# Documents in Support of a

Significant New Use Rule for

Premanufacture Notice (PMN) P-14-0066

Docket ID Number

EPA-HQ-OPPT-2015-0220

# 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

# Sanitized SAT Report for P-14-0066

## 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: N o

Ecotox: Yes

Routes of exposure : Health: Inhalation

Ecotox: All releases to water

Fate: ;

Keywords :
Keywords: DEVEL; MUTA; N EURO; 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)

### 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: N ot absorbed from the skin, moderate absorption from

the GI tract and good absorption from the lung ( p che m ); expected to release in

the acid of the stomach. Concerns for are developmental ( N TP 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); p H7; 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

( p pb) 1

SARs

SAR Class

Ecotox Category

### Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

# Sanitized Engineering Report for P-14-0066P140066.en4

INITIAL REVIEW ENGINEERING REPORT

PMN: 14-0066

Post-Focus Draft Revision 4 5/20/2014

ENGINEER: Austin \ AG PV (kg/yr): 750,000 NX P2RECP140066.en4

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.P140066.en4

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.P140066.en4P140066.en4

INITIAL REVIEW ENGINEERING REPORT

PMN: 14-0066

Manufacturing:P140066.en4

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 2

Inhalation:

negligible (VP < 0.001 torr)P140066.en4

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: 1P140066.en4

INITIAL REVIEW ENGINEERING REPORT

PMN: 14-0066

Processing 1:

Number of Sites/ Location: 1

Baze Chemical Company New Iberia TX 70560

Days/yr: 251P140066.en4P140066.en4

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 0

Inhalation:

negligible (VP < 0.001 torr)

Dermal:P140066.en4P140066.en4

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.

Page 15P140066.en4

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 0

Inhalation:

negligible (VP < 0.001 torr)

Dermal:P140066.en4P140066.en4

# Sanitized Exposure Report for P-14-0066