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NM: Kristan Markey 564-8716 CONTAINS TSCA CBI 

TIs: Maggie Johnson 564-8924, Phil Sayre, 564-7673 

LIMITED STANDARD REVIEW: P10-0039 & 40 

SUMMARY: Human Health Hazard and Risk: No data were submitted with this case; risk is 

estimated based on analogous case ; concerns for lung effects based on 90-D rat inhalation 

study on which had a LOAEC of 0.1 mg/m3. Possible concerns for immunotoxicity, 

oncogenicity and mutagenicity based on analogs. NCEL of 0.0037 mg/m3 is based on LOAEC. RAD 

assumes that all material to which workers are exposed is respirable (≤10μm). MOEs indicate a 

potential for risk exists from occupational inhalation exposures during both Manufacturing and Use.

NOTE: Worker exposure data submitted by the company is currently under review. The current risk 

management options and testing in this risk assessment are sufficiently protective of health and 

the environment. 

Recommendations include Tiered Testing as follows: 

(1) Particle Size Distribution Testing reflective of workplace exposures to specifically provide the 

fraction of the size distribution in the respirable range for humans and using a method acceptable to 

EETD. 

(2) Subchronic Inhalation Toxicity Test Following receipt and analysis of these data, subchronic 

inhalation toxicity testing on the PMN substance may be required. The specific test is OPPTS 

870.3465: 90-day inhalation toxicity test, by nose-only exposure with a post-exposure observation 

period of up to 3 months, bronchoalveolar lavage fluid (BALF) analysis, aggregation/agglomeration 

state, shape, size/size particle distribution and surface properties of materials as-administered, 

aggregation/agglomeration state, shape, size/size particle distribution and surface properties of 

materials of the delivered materials after administration, determination of cardiovascular toxicity, heart 

histopathology, and data on pulmonary deposition. 

(3) PPE & IH Controls Until such testing is completed and PPE & IH Controls specifically a NIOSHapproved, full-face air-purifying particulate respirator with N, P, or R-100 filter, or hood respirator with 

an assigned protection factor (APF) of at least 25; permeation resistant gloves; and impervious clothing. 

Aquatic Toxicity & Risk: Minimal releases to water are possible during Mfg of 

nanotube sheets. Data from the literature indicate that effects on aquatic species can occur at 

concentrations as low as 100 ppb. exposed juvenile rainbow trout to CNTs at 

concentrations of 0, 0.1, 0.25, or 0.5 mg/L (facilitated by the detergent-like solvent, sodium dodecyl 

sulfate and sonication) for up to 10 days under semi-static conditions monitoring a variety of 

endpoints including clinical observations, clinical chemistry, differential blood analysis, and 

histopathology. Effects on the gill and brain were found that may be related to the accumulation of 

CNTs on gills (inhibiting oxygen uptake) and/or to the sodium dodecylsulfate vehicle rather than a 

direct toxic effect of CNTs to fish. 

Surface water concentrations cannot be predicted by traditional methods; 

Since the EETD assumption of is made without justification, the ecotoxicity value 

above cannot be compared to the surface water concentrations and a subsequent ecological risk 

assessment cannot be completed. 

CONTAINS TSCA CBI LIMITED STANDARD REVIEW: P10-0039 & 40 1 of 85
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I. BACKGROUND 

Structure: 

Identity: Multi-walled carbon nanotubes (MWNT), 

 Submitter: Nanocomp Technologies Inc. 

 

P/Chem Properties: MW = 1,000,000; High BP Solid; WS = Insoluble; Non volatile; 

MW is variable and depends on the size of the nanotube. It is estimated to be 

>1,000,000 g/mole. 

 NOTE: To be conservative RAD at this time is assuming all materials are respirable 

and ≤10 μm. However, area monitoring data are under review in EETD at the time this risk assessment 

was written and the EETD analysis will likely not conclude for at least several weeks. Since this 

analysis, per EETD correspondence, will not likely change (or could perhaps lower) the estimated 

exposures to workers, the current risk assessment conclusions and risk management 

recommendations should be protective of human health and the environment. 

Fate Ratings (per EETD, see Focus Report): Removal in WWT/POTW = 0-90% via sorption 

SAT (11/13/2009) Ratings: HH = 1, Eco = 1 

CONTAINS TSCA CBI LIMITED STANDARD REVIEW: P10-0039 & 40 2 of 85
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Health Concerns FOCUS Report 11/23/2009 (attached): Absorption is nil all routes (pchem); 

 No significant health concerns. 

Exposure Routes of Concern (Engineering Reports attached): Engineering estimates indicate 

occupation exposure is possible via inhalation of particulates. Exposure values are provided below. 

Consumer exposure is not expected. 

Toxicity Data Provided: None provided with submission. Hazards will be estimated by analogy to a 

previous 

II. HEALTH ASSESSMENT 

Information below is summarized from Risk Assessment for RAD Dispo by Steve Cragg 

attached). 

Absorption, Distribution, Metabolism, Excretion: PMN is poorly absorbed via all routes; concerns for 

lung overload for poorly soluble particulates and for lung effects based on submitted test data 

(submitted with . There are possible concerns for immunotoxicity, oncogenicity and 

mutagenicity based on analogs (SAT Report for ). 

General Toxicity: A 90-day inhalation study conducted by MWCNT’s revealed 

moderate granulomatous inflammation, severe alveolar histiocytosis, lipoproteinosis and minimal 

neutrophil infiltration at 2.5 mg/m3. The histopathological findings at lower concentration levels were 

similar to those observed at 2.5 mg/m3 but of less severity. The No Lowest Observed Adverse Effect 

Concentration (LOAEC) from this study was 0.1 mg/m3. 

 

Mutagenicity: Concern exists for mutagenicity based on reports on analogous materials, however no 

testing of the PMN is recommended at this time. 

Immunotoxicity: Published scientific data for similar MWCNT indicate potential to cause 

immunotoxicity. Pulmonary exposure to this PMN may lead to lung effects including: reduced alveolar 

macrophage phagocytosis, impaired clearance of inhaled bacteria, inflammation, possible systemic 

immunosuppression, and promotion of allergy.

Occupational Inhalation Exposure Values: Assumptions are that 100% of the material is respirable 

(≤ 10 microns), estimated toxicity is occurring from both nano-particle containing elemental carbon 

and organic carbon and workers are exposed to dust. T = 

typical & WC = Worst Case. 

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Development of a New Chemical Exposure Limit (NCEL) A NCEL of 0.0037 mg/m3 for inhalation 

exposure was derived based on by dividing the LOAEC of 0.1 mg/m3

 from 

that study by uncertainty factors (see Table 1). This rationale is described in a memo from Steven 

Cragg to Phil Sayre, dated 2009-10-19 (attached). 

Table 1. Calculation of a New Chemical Exposure Limit (NCEL) for Non-Cancer Effects 

Using LOAEC from Inhalation Study (UF = Uncertainty Factor)

LOAEC 

UF using 

subchronic 

not 

chronic 

study 

 

UF 

extrapolating 

rat to 

humans 

 

UF 

extrapolating 

LOAEL to 

NOAEL 

 

UF 

uncertainty 

to protect 

most 

sensitive 

worker 

 

UF 

Uncertainty 

in data 

base 

 Permissible 

Daily Dose 

mg/m3 unitless unitless unitless unitless unitless mg/m3 

0.1 

÷ 

by 1 

÷ 

by 1 

÷ 

by 3 

÷ 

by 3 

÷ 

by 3 = 0.0037 

Table 2. Occupational Inhalation Exposure and Risk MOE Calculations 

Using LOAEC from 

 

 Dose Air Vol Exp conc NCEL 

 mg/day m3/day mg/m3 mg/m3 MOE 

P10-0039

Typical 0.73 ÷by 10 = 0.073 ÷by 0.0037 = 20 

Worst Case 2.5 ÷by 10 = 0.250 ÷by 0.0037 = 68 

Typical 0.095 ÷by 10 = 0.010 ÷by 0.0037 = 3 

Worst Case 3.20 ÷by 10 = 0.320 ÷by 0.0037 = 86 

 

P10-0040

Typical 0.037 ÷by 10 = 0.004 ÷by 0.0037 = 1 

Worst Case 0.12 ÷by 10 = 0.012 ÷by 0.0037 = 3 

Typical 0.0067 ÷by 10 = 0.001 ÷by 0.0037 = 0.2 

Worst Case 0.023 ÷by 10 = 0.002 ÷by 0.0037 = 1 

MOEs indicate a potential for risk does exist from occupational inhalation exposures during 

both Manufacturing and Use. 

RECOMMENDATIONS 

Tiered testing is recommended: 

(1) Particle size distribution of respirable particles Due to the great uncertainty in assessing particle 

sizes of the PMN better characterization of actual particle size distributions, including the fraction of the 

distribution that represents respirable particles in the work environment, are needed using instruments 

such as a cascade impactor. Definitive particle-size distribution information would indicate the need for 

and structure of subsequent toxicity testing on the PMN substance.

CONTAINS TSCA CBI LIMITED STANDARD REVIEW: P10-0039 & 40 4 of 85
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(2.) 90-day inhalation toxicity test (OPPTS 870-3465) by nose-only exposure with a post-exposure 

observation period of up to 3 months, bronchoalveolar lavage fluid (BALF) analysis, 

aggregation/agglomeration state, shape, size/size particle distribution and surface properties of 

materials as-administered, aggregation/agglomeration state, shape, size/size particle distribution and 

surface properties of materials of the delivered materials after administration, determination of 

cardiovascular toxicity, heart histopathology, and data on pulmonary deposition. 

(3). Personal Protective Equipment and Industrial Hygiene Control Recommendations Until such 

time as particle size information is better characterized, PPE and IH controls should include: a NIOSHapproved, full-face air-purifying particulate respirator with N, P, or R-100 filter, or hood respirator with 

an assigned protection factor (APF) of at least 25; permeation resistant gloves; and impervious 

clothing. 

III. AQUATIC TOXICITY AND RISK 

Minimal releases to water are possible during Mfg of nanotube . Data from the 

literature indicate that effects on aquatic species can occur at concentrations as low as 100 ppb. Smith 

et al. (2007) exposed juvenile rainbow trout to CNTs at concentrations of 0, 0.1, 0.25, or 0.5 mg/L 

(facilitated by the detergent-like solvent, sodium dodecyl sulfate and sonication) for up to 10 days under 

semi-static conditions monitoring a variety of endpoints including clinical observations, clinical 

chemistry, differential blood analysis, and histopathology. Effects on the gill and brain were found that 

may be related to the accumulation of CNTs on gills (inhibiting oxygen uptake) and/or to the sodium 

dodecylsulfate vehicle rather than a direct toxic effect of CNTs to fish.

Surface water concentrations cannot be predicted by traditional methods; EETD assumed

ince the EETD 

assumption of is made without justification, the ecotoxicity value above cannot be 

compared to the surface water concentrations and a subsequent ecological risk assessment cannot be 

completed. 

REFERENCES CITED 

Smith, C.J., Shaw, B.J., Handy, R.D., (2007). Toxicity of Single Walled Carbon Nanotubes to Rainbow 

Trout, (Oncorhynchus mykiss): Respiratory Toxicity, Organ Pathologies, and other Physiological 

Effects. Aquatic Toxicol. 82:84-109. 

ATTACHMENTS Pages 

Chemistry Reports 7 

Engineering Reports (Focus ready draft) 11 

Exposure Reports (pages with 7Q10 predictions only) 23

FOCUS Reports 11/23/2009 27 

Risk Assessment for RAD Dispo by Steve Cragg 39 

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