Documents in Support of a 

Significant New Use Rule for 

Premanufacture Notice (PMN) P-14-0066 

Docket ID Number 

EPA-HQ-OPPT-2015-0220 

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 Table of Contents 

1. Sanitized SAT Report for P-14-0066 

2. Sanitized Engineering Report for P-14-0066 

3. Sanitized Exposure Report for P-14-0066 

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Sanitized SAT Report for P-14-0066 

 

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SAT Report

PMN Number: P-14-0066

SAT Date: 11/15/2013

Related cases: 

Health related cases: 

Ecotox related cases: Analogs: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 3

 Persistence Bioaccum Toxicity Comments

2 11

Exposure Based Review:

Health: No

Ecotox: Yes

Routes of exposure: Health: Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: DEVEL; MUTA; NEURO; ONCO (UNCERT); MALE REPRO 

(UNCERT); AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-14-0066

FATE: Estimations for covalent ion pair 

Solid with MP = 349 C (E)

log Kow = -1.72 (E) 

S = 9 g/L at 25 C (E)

VP < 1.0E-6 torr at 25 C (E)

BP > 400 C (E)

H < 1.00E-8 (E)

log Koc = 5.91 (E)

log Fish BCF = 1.52 (E)

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log Fish BAF = 1.58 (E) 

POTW removal (%) = 90 via sorption and biodeg

Time for complete ultimate aerobic biodeg = mo

Sorption to soils/sediments = v.strong

PBT Potential: P2B1

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Not absorbed from the skin, moderate absorption from 

the GI tract and good absorption from the lung (pchem); expected to release in 

the acid of the stomach. Concerns for are developmental (NTP rabbit oral developmental 

toxicity LOEL = 25 mg/kg, resorptions at all doses); mutagenicity [(+) for SCE in CHO cells, (+) 

for sperm head abnormalities]; and neurotoxicity; uncertain concerns for male reproductive 

toxicity based on the mutagenicity tests and oncogenicity.

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 1.0

daphnid 48-h LC50 0.634

green algal 96-h EC50 0.139

fish _ chronic value 0.008

daphnid _ chronic 

value

0.004

algal _ chronic 

value

0.053

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for 

SAR chemical class = ; log Kow = 4.9 (EPI); S = >500,000 

mg/L at 25 C (P); solid with unknown mp (P); pH7; effective concentrations based on 100% 

active ingredients and measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC 

<2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

1

SARs

SAR Class

Ecotox Category 

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Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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Sanitized Engineering Report for P-14-0066 

 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 14-0066 

Post-Focus Draft Revision 4 5/20/2014

ENGINEER: Austin \ AG 

PV (kg/yr): 750,000 NX P2REC

 

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SUBMITTER: Baze Chemical Company 

 

 

 

MSDS: Yes Label: No

Gen Eqpt: chemical splash goggles and face shield / impervious suit with 

gloves, boots, and full head and face protection / local exhaust or general 

room ventilation is usually required

Respirator: If exposure can exceed the PEL/TLV, use only NIOSH/MSHA approved 

air-purifying or supplied air respirator operated in a positive pressure 

model per the NIOSH/OSHA 1981 Occuaptional Health Guidelines for chemical 

hazard.

Health Effects: May be harmful if swallowed, inhaled, or absorbed through the 

skin. Avoid contact with skin, eyes, or clothing. / Eyes: causes irritation 

of the eyes, and with greater exposures it can cause burns that may result in 

permanent impariment of vision, even blindness. / Skin: contact with skin can 

cause irritation or severe burns and scarring with greater exposure. / 

Inhalation: effects from inhalation of mist may vary from mild irritation to 

serious damange of the upper respiratory tract, depending on severity of 

exposure. / Ingestion: swallowing may cause severe burns of mouth, throat, 

and stomach.

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TLV/PEL:

None Established 

 

 

 

 

 

 

 

 

 

 

SAT (concerns) (11/15/2013):

Related Cases and Misc SAT Info: 

Analogs: 

Migration to groundwater: Negligible 

PBT rating: P2B1T1 

Health: 1-2 Inhalation 

Eco: 3 Water (All releases to water with a CC = 1 ppb), XB Testing (Testing 

desired) 

OCCUPATIONAL EXPOSURE RATING: 1A

NOTES & KEY ASSUMPTIONS: 

Generated by the 09/30/2013 version of ChemSTEER. 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 14-0066 

Manufacturing: 

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 2

 

Inhalation:

negligible (VP < 0.001 torr)

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Dermal:

Exposure to Liquid at 52.00% concentration

High End:

> Potential Dose Rate: 1.2E+3 mg/day over 71 days/yr

> Lifetime Average Daily Dose: 1.9E+0 mg/day over 71 days/yr

> Average Daily Dose: 3.2E+0 mg/day over 71 days/yr

> Acute Potential Dose: 1.7E+1 mg/day over 71 days/yr

Number of workers (all sites) with dermal exposure: 1

Exposure to Liquid at 52.00% concentration

High End:

> Potential Dose Rate: 1.2E+3 mg/day over 71 days/yr

> Lifetime Average Daily Dose: 1.9E+0 mg/day over 71 days/yr

> Average Daily Dose: 3.2E+0 mg/day over 71 days/yr

> Acute Potential Dose: 1.7E+1 mg/day over 71 days/yr

Number of workers (all sites) with dermal exposure: 1

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 14-0066 

Processing 1: 

Number of Sites/ Location: 1 

Baze Chemical Company New Iberia TX 70560

Days/yr: 251

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 0 

Inhalation:

negligible (VP < 0.001 torr)

Dermal:

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 14-0066 

Use: 

Number of Sites/ Location: 144 

Unknown Sites 

Days/yr: 350

 

 

 

 

 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below may coincide with 

daily releases from the other sources to the same medium.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 0

Inhalation:

negligible (VP < 0.001 torr)

Dermal:

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Sanitized Exposure Report for P-14-0066 

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