Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-00-1099 

EPA Docket EPA-HQ-OPPT-2011-0577 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-00-1099 

A-002 Initial Review Engineering Report for 

PMN P-00-1099 

A-003 Initial Review Exposure Report for 

PMN P-00-1099 

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A-001 

Structure Activity Team (SAT) Report

for PMN P-00-1099 

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STRUCTURE ACTIVITY TEAM REPORT 25 August 2000 

CASE NUMBER: P00-1099

RELATED CASES: 

CONCLUSIONS/DISCUSSIONS 

TYPE OF CONCERN: HEALTH ECOTOX 

LEVEL: 2 3 

KEYWORDS: IRR/CORROS-E,MM, SENS-S, NEURO, IMMUNOTOX, DEVEL, 

AQUATOX-A,C 

SUMMARY OF ASSESSMENT 

FATE: MW564; 

solid with decomposition at 216 C (P001099) 

solid with decomposition at 89 C ( ); 

log Kow = 3.88 at pH6.6, 25 C, shake flask (P001099); 

 = 3.30 at pH5.0, 20 C, shake flask ( ); 

S = 0.880 mg/L at pH 3.8, 25 C, shake flask (P001099); 

 = 52.83 mg/L at pH 5.5, 20 C, shake flask ( ); 

hydrolysis at 50 C and pH 4 and 7 > 10% in 5 d (P001099); 

H < 1.0E-8 (P); 

bp > 400 C (P); 

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

log Koc = 8.6 (P); 

log fish BCF = 0.50 (P); 

COD = 1.65 g O2/g (P001099); 

POTW removal = 10 to 25% via sorption; 

submitted test data were aerobic biodegradation: 

P001099: less than 5% biodegradation via BOD in 28 d, thus, not 

readily biodegradable, via the EU manometric respiration test; 

: 0% biodegradation in 28 d, thru, not readily 

biodegradable via manometric respiration (OECD301F); 

time for complete ultimate aerobic biodegradation >= months; 

sorption to soils and sediments = very strong; 

direct photolysis half-life = slow to moderate (P); 

PBT Potential: P1B1T2 

*CEB FATE: migration to ground water = negligible; 

HEALTH: Not absorbed thru skin as the neat material, but poor 

absorption from the skin if in solution based on 

physical/chemical properties; poor absorption thru the lungs and 

poor thru the GI tract based on physical/chemical properties; 

submitted test data were: 

rat acute oral LD0 = 50 mg/kg with toxic signs; 

severe eye irritation in rabbits, rabbits were killed for humane 

reasons after 2 d; 

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slight skin irritation in rabbits; 

Ames test was negative; 

E. coli test was negative; 

positive skin sensitization in guinea pigs (M&K); 

submitted test data with were: 

(-) Salmonella with and without activation; 

rat oral LD50 = 144 mg/kg with possible neurotoxic signs; 

irritation to rabbit eyes with corneal staining, did not report 

if staining resolved; 

no skin irritation in rabbits; 

100% (+) for skin sensitization with strong reaction in guinea 

pigs tested with a 10% solution using the Magnusson-Kligman 

assay; 

concern for irritation and possible corrosion to eyes and mucous 

membranes, dermal sensitization, acute toxicity, and 

neurotoxicity based on submitted test data; 

concern for immunotoxicity based on data for which 

reported bone marrow and thymus effects in the acute study at 5 

g/kg; 

concern for possible developmental toxicity based on the bromide 

ion; 

moderate concern for toxicity; 

*CEB HEALTH: Dermal, inhalation, ingestion, and drinking water; 

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

(ppm) are: 

fish 96-h LC50 <= 3.0 P 

fish (RT) 96-h LC50 = 0.014 M S,N to M43%N D48DT RF 

daphnid 48-h LC50 = 0.002 P 

daphnid 48-h LC50 = 0.002 M S,M H205 pH8.0 M43%N P001099 

daphnid 48-h LC50 = 0.014 M S,M H250 pH7.9 M40%N 

green algal 96-h EC50 = 0.500 P 

algal 72-h EC50 a = 0.014 M S,N to M43%N D48DT RF 

algal 72-h EC50 r = 0.090 M S,N to M43%N D48DT RF 

fish chronic value = 0.300 P 

daphnid ChV = 0.001 P 

algal ChV = 0.100 P 

algal ChV a = 0.004 M S,N to M43%M D48DT RF 

algal ChV r = 0.010 M S,N to M43%M D48DT RF 

Predictions are based on SAR-nearest analog analysis for delocalized cationic dyes and ; SAR chemical class = dye-cationic-D; MW564; pH7; 100% active ingredients and mean measured 

concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 

mg/L; 

high concern for acute toxicity in clean water; 

minimal mitigation of toxicity expected in the presence of 10 mg 

TOC/L, i.e., <10 times; 

high concern for environmental risk; 

assessment factor = 10.0 

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CC fish = 0.001 

CC daphnids = 0.001 

CC green algae = 0.001 

*CEB ECOTOX: All releases to water 

SAT co-chairperson: Vince Nabholz, 260-1271 

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A-002 

Initial Review Engineering Report

for PMN P-00-1099 

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A-003 

Initial Review Exposure Report

for PMN P-00-1099 

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FINAL 11/20/2000 

Page 1 of 1 

INITIAL REVIEW EXPOSURE REPORT 

Case Number: P-00-1099 Assessor: C. Greene 

ENVIRONMENTAL RELEASES 

Scenario#: 1 Number of Release Sites: 

Release Activity: Processing/Use 

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: 

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