# Support Documents for Significant New Use Rules (SNUR) on Premanufacture Notices (PMN)
P-12-276

EPA Docket EPA-HQ-OPPT-2012-0450

# Index A-001 Structure Activity Team (SAT) Report for PMN P-12-276 A-002 Initial Review Engineering Report for PMN P-12-276 A-003 Initial Review Exposure Report for PMN P-12-276

# A-001 Structure Activity Team (SAT) Report
for PMN P-12-276

## SAT Report PMN Number: P-12-0276 SAT Date: 4/10/2012 Print Date: 5/2/2012

Related cases : Health related cases:

Ecotox related cases:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 2 2 Health: ; Eco: algal shading only

Persistence Bioaccum Toxicity Comments 1 12

Exposure Based Review : Health: N o Ecotox: N o Routes of exposure : Health: Drinking Water Inhalation Ecotox: All releases to water Fate: ;

P 2 Rec Comments : Comment: N o Commen t Keywords : Keywords: UNCERT IRR-E CORNEAL STAINING MUTA ONCO DEVEL LIVER KIDNEY SENS-S,L AQUATOX-A,C

### Summary of Assessment :
Fate : Fate Summary: P-12-0276 FATE: Solid S = 50 g/L at 25 C (M) Hydrolysis half-life = da VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) POTW removal (%) = 0; OECD 301F(Mano Resp): 0%/28d NRB. Time for complete ultimate aerobic biodeg > mo Time for primary anaerobic biodeg (azo) da Sorption to soils/sediments = low PBT Potential: P1B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption is nil through the skin, nil through the GI tract for the intact dye, and good through the lung, based on physical/chemical properties. Expect azo reduction in the GI tract, with good absorption of the reduction products. The terminal group is an alkylating agent. There is concern for dermal sensitization and uncertain concern for eye irritation , based on submitted test data. There also are concerns for nutagenicity and corneal staining, based on analogs. There also are concerns for skin and lung sensitization, mutagenicity, oncogenicity, and developmental, liver, and kidney toxicities, as well as uncertain concern for irritation, based on alkylation potentials. There also are concerns for mutagenicity and oncogenicity, based on the azo reduction product. There also are concerns for dermal and respiratory sensitization, mutagenicity, oncogenicity, and developmental toxicity from the formed in the dye bath and released to drinking water. Test Data: Submitted with the PMN:
Rat (F ) acute (15D) oral (gavage) toxicity LD50 > 2000 mg/kg; N ot corrosive to cultivated human skin in vitro; Mild eye irritant in bovine corneal opacity and permeability test; Dermal sensitizer in female mice;

Submitted with
Positive for chromosome aberrations in CHL cells without activation;

Submitted with

N egative in Salmonella assay with and without activation; N egative in E. coi reverse mutation assay with and without activation; Rat acute (15D) oral (gavage) toxicity LD50 > 2000 mg/kg;

### Eye irritant in rabbits, based on irreversability of corneal staining; N ot a dermal irritant in rabbits; N ot a dermal sensitizer in guinea pigs

Ecotox : Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 >100 daphnid 48-h LC50 >100 green algal 96-h EC50 20 fish

_ chronic value >10 daphnid

_ chronic value >10
algal

_ chronic value 2.0
Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for anionic dyes; SAR chemical class = dye-anionic MW 1111; solid with unknown mp (P); S = 50 g/L at 25 C (M); p H7; effective concentrations based on 100% active ingredients and nominal 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) 200 algal shading only

SARs anionic dyes SAR Class dye-anionic Ecotox Category Acid Dyes and Amphoteric Dyes
Ecotox Factors Comments:
SAT Chair: J. Kwiat

# A-002 Initial Review Engineering Report
for PMN P-12-276

### INITIAL REVIEW ENGINEERING REPORT PMN: 12-0276 Focus Ready Draft 4/19/2012
ENGINEER: Avcin \ DDH PV (kg/yr):

SUBMITTER: Huntsman Corporation

USE:

OTHER USES:

MSDS: Yes Label: No Gen Eqpt: Chemical-resistant, impervious gloves complying with an approved standard should be worn at all times when handling chemical products if a risk assessment indicates this is necessary. <1 hours (breakthrough time): butyl or neoprene // Safety eyewear complying with an approved standard should be used when a risk assessment indicates this is necessary to avoid exposure to liquid splashes, mists or dusts. Recommended: Tightly fitting safety goggles. // Personal protective equipment for the body should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product. // Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation. In some cases, fume scrubbers, filters or engineering modifications to the process equipment will be necessary to reduce emissions to acceptable levels. Respirator: Recommended: Repiratory protection, filter P3 In case of inadequate ventilation wear respiratory protection. Respirator selection must be based on known or anticipated exposure levels, the hazards of the product and the safe working limits of the selected respirator. Health Effects: Causes eye irritation/ may cause allergic skin reaction. May cause sensitization by skin contact. TLV/PEL: none established.

CRSS :

### Consumer Use:
SAT (concerns) (04/10/2012): Related Cases and Related Cases and Misc SAT Info: Ecotox Related Cases: Analogs: Human Health Related Cases: Migration to groundwater: Negligible PBT rating: P1B1T2 . Health: 2 Drinking Water, Inhalation Eco: 2 Water (All releases to water with a CC = 200 ppb (algal shading only).)

OCCUPATIONAL EXPOSURE RATING: 1-2B

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

### POLLUTION PREVENTION CONSIDERATIONS: P2 Claim:

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0276 Processing:

Number of Sites/ Location: 1 Huntsman International LLC Charlotte NC 28273 Days/yr: 5 Basis:

Process Description:

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.

Water Output 2: 5.0E-1 kg/site-day over 5 days/yr from 1 site

RELEASE TOTAL 2.5E+0 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 3 Basis: The submission does not provide estimates for the number of workers potentially exposed. CEB uses the

### minimum default of 3 workers per site.

Inhalation: Exposure to Particulate (Class I) Typical: 1.9E-2 mg/day over 5 days/yr Worst Case: 6.5E-2 mg/day over 5 days/yr Number of workers (all sites) with inhalation exposure: 3 Basis:

NOTE: The respirator class is: I. Particulate (including solid or liquid droplets).

INHALATION MONITORING DATA REVIEW 1) Uncertainty (estimate based on model, regulatory limit or data not specific to industry): Yes 2)a) Exposure level > 1 mg/day? No OR b) Hazard Rating for health of 2 or greater? 2 Yes Inhalation Monitoring Data Desired? Yes (both criteria met)

Dermal: Dermal not required, per SAT.

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0276

Use:

Number of Sites/ Location: 4 unknown site(s) Days/yr: 72 Basis:

Process Description:

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.

Water Submission Estimate: 9.1E-1 kg/site-day over 72 days/yr from 4 sites

### Water or Air or Incineration or Landfill Output 2: 2.6E-2 kg/site-day over 72 days/yr from 4 sites or 7.5E+0 kg/yr

RELEASE TOTAL 2.7E+2 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 24 Basis:

Inhalation: Exposure to Particulate (Class I) Typical: 2.5E-1 mg/day over 72 days/yr Worst Case: 8.4E-1 mg/day over 72 days/yr Number of workers (all sites) with inhalation exposure: 24 Basis:

NOTE: The respirator class is: I. Particulate (including solid or liquid droplets).

INHALATION MONITORING DATA REVIEW 1) Uncertainty (estimate based on model, regulatory limit or data not specific to industry): Yes 2)a) Exposure level > 1 mg/day? No OR b) Hazard Rating for health of 2 or greater? 2 Yes Inhalation Monitoring Data Desired? Yes (both criteria met)

Dermal: Dermal not required, per SAT.

# A-003 Initial Review Exposure Report
for PMN P-12-2764/18/12 Page of



### INITIAL REVIEW EXPOSURE REPORT (IRExR)

Chemical ID: P-12-0276 Reviewer: Flessner/AG

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 = 200 PDM Days Exceede d 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 μg/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

PROC: Max ADR: max acute eco 2.46E04 --- --- --- 4.61E+00 --- --- --- --- --- ---

PROC: Max LADD --- 2 .87E-07 --- --- --- --- --- --- --- --- ---

USE: Max ADR: max acute eco 6.04E03 --- --- --- 1.24E+02 --- --- --- --- --- ---

USE: PDM1 --- --- --- --- 1.24E+02 --- --- --- --- --- USE: Max LADD --- 3 .60E-05 --- --- --- --- --- --- --- --- ---

1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 2 Release activities are from engineering report's Manuf acturing (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 (A DR), Lifetime Average Daily Dose (LADD), and Probabilistic Dilution Model (PDM). Th ere 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 7Q 10 streamflow, which is defined as the average daily streamflow of the seven consecutive days of lowest flow within a ten year period.

Remarks:4/18/12 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-12-0276 Assessor: Flessner/AG

ENVIRONMENTAL RELEASES
Scenario#:1 Number of Release Sites: Release Activity: PROC: Max ADR 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:4/18/12 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0276 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO NUMBER:1 RELEASE ACTIVITY: PROC: Max ADR
FACILITY NAME :
FACILITY LOCATION:
RECEIVING WATER NAME:
REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct
NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)
0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER
FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT FLOW (MLD) CONCENTRATION ( μ g/L) 2.69 2.94 4.61 4.61 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 2.87E-07 mg/kg/day 0.00 mg/kg/day
LADC pot 1.47E-05 mg/L 0.00 mg/kg
Acute

ADR pot 2.46E-04 mg/kg/day 0.00 mg/kg/day

Surface Water Comments:4/18/12 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-12-0276 Assessor: Flessner/AG

ENVIRONMENTAL RELEASES
Scenario#:2 Number of Release Sites: Release Activity: PROC: Max LADD 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:4/18/12 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0276 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO NUMBER:2 RELEASE ACTIVITY: PROC: Max LADD
FACILITY NAME :
FACILITY LOCATION:
RECEIVING WATER NAME:
REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct
NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)
0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER
FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT FLOW (MLD) CONCENTRATION ( μ g/L) N/A N/A N/A N/A 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 2.87E-07 mg/kg/day 0.00 mg/kg/day
LADC pot 1.47E-05 mg/L 0.00 mg/kg
Acute

ADR pot N/A mg/kg/day N/A mg/kg/day

Surface Water Comments:4/18/12 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-12-0276 Assessor: Flessner/AG

ENVIRONMENTAL RELEASES
Scenario#:3 Number of Release Sites: Release Activity: USE: Max ADR 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:4/18/12 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0276

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

SCENARIO #: 3 Number of Site s: RELEASE ACTIVITY:USE: Max ADR
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)
0.00 0.00

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 4.60 8.13 12.91 15.00
ALL 10 23.43 72.22 123.81 148.10

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 7.08E-06 3.60E-05 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 3.63E-04 1.85E-03 mg/L 0.00 0.00 mg/kg
Acute
ADR pot 6.80E-04 6.04E-03 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:4/18/12 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-12-0276 Assessor: Flessner/AG

ENVIRONMENTAL RELEASES
Scenario#:4 Number of Release Sites: Release Activity: USE: PDM1 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:4/18/12 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0276

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

SCENARIO #: 4 Number of S ites: RELEASE ACTIVITY:USE: PDM1
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)
0.00 0.00

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 4.60 8.13 12.91 15.00
ALL 10 23.43 72.22 123.81 148.10

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 7.08E-06 3.60E-05 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 3.63E-04 1.85E-03 mg/L 0.00 0.00 mg/kg
Acute
ADR pot 6.80E-04 6.04E-03 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:4/18/12 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0276

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 4 RELEASE ACTIVITY: USE: PDM1
SIC CODE DESCRIPT ION:
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

200.00 High4/18/12 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-12-0276 Assessor: Flessner/AG

ENVIRONMENTAL RELEASES
Scenario#:5 Number of Release Sites: Release Activity: USE: Max LADD 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:4/18/12 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-12-0276

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

SCENARIO #: 5 Number of Site s: RELEASE ACTIVITY:USE: Max LADD
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)
0.00 0.00

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 N/A N/A N/A N/A
ALL 10 N/A N/A N/A N/A

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 7.08E-06 3.60E-05 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 3.63E-04 1.85E-03 mg/L 0.00 0.00 mg/kg
Acute
ADR pot N/A N/A mg/kg/day N/A N/A mg/kg/day

SIC Code Comments: