Registration Dossier
Registration Dossier
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EC number: 240-383-3 | CAS number: 16291-96-6 An amorphous form of carbon produced by partially burning or oxidizing wood or other organic matter.
Endpoint summary
Administrative data
Description of key information
28-d repeated dose testing is not required as it is suggested to perform a long-term (90-d) repeated dose toxicity instead (see "discussion " below).
Key value for chemical safety assessment
Additional information
28-d repeated dose testing of charcoal is not required as it is suggested to perform a long-term (90-d) repeated dose toxicity study by inhalative route of administration instead.
As some exposure to inhalable charcoal particles (< 100 µm) in particular during manufacturing and (re)packing cannot be ruled out, a study investigating the sub-chronic toxicity of charcoal is recommended. To this end, in accordance with REACh Regulation (EC) No. 1907/2006, Annex IX, 8.6.2. a 90-d repeated dose inhalation study should be performed. Alternatively, the 90-day repeated dose study might be replaced by a chronic in vitro CULTEX study using epithelial cell lines, such as alveolar cells type (A549) or bronchial cells 16 HBE14o- (Cultex Laboratories Ltd, Hannover Germany). In each study, as in the acute inhalation toxicity study already performed (see IUCLID section 7.2.2) charcoal particles with average sizes of ≈ 4 µm should be used.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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