Registration Dossier
Registration Dossier
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EC number: 604-314-4 | CAS number: 142844-00-6
Endpoint summary
Administrative data
Description of key information
Key Interpretation of the results from the repeated dose inhalation studies is limited due to particulate contamination of the fibre samples used
Key value for chemical safety assessment
Additional information
Only inhalation and oral data can be considered. Dermal administration is not likely to produce any repeated dose effects. Interpretation of the inhalation results is complicated by the presence of non fibrous particulate in the samples used for the 2 year inhalation studies, these particles are an artefact caused by the method of preparation. The combination of fibres and particles caused extreme pulmonary overload (reference section 7.5.3.3) ,which makes any extrapolation from the data scientifically impossible.The sample used in the 90 day study (section 7.5.3.1) was also heavily contaminated by particulate. Work place atmospheres do not contain these particles.
Justification for classification or non-classification
Pulmonary fibrosis was produced at high exposure concentrations in both rats and hamsters. The appropriate classification for this material would be carcinogen category 3 under DSD and 2 under CLP. The pulmonary overload that led to more stringent classification under the DSD means that there is no reason from animal experimental data to classify for repeated toxicity
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