## Support Documents for

Significant New Use Rule (SNUR) on

Premanufacture Notice (PMN)

P-00-1099

EPA Docket EPA

- HQ

- OPPT -2011-0577

## 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

## A-001

Structure Activity Team (SAT) Report

for PMN P-00-1099STRUCTURE 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;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 = 10.0CC 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

## A-002

Initial Review Engineering Report

for PMN P-00-1099

## A-003

Initial Review Exposure Report

for PMN P-00-1099FINAL 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: