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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION

February 11, 2015 

THIS MEMORANDUM CONTAINS 

TSCA CONFIDENTIAL BUSINESS INFORMATION 

MEMORANDUM

SUBJECT: Standard Review Risk Assessment of P-15-0059, P-15-0060, 

and P-15-0104. 

FROM:

Assessment Branch 3 

 Risk Assessment Division (7403M) 

TO: 

New Chemicals Management Branch 

Chemical Control Division (7405M) 

THRU: 

Assessment Branch 1 

 Risk Assessment Division (7403M) 

 
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I. BACKGROUND 

 
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Figure 1. Structures of P-15-0059, P-15-0060, and P-15-0104. 

I.B. Chemical Identity 

(Per Chemistry Report in PMN GOLD, 11/06/2014, 12/04/14 and 12/22/2014)

Submitter: Nanosys Inc. 

Production Volume: 

Chemical Names: 

CAS No: 

1623456-05-2 (P-15-0059) 

None (P-15-0060 and P-15-0104) 

Trade Name: 

Physical Form (all three PMN): Solid (Est.) 

Molecular Formula: 

 
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Manufacturing and Use (taken largely from the Chemistry Report): 

Manufacturing and Processing Information: The PMN substances are manufacturing 

Fate Summary (same for all three PMN, except POTW removal):

Solid 

S < 0.001 mg/L at 25 °C (E) 

VP < 1.0E-6 torr at 25 °C (E) 

BP > 400 °C (E) 

H < 1.00E-8 (E) 

POTW removal (%) = 0-99 (P-15-0059 and P-15-0060) ; 0-90 (P-15-0104) via sorption 

Time for complete ultimate aerobic biodeg > mo 

Sorption to soils/sediments = low - v.strong 

PBT Potential: P3B? 

Migration to ground water = negl - rapid
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I.C. Concerns Identified at FOCUS: 

(Per FOCUS Reports in PMN GOLD): 

11/20/2014 

 

12/18/2014 

II. TOXICITY / HAZARD SUMMARIES 

II.A. Human Health Hazard Summary 

II.A.1. Human Health Effects of Concern 

(Largely per SAT Reports in PMN GOLD): 

Expect poor absorption via all routes (pchem/analog). Concern for lung toxicity if inhaled 

based on lung overload for . There is an uncertain concern for 

oncogenicity via inhalation exposure for The 
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II.B. Environmental (Aquatic) Hazard Summary 

II.B.1. Aquatic Toxicity Data 

(Per Ecotox Reports in PMN GOLD, 11/06/2014 and 12/11/2014):

P-15-0059 

Ecotoxicity Test Data were submitted for P-15-0059:

Fish Ecotoxicity Test: 

Block Environmental Services, Inc. conducted a 96-hour bioassay in rainbow trout 

(Oncorhynchus mykiss) with 

 under static conditions. The test procedures for this study were 

based upon the following references: California’s Title 22 Code, Section 

#66261.24(a)(6), Static Acute Bioassay Procedures for Hazardous Waste Samples 

(Polisini and Miller, 1988); Guidelines for Performing Static Acute Toxicity Fish 

Bioassays in Municipal and Industrial Wastewaters (Kopperdahl, 1976); and Standard 

Methods for the Examination of Water and Wastewater (American Public Health 

Association, 1995). Two replicates of ten O. mykiss were exposed to a control or the test 

substance at nominal concentrations of 250, 500 or 750 mg . Concentrations of 

the test substance were not analytically verified. To prepare the test solutions, the test 

substance was cut into small (~ 6 inch) pieces and weighed. Appropriate amounts of the 

test substance were placed into 250 mL flasks with 200 mL deionized water to create the 

desired nominal test concentrations. The flasks were placed on an orbital shaker for a 

minimum of 6 hours before testing. Over the course of testing, temperature ranged from 

11.8 – 12.3°C, pH ranged from 6.9 – 7.7, and dissolved oxygen ranged from 8.6 – 10.4 

mg/L. The average water hardness was 44 mg/L as CaCO3/L. No mortalities occurred 

during the study in both the control and test replicates. Based on nominal concentrations, 

the 96-hour LC50 was > 750 mg The study report did not indicate whether the 

study was conducted under GLP conditions. 

The study was conducted with the 

. Since 
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concentrations of the PMN material in the water were not analytically verified, there is no 

way of knowing the concentrations of the PMN material to which the fish were exposed. 

Therefore, this test is considered unacceptable for evaluating the toxicity of the PMN 

material to fish. 

Since the submitted study is unacceptable for evaluating the toxicity of the PMN material 

to fish, SARs were used for estimating the toxicity of P-15-0059 to aquatic taxa. 

Predictions are based on SARs for SAR chemical class = 

; solid with mp unknown (P); S < 0.001 mg/L at 20 C (P); pH7; 

effective concentrations based on 100% active ingredients and nominal concentrations; 

hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L. 

Based on SARs for , no 

effects at saturation are predicted for 96-hour fish, 48-hour daphnid, and 96-hour green 

algae studies as well as chronic fish and daphnid studies. 

COC: No effects at saturation 

Ecotox Study Reviewer: 

Same for P-15-0060 and P-15-0104 

Predictions are based on SARs for

S < 0.001 mg/L at 20 C (P); pH7; 

effective concentrations based on 100% active ingredients and nominal concentrations; 

hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L. 

COC: No effects at saturation 

II.B.2. Concentration of Concern 

Based on SARs for P-15-104, P-15-60, and P-15-59 - 

 are predicted for 96-hour fish, 48-hour 

daphnid, and 96-hour green algae studies as well as chronic fish and daphnid studies. 

 
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III. RELEASES AND EXPOSURES 

 

 

 

 

 

 

 

 

 

 

 

End 5.8E+0 250 

 
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Incineration High End 5.9E+0 255 

 

 

 

 

 
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IV. RISK ASSESSMENT 

IV.A. Human Health Risk Discussion 

IV.A.1. The Toxicity Effect Levels Used to Determine Risk are based on lung toxicity 

from 

. 

By analogy to other 

Although dermal exposures exist for the PMN, the hazards concerns for the PMN via the 

dermal route are low; however, the PMN 

Routes of Concern – Inhalation, Dermal.

Populations of Concern – Occupational, General Population. 

IV.A.2. Occupational Exposure Discussion 

IV.A.3. General Population Exposure via Stack Air Inhalation. 

IV.A.4. Consumer Exposure. 

IV.B. Environmental Risk Discussion 

 

V. CONCLUSIONS 

V.A. Occupational Health Conclusion: P
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V.B. General Population Health Conclusion: 

V.C. Environmental / Aquatic Conclusion:

VI. RECOMMENDATIONS 

VI.A. Occupational Health Recommendations: 

Table 3. 

 
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VI.B. Testing Recommendations.

VI.C. Consumer Exposure. 

 

VI.D. Environmental / Aquatic Recommendations. 

 
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Attachment

 
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MEMO CBI: Yes 

SUBJECT: Gloves for P-15-59, 60, and 104 

FROM: Scott Prothero, EPA/ AB4 

TO: Jim Alwood, EPA/ NCB 

DATE: 1/28/2015 

Regarding glove use, the submissions indicate nitrile glove use for 

rts 

s as they indicate, dermal exposure 

would be reduced or eliminated.” 

Publicly available information differs on the effectiveness of 

s the carrier 

fluid for the new chemical substances in these cases. 

I consulted Anjali Lamba, our industrial hygienist, for input on the 

issue. 

We conclude that nitrile rubber is not suitable for protection 

against toluene. 

The submitter should investigate what glove materials are adequate 

ew chemical substances in the worker activities for 

these cases. 

Glove manufacturers can provide information on suitable glove types