# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)

P-09-366

EPA Docket EPA-HQ-OPPT-2010-1075

# Index

A-001 Structure Activity Team (SAT) Report for PMN P-09-366

A-002 Initial Review Engineering Report for PMN P-09-366

A-003 Initial Review Exposure Report for PMN P-09-366

# A-001 Structure Activity Team (SAT) Report

for PMN P-09-366

## SAT Report PMN Number: P-09-0366 SAT Date: 5/27/2009

Related cases : Health related cases:

Ecotox related cases:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1-2 3

Persistence Bioaccum Toxicity Comments 1 1 1
Exposure Based Review : Health: N o Exposure based testing (health):

Ecotox: Yes

Routes of exposure : Health: Inhalation and dermal Ecotox: All releases to water Fate: ;
Keywords : Keywords: SENS-DERMAL, ONCO, LUNG, IRR, THYROID, UNCERT-DEVEL/ N EURO, AQUATOX-A,C
Summary of Assessment :

Fate : Fate Summary: P-09-0366 FATE: Estimations for low weight MW 231 Liquid with MP < 25 EC (E) log Kow = 0.92 (E); S = Disp./>10 g/L at 25 EC (ICB/E) VP < 1.0E-6 torr at 25 EC (E) BP > 400 EC (E) H < 1.00E-8 (E) log Koc = 1.00 (E) log Fish BCF = 0.50 (E)

### POTW removal (%) = 90 via sorption and biodeg; OECD 303A(ASST): 92.2% (test unit 1), 93.9% (test unit 2)/28d. Time for complete ultimate aerobic biodeg = wk Sorption to soils/sediments = low - moderate PBT Potential: P1B1 *CEB FATE: Migration to ground water = moderate - rapid

Health : Health Summary: Absorption is poor through the skin, moderate through the GI tract, and good through the lungs based on analogs. There is concern for dermal sensitization by analogy to which was reported to be a dermal sensitizer in humans. There is a marginal concern for oncogenicity based on NTP reports where one analog was reported to be positive after dermal administration and the other analog was equivocal. There is concern for irritation and lung effects if inhaled based on the properties of the PMN material. There is uncertain concern for developmental neurotoxicity based on analogs thyroid gland hyperplasia in two year dermal study in mice . Low moderate concern.

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 0.20 11.3 daphnid 48-h LC50 0.20 1.97 green algal 96-h EC50 0.20 3.84 (growth rate) 2.39 (yeild) fish

_ chronic value 0.040 daphnid

_ chronic value 0.040 algal

_ chronic value 0.050 Sewage Sludge 3-h EC50

_ Sewage Sludge Chronic Value

Ecotox Values Comments: Predictions are based on SAR-nearest analog method for compare , identical to one component of the PMN substance; SAR chemical class = MW 231; liquid with unknown mp (P); S = dispersible at 20 C, p H 7 (P); p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; DW hardness <150.0 mg/L as CaCO3; and DW TOC <2.0 mg/L;

This PMN was accompanied by acute fish, daphnia, and algal studies. Complete details of their evaluation are provided in the attached spreadsheet.

Conclusion: The results from all three tests are considered valid . The test substance is a complex mixture that forms an emulsion in water. Results from the analytical evaluation of the PMN substance indicated in the chromatograms shows overall consistency in the test substance during

### exposures. All measured concentrations were within 83-93%, 84-95%, or 94-117% of nominal for algae, daphnia and bluegill respectively. Therefore measured concentrations are reported. Dissolution in the fish test resulted in turbidity of the test substance at 10 mg/L but this does not invalidate the test. The most sensitive species considered for these analyses is Daphnia magna therefore the CC is derived from the 48-hr EC50 value of 1.97 mg/L. This value is divided by a factor of 10 to simulate a chronic toxicity value and then again by an assessment (uncertainty) factor of 10 to derive a CC = 0.0197 mg/L or 20 μg/L ( p pb). The PMN substance P09-0366 is of moderate concern for ecotoxicity.

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 20 Based on acute daphnia study. This supersedes ECOSAR predictions (4 p pb). SARs SAR Class

Ecotox Factors Comments:

SAT Chair: Becky Jones

# A-002 Initial Review Engineering Report

for PMN P-09-366

### INITIAL REVIEW ENGINEERING REPORT P-09-0366 Focus Ready Draft 6/4/2009

ENGINEER: Hall \ AH PV (kg/yr):

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

Consumer Use:

SAT (concerns): (5/27/2009):

Migration to groundwater: Moderate to Rapid PBT rating: P 1 B 1 T 1 Health: 1-2, Dermal, Inhalation ( N o testing desired) Eco: 3, Water (All releases to water with a CC = 20ppb),

OCCUPATIONAL EXPOSURE RATING: 1A

NOTES & KEY ASSUMPTIONS: Generated by the 06/01/2009 version of ChemSTEER.POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE -BASED REVIEW:P-09-0366

Manufacturing

Number of Sites/Location:



## 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.



## RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARYP-09-0366

Use:

Number of Sites/Location:



## 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.



## RELEASE TOTAL
1



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

# A-003 Initial Review Exposure Report

for PMN P-09-3666/3/2009 Page of

INITIAL REVIEW EXPOSU RE REPORT (IRExR)

Chemical ID: P090366 Reviewer: Kwon

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 4 CC=20 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, PDM --- --- --- --- 5175.60 58 --- --- --- --- ---

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.
4 This column displays concentration values for the 7Q10 streamflow, which is defined as the average streamflow of the 7 consecutive days of lowest flow within a 10 year period.

Remarks:

.

Results Table: Exposure Based (XB)/Persistent (P2B2) Criteria

Parameter Drinking (Surface) Wate r Dose (mg/kg/day) Fish Ingestion Dose (mg/kg/day) Inhalation Dose (mg/kg/day) Groundwater Dose (mg/kg/day) Surface Water Release After Treatment (kg/yr) Total Release After Treatment (kg/yr) Consumer Use?

Fate test recommendations?:6/3/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090366 Assessor: Kwon

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: Release Activity: max Acute Eco, PDM
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:6/3/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090366

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 1 Number of Site s: RELEASE ACTIVITY max Acute Eco, PDM

SIC-CODE DESCRIPTION
SIC-CODE (S): 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

PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic Mean 30Q5 7Q10 1Q10

ALL 50 9.91 29.93 44.15 54.45

ALL 10 553.69 2985.07 5175.60 6181.02

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

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

Units
50% 10% 50% 10%

Cancer

LADD pot 1.25E-05 6.98E-04 mg/kg/day 1.69E-07 9.45E-06 mg/kg/day

LADC pot 6.41E-04 3.58E-02 mg/L 2.02E-03 0.11 mg/kg

Acute

ADR pot 2.50E-03 0.25 mg/kg/day 5.63E-05 3.14E-03 mg/kg/day

SIC Code Comments:6/3/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090366

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 1 RELEASE ACTIVI TY: max Acute Eco, PDM

SIC CODE DESCRIPTION:

ASSOCIATED SIC CODES:

SIC CODE RESULTS

COC ( μ g/L) Percent of Year COC Exceeded Number of Days COC Exceeded Release days/year Loading (kg/site/day) Waste Water Treatment (%) High/Avg Analysis

20.00 16 58 High

Remark: COC exceeded great er than 20 days/year.6/3/2009 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.