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EC number: 231-955-3
CAS number: 7782-42-5
Acute toxicity: oral
- OECD 423, conducted as limit test
- None of the animals showed any clinical signs of reaction to the treatment.
- LD50 > 2000mg/kg bw
Acute toxicity: inhalation
- OECD 403, conducted as limit test
- Upon cessation of exposure via inhalation none of the rats exposed to Graphite showed any signs of toxicity.
- Only usual signs of discomfort after exposure to particles were observed. Grooming activity started immediately after the end of exposure.
- LC50 > 2000mg/m3
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 making it the slightly more adverse test item for inhalation
exposure, which was primarily investigated. Due
to the absence of crystalline impurities and the fact that no other
impurities of concern are contained in SG, results obtained for EG are
valid for SG as well. For animal welfare and technical reasons, i.e. to
prevent agglomeration of particles and to assure an MMAD in the
respirable range from 1 -4µm, an aerosol concentration of 2000mg/m3
was used in this limit test as recommended by Regulation (EC) 1272/2008
Based on the physico-chemical properties
(i.e. water solubility and particle size) it is not expected that
Graphite can be absorbed via the gastrointestinal tract after oral
administration. In the study on acute toxicity via oral route of
exposure (conducted as limit test as well) no sign of systemic toxicity
was found. EG was used as test item for these studies, however, it is
not expected that any of the impurities of SG (i.e. traces of iron)
would show any effects (GESTIS-database on hazardous substances (2010
-08 -06) LD50 > 30000 mg/kg). Consequently, the results of the acute
toxicity study via oral route of exposure using EG are applicable for SG
Studies on dermal exposure were
disregarded, since it is based on the physico-chemical properties (e.g.
water solubility and particle size) not expected that Graphite particles
can be absorbed through skin. Additionally, Graphite proved to be
neither irritating nor corrosive to the skin or to the eyes in the newly
the results of these newly conducted OECD studies, Expanded Graphite
powder (and Synthetic Graphite powder) is neither acute toxic via
inhalation nor via oral route of exposure, with LC50-/LD50-values above
the respective limit concentrations. Dermal penetration is not likely.
Therefore, according to the provisions laid down in Council Regulation
(EC) No 1272/2008 Graphite powder does not meet the criteria for being
classified as acute toxic, neither by oral route or via inhalation.
Classification for acute toxicity via dermal route of exposure is not
justified, since skin adsorption cannot be expected and all studies on
irritation clearly showed no irritating effect to the skin. Hence no
classification for acute dermal toxicity is proposed.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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