Single Wall Carbon Nanotubes (SWCNT)

Endpoint summary

Description of key information

Acute Oral Toxicity waived as technically not feasible.

The Acute Oral Toxicity study on test item was not performed as the test item was found to be impossible to formulate satisfactorily in a suitable vehicle for oral dosing. It is the opinion of Envigo Research Limited that the bio‑availability of the test item is negligible, due to its inert nature, and it is reasonable to assume that the test item presents no significant acute toxic risk under the conditions of the test.

However, meanwhile a repeated dose oral toxicity study (in combination with a repro-screen, according to OECD 422) was performed, in which rats were dosed via feed. In this study, dosed up to >1000 mg/kg bw/d no adverse effects were observed and thus, an acute oral toxicity study is not required anymore and the substance is considered not subject for classification for acute toxicity.

An repeated dose inhalation study was ordered by US EPA to be performed, but in pre-tests for dosing via air it was found, that the substance cannot be dosed via air; a stable atmosphere of the test substance in air could not be generated as described in the supporting study and thus, performance of an acute inhalation study is technically not feasible.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Justification for type of information:

The Acute Oral Toxicity study on test item, was not performed as the test item was found to be impossible to formulate satisfactorily in a suitable vehicle for oral dosing.

It is the opinion of Envigo Research Limited that the bio-availability of the test item is negligible, due to its inert nature, and it is reasonable to assume that the test item presents no significant acute toxicity risk under the conditions of the test.

Reason / purpose for cross-reference:

reference to other study

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

the study does not need to be conducted because inhalation of the substance is likely

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In lack of signs of toxicity in all studies performed so far, the substance is not subject to classification for acute toxicity according to CLP (Regulation EU No. 1272/2008).