Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
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 sensitizing properties none of the impurities contained in either of these qualities is of concern with respect to sensitization. However, since EG was considered as the more adverse test item compared to SG in all other studies conducted, it was chosen as test item for this study as well, having in mind that the study results are also valid for SG.

Migrated from Short description of key information:

- OECD 429 study

- Method according to Ehling et al. (see IUCLID 5 file) was used for assessment instead of radioactive labelling (acc. section 5 of OECD 429)

- Result: not sensitising

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Migrated from Short description of key information:

See section "Justification for classification or non-classification".

Justification for classification or non-classification

Based on the results of the present study, there is no indication of any sensitizing potential of Expanded Graphite (and consequently for SG). According to the provisions laid down in Regulation (EC) No 1272/2008 Graphite is not a skin sensitizer.

Graphite failed to induce a positive response in the LLNA for skin sensitisation and is therefore regarded to be not a respiratory sensitiser. According to Guidance on Information Requirements and Chemical Safety Assessment, Part 7a: and Kimber et al. (cited in guidance): “The interpretation is therefore that a chemical which fails to induce a positive response in the LLNA […] most probably lacks the potential for respiratory allergy”. Additionally, none of the data available showed any evidence for respiratory sensitization. Consequently, according to provisions as laid down in Regulation (EC) No 1272/2008, Graphite is not a respiratory sensitizer.