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P-15-0059, P-15-0060, and P-15-0104

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 Assessm ent 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)Contains CBI Page 2 of 15

P-15-0059, P-15-0060, and P-15-0104



### I. BACKGROUNDContains CBI Page 3 of 15

P-15-0059, P-15-0060, and P-15-0104

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

I.B. Chemical Identity

(Per Chemistry Report in PMN GOL D, 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 :Contains CBI Page 4 of 15

P-15-0059, P-15-0060, and P-15-0104

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 - rapidContains CBI Page 5 of 15

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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/a nalog). Concern for lung toxicity if inhaled

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

oncogenicity via inhalation exposur e for TheContains CBI Page 6 of 15

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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 a nd 12/11/2014):



### P-15-0059

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

Fish Ecotoxicity Test:

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

( Oncorhynchus mykiss ) with

under static conditions. The test pr ocedures for this study were

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

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

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

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

Methods for the Examination of Water a nd Wastewater (Ameri can 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 veri fied. To prepare the test solutions, the test

substance was cut into small (~ 6 inch) pie ces 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, te mperature 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 co ntrol and test replicates. Ba sed 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

. SinceContains CBI Page 7 of 15

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concentrations of the PMN material in the wate r were not analytically verified, there is no

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

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

material to fish.

Since the submitted study is unacceptable for ev aluating the toxicity of the PMN material

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

Predictions are based on SARs for SAR chemi cal class =

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

effective concentrations based on 100% ac tive ingredients and nom inal concentrations;

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

Based on SARs for , no

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

algae studies as well as chr onic 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% ac tive ingredients and nom inal 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 predicte d for 96-hour fish, 48-hour

daphnid, and 96-hour green algae studies as we ll as chronic fish and daphnid studies.Contains CBI Page 8 of 15

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III. RELEASES AND EXPOSURES

End 5.8E+0 250Contains CBI Page 9 of 15

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Incineration High End 5.9E+0 255Contains CBI Page 10 of 15

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IV. RISK ASSESSMENT

IV.A. Human Health Risk Discussion

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

from

. By analogy to other

Although derm al 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 : PContains CBI Page 12 of 15

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V.B. General Population Health Conclusion :

V.C. Environmental / Aquatic Conclusion :

VI. RECOMMENDATIONS

VI.A. Occupational Health Recommendations :

Table 3

.Contains CBI Page 13 of 15

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VI.B. Testing Recommendations.

VI.C. Consumer Exposure.

VI.D. Environmental / Aquatic Recommendations.Contains CBI Page 14 of 15

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# AttachmentContains CBI Page 15 of 15

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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