Support Documents for 

Significant New Use Rules (SNURs) on 

Premanufacture Notices (PMNs) 

P-06-36 and P-06-37 

EPA Docket EPA-HQ-OPPT-2010-1075 

 

EPA SANITIZED Page 1 of 106
Index

A-001 Structure Activity Team (SAT) Reports for 

PMNs P-06-36 and P-06-37 

A-002 Initial Review Engineering Reports for 

PMNs P-06-36 and P-06-37 

A-003 Initial Review Exposure Reports for 

PMNs P-06-36 and P-06-37 

A-004 TSCA Section 5(e) Consent Order and 

Determinations Supporting Consent Order for 

PMNs P-06-36 and P-06-37 

EPA SANITIZED Page 2 of 106
A-001 

Structure Activity Team (SAT) Reports 

 for PMNs P-06-36 and P-06-37 

 

EPA SANITIZED Page 3 of 106
STRUCTURE ACTIVITY TEAM REPORT 28 October 2005

CASE NUMBER: P06-0036

RELATED CASES: 

ANALOGS; 

P2REC CLAIM: alternative for 

CONCLUSIONS/DISCUSSIONS

TYPE OF CONCERN: HEALTH ECOTOX

LEVEL OF CONCERN: 2 1

KEYWORDS: LUNG, ONCO-L, IMMUNO, NEURO, DEVEL, MUTA

SUMMARY OF ASSESSMENT

FATE: MW100 000

solid with mp > 1000 C (M)

S < 0.001 mg/L at 20 C (P)

vp < 1.0E-6 mm Hg or torr at 25 C (P)

bp >> 1000 C (P)

H < 1.0E-8 (P)

log Koc > 4.5 b(P)

log fish BCF = 0.50 (P)

POTW removal = 90% via sorption

time for complete ultimate aerobic biodegradation > months

sorption to soils and sediments = very strong

PBT Potential: P3B1T1

*CEB FATE: migration to ground water = negligible

HEALTH: Absorption, if calcined, nil all routes based on

physical/chemical properties; but, if not calcined, then nil

thru skin based on physical/chemical properties, poor thru lungs

based on analogs, and poor absorption from the GI tract based on

analogs;

submitted test data with this PMN were:

rat acute oral LD0 = 2.0 g/kg with no toxic signs;

concern for lung toxicity from lung overload and fibrosis if

respirable particles are inhaled;

concern for pulmonary oncogenicity due to crystalline nature of

the PMN substance and data for ;

concern for lung toxicity if inhaled was supported in a review of

 which is the of the PMN substance;

concern for immunotoxicity and reproductive toxicity if is

bioavailable;

concern for immunostimulation, neurotoxicity, developmental

EPA SANITIZED Page 4 of 106
toxicity and mutagenicity if is bioavailable;

concern for mutagenicity and lung toxicity for if

bioavailable;

concerning possible ingredients in fume fever from

inhalation exposure to and some observations of

respiratory tract toxicity from inhalation exposure to 

 have been reported; was oncogenic in

the lung of rats exposed by inhalation to a high level;

if P060036 were oral-gavaged to rats in a 28-d toxicity test as a

fine powder, then toxic effects could be observed probably from

release of individual in the GI tract based on data for an

analog;

moderate concern for toxicity

*CEB HEALTH: Inhalation only

ECOTOX: Predicted (P) and measured (M) toxicity values in mg/L

(ppm) are:

fish 96-h LC50 = * P

daphnid 48-h LC50 = * P

green algal 96-h EC50 = * P

fish chronic value = * P

daphnid ChV = * P

algal ChV = * P

Predictions are based on SAR-nearest analog method for 

; SAR chemical class = ; MM>1M as a fine

particle; S < 0.001 mg/L at 20 C, pH 7 (P); pH7; effective

concentrations based on 100% active ingredients and nominal

concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0

mg/L;

low concern for toxicity

assessment factor = 10.0

concern concentration = *

*CEB ECOTOX: No releases to water;

P2REC: Claim supported.

SAT co-chair: Vince Nabholz, 564.8909

EPA SANITIZED Page 5 of 106
STRUCTURE ACTIVITY TEAM REPORT 28 October 2005 

CASE NUMBER: P06-0037

RELATED CASES: 

ANALOGS: 

P2REC CLAIM: replacement for 

CONCLUSIONS/DISCUSSIONS

TYPE OF CONCERN: HEALTH ECOTOX

LEVEL: 2 1

KEYWORDS: LUNG, ONCO-L, IMMUNO, NEURO, DEVEL, MUTA

SUMMARY OF ASSESSMENT:

FATE: MW>>376, probably >1M as fine particles

solid with mp > 1000 °C (ICB)

S < 0.001 mg/L at 20 °C or negligible (P)

vp < 1.0E-6 mm Hg or torr at 25 °C (P)

bp >> 1000 C (P)

H < 1.0E-8 (P)

log Koc > 4.5 (P)

log fish BCF = 0.50 (P)

POTW removal = 90% via sorption (P)

time for complete ultimate aerobic biodegradation > months (P)

sorption to soils and sediments = very strong (P)

PBT Potential: P3B1T1

*CEB FATE: migration to ground water = negligible (P)

HEALTH: Absorption, if calcined, nil all routes based on

physical/chemical properties; but, if not calcined, then nil

thru skin based on physical/chemical properties, poor thru lungs

based on analogs, and poor absorption from the GI tract based on

analogs;

submitted test data with this PMN were:

rat acute oral LD0 = 2.0 g/kg with no toxic signs;

test data for 

rat acute oral LD0 = 2.0 g/kg with no toxic signs;

test data for 

rat acute oral LD0 = 2.0 g/kg;

concern for lung toxicity, lung-overload, fibrosis if inhaled

solid particles;

concern for pulmonary oncogenicity due to crystalline nature of

PMN substance and data for 

EPA SANITIZED Page 6 of 106
concern for lung toxicity if inhaled based on review of 

which is the of this PMN;

concerns for are immunotoxicity and reproductive toxicity if

bioavailable;

concerns for are immunostimulation, neurotoxicity,

developmental toxicity, and mutagenicity if bioavailable;

concerns for are mutagenicity, lung toxicity if inhaled if

bioavailable;

concerning possible ingredients in fume fever from

inhalation exposure to and some observations of

respiratory tract toxicity from inhalation exposure to 

 have been reported; was oncogenic in

the lung of rats exposed by inhalation to a high level;

if P060037 were oral-gavaged to rats in a 28-d toxicity test as a

fine powder, then toxic effects could be observed probably from

release of individual in the GI tract based on data for an

analog;

moderate concern for toxicity if inhaled;

*CEB HEALTH: Inhalation exposure only.

ECOTOX: Predicted (P) and measured (M) toxicity values in mg/L

(ppm) are:

fish 96-h LC50 = * P

daphnid 48-h LC50 = * P

green algal 96-h EC50 = * P

fish chronic value = * P

daphnid ChV = * P

algal ChV = * P

Predictions are based on SAR-nearest analog method for 

; SAR chemical class = ; MM>1M as a fine

particle; pH7; effective concentrations based on 100% active

ingredients and nominal concentrations; hardness < 180.0 mg/L as

CaCO3; and TOC <2.0 mg/L;

low concern for toxicity

assessment factor = 10.0

concern concentration = *

*CEB ECOTOX: No releases to water;

P2REC: SAT supports claim.

SAT Co-chair: Vince Nabholz, 564.8909

EPA SANITIZED Page 7 of 106
A-002 

Initial Review Engineering Reports 

 for PMNs P-06-36 and P-06-37 

 

EPA SANITIZED Page 8 of 106
 

 

 

EPA SANITIZED Page 9 of 106
 

 

 

 

EPA SANITIZED Page 10 of 106
 

 

EPA SANITIZED Page 11 of 106
 

EPA SANITIZED Page 12 of 106
 

EPA SANITIZED Page 13 of 106
 

 

 

EPA SANITIZED Page 14 of 106
 

EPA SANITIZED Page 15 of 106
 

 

 

EPA SANITIZED Page 16 of 106
 

 

 

 

 

 

EPA SANITIZED Page 17 of 106
EPA SANITIZED Page 18 of 106
 

EPA SANITIZED Page 19 of 106
A-003 

Initial Review Exposure Reports 

 for PMNs P-06-36 and P-06-37 

 

EPA SANITIZED Page 20 of 106
EPA SANITIZED Page 21 of 106
EPA SANITIZED Page 22 of 106
A-004 

TSCA Section 5(e) Consent Order 

 and Determinations Supporting Consent Order 

 for PMNs P-06-36 and P-06-37 

 

EPA SANITIZED Page 23 of 106
EPA SANITIZED Page 24 of 106
EPA SANITIZED Page 25 of 106
EPA SANITIZED Page 26 of 106
EPA SANITIZED Page 27 of 106
EPA SANITIZED Page 28 of 106
EPA SANITIZED Page 29 of 106
EPA SANITIZED Page 30 of 106
EPA SANITIZED Page 31 of 106
EPA SANITIZED Page 32 of 106
EPA SANITIZED Page 33 of 106
EPA SANITIZED Page 34 of 106
EPA SANITIZED Page 35 of 106
EPA SANITIZED Page 36 of 106
EPA SANITIZED Page 37 of 106
 

EPA SANITIZED Page 38 of 106
EPA SANITIZED Page 39 of 106
 

EPA SANITIZED Page 40 of 106
EPA SANITIZED Page 41 of 106
EPA SANITIZED Page 42 of 106
 

EPA SANITIZED Page 43 of 106
 

 

EPA SANITIZED Page 44 of 106
 

 

EPA SANITIZED Page 45 of 106
 

 

 

EPA SANITIZED Page 46 of 106
 

EPA SANITIZED Page 47 of 106
 

EPA SANITIZED Page 48 of 106
EPA SANITIZED Page 49 of 106
EPA SANITIZED Page 50 of 106
EPA SANITIZED Page 51 of 106
 

EPA SANITIZED Page 52 of 106
EPA SANITIZED Page 53 of 106
EPA SANITIZED Page 54 of 106
 

 

EPA SANITIZED Page 55 of 106
EPA SANITIZED Page 56 of 106
EPA SANITIZED Page 57 of 106
EPA SANITIZED Page 58 of 106
 

EPA SANITIZED Page 59 of 106
EPA SANITIZED Page 60 of 106
EPA SANITIZED Page 61 of 106
EPA SANITIZED Page 62 of 106
EPA SANITIZED Page 63 of 106
 

EPA SANITIZED Page 64 of 106
EPA SANITIZED Page 65 of 106
 

 

EPA SANITIZED Page 66 of 106
 

EPA SANITIZED Page 67 of 106
 

EPA SANITIZED Page 68 of 106
 

EPA SANITIZED Page 69 of 106
 

EPA SANITIZED Page 70 of 106
EPA SANITIZED Page 71 of 106
EPA SANITIZED Page 72 of 106
EPA SANITIZED Page 73 of 106
 

EPA SANITIZED Page 74 of 106
EPA SANITIZED Page 75 of 106
EPA SANITIZED Page 76 of 106
 

EPA SANITIZED Page 77 of 106
EPA SANITIZED Page 78 of 106
EPA SANITIZED Page 79 of 106
EPA SANITIZED Page 80 of 106
EPA SANITIZED Page 81 of 106
EPA SANITIZED Page 82 of 106
EPA SANITIZED Page 83 of 106
 

 

EPA SANITIZED Page 84 of 106
EPA SANITIZED Page 85 of 106
 

EPA SANITIZED Page 86 of 106
 

EPA SANITIZED Page 87 of 106
 

EPA SANITIZED Page 88 of 106
EPA SANITIZED Page 89 of 106
EPA SANITIZED Page 90 of 106
EPA SANITIZED Page 91 of 106