# 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

# Index

A-001 Structure Activity Team (SAT) Report s 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

# A-001

Structure Activity Team (SAT) Reports

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

### 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

### 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

### 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

### 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

# 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