## Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-12-191

EPA Docket EPA-HQ-OPPT-2012-0740

## Index A-001 Structure Activity Team (SAT) Report for PMN P-12-191 A-002 Initial Review Engineering Report for PMN P-12-191 A-003 Initial Review Exposure Report for PMN P-12-191

## A-001 Structure Activity Team (SAT) Report
for PMN P-12-191

### SAT Report PMN Number: P-12-0191 SAT Date: 2/28/2012 Print Date: 7/2/2012

Related cases : : Yes Health related cases: Ecotox related cases:

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 2 2

Persistence Bioaccum Toxicity Comments 1 1 2 PMN 1 1 2 Hyd Pdt

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

P 2 Rec Comments : Comment: N o Commen t Keywords : Keywords: SENS-S,L MUTA ONCO DEVEL MALE REPRO LIVER KIDNEY AQUATOX-A,C Summary of Assessment :Fate : Fate Summary: P-12-0191 FATE: Estimations for hydrolysis product tetra-ol MW 198 C10H14O4 log Kow = -1.53 (E) log Koc = 1.45 (E) log Fish BCF = 0.50 (E) log Fish BAF = -0.05 (E) PMN Substance: Liquid with MP = -20 C (M) S = Reacts, 2.76 g/L at 25 °C (M) Hydrolysis Half-life = hr VP = 4.0E-4 torr at 25 C (M) BP = Dec. >270 C (M) BP = 291 C ( N OMO5) based on 120 C @ 2 mm Hg (M) H = 3.09E-8 (E) POTW removal (%) = PMN 90-99 via hydrolysis; then Hyd Pdt 90-99 via biodeg; t1/2 ( p H 4,7,9): 0.102-0.398h/20.5-52.9h/33.6-68.3h. OECD 301B (Mod Sturm CO2 ev): 16%/28d. Time for complete ultimate aerobic biodeg = Hyd Pdt wk Sorption to soils/sediments = Hyd Pdt low PBT Potential: PMN P1B1; Hyd Pdt P1B1 *CEB FATE: Migration to ground water = Hyd Pdt rapid

Health : Health Summary: Absorption is good with reaction all routes, based on analogs. The PMN substance is a crosslinking agent. There are concerns for skin and lung sensitization, mutagenicity, oncogenicity, and developmental, male reproductive, liver, and kidney toxicities, based on epoxides and the crosslinking potential.. Test Data: Submitted with the PMN: Salmonella assay positive with and without activation; E. coli reverse mutation assay positive with and without activation; N egative in the mouse micronucleus assay via the oral route; Rat (F) acute (15 D) oral (gavage) LD50 > 2000 mg/kg; Rat acute (8 D) oral (gavage) LOAEL 250 mg/kg; Rat repeated dose (54 D) oral (gavage) toxicity test with reproduction/developmental screening: systemic NOEL 50 mg/kg, reproductive NOAEL 200 mg/kg; Dermal irritant to human tissue culture in vitro (MTT test); N ot corrosive to human tissue culture in vitro (MTT test); N ot an irritant in enucleated rabbit eyes in vitro; Dermal sensitizer in female mice; N ot an irritant to human reconstituted corneal tissue in vitro (Human Corneal Model test); Moderate eye irritant in male rabbits
Ecotox :Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 2.8 2.4 N OEC = 1 acceptable
daphnid 48-h LC50 28 1.2 mg/L (95 % C.I. = ± 0.96

– 1.5 mg/L) N OEC = 0.18 mg/L acceptable

green algal 96-h EC50 140 72-hour ErC50 = 21 mg/L (95 % C.I. = ± 16

– 26 mg/L) N OErC = 3.2 mg/L LOErC = 10 72-hour EyC50 = 6.6 mg/L (95 % C.I. = ± 5.6

–7.8 mg/L) N OEyC = 1.0 mg/L LOEyC = 3.2 mg/L acceptable

fish

_ chronic value 0.19 acceptable daphnid

_ chronic value 2.6
algal

_ chronic value 35 GMATC = 1.7 mg/L Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs polyepoxides; SAR chemical class = epoxide-bis; MW 162; liquid (P); S = 18 g/L C (P); p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L; This PMN material was previously submitted as . Below is a summary of the test data report from both, but relvant to the current PMN P-12-0191. The attached documents include both test data report reviews. Ecotoxicity Study Review for (CASRN 30424-08-9)P12-0191 Three ecotoxicity studies were submitted with the PMN P12-0191 from the Dow Europe GmbH, Horgen, Switzerland: a 96-hour acute fish test, a 72-hour algae growth inhibition test, and a 48-hour acute daphnid test. The studies were conducted in 2009 and the substance was described as a clear, extremely pale yellow liquid with MW = 162.19 and no purity information was given. The studies were conducted by Harlan Laboratories Ltd, Derbyshire, UK. All studies were p erformed under GLP conditions with a quality assurance statement also provided. The water solubility is the following for each portion of the material: = 2.762 g/L, = 0.563 to 0.264 g/L. All three tests followed the OECD Guideline for Testing of Chemicals (203, 202, and 201) for 1) water quality p arameters; 2) species, age 3) appropriate response in controls, and 4) loading rates. 1) The 96-hour acute fish test with Rainbow trout (Oncorhynchus mykiss) (7 fish per test concentration and one replicate per concentration) was a semi-static test with renewals every 48 hours. The test solution concentrations (0.56, 1.0, 1.8, 3.2, and 5.6 mg/L) were prepared by mixing the appropriate amount of the PMN material in dechlorinated tap water and stirring at ~ 1500 rpm for 24 hours. The test concentrations were measured using HPLC methods with a limit of quantification (LOQ) of 0.05 mg/L. All values were within 87

–105 % of nominal. The fish had a mean standard length of 5.1 cm (sd = 0.7) and a mean weight of 1.80 g (sd = 0.62) at the end of the definitive test. Based on the mean weight value this gave a loading rate of 0.63 g bodyweight/liter. The light cycle was 16:8 light: dark and water quality parameters were the following: temp = 14 °C, DO = 8.6

–11.2 mg/L and pH = 7.3

–8.1. The test vessels were aerated during the test. Observations on the test fish were made at 4, 6, 24, 48, 72, and 96 hours after test initiation. Sub-lethal effects were observed in all test concentrations above 1.8 mg/L. The responses were increased pigmentation, swimming at the surface, gaping, loss of equilibrium and moribund behavior. At 30 hours, 5 fish in the 5.6 mg/L treatment group were moribund and were humanely euthanized. At 53 and 71 hours, 7 fish and then 2 of the four remaining fish at the 3.2 mg/L test group were moribund and then humanely euthanized. 96-hour LC50 = 2.4 mg/L (95 % C.I. = ± 1.8

–3.2 mg/L) N OEC = 1.0 mg/L 3) The 48-hour acute toxicity test for Daphnia magna (2 replicates per test concentration/ 10 daphnids per replicate) was a static test with nominal concentrations of 0, 0.10, 0.18, 0.32, 0.56, 1.0, 1.8, 3.2, 5.6, and 10 mg/L. The test solutions were prepared by dissolving the PMN material in dilution water and inverting several times to mix well. Water quality parameters were the following: temperature = 21

–22°C, p H = 7.9, DO = 8.4

–9.0 mg/L. Measured concentrations were determined using HPLC methods with LOQ = 0.050 mg/L and were within 94

–117 % of nominal. Observations on the test organisms were made at 0, 24, and 48 hours after test initiation. Immobilisation was observed in the following treatment groups at 24 hours: 1.0, 1.8, 3.2, 5.6 and 10 mg/L. At 48 hours, immobilization was observed at the 0.32, 0.56, 1.0, 1.8, 3.2, 5.6, and 10 mg/L treatment groups. 48-hour EC50 = 1.2 mg/L (95 % C.I. = ± 0.96

–1.5 mg/L) N OEC = 0.18 mg/L 4) The 72-hour algae growth inhibition test was a static test with the algal species Desmodesmussubspicatus. The test substance was nominal concentrations of 0, 1.0, 3.2, 10, 32, and 100 mg/L with three replicates per test concentration. Test concentrations were prepared by dissolving the test material in culture medium and inverting several times to mix well. Initial cell density was stated as 1 X 104 - 105 cells/mL. Flasks containing the algal cells were under constant illumination of ~ 7,000 lux and were shaken at 100 - 150 rpm. Temperature was maintained at 24°C and pH = 7.2

–7.7. Samples of the test material in solution during the test were measured using HPLC and observations on the algal cells were taken at 0, 26, 48, and 72 hours after exposure. Mean, measured values were within 85 - 110 % of nominal and the LOQ = 0.53 mg/L. 72-hour ErC50 = 21 mg/L (95 % C.I. = ± 16

–26 mg/L) N OErC = 3.2 mg/L LOErC = 10 72-hour EyC50 = 6.6 mg/L (95 % C.I. = ± 5.6

–7.8 mg/L) N OEyC = 1.0 mg/L LOEyC = 3.2 mg/L GMATC = 1.7 mg/L All four tests are considered acceptable. The mean, measured concentrations are within a suitable range of nominal and were measured using an adequately robust and precise method. This PMN material was previously submitted as and the purity was stated as 80 %.. The species which demonstrates the most environmentally protective toxicity value is used to determine the chronic concern concentration: the daphnid acute toxicity value of 1.2 mg/L. To calculate the chronic concern concentration, 1.2 mg/L (48-hour EC50 value) is first multiplied by the purity (0.80) to yield 0.96 mg/L. This value is then divided by an acute to chronic ratio of 10 to yield 0.096 mg/L. This value (0.096 mg/L) is divided again by an assessment factor of 10 to yield 0.0096 mg/L or 9.6 ìg/L or 10 p pb. To calculate the acute concern concentration, 1.2 mg/L (48-hour EC50 value) is first multiplied by the purity (0.80) to yield 0.96 mg/L. This value is then divided by an assessment (uncertainty) factor of 5 to yield 0.192 mg/L or 192 ìg/L Chronic CC = 10 p pb Acute CC = 192 p pb Reviewer: S. Pollack Qa/Qc: A. Kim 12th March, 2012
Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 10

SARs p olyepoxides SAR Class p olyepoxide Ecotox Category N one
Ecotox Factors Comments:SAT Chair: J. Kwiat

## A-002 Initial Review Engineering Report
for PMN P-12-191file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] INITIAL REVIEW ENGINEERING REPORT PMN: 12-0191 Focus Ready Draft 3/8/2012
ENGINEER: Arnold \ AH PV (kg/yr):

SUBMITTER: The Dow Chemical Company

USE:

OTHER USES:

MSDS: Yes Label: No Gen Eqpt: Use chemical goggles, protective clothing chemically resistant to this material, such as face shield, boots, apron, or bull body suit; butyl rubber, ethyl vinyl alcohol laminate, or neoprene gloves Respirator: For most conditions, no respiratory protection should be needed; however, if handling at elevated temperatures without sufficient ventilation, use an approved air-purifying respirator. The following should be effective types of air-purifying respirators: Organic vapor cartridge Health Effects: Eye Contact: May cause moderate eye irritation which may be slow to heal. Corneal injury is unlikely. Skin Contact: Brief contact may cause skin irritation with local redness. Prolonged contact may cause severe skin irritation with local redness and discomfort. Skin Absorption: Prolonged skin contact is unlikely to result in absorption of harmful amounts. Skin Sensitization: Skin contact may cause an allergic skin reaction. Inhalation: At room temperature, exposure to vapor is minimal due to low volatility; vapor from heated material may cause respiratory irritation. Ingestion: Low toxicity if swallowed. TLV/PEL: None established.file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] SAT (concerns) (02/28/2012): Migration to groundwater: Rapid PBT rating: P1B1T2 Health: 2 Dermal, Drinking Water, Inhalation Eco: 2 Water (All releases to water with a CC = 19 ppb)

OCCUPATIONAL EXPOSURE RATING: 1B

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] POLLUTION PREVENTION CONSIDERATIONS: P2 Claims:

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0191 Manufacturing:

Number of Sites/ Location: Days/yr: Basis:file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] 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.file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0191 Processing:

Number of Sites/ Location: Days/yr: 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.file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0191 Processing 1:

Number of Sites/ Location: Days/yr: Basis:

Process Description:file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] 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.

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARYfile:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] INITIAL REVIEW ENGINEERING REPORT PMN: 12-0191

Use 1:

Number of Sites/ Location

Days/yr: 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.

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0191file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] Processing 2:

Number of Sites/ Location:

Days/yr: 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.file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0191 Processing 3:

Number of Sites/ Location:

Days/yr: 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.file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0191file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] Use 3:

Number of Sites/ Location: Days/yr: 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. Submission states all residues are disposed via incineration.file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0191 Processing 4:

Number of Sites/ Location

Days/yr: 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.file:///J|/SNURS/Quarterly%20SNUR%20Batches/Q12-4/Sanitization/June%202012/P-12-0191/p120191.eng.txt[7/2/2012 8:02:42 AM] OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:

## A-003 Initial Review Exposure Report
for PMN P-12-191Page 1 of 1

POST FOCUS EXPOSURE REPORT Release information for this compound does not meet criteria for preparation of an exposure assessment; were eliminated and the were be low the threshold for exposure assessment

Assessor:

ENVIRONMENTAL RELEASES

Scenario#: Number of Release Sites: Release Activity:
Release Description: WATER LANDFILL INCINER LAND/INCIN FUGITIVE

Total Releases: (kg/yr) (kg/yr) (kg/yr) (kg/yr) (kg/yr) Release Days/yr:
Per Site Release: (kg/day) (kg/yr) (kg/yr) (kg/yr) (kg/day)
Remarks: EAB DROP: Release information for this compound does not meet criteria for preparation of an exposure assessment in the Exposure Assessment Branch = s (EAB) Initial Review Exposure Report (this report).