# Documents in Support of a Significant New Use Rule for
Premanufacture Notice (PMN) P-14-0452

Docket ID Number
EPA-HQ-OPPT-2015-0220

# Table of Contents

1. Sanitized SAT Report for P-14-0452
2. Sanitized Engineering Report for P-14-0452
3. Sanitized Exposure Report for P-14-0452

# Sanitized SAT Report for P-14-0452

### Biodegradability Test: 28d: 0%(BOD), 0%(HPLC) N RB; OECD 305(Bioconcentration): </=13(low), </=1.3(high)/8 weeks ; OECD111(Hydrolysis): 1.0 mg/L ( p H 4,7,9): 77.2%,59.4%,66.4%, 0.15 mg/L ( p H 4,7,9): 100%,100%,100%/5d. Time for complete ultimate aerobic biodeg > mo Sorption to soils/sediments = v.strong PBT Potential: PMN P3B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption of the neat material is nil all routes and when in solution, p oor all routes ( p che m ). There are concerns for lung effects, oncogenicity, mutagenicity, developmental toxicity and male reproductive toxicity based on . The PMN is expected to be irritating to the skin and mucous membranes and a dermal and respiratory sensitizer.
Test Data: The PMN was negative in E. coli, p ositive for chromosomal aberrations, p ositive in Salmonella with activation and positive for dermal irritation in rabbits. A 28-day (oral) study showed no effects at doses up to 1000 mg/kg (highest dose tested).

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 * daphnid 48-h LC50 * green algal 96-h EC50 *
fish

_ chronic value 0.011 daphnid

_ chronic
value 0.061

algal

_ chronic
value 0.011

Sewage Sludge 3-h EC50 Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for SAR chemical class = with 66% < 1000 and 11.3% < 500; log Kow = 4.85 (EPI, n=0); solid with mp 90 C (M); S = 0.3 mg/L (P); effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Factors Values Comments
Assessment Factor 10
Concentration of Concern ( p pb) 1

### SARs
SAR Class Ecotox Category N one

Ecotox Factors Comments:

SAT Chair: Doritza Pagan-Rodriguez

# Sanitized Engineering Report for P-14-0452P140452.en2

INITIAL REVIEW ENGINEERING REPORT PMN: 14-0452

Post-Focus Draft Revision 2 9/11/2014 ENGINEER: Hall / Austin \ REC

MSDS: Yes Label: No Gen Eqpt: Glove material has to be impermeable and resistant to the product/substance/preparation. // No eye protection required. Respirator: Not required. Health Effects: No irritating effect upon skin or eye contaact. When used and handled according to specifications, the product does not have any harmful effects.

TLV/PEL: None established.P140452.en2

Consumer Use: No

SAT (concerns) (04/08/2014): Related Cases and Misc SAT Info: Same as

Migration to groundwater: Negligible PBT rating: P3B1T1 Health: 1-2 Dermal, Drinking Water, Inhalation Eco: 3 Water (All releases to water with a CC = 1 ppb)P140452.en2 OCCUPATIONAL EXPOSURE RATING: 0-1

NOTES & KEY ASSUMPTIONS: Generated by the 09/30/2013 version of ChemSTEER.P140452.en2

INITIAL REVIEW ENGINEERING REPORT PMN: 14-0452

Use1:

Number of Sites/ Location: 20

unknown site(s)P140452.en2

Days/yr: 200

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below may coincide with daily releases from the other sources to the same medium. Due to the uncertainty surrounding unknown, non-submitter controlled sites, CEB conservatively assesses all releases to uncertain media. Unloading solid material The material is a 'waxy - marble ' solid and is melted, there is no dusting.

Incineration Output 2: 2.0E-1 kg/site-day over 112 days/yr from 20 sites or 2.2E+1 kg/site-yr from 20 sites or 4.5E+2 kg/yr-all sites

IncinerationP140452.en2 Output 2: 1.1E-1 kg/site-day over 200 days/yr from 20 sites or 2.2E+1 kg/site-yr from 20 sites or 4.5E+2 kg/yr-all sites

Incineration or Landfill Output 2: 3.0E-1 kg/site-day over 200 days/yr from 20 sites or 6.0E+1 kg/site-yr from 20 sites or 1.2E+3 kg/yr-all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARYP140452.en2P140452.en2

INITIAL REVIEW ENGINEERING REPORT PMN: 14-0452

Use2:

Number of Sites/ Location: 10

unknown site(s)

Days/yr: 200P140452.en2

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below may coincide with daily releases from the other sources to the same medium. Due to the uncertainty surrounding unknown, non-submitter controlled sites, CEB conservatively assesses all releases to uncertain media.

Incineration Output 2: 2.0E-1 kg/site-day over 25 days/yr from 10 sites or 5.0E+0 kg/site-yr from 10 sites or 5.0E+1 kg/yr-all sites

.

Incineration Output 2: 2.5E-2 kg/site-day over 200 days/yr from 10 sites or 5.0E+0 kg/site-yr from 10 sites or 5.0E+1 kg/yr-all sitesP140452.en2

Incineration Output 2: 2.5E-2 kg/site-day over 200 days/yr from 10 sites or 5.0E+0 kg/site-yr from 10 sites or 5.0E+1 kg/yr-all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARYP140452.en2

MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: Rachel Corbett

Organization: ERG

CALL TO: Takao Iribe

Organization: DIC International (USA) LLC

Date: 04/09/2014

Time: 1:50 PM

Phone:

Concerning what TSCA CBI?

PMN: 14-0452P140452.en2P140452.en2

# Sanitized Exposure Report for P-14-0452