Documents in Support of a 

Significant New Use Rule for 

Premanufacture Notice (PMN) P-14-0452 

Docket ID Number 

EPA-HQ-OPPT-2015-0220 

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 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 

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Sanitized SAT Report for P-14-0452 

 

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Biodegradability Test: 28d: 0%(BOD), 0%(HPLC) NRB; OECD 305(Bioconcentration): 

</=13(low), </=1.3(high)/8 weeks; OECD111(Hydrolysis): 1.0 mg/L (pH 4,7,9): 

77.2%,59.4%,66.4%, 0.15 mg/L (pH 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, poor all routes (pchem). 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, positive for 

chromosomal aberrations, positive 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 

(ppb)

1

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SARs

SAR Class

Ecotox Category None

Ecotox Factors Comments: 

 SAT Chair: Doritza Pagan-Rodriguez

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Sanitized Engineering Report for P-14-0452 

 

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P140452.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. 



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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) 



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OCCUPATIONAL EXPOSURE RATING: 0-1

NOTES & KEY ASSUMPTIONS: 

Generated by the 09/30/2013 version of ChemSTEER. 

 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 14-0452 

Use1: 

Number of Sites/ Location: 20 

unknown site(s) 

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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

Incineration

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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 SUMMARY

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 14-0452 

Use2: 

Number of Sites/ Location: 10 

unknown site(s) 

Days/yr: 200

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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 sites

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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 SUMMARY

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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: 14-0452 

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Sanitized Exposure Report for P-14-0452 

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