Support Documents for 

Significant New Use Rule (SNURs) on 

Premanufacture Notices (PMNs) 

P-01-384, P-01-385, P-01-386, 

P-01-387, and P-01-388 

EPA Docket EPA-HQ-OPPT-2011-0577 

EPA SANITIZED Page 1 of 40
Index

A-001 Structure Activity Team (SAT) Report for 

PMNs P-01-384, P-01-385, P-01-386, 

 P-01-387, and P-01-388 

A-002 Initial Review Engineering Report for 

PMNs P-01-384, P-01-385, P-01-386, 

 P-01-387, and P-01-388 

A-003 Initial Review Exposure Report for 

PMNs P-01-384, P-01-385, P-01-386, 

 P-01-387, and P-01-388 

EPA SANITIZED Page 2 of 40
A-001 

Structure Activity Team (SAT) Report

for PMNs P-01-384, P-01-385, P-01-386, 

P-01-387, and P-01-388 

EPA SANITIZED Page 3 of 40
 

 

 

EPA SANITIZED Page 4 of 40
 

 

 

EPA SANITIZED Page 5 of 40
EPA SANITIZED Page 6 of 40
 

 

 

EPA SANITIZED Page 7 of 40
 EPA SANITIZED Page 8 of 40
EPA SANITIZED Page 9 of 40
EPA SANITIZED Page 10 of 40
EPA SANITIZED Page 11 of 40
EPA SANITIZED Page 12 of 40
EPA SANITIZED Page 13 of 40
EPA SANITIZED Page 14 of 40
EPA SANITIZED Page 15 of 40
EPA SANITIZED Page 16 of 40
EPA SANITIZED Page 17 of 40
EPA SANITIZED Page 18 of 40
EPA SANITIZED Page 19 of 40
EPA SANITIZED Page 20 of 40
Page 26 of 45 EPA SANITIZED Page 21 of 40
EPA SANITIZED Page 22 of 40
A-002 

Initial Review Engineering Report

for PMNs P-01-384, P-01-385, P-01-386, 

P-01-387, and P-01-388 

EPA SANITIZED Page 23 of 40
FINAL-Revised 8/9/01

Changes are in bold.

INITIAL REVIEW ENGINEERING REPORT 

PMN: 01-384, 385, 386, 387 & 388 ENGINEER: Hall/TMB 

PV (kg/yr): 

SUBMITTER: 

USE: 

OTHER USES: None found. 

MSDS: Yes Label: No 

General Eqp.: 

Respirator: 

Health Effects: 

TLV/PEL (PMN or raw materials): 

CRSS: (same for all chemicals) 

Chemical Category: 

VP: <1E-06 torr @25C 

S-H2O: d ersible

MW: 

Phys State: Neat: solid (est); Mfg: 

 Proc/Form: 

; End Use: 

Consumer Use: No 

SAT (concerns): 

Related cases: 

Ground Water: negligible 

Health: 385, 386, 387: 1 no 

384, 388: 1-2 inhalation, dermal, ingestion, 

Eco: All: 2 all exposures needed for 

environmental risk 

PBT: P2B1T1 

EPA SANITIZED Page 24 of 40
OCCUPATIONAL EXPOSURE RATING: 2-3 

EPA SANITIZED Page 25 of 40
INITIAL REVIEW ENGINEERING REPORT Page # 3 

PMN: 01-384, 385, 386, 387 & 388 

ASSUMPTIONS: The submission does not indicate if the production 

volume is for a combination of the substances or for each individual 

substances, therefore assessed as if any one substance is produced 

at the production volume. All release and exposure estimates are 

applicable to all PMN substances, unless otherwise noted. 

PREVENTION CONSIDERATIONS: 

 

EPA SANITIZED Page 26 of 40
INITIAL REVIEW ENGINEERING REPORT Page # 4 

PMN: 01-384, 385, 386, 387 & 388 

EXPOSURE-BASED REVIEW 

EXPOSURE-BASED REVIEW 

EPA SANITIZED Page 27 of 40
INITIAL REVIEW ENGINEERING REPORT Page # 5 

PMN: 01-384, 385, 386, 387 & 388 

MFG: 

Site/Location: 

Days/yr: 

Process Description: 

ENVIRONMENTAL RELEASES (Eqpt. cleaning, container residue, etc.): 

 

NOTE: 

 

from: 

to: 

basis: 

 

 

 

OCCUPATIONAL EXPOSURE 

 Tot. # of workers: (submission) 

 Days/yr: (submission, based on one day per 

batch) 

Inhalation: negligible (VP < 0.001 torr ) 

Dermal with : 900 mg/day 

 

Basis: 

Note: 

EPA SANITIZED Page 28 of 40
INITIAL REVIEW ENGINEERING REPORT Page # 6 

PMN: 01-384, 385, 386, 387 & 388 

PROC: 

Site/Location: (submission) 

Days/yr: (submission) 

Process Description: 

ENVIRONMENTAL RELEASES (Eqpt. cleaning, container residue, etc.): 

 

 

 

 

OCCUPATIONAL EXPOSURE 

 Tot. # of workers: (submission) 

 Days/yr: 

Inhalation: negligible (VP < 0.001 torr

Dermal : 900 mg/day 

 

Basis: 

EPA SANITIZED Page 29 of 40
INITIAL REVIEW ENGINEERING REPORT Page # 7 

PMN: 01-384, 385, 386, 387, 388 

USE: 

 

Site/Location: 

Days/yr: 

Process Description: 

ENVIRONMENTAL RELEASES (Eqpt. cleaning, container residue, etc.): 

 

 

 

from: 

basis: 

OR 

from: 

EPA SANITIZED Page 30 of 40
INITIAL REVIEW ENGINEERING REPORT Page # 8 

PMN: 01-384, 385, 386, 387, 388 

USE: (cont) 

OCCUPATIONAL EXPOSURE 

 Tot. # of workers: 

 Days/yr: 

Inhalation: 

<3.8 mg/day (upper limit) 

<0.2 mg/day (lower limi

Number of w

Basis: 

Note: 

Dermal with : 110 mg/day 

 

Basis: 

EPA SANITIZED Page 31 of 40
A-003 

Initial Review Exposure Report

for PMNs P-01-384, P-01-385, P-01-386, 

P-01-387, and P-01-388 

EPA SANITIZED Page 32 of 40
EPA SANITIZED Page 33 of 40
 

 

EPA SANITIZED Page 34 of 40
 

EPA SANITIZED Page 35 of 40
EPA SANITIZED Page 36 of 40
EPA SANITIZED Page 37 of 40
EPA SANITIZED Page 38 of 40
 

 

EPA SANITIZED Page 39 of 40
8/15/01 FINAL Page 1 of 1 

POST FOCUS EXPOSURE REPORT 

P-01-384c Reviewer: Wormell/Flessner 

No exposure assessment needed; the revised engineering report dropped the original 

 release amount was below assessment threshold. 

EPA SANITIZED Page 40 of 40