at test termination. A single test substance stock solution was

p repared according to the water accommodated fraction (WAF) method. A supersaturated test substance solution (1000 mg/L) was prepared by dispersing/dissolving the test substance amount without the use of any organic solvent into the test medium (ISO Medium) two days before the start of the study (on day -2). This solution was shaken for 24 hours at ~30°C, and then was left settling for 24 hours at ~30°C. Thereafter, the solution was filtrated by paper filter (0.22 μ m). The test solutions were prepared by the appropriate diluting of the stock solution on day 0. Over the course of the study, temperature ranged from 19.9-20.2°C, p H ranged fro m 7.79-7.89, and dissolved oxygen ranged from 6.3-6.7 mg/L. Dilution water hardness was 144 mg/L as CaCO3. A loading rate of 125 daphnids/L, which exceeds the recommended loading of 40 daphnids/L (USEPA OPPTS 850.1010, 1996), was calculated. The cumulative percent immobility at geometric mean-measured test concentrations of 0 (control), 0.012, 0.025, 0.051, 0.103 and 0.25 mg/L were 0, 0, 50, 75, 100 and 100%, respectively. Although the following concerns lend some uncertainty with respect to the exposure regime, the test is considered adequate:· A single test substance stock solution was prepared according to the WAF method: the test substance was dispersed/dissolved in media, and the resulting stock solution was shaken, allowed to settle, filtered, and serially diluted to prepare the test solutions. According to OECD Series on Testing and Assessment No. 23 (2000), WAFs are prepared individually and not by serial dilution of a single stock WAF. · Measured concentrations differed from the nominal values by greater than 20% at all test concentrations except the highest at test termination. Based on geometric mean-measured concentrations, the 48-hour EC50 (95% confidence interval) was 0.030 (0.024-0.037) mg/L. 48-hour EC50 = 0.030 mg/L

Algal Ecotoxicity Test: conducted a 72-hour growth inhibition test in algae (Pseudokirchneriella subcapitata) with (100% p urity; 98.3 % UVCB substance), an analog substance, under static conditions. This study was reported to follow Commission Directive 92/69/EEC, Part C, C.3 (1992), OECD No. 201, and International Organization for Standardization (1998) ISO/DIS 14442. Following two preliminary studies, six replicates of P. subcapitata (104 cells/mL) were exposed to a control medium (algal mineral salts test medium) and three replicates of P. subcapitata (104 cells/mL) were exposed to the test substance at nominal concentrations of 0.008, 0.016, 0.031, 0.063, 0.125 and 0.25 mg/L. Corresponding geometric mean-measured concentrations of the test substance were 0.004, 0.006, 0.012, 0.017, 0.024 and 0.052 mg/L, as determined via HPLC with UV-VIS detection (LOQ = 0.1 μg/mL; LOD = ~0.05 μg/mL). The analytically determined geometric mean test substance concentrations in the test media ranged from 65-91% of nominal at test initiation and from 5-27% of nominal at test termination. The algae were illuminated with a light intensity of 8166 lux with constant shaking. A single test substance stock solution was prepared according to the water accommodated fraction (WAF) method. A supersaturated test substance stock solution (nominally 1000 mg/L) was prepared by dispersing/dissolving the test substance amount without the use of any organic solvent into the test medium (OECD medium) two days before the start of the study (on day -2). This solution was shaken for 24 hours at 30°C, and then was left settling for 24 hours at 19.1-19.6°C. Thereafter, the solution was filtrated by paper filter (0.22 μ m). The test solutions were prepared by the appropriate diluting of the stock solution on day 0. The test flasks were covered with air- p ermeable stoppers. Over the course of the study, temperature ranged from 23.0-23.3°C, and pH ranged from 8.78-9.83. The cell density in the control cultures increased by a factor of 70 within 72 hours. Although the following concerns lend some uncertainty with respect to the exposure regime, the test is considered adequate: · A single test substance stock solution was prepared according to the WAF method: the test substance was dispersed/dissolved in media, and the resulting stock solution was shaken, allowed to settle, filtered, and serially diluted to prepare the test solutions. According to OECD Series on Testing and Assessment No. 23 (2000), WAFs are prepared individually and not by serial dilution of a single stock WAF. · Measured concentrations differed from the nominal values by greater than 20%. Based on geometric mean-measured concentrations, the 72-hour EC50’s for biomass, growth rate and yield were 0.046, 0.143 and 0.046 mg/L, respectively. The 72-hour NOEC and LOEC were 0.012 and 0.017 mg/L, respectively. The 72-hour ChV was 0.014 mg/L. 72-hour EC50 (Biomass; Yield) = 0.046 mg/L72-hour EC50 (Growth rate) = 0.143 mg/L
N OEC = 0.012 mg/L LOEC = 0.017 mg/L ChV = 0.014 mg/L

The 96-hour freshwater fish toxicity test (LC50 = 12.18 mg/L), the 48-hour freshwater invertebrate (daphnid) toxicity test (LC50 = 0.030 mg/L), and the 72-hour green algae toxicity test (EC50 = 0.046 mg/L; N OEC = 0.012 mg/L; LOEC = 0.017 mg/L; ChV = 0.014 mg/L) with an analog of P-14-0800 were adequate. Applying an acute-to-chronic (ACR) ratio of 10 to the acute experimental values yields chronic values of 1.218 mg/L (=12.18/10) for fish and 0.003 mg/L (=0.030/10) for daphnids. For comparative purposes, the 96-hour fish LC50 of 2.7 mg/L, the 48-hour daphnid LC50 of 0.16 mg/L, the 96-hour green algae EC50 of <1 mg/L, and the fish, daphnid, and green algae chronic values (ChV) of 0.27, 0.016, and <1 mg/L, respectively, were

p redicted based on the SAR nearest analog method for The daphnid experimental results indicate that it is the most acutely sensitive species. Based on the daphnid experimental EC50 of 0.030 mg/L and application of an assessment factor of 5, the acute concentration of concern (CoC) for P-14-0800 is 0.006 mg/L (=0.030/5) or 6 p pb. Based on predicted and experimental ChV values, the daphnid is the most sensitive species on a chronic exposure basis. Applying an assessment factor of 10 to the daphnid ChV of 0.003 mg/L yields a chronic CoC of 0.0003 mg/L (=0.003/10) or 1 p pb rounded to one significant figure for
P-14-0800.

Acute CoC = 6 p pb Chronic CoC = 1 p pb

Ecotox Study Reviewer: R. Sternberg September 17, 2014

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

SARs
SAR Class Ecotox Category

Ecotox Factors Comments:

SAT Chair: Viktor Morozov