Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

The substance Tuball™ is a single wall carbon nanotube (SWCNT), designed in a diameter of 1.6 nm and a length in the range of 1 – 20 µm. It’s properties, making it so valuable in use, are that the tubes are extremely long, compared to their diameter, making the substance a very useful additive as reinforcement in plastic and other composite material. Due to its size a fluffy behaviour, its ability to form highly aggregated agglomerates combined with insolubility in almost all media, it shows a very low dustiness and all attempts to establish a stable atmosphere in air, allowing investigations of its inhalative toxicity, have failed.

In conclusion, inhalative exposure in use cannot be excluded, but is considered low and limited to only those workers, handling the substance as such, e.g. in composite manufacturing. Effects reported in scientific literature for single wall carbon nanotubes are mainly respiratory inflammation, but the weight of evidence of scientific literature is hard to assess, as the size properties of such single wall carbon nanotubes are not always well characterized and impurities such as carbon black or iron (typically used as catalyst in single wall carbon nanotubes and remaining in the final product, usually) are often not considered in test material characterization.

In principle, hazards resulting from the use of single wall carbon nanotubes are surrounding respiratory inflammation in lung cells and considering the low dustiness and inability to create a stable atmosphere under laboratory conditions leads to the conclusion that risk from inhalation exposure is low and cannot be quantified.

This is supported by investigations in scientific literature, where many reports can be found addressing deposition of single wall carbon nanotubes and multi wall carbon nanotubes, having a much bigger diameter, in human tissue and much research has been published in scientific literature investigating biodegradation of those deposit by natural clearance mechanisms in cells. The reason for such intensive research is that singe wall carbon nanotubes are interesting candidates to serve as drug delivery carriers for pharmaceutical industry in medicine, delivered intravenously. Thus, metabolism of these carriers, intentionally deposited in human bodies, is intensively investigated to ensure safety of such carriers in medicinal use. In various scientific papers it has been described that there are different enzymatic peroxidase assisted mechanisms that biodegrade singe wall carbon nanotubes, finally leading to CO2 by such an oxidative clearance mechanism. It appears that BSA (blood serum proteins) and different oxidase enzymes such as lactoperoxidase, horseradish peroxidase, lignin peroxidase and myeloperoxidase all were confirmed degrading single wall carbon nanotubes in vivo.

In conclusion, respiratory exposure is considered of low risk, and in lack of quantitative data no DNEL can be derived.

For dermal exposure, no quantitative data are available, but based on an OECD 431 study (in vitro skin corrosion; reconstructed human epidermis RHE test method), that showed no significant difference from negative controls and considering the outcome of an OECD 439 (in vitro skin irritation; reconstructed human epidermis test method) study, also not showing any difference versus negative controls, it is fair to assume that dermal exposure to Tuball™ does not lead to any hazards.

Finally, in an OECD 422 study (combined repeated dose toxicity study with the reproduction/developmental toxicity screening test), in which Tuball™ was dosed via diet up to 1000 mg/kg bw/d to male and female rats, no systemic toxicity was found, neither to parental animals, nor to pups. Hence, absorption of the test material and subsequent systemic toxicity was not observed, and the black discoloration of feces that was observed, support the argument, that the single wall carbon nanotubes are excreted from rodent, without significant absorption or toxicity.

Since in an in vitro eye irritation study according to OECD 492 (reconstructed human cornea-like epithelium RhCE test method) eye irritation was observed, the substance is considered of low hazards to eyes following ECHA Guideline Part E: Risk Characterisation, Version 3.0, May 2016. As a result, a qualitative risk assessment is performed for Tuball™.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

For general comments please also refer to the section on workers.

With respect to consumer exposure, no risk is assumed, as consumers only do get in contact with Tuball™, when this is incorporated in composite materials, mainly polymer based or sometimes concrete. Once Tuball™ was used as re-enforcing material in polymer composites, it is highly agglomerated and surrounded by polymers. Thus, any nano particle characteristic get void and even in cases where such composite material is grinded, cut or otherwise mechanically degraded, pure Tuball™ typically does not become release, but only as part of higher aggregated, polymer bound particles.

In conclusion, exposure of consumers to Tuball™ is extremely limited and not considered of posing any hazards to consumers, neither by inhalation, dermal or oral exposure.