Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 (with the Read-Across substance charcoal) instead.

Key value for chemical safety assessment

Additional information

28-d repeated dose testing of coconut shell 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 (with the Read-Across substance charcoal).

As some exposure to inhalable coconut shell charcoal particles (< 100 µm) in particular during manufacturing and (re) packing cannot be ruled out, a study investigating the sub-chronic toxicity of charcoal(the Read-Across substance)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 section 5.2.1.2), charcoal particles with average sizes of ≈ 4 µm should be used.

Justification for classification or non-classification