Documents in Support of a 

Significant New Use Rule for 

Premanufacture Notice (PMN) P-15-0116 

Docket ID Number 

EPA-HQ-OPPT-2015-0220 

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 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 

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Sanitized SAT Report for P-15-0116 

 

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Sorption 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 

properties; poor 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 

phenols.

 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); pH7; effective concentrations based on 100% active 

ingredients and nominal concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;

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 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

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Sanitized Engineering Report for P-15-0116 

 

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Sanitized Exposure Report for P-15-0116 

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