Registration Dossier
Registration Dossier
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EC number: 610-130-5 | CAS number: 436083-99-7
Endpoint summary
Administrative data
Description of key information
Most repeated dose studies carried out have used inhalation, this is the most relevant route of exposure due to the fibrous nature of the material, no unusual ill effects were reported in any of the studies. A reproductive toxicity screening study (OECD 421) was carried out using this material administered orally, again no toxic effects were seen.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 30 mg/m³
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 30 mg/m³
- Study duration:
- chronic
- Species:
- rat
Additional information
The NOAEC reported for inhalation above is in mg/m3 but this is inappropriate for fibres where the concentration should be given in f/ml (specifying size characteristics), for this study the NOAEC should be reported as 174 WHO f/ml ±72 and 47 fibres >20µm/ml ±23.
Only physiological changes typical of the dust loading were seen, no pathological endpoints could be distinguished.
Repeated dose toxicity: via oral route - systemic effects
(target organ) urogenital: ovaries; urogenital: testes
Repeated dose toxicity: inhalation - systemic effects (target organ)
respiratory: lung
Justification for classification or non-classification
No abnormal effects observed in any long term inhalation study or shorter term oral study.
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