Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

- No study on toxicokinetics of Graphite was found

- Graphite belongs to the group of poorly soluble dusts with low toxicity, comparable to titanium dioxide

- In the available literature as well as in ECHA Guidance information on prolonged lung clearance after chronic exposure to poorly soluble dusts can be found

Key value for chemical safety assessment

Additional information

There was no study available dealing with the toxicokinetics of Graphite powder. However, based on common knowledge and all experimental data available in this dossier it is reasonable to regard Graphite as a poorly soluble substance of low toxicity, comparable to other representatives from the group of poorly soluble dusts with low toxicity, such as Titanium dioxide (TiO2 is often used as a benchmark substance for this group of substances).

In an experiment preceding the repeated dose studies, two Graphite qualities were assessed for differences in their effects compared to DQ12 Quartz. Here BAL was used to quantify severity of effects found. Additionally, gross pathology was performed. As a result, no animals in any of the groups died due to the treatment. Also, there was no sign of systemic toxicity - indicating that no adsorption occurred. Recovery of the primary effects was not complete after 14 days, hence the recommendation to prolong the recovery period to 28 days for the repeated dose studies.