# Documents in Support of a Significant New Use Rule for Premanufacture Notice (PMN) P-15-0116

Docket ID Number EPA-HQ-OPPT-2015-0220

# Table of Contents

1. Sanitized SAT Report for P-15-0116 2. Sanitized Engineering Report for P-15-0116 3. Sanitized Exposure Report for P-15-0116

# Sanitized SAT Report for P-15-0116Sorption to soils/sediments = v.strong PBT Potential: P3B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption nil thru skin based on physical/chemical
p roperties; p oor thru lungs based on physical/chemical properties; and poor thru GI tract based on the submitted 28-d toxicity test data. Concern for systemic toxicity and effects to the liver and GI tract based on submitted test data for . Also concern for dermal sensitization based on
p henols. Test Data: : (-) Salmonella with and without activation; (-) E. coli with and without activation; (-) for chromosome aberrations in CHL cells with and without activation; rat oral LD0 = 2000 mg/kg; no eye irritation in rabbits; no skin irritation in rabbits

P15-116: (-) Salmonella with and without activation; (-) E. coli with and without activation; (-) for chromosome aberrations in CHL cells with and without activation; rat oral LD0 = 2000 mg/kg; no eye irritation in rabbits; no skin irritation in rabbits; rat 28-day oral NOEL = 400 mg/kg (highest dose tested)

S14-8: (-) Salmonella with and without activation; (-) E. coli with and without activation; (-) for chromosome aberrations in CHL cells with and without activation; rat oral LD0 = 2000 mg/kg; no skin irritation in rabbits; mild eye irritation in rabbits; rat 28-day oral NOEL = 40 mg/kg, effects on the liver, GI tract and general systemic toxicity at 200 mg/kg and higher

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 * 0.473 daphnid 48-h LC50 * 0.86 green algal 96-h EC50 * >0.398 fish

_ chronic value * 0.048 analog daphnid

_ chronic value * 0.086

algal

_ chronic value * >0.398

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for ; SAR chemical class = with 2.6%/1.6%<500 and 29%/30%<1000; solid with mp 65/70 C (P); S = 0.005 mg/L at 25 C (P); p H7; effective concentrations based on 100% active ingredients and nominal concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;The solubility of the test substance in dilution water was reported to be 3.5 mg/L. Following a range -finding test, three replicates of P. subcapitata (5 x 103 cells/mL) were exposed to the test substance prepared as a water accommodated fraction (WAF) at nominal loading rates of 10, 18, 32, 56 or 100 mg/L. Corresponding time-weighted mean-measured concentrations of the test substance were 0.0181, 0.0756, 0.0925, 0.398 and 0.324 mg/L, as determined via LC/MS (LOD = 0.0004-0.0007 mg/L). A control group (6 replicates) was exposed to OECD medium only. Some of the measured values at the beginning and end of the exposure and the time-weighted means were inversely ordered based on loading rate. The causes for variation were considered to be that the test substance was difficult to dissolve stably in test solution; there were slight differences of stirring intensity; the test substance was multi-component; and the test solutions were WAFs. Concentrations of the test substance decreased during the exposure, and according to the study report, the cause for decreases in concentrations may have been precipitation of the test substance caused by rotation during the exposure period. The algae were illuminated with a light intensity within the range of 70-74 μE/m2/s with constant shaking (100 rpm). To prepare a test solution, an appropriate amount of the test substance was diluted with (depending on the test concentration); the solution was mixed with a magnetic stirrer for 48 hours at room temperature; solution was filtered (Qualitative filter paper No. 2, equivalent to JIS 3801 type 2, retention particle size: 5 μm); and the filtrate was transferred to the test vessels. An extra vessel for pH measurement and color observations was prepared (1 vessel/test group). The test vessels were capped with aluminum caps. Before inoculation, nominal test concentrations ≤ 32 mg/L were colorless and had no suspended solids, floating solids, or precipitation; nominal concentrations of 56 and 100 mg/L were white in color and showed suspended solids but no floating solids or precipitates. Over the course of the study, temperature ranged from 21.9-22.4°C and pH ranged from 7.8-8.0. The cell density in the control cultures increased by a factor of 562 within 72 hours. By microscopic observation at the end of exposure, in the concentration groups neither unusual cell shape (contraction, expansion, damaged cell, etc.) nor agglutination was observed, and the algae looked normal compared with that in the control group. The % inhibition of growth rates of 0.0181, 0.0756, 0.0925, 0.398 and 0.324 mg/L compared to the control were -0.7, 1.7, 0.8, 1.7, and 2.0%. Based on time-weighted mean-measured concentrations, the study report stated that the 72-hour EC50 for growth inhibition was > 0.398 mg/L; the NOEC and LOEC were 0.398 and > 0.398 mg/L, respectively. Based on nominal loading rates, the study report stated that the 72-hour EL50 for growth inhibition was > 100 mg/L; the NOEC and LOEC were 100 and > 100 mg/L, respectively.

There is some uncertainty associated with concentration, 0.398 mg/L, used to set the NOEC. This time-weighted mean-measured concentration corresponded to the second highest nominal concentration (56 mg/L) rather than the highest nominal concentration (100 mg/L). The highest two nominal concentrations were white in color and had suspended solids before inoculation suggesting that the water solubility in the test medium was exceeded even though the water solubility in dilution water was reported to be 3.5 mg/L (corresponding to a nominal concentration of 100 mg/L). This study is acceptable.

Growth Inhibition Concentration: 72-hour EC50 > 0.398 mg/L 72-hour NOEC = 0.398 mg/L

# Sanitized Engineering Report for P-15-0116

# Sanitized Exposure Report for P-15-0116