Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Two qualities of Graphite were considered for the present registration dossier: Synthetic Graphite (SG) and Expanded Graphite (EG). Both are high purity graphite qualities with SG having the higher purity (>99%) and no amounts of quartz or any other crystalline impurities. EG however may contain certain (but low) amounts of quartz (typical quantity: 0.9%) and muscovite (typical quantity: 1.2%). With respect to genotoxic properties Quartz may be the most problematic impurity of EG (although the Quartz content is rather low), making EG the worst case sample for assessing genotoxicity. Due to the fact that SG does not contain Quartz, results obtained for EG arevalid for SG as well.

Short description of key information:

OECD 471 (bacterial reverse mutation)

- Four Salmonella strains and one E. Coli strain were used

- Plate incorporation method was applied

- Graphite did not induce neither with nor without S9 an increased number of revertants

OECD 473 (in vitro mammalian chromosome aberration test)

- Chinese Hamster Lung Fibroblasts (V79) cells were used

- Soy lecithin (in PBS) was used as an emulsifier for Graphite

- Graphite did not induce neither with nor without S9 the number of aberrant cells

OECD 476 (in vitro mammalian gene mutation)

- Mouse Lymphoma L5178Y/TK+/- cells were used

- Soy lecithin (in PBS) was used as an emulsifier for Graphite

- Graphite die not induce neither with nor without S9 an increased numbers of TFT-resistant mutants

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Results of all three OECD compliant studies assessing genotoxicity had clearly negative outcome, hence there is no evidence for any genotoxic potential of Graphite. According to provisions laid down in Regulation (EC) No 1272/2008 Graphite is not regarded as genotoxic.