Registration Dossier
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EC number: 231-955-3 | CAS number: 7782-42-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Assessment factors
Assessment factors were chosen based on the respective ECHA Guidance on CSA (except for duration of exposure extrapolation and interspecies differences, see below).
Rationale for deviation from standard factors as given in ECHA Guidance on CSA
a) Duration of exposure
The default assessment factor given in ECHA Guidance on CSA for extrapolation of exposure duration from sub-acute exposure to chronic exposure is 6. However, according to Guidance given in ECETOC Technical Report 86 (2003) "No additional assessment factor is needed for duration of exposure extrapolation for substances with a local effect below the threshold of cytotoxicity", because it is believed that the threshold for cytotoxicity is the similar between species (sources cited in ECETOC Technical Report 86 (2003)).
In both repeated dose studies available (with Synthetic Graphite and Expanded Graphite powder) the low dose represented the NOAEL, where no adverse histopathological effects were found in the low dose, which can be understood as an absence of cytotoxicity. Hence, no additional assessment factor was applied, i.e. AF=1 was chosen.
b) Interspecies differences
The default assessment factor foreseen in ECHA Guidance on CSA for interspecies differences is 2.5 for local effects on the respiratory tract. According to available literature (Mermelstein et al., Lung Overload, Dosimetry of Lung Fibrosis and Their Implications to the Respiratory Dust Standard, Ann. occup. Hyg. Vol 38, Suppl. 1, pp 313 -322, 1994) lung overload is a general phenomenon occurring in most species and its onset occurs at 1mg/g lung burden. Based on the MPPD a lung burden of 0.45mg/lung (approx. 0.3mg/g lung) was calculated for the low dose (12mg/m3) of Synthetic Graphite powder. This dose represented the NOAEL of this repeated dose study (i.e. 20 exposure days). Compared to a hypothetical exposure of man to the same Synthetic Graphite powder at a concentration of 1.5mg/m3 (which is half of current occupational exposure levels), for 20 exosure days, 8hrs of exposure per day, respiratory rate of 8.4L/min, a lung burden of 16.8mg/lung (i.e. 0.0168mg/g lung) is calculated for man according to the MPPD model. This is well below the 1mg/g lung which is indicative for lung burden, as well as well below (about 18 times) the lung burden calculated for the experimental animals. Additionally taking into account that 1.5mg/m3 is higher than the calculated DNEL for inhalation it is prudent to deviate from the proposed AF of 2.5 and apply no additional AF, i.e. AF=1.
As for inhalation, long-term, local: two inhalation studies were conducted: Synthetic Graphite and Expanded Graphite
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. However, results after repeated dose inhalation indicated that both qualities are similar in their effects - both qualities the NOAEL was equalling the low dose. Due to a different dosing scheme (please see IUCLID5 file) the low dose of EG was slightly lower, i.e. 8mg/m3 vs. 12mg/m3 for SG. Since both studies showed quite similar results and because of the relatively low Quartz-content of EG, 12mg/m3 was chosen as the effect level for calculation of the DNEL. Supportive for this assumption is, that EG was used in all other studies, none of which showed an adverse outcome. Additionally, the DNEL calculated from SG-NOAEL is more stringent than the recent occupational exposure limit for poorly soluble substances, providing a sufficient level of safety.
Additional Information
Expanded Graphite powder, DNEL worker, inhalation, local effects: 0,8mg/m3
Overall Assessment Factors: 5 (Applied Assessment Factors: Dose Descriptor (LOAEL/NOAEL): 1; Interspecies differences: 1; Intraspecies differences: 5; Duration of repeated dose study: 1; Qualitiy of whole database: 1; Dose descriptor modified according to ECHA Guidance)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Not systemically available after inhalation, hence no DNEL derived. Not classified as acute toxic via inhalation.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Not systemically available after inhalation, hence no DNEL derived. Not classified as acute toxic via inhalation.
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Graphite is not expected to be systemically available via dermal exposure. Not classified as skin- or eye-irritant. After oral administration no toxicity observed up to the limit dose in an acute toxicity study, as well as in a repeated dose study (OECD 422). Therefore, no calculation of a DNEL.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Graphite is not expected to be systemically available via dermal exposure. Not classified as skin- or eye-irritant. After oral administration no toxicity observed up to the limit dose in an acute toxicity study, as well as in a repeated dose study (OECD 422). Therefore, no calculation of a DNEL.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 813 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Assessment factors
See discussion section "Workers".
Rationale for deviation from standard factors as given in ECHA Guidance on CSA
See discussion section "Workers".
As for DNELoral, long-term, general population no additional AFs were selected for interspecies differences and intraspecies differences, as well as for duration of exposure. This is justified, because due to the physico-chemical properties (e.g. water solubility and particle size) of Graphite it is highly unlikely that Graphite can be absorbed after oral administration, resulting in virtually no bioavailability. This scientific assumption is also supplemented by results from the OECD 422 study, where nominal doses up to 1000 mg/kg bw/day were well tolerated and did not show any sign for systemic toxicity. Since the study was conducted as a combined repeated dose toxicity study with the reproductive/developmental toxicity screening test, several NOAELs were obtained, all representing the nominal dose of 1000 mg/kg bw/day. However, the actual substance intake varied from about 813 mg/kg bw/day up to 1159 mg/kg bw/day. DNELs were calculated using the NOAEL of 813 mg/kg bw/day.
As for inhalation, long-term, local: two inhalation studies were conducted: Synthetic Graphite and Expanded Graphite
See discussion section "Workers".
Additional Information
Expanded Graphite powder, DNEL general population, inhalation, local effects: 0,2mg/m3
Overall Assessment Factors: 10 (Applied Assessment Factors: Dose Descriptor (LOAEL/NOAEL): 1; Interspecies differences: 1; Intraspecies differences: 10; Duration of repeated dose study: 1; Qualitiy of whole database: 1; Dose descriptor modified according to ECHA Guidance)
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