Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-12-191 

EPA Docket EPA-HQ-OPPT-2012-0740 

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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 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-12-191 

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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: No

Ecotox: No

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ; Hyd Pdt rapid

P2Rec Comments:

Comment: No Comment

Keywords:

 Keywords: 

SENS-S,L

MUTA

ONCO

DEVEL

MALE REPRO

LIVER

KIDNEY

AQUATOX-A,C

Summary of Assessment:

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 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 (NOMO5) 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 (pH 

 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;

Negative 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);

Not corrosive to human tissue culture in vitro (MTT test);

Not an irritant in enucleated rabbit eyes in vitro;

Dermal sensitizer in female mice;

Not an irritant to human reconstituted corneal tissue in vitro (Human Corneal Model test); 

Moderate eye irritant in male rabbits

 Ecotox:

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Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 2.8 2.4

NOEC = 1

acceptable

daphnid 48-h LC50 28 1.2 mg/L (95 % 

C.I. = ± 0.96 –

1.5 mg/L)

NOEC = 0.18 

mg/L

acceptable

green algal 96-h EC50 140 72-hour ErC50 

= 21 mg/L (95 

% C.I. = ± 16 –

26 mg/L)

NOErC = 3.2 

mg/L

LOErC = 10

72-hour EyC50 

= 6.6 mg/L (95 

% C.I. = ± 5.6 

– 7.8 mg/L)

NOEyC = 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); pH7; 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)

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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 

performed 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 

parameters; 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)

NOEC = 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, pH = 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)

NOEC = 0.18 mg/L

4) The 72-hour algae growth inhibition test was a static test with the algal species Desmodesmus 

EPA SANITIZED Page 7 of 26
subspicatus. 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)

NOErC = 3.2 mg/L

LOErC = 10

72-hour EyC50 = 6.6 mg/L (95 % C.I. = ± 5.6 – 7.8 mg/L)

NOEyC = 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 ppb. 

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 ppb

Acute CC = 192 ppb

Reviewer: S. Pollack

Qa/Qc: A. Kim

12th March, 2012

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

10

SARs polyepoxides

SAR Class polyepoxide

Ecotox Category None

Ecotox Factors Comments: 

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 SAT Chair: J. Kwiat

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A-002 

Initial Review Engineering Report 

 for PMN P-12-191 

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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.

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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. 

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POLLUTION PREVENTION CONSIDERATIONS:

P2 Claims:

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0191

Manufacturing:

Number of Sites/ Location: 

Days/yr: 

Basis:

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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.

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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.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0191

Processing 1: 

Number of Sites/ Location: 

Days/yr: 

Basis:

Process Description: 

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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

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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: 12-0191

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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. 

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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.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0191

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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.

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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.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

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A-003 

Initial Review Exposure Report 

 for PMN P-12-191 

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Page 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 below 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). 

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