Registration Dossier
Registration Dossier
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EC number: 614-074-2 | CAS number: 675106-31-7
Endpoint summary
Administrative data
Description of key information
Acute toxicity testing waived
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Value:
- mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Value:
- mg/kg bw
Additional information
Testing the acute toxicity of a material such as this is extremely difficult. In accordance with annex xi section 1 acute oral toxicity testing is not scientifically necessary. Administering sufficiently large doses to produce an acute effect would physically damage the nose, throat and mouth of any animal. Study Basic toxicokinetics.002 used a dose of 4 g/kg and over 48 hours post dose only transient distress was seen. In study basic toxicokinetics 001 rats were fed up to 2.5% in diet over two years without evident toxicity. Again in accordance with annex xi section 1 acute inhalation toxicity testing is not scientifically necessary. A chronic inhalation study described at section 7.7 used a fibre test atmosphere of 28 mg/m3 without evident toxicity and another described at 7.5.2 exposed rats to concentrations close to 12 mg/m3 of milled fibre dust (with respirability greater than that of the fibres themselves) up to 86 weeks with minimal effect. Taken together with the chemically inert nature of the substance and the absence of absorption/ systemic distribution reported at section 7.1.1, this information makes low acute inhalation toxicity of the fibres predictable and new animal testing unjustifiable. In accordance with annex xi section 1 acute toxicity testing is not necessary. Low toxicity by oral and inhalation routes is shown elsewhere in this dossier together with a demonstration of a lack of absorption and systemic distribution following repeated oral intake. Taken together with the chemically inert nature of the substance makes acute dermal toxicity predictably insignificant and new animal testing unjustifiable. Overall there is no liklihood of acute toxic effects.
Justification for classification or non-classification
Testing the acute toxicity of a material such as this is extremely difficult. There are no valid results for these endpoints and classification as acutely toxic should not apply.
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