May 17, 2oi3 

U.S. Environmental Protection Agency 

Office of Air and Radiation 

Stratospheric Protection Division 

Attention: Margaret Sheppard 

1310 L Street NW, ioth Floor (1027N) 

Washington, DC 20005 

Dear Ms. Sheppard: 
SANITIZED SUBMISSION 

SUP2013P1 Form Approved. O.M.B. No. 2070-0173. 

EPA Support Form 

Support Form Report Number EPAX130515090213009 Mark (X) if anything is CBI ~ 

I. ORIGINAL NOTICE SUBMISSION IDENTIFICATION 

Report Number PPXP120622354273551 

TS 

Number D1493P 

Case 

Number P120425 

Original Submission Date Jun 22, 2012 

Original Submission Media Type CDx 

1I. ORIGINAL NOTICE SUBMITTER IDENTIFICATION CBI ~ 

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e-mail 

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III. CURRENT SUPPORT DOCUMENT IDENTIFICATION INFORMATION CBI ~ 

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AIl information provided in this Letter of Support is complete and truthful I 

as of the date of the submission. 

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~ TEST DATA (Health/Eco/Fate) 

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SUP2013P2 

V. TEXT / ®ESCRIPTION OF CIIANGES WO-Ti 

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[nsci-t Attachmcnt 
WVl~l~ll~m~~ll~ SANITIZED SUBMISSION 

LIST OF ATTACHMENTS 

# Attachment Name Attachment Filename Number 

of Pages 

Associated 

Section 

Number 

CBI 

001 EPA Letter (P-12-0425) (Final Report - acute 

inhalation on blend) (5-15-2013) (public) 

EPA Letter (P-12-0425) (Final 

Report - acute inhalation on 

2 

002 Report-20058-721 redacted Report-20058-721 Redacted.pdf 150 

003 P-12-425 Toxicity Testing Summaries (Updated 

5-7-2013) (public) 

P-12-425 Toxicity Testing 

Summaries (Updated 5-7-2013) 

4 

Mark (X) this box if the data continues on the next page. ~ 
SANITIZED SUBMISSION 

ATTACHMENT HEADER SHEET 

Attachment fVumber 001 

Attachment Name 

EPA Letter (P-12-0425) (Final Report - acute inhalation on blend) (5-15-2013) (public) 

Associated PMN Section fVumber 

N/A 

Does not contain CBI 

Report Number 

EPAX130515090213009 
May 15, 2oi3 

U.S. Environmental Protection Agency 

Office of Pollution Prevention and Toxics 

Confidential Business Information Center (CBIC) — TS7407M 

Attention: Audrey Binder 

EPA East Building, Room 6428 

1201 Constitution Avenue, NW 

Washington, DC 20004-33O 2 

Dear Ms. Binder: 

Reference: PMN P-12-0425 

Submission Report Number — 

Please find attached the following final report on the PMN substance: 

Acute Inhalation Toxicity Study of in Albino Rats 

One confidential copy and one public copy are attached. 
Via eTSCA Client (attachments) 
SANITIZED SUBMISSION 

ATTACHMENT HEADER SHEET 

Attachment fVumber 002 

Attachment fVame 

Report-20058-721 redacted 

Associated PMfN Section Number 

N/A 

Does not contain CBI 

Report Number 

EPAX130515090213009 
SANITIZED SUBMISSION 

ATTACHMENT HEADER SHEET 

Attachment Number 003 

Attachment Name 

P-12-425 Toxicity Testing Summaries (Updated 5-7-2013) (public) 

Associated PMN Section Number 

N/A 

Does not contain CBI 

Report Number 

EPAX130515090213009 
15.1un-2012; UPDATED 12-Nov-2012, 7-May-2013 

# Test SYstem I Comments 

The female rat oral LD50 was greater than 5000 mg/kg (limit dose). There were no 

Acute Oral (LD50) Rat GLP; 

Guideline deaths during the exposure recovery period. 

The male and female rat, whole-body inhalation 4-hr LC50 was greater than 15,000 

ppm (the highest achievable vapor concentration). There were no deaths during the exposure 

or recovery period. Anesthetic effects were observed at concentrations greater than or equal 

Rat, whole- GLP; to 9700 ppm and the no-observed-adverse-effect-level (NOAEL) for CNS effects during 

Acute Inhalation (4-hr LC50) body Not exposure was 5000 ppm. There were no abnormal clinieal signs of toxicity observed in any Guideline mts when they were removed from the exposure chamber or throughout the 14-day recovery 

periods. The NOAEL for histopathological changes of the respiratory tract, liver and kidneys 

is also 15,000 ppm. _ 

The test substance was an azeotrope blend containing 

Acute Inhalation (4-hr LC50) Rat, nose-only GLP; 

Guideline The azeotrope blend male and female rat, nose-only inhalation 4-hr LC50 was 31,000 ppm 

(140 mg/L). 

GLP; The male and female rat dermal LD50 was greater than 5000 mg/kg (limit dose). 

Acute Dermal (LD50) Rat Guideline There were no deaths during the ex osure recovery period. 

GLP; was not a dermal irritant when tested in rabbits. No clinical signs of toxicity was 

Detmal Irritation Rabbit Guideline observed in the study. 

GLP; was not a dermal sensitizer when tested in mice. No clinical signs of toxicity was 

Dermal Sensitization Mouse Guideline observed in the study. 

C'LP' was not an eye irritant when tested in rabbits. No clinical signs of toxicity was 

Eye Irritation Rabbit Guideline observed in the study. 

was not mutagenic in the Bacterial Reverse Mutation Assay (Ames) test using 

Bacterial Reverse Mutation Assay (Ames) Bacteria GLP; 

Guideline Salmonella strains TA98, TA100, TA1535, and TA1537 and B. colf strain WP2 uvrA either 

in the presence or absence of an S9-activated test system. 

C LP' 

Chinese did not produce structural or numerical chromosome aberrations in an fn vftro 

In Vitro Chomosome Aberration hanister ovary Guideline mammalian chromosome aberration test using Chinese hamster ovary (CHO) cells either in 

(CHO) cells the presence or absence of an S9-activated test system. 

Male and female rats were exposed to a single oral dose of 0, 500, 1000, or 2000 mg/kg 

GLP; . No clinical signs of toxicity or mortality was observed in the study. did not 

In Vivo Micronucleus Rat Guideline induce biologically relevant increases in nucronucleated reticulocytes in peripheral blood 

cells. 

Male and female rats were exposed to 0, 250, 500 or 1000 mg/kg via oral gavage 

GLP; for 28 days. No test substance-related adverse effects were observed in clinical or anatomical 

28-Day Oral Rat Guideline pathology assessments. The no-observed-adverse-effect level (NOAEL) was 1000 

Page 1 of 4 
Male and female rats were exposed to 0, 100, 250, or 1000 mg/kg via oral gavage 

Rat GLP; for 28 days. No test substance-related adverse effects were observed in clinical, 

Guideline neurobehavioral, or anatomical pathology assessments. The no-observed-adverse-effect level 

(NOAEL) was 1000 mg/kg/day. 

Male and female rats were exposed to 0, 250, 500 or 1000 mg/kg via oral gavage 

for 90 days. No test substance-related adverse effects were observed in clinical, 

GLP; neurobehavioral, or anatomical pathology assessments in females. A slight increase in 

Rat Guideline severity, but not incidence, of chronic progressive nephropathy (CPN) and associated clinical 

pathology changes was observed in males at all dose levels. The no-observed-adverse-effect 

level (NOAEL) for female rats was 1000 mg/kg/day. The NOAEL was not determined for 

male rats. 

Female rats were exposed to 0, 250, 500, or 1000 mg/kg per day via oral gavage 

Rat GLP; during gestation day (GD) 6-20. No test substance-related matemal or developmental toxiciry 

Guideline was observed at any dose level. The no-observed-adverse-effect level (NOAEL) for rnatemal 

and fetal effects was 1000 mg/kg. 

Not GLP; Male and female rats were exposed to to a single intravenous injection of 0, 1, or 5 mg/kg 

Rat Not . No deaths, clinical signs, or body weight losses oecurred in any animal after 4 

Guideline days of observation. 

Male rats were administered 10 mg/kg by a single intravenous injection, 1500 or 

Not GLP; 30,000 mg/kg by a single oral gavage, or 1500 mg/kg by oral gavage for 14 

Rat Not consecutive days. Blood was withdrawn at various timepoints by direct venous puncture and 

Guideline the eoncentration of in the blood was measured by GC-MS. may have 

limited cumulative effects in rats after repeated exposure. 

Medaka were exposed to 0.005 or 0.05 mg/i. in a continuous flow-through dilution 

system for 60 days followed by a 14-day depuration period. The steady-state BCF values 

Fish GLP; ranged from 1100 to 2210 for the 0.05 mglL level and from 1560 to 2850 for the 0.005 mg/L 

Guideline level. The concentration of in the fish decreased with time during the depuration 

period. The biological half-lives ranged from 3.1 to 6.6 days for the 0.05 mg/L level and 

from 2.5 to 4.7 days for the 0.005 mg/L level. Average BCF for 12 datapoints = 1990 t 460. 

The green algae 72-hr ErC50 was greater than 0.000477 mg/L (the highest 

conoentration tested). The no observed effect concentration (NOECr) at 72 hours was 

GLP; 0.000477 mg/L (the highest dose tested). The concentration was the time-weighted mean of 

Green algae Guideline the limit of solubiliry (0.16 mg(I.) after 72-hours. During the course of the study, it was 

determined that the test substance was volatilized from the test solutions due to a large 

Henry's law constant of 4.75E6 m3/mol. 

Not GLP; The green algae 72-hr ErC50 was greater than 120 mg/[. (the highest concentration Green algae Not tested). Guideline 

The Medaka 96-hr LC50 was greater than 0.0.960 mg/L (the highest concentration GLP; Medaka Guideline 

tested). The concentration was the time-weighted mean of the limit of solubiliry (0.1 mg/L) 

after 96-hours. The test solution was renewed every 24 hours. 

Fathead Not GLP; The fathead minnow 96-hr LC50 wasreater than 120 m the hi hest 

g ~ ( g Minnow Not 

Guideline concentration tested). 

Oral with FOB tal 

90-Day Oral with FOB 

Pre-natal Oral Developmental 

Intravenous Tolerability Study 

Toxicokinetics Test (Absorption) 

Bioconcentration Study rol 

Algae Growth Inhibition Test ro~ 

Algae Growth Inhibition Test 

Fish Acute Toxicity Test (b) 

Fish Acute Toxiciry Test 

Page 2 of 4 
Daphnia Acute Immobilization Test (b) 

Daphnia Acute Immobilization Test 

Daphnia Reproduction Test (`) 

Zebrafish 14-day Growth Study t`1 

Earthworm Acute Toxicity Test (`) 

Activated Sludge Respiration Inhibition Tes 

Adsorption Coefficient (Log Koc) 

LogKow (modelled) 

Ready Biodegradability (b) 

Inherent Biodegradability Test tdt 

Daphnia GLP; The Daphnia magna 48-hr EC50 was greater than 0.157 mg/L (the highest 

Guideline concentration tested). The concentration was the time-weighted mean of the limit of magna solubili (0.17 mg/L) after 48-hours. The test solution was renewed after 24 hours. 

Daphnia Not GLP; The Daphnia magna 48-hr EC50 was greater than 120 mg/L (the highest 

~~a 

Not 

Guideline concentration tested). 

Daphnia Guideline The 21-day NOAEL (reproduction and body length) = 100 mg/L (measured concentration 

magna was 0.107 mg/L based on solubility) - highest concentration tested; LOAEC > 100 mg/L 

Zebrafish Guideline The 14day NOAEC (lethality) = 100 mg/L (measured concentration was 0.08851 mg/Ibased on solubility) - highest concentration tested; LOAEC > 100 mg/L 

Eisenia GLP; The Eisenia foetida 14-day LC50 was greater than 1011 mg/kg dry soil (the highest 

foetida Guideline and only concentration tested). 

The microbial respiration inhibition EC50 was greater than 1000 ppm (highest Microbial GLP; 

Guideline dose tested). No inhibition was noted at any concentration. 

The study was conducted using the HPLC Method for detemnining a substance's absorption 

GLP; coefficient (soil organic carbon/water) on soil and sewage sludge. The adsorption coefficient NA Guideline (log Koc) value of the test substance was calculated to be 4.50 on soil and 4.43 on sewage 

sludge. 

KOW WIN v1.68 was used to estimate LogKow. components failed to satisy the 

Not GLP; training set's structural domain requirements completely, however, other evidence by way of 

related analogues and water solubility information provide corroborating evidence that the NA Not 

Guideline ~

nmates made by the model are reasonable. LogKow prediction ranged from 4.57 to 5.22 

for . A weighted average based on the typical component percentages and their 

estimated LogKow values was calculated to be approximately 4.97. 

is not readily biodegradable. No transformation product was generated under the NA GLP; 

Guideline conditions of the test. 

NA GLP; is inherently biodegradable. Biodegradation was 44.3% after 28 days under the 

Guideline conditions of the test. 

Page 3 of 4 
On-going Studies 

LogKow (measured) (b) rA Guideline The average log ranged from 4.5 to 4.9 among 5 components. 

in ro ress: testing uoderwa ; re ort ex ected May 2013 

Page 4 of 4