Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion

- One in vitro study (OECD 431) and one in vivo study (OECD 404) were conducted

- No signs of skin reaction were observed in the in vivo test

- Results of the in vitro assay were negative as well

Eye irritation

- One in vitro study (acc. to recent (yet not validated) MatTek Corp. Neat-protocol) and one in vivo study (OECD 405) were conducted

- In the in vivo study only slight changes to the eyes were found, which were fully reversible

- Results of the in vitro assay were in the best possible category as well

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

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%), hence possibly making it the slightly more adverse test item for studies assessing skin irritation/corrosion or eye irritation. Due to the absence of crystalline impurities and other impurities of concern in SG, results obtained for EG are valid for SG as well. Following provisions laid down in REACH and for animal welfare reasons prior to investigating both parameters in vivo, in vitro assays were conducted. Results obtained from both in vitro assays justified subsequent testing in animals.

Justification for classification or non-classification

Following the results obtained from all available studies on skin or eye irritation, none of the criteria for classification as irritant to skin or eye according to Regulation (EC) No 1272/2008 were met.