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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

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