## Supp ort Documents for

Significant New Use Rule (SNUR) on

Premanufacture Notice (PMN)

P-03-362

EPA Docket EPA

- HQ

- OPPT -2011-0577

## Index

A-001 Structure Activity Team (SAT) Report for

PMN P-03-362

A-002 Initial Review Engineering Report for

PMN P-03-362

A-003 Initial Review Exposure Report for

PMN P-03-362

## A-001

Structure Activity Team (SAT) Report

for PMN P-03-362STRUCTURE ACTIVITY TEAM REPORT 07 March 2003

CASE NUMBER: P03-0362

RELATED CASES:

CONCLUSIONS/DISCUSSIONS

TYPE OF CONCERN: HEALTH ECOTOX

LEVEL OF CONCERN: 1-2 2

KEYWORDS: ONCO, IRR, NEURO, AQUATOX-A,C, SENS-S, DEVEL

SUMMARY OF ASSESSMENT

FATE: MW233

liquid with mp < 20 C (P)

log Kow = mf (ClogP), 3.5 (EPI)

S = 103 mg/L at 25 C (P)

H = 7.1E-8 (P)

bp = 300 C (P)

vp = 2.2E-3 (P)

log Koc = 1.0 (P)

log fish BCF = 2.0 (P)

submitted test data for aerobic biodegradation were:

17.5% biodegradation in 28 d, thus, not readily biodegradable,

via the modified Sturm test (OECD301B)

POTW removal = 25 to 90 percent via possible partial

biodegradation

time for primary aerobic biodegradation = weeks

time for complete ultimate aerobic biodegradation = months

sorption to soils and sediments = moderate

atmospheric oxidation half-life via OH radical = 5.1 h (P)

PBT Potential: P1B1T2

*CEB FATE: migration to ground water = moderate

HEALTH: Absorption is good all routes based on analogs;

submitted test data with this PMN were

rat acute oral (in progress)

rabbit acute dermal LD20 = 2.0 g/kg with irritation at site of

application which persisted for 7 days and not other significant

toxic signs;

no skin irritation in rabbits;

mild and transient (3 d) eye irritation in rabbits;

Ames test was negative;

E. coli test was negative;

mouse micronucleus test via oral route was negative;

mouse micronucleus test via oral route was weakly positive;

chromosome aberration test with human lymphocytes was negative;

skin sensitization in guinea pigs (in progress)test data for an analog, reported a rat acute oral LD50 =

570 mg/kg;

expected to be an irritant and to cause solvent-type

neurotoxicity (sedation) based on its solvent properties;

concern for developmental toxicity and a marginal concern for

oncogenicity as a carbamate;

concern for possible skin sensitization based on

analogs;

low to moderate concern for toxicity;

*CEB HEALTH: Exposures to humans: inhalation, dermal,

ingestion, and drinking water; XB:

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

(ppm) are:

fish 96-h LC50 = 9.9 P

fish (RT) 96-h LC50 = 5.0 M S,N

daphnid 48-h LC50 <= 10.0 P

daphnid 48-h LC50 = 5.4 M S,N

green algal 96-h EC50 <= 10.0 P

algal 72-h EC50 = in progress

fish chronic value = 1.0 P SAR

fish ChV = 0.500 P RT96/ACR10

daphnid ChV <= 1.0 P

daphnid ChV = 0.500 P D48/ACR10

algal ChV <= 1.0 P

Predictions are based on SARs for thiocarbamates ; SAR

chemical class = thiocarbamate ; log Kow = 3.5 (EPI);

MW233; pH7; effective concentrations based on 100% active

ingredients and mean measured concentrations; hardness <180.0

mg/L as CaCO3; and TOC <2.0 mg/L;

moderate concern for toxicity;

assessment factor = 10.0

concern concentration = 0.050 mg/L (ppm)

*CEB ECOTOX: All releases to surface waters; XB:

SAT co-chair: Vince Nabholz, 564.8909

## A-002

Initial Review Engineering Report

for PMN P-03-362

## A-003

Initial Review Exposure Report

for PMN P-03-362