# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-09-207

EPA Docket EPA-HQ-OPPT-2010-1075

# Index
A-001 Structure Activity Team (SAT) Report for PMN P-09-207
A-002 Initial Review Engineering Report for PMN P-09-207
A-003 I nitial Review Exposure Report for PMN P-09-207

# A-001 Structure Activity Team (SAT) Report
for PMN P-09-207

## SAT Report PMN Number: P-09-0207 SAT Date: 2/20/2009

Related cases : Health related cases: Ecotox related cases:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 2 3 Health: ; Eco: worst case 2 Health: ; Eco: as intended in PMN

Persistence Bioaccum Toxicity Comments 1 1 1
Exposure Based Review : Health: Ecotox: N o
Routes of exposure : Health: Dermal, inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: EYE; LUNG; IRR-E,S,MM; AQUATOX
Summary of Assessment :
Fate : Fate Summary: FATE: Liquid with MP = 22 EC (M) S = Disp. VP < 1.0E-6 torr at 25 EC (E) BP > 400 EC (E) H < 1.00E-8 (E) POTW removal (%) = 90 via sorption and biodeg; OECD 301E: 96%/28d; OECD 209: 3-h EC50 = 98 mg/L. Time for complete ultimate aerobic biodeg = wk Sorption to soils/sediments = moderate PBT Potential: P1B1 *CEB FATE: Migration to ground water = negl due to biodeg

### Health : Health Summary: Absorption is poor from the skin, moderate from the GI tract, and good from the lung (analog). Concern for effects on the lung; irritation to eye, skin (chronic), mucous membranes and lung based on properties of the compounds. As a the PMN substance may anesthetize the eye allowing considerable damage before anything is noticed.

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 0.72 worst case daphnid 48-h LC50 0.72 worst case green algal 96-h EC50 0.72 worst case fish

_ chronic value 0.14 worst case daphnid

_ chronic value 0.14 worst case algal

_ chronic value 0.18 worst case Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for ; SAR chemical class = p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;
This PMN came with ecotoxicity data. Attached spreadsheet shows details. Below are conclusions

Conclusion: The 96-hr LC50 acute fish test is considered invalid. There is no information p roviding details on the test concentration replication, whether the test was static or flow-thru, or whether the testing concentrations were nominal or measured. The nominal concentrations reported are not acceptable because the PMN substance is a moderately dispersible . Toxicity of the PMN substance is therefore based on ECOSAR predictions for the fish acute 96-hr LC50 test with a value of 0.720 mg/L. The COC is derived by dividing the acute value (0.720 mg/L) by an uncertainty (assessment) factor of 10, yielding a COC of 0.072 mg/L or 72 p pb. The PMN substance, P09-207 represents a moderate concern for ecotoxicity for the intended product based on ECOSAR predictions. However, there is a high concern for toxicity for worst case scenario that can be made under the given CAS name for . Under the PMN definition, shorter could be made and sold in commerce that would have higher toxicity to aquatic organisms than the substance tested in these assays. Consequently, the predicted values from ECOSAR will be used for assessing ecological hazard for the environment. The predicted concern concentration is 1 p pb.

Factors Values Comments

### Assessment Factor 10 Concentration of Concern ( p pb) 14

SARs SAR Class

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

# A-002 Initial Review Engineering Report
for PMN P-09-207

### INITIAL REVIEW ENGINEERING REPORT P-09-0207 Focus Ready Draft 2/26/2009

ENGINEER: Jon \ DDH PV (kg/yr):

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

MSDS: LABEL : Gen Eqpt: Respirator:

Health Effects :

TLV/PEL : -

CRSS: (12:00:00 AM): Chemical Name:

Consumer Use:
SAT (concerns): (2/19/2009 ):

Related Cases and Misc SAT Info: Eco rating of PMN as intended is: 2; Eco rating using worst case 5 EO units is 3. Migration to groundwater : negl due to biodeg PBT rating: P 1 B 1 T 1 Health: 2, Dermal, Inhalation Eco: 3, Water (All releases to water with a CC = 14 ppb)

OCCUPATIONAL EXPOSURE RATING: 1ANOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE -BASED REVIEW: N o (0 criteria met)P-09-0207

Use:

Number of Sites/Location:

Basis: Process Description:



## ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:P-09-0207

Manufacturing

Number of Sites/Location:

Basis: Process Description:



## ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

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

# A-003 Initial Review Exposure Report
for PMN P-09-2072/25/2009 Page of

INITIAL REVIEW EXPOSU RE REPORT (IRExR)

Chemical ID: P090207 Reviewer: Cinalli
Results Table: Dose, Concentration, and Days Exceeded Results Summary

Exposure Scenario 1 Water Landfill Stack Air Fugitive Air Drinking Water Fish Ingestion
ADR LADD ADR LADD 7Q10 CC=14 PDM Days Exceeded LADD ADR LADD ADR LADD Release activity(ies) 2 ; exposure calculation(s) 3 mg/kg/day mg/kg/day mg/kg/day mg/kg/day μ g/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day
max Acute Eco --- --- --- --- 19.83 --- --- --- --- --- ---

1 Exposure scenario titles consist of release activ ity followed by exposure calculation abbreviation. 2 Release activities are from engineering report's Manufactur ing (Mfg), Processing (Proc) and Use release activity labels. Multiple release activities are combined in one exposure scenario if their releases occur at same location. 3 Exposure calculations are Acute Dose Rate (ADR), Lifetime Average Daily Dose (LADD), and Probabilistic Dilution Model (PDM). There may be one, two, or all three exposure calculations per exposure scenario. CC is the aquatic concentration of concern.

Remarks:

Fate test recommendations?:2/25/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090207 Assessor: Cinalli

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: Release Activity: max Acute Eco Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr:

Per Site Release: (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:2/25/2009 Page of

INITIAL EXPOSURE REVIEW REPORT

Chemical ID: P090207

SCENARIO NUMBER:1 RELEASE ACTI VITY: max Acute Eco

FACILITY NAME:

FACILITY LOCATION:

DISCHARGE TYPE:
EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT FLOW (MLD) CONCENTRATION ( μ g/L) 5.96 13.66 19.83 24.54 NA

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion Units

Cancer

LADD pot 7.63E-07 mg/kg/day 0.00 mg/kg/day

LADC pot 3.92E-05 mg/L 0.00 mg/kg

Acute

ADR pot 1.14E-03 mg/kg/day 0.00 mg/kg/day

Surface Water Comments:2/25/2009 Page of



## LEGEND FOR NEW CHEMICAL S EXPOSURE REPORT

This new chemicals exposure report wa s prepared by the Exposure Assessment Branch (EAB) of the Economics, Exposure and Technology Division, Office of Pollution Prevention and Toxics, USEPA.
The goals of these reports are to calcula te conservative (protective) estimates of exposure endpoints for consumers, the general population, and the environment.
For each exposure scenario to industrial releases, the following three endpoints are calculated: (1) maximum possible acute concentrations and doses (2) maximum possible chronic concentrations and doses (3) for water releases ≥ 20 days, the probability of exceedence of the aquatic concentration of concern These endpoints are identified by abbreviati ons on the Release Activity line, e.g., (1) max ADR , (2) max LADD , (3) max PDM . Depending on the release inputs, these e ndpoints may be calculated and presented on the same page or different pages. That is, a release activity ID of mfg; max ADR, max PDM, max LADD indicates that all the exposure endpoints were cal culated from common manufacturing release values; conversely, a release activity ID of mfg &proc; max ADR indicates that only the maximum acute exposure values were calculated for manufacturing and proce ssing releases that occurred at the same site.
For each consumer product use exposure scenario, whether exposure is to the user directly or to the general population/environment, the maximum exposure values are calculated and presented together.
In addition to the exposure values above, EPA policy dir ects that exposure and release values be compared to criteria threshold values for Exposure-based and PBT Exposure-based cases.
Exposure-based (YX) cases (those with ≥ 100,000 kg/yr production volume) Criteria are exceeded under the following conditions: Presence in consumer product with likely exposure ≥ 3E-3 mg/kg/d exposure via air, fish ingestion or drinking water ≥ 10,000 kg/yr release to environment (post-treatment) ≥ 1,000 kg/yr release to water (post-treatment)
Persistent, Bioaccumulative, Toxic (PBT) chemical s of P2B2 rating or hi gher and production volume ≥ 20,000 kg/yr Criteria are exceeded as for YX cases, with the following differences: ≥ 2,000 kg/yr release to environment (post-treatment) ≥ 200 kg/yr release to water (post-treatment)
Bolding rules in the Report: Values for endpoints above th at are also health or eco concerns are bolded.