Registration Dossier
Registration Dossier
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EC number: 231-955-3 | CAS number: 7782-42-5
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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