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Diss Factsheets
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EC number: 931-328-0 | CAS number: 7440-44-0
- 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:
- no hazard identified
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:
- 1.84 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: ECHA Guidance on Information Requirements R8, ECETOC Guidance on Assessment Factors to Derive a DNEL (2010) and ECETOC TR122, Poorly soluble particles/lung overload (2013)
- Overall assessment factor (AF):
- 2
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- The default assessment factor when the starting point is a NOAEL, in accordance with the ECHA Guidance on Information Requirements R.8.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default assessment factor from sub-chronic to chronic is 2, in accordance with the ECHA Guidance on Information Requirements R.8, as the effect is due to the removal of accumulated particles by macrophages.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No assessment factor for allometric scaling is necessary as the study is an inhalation study.
- AF for other interspecies differences:
- 1
- Justification:
- The default assessment factor for remaining interspecies differences (i.c. by default 2.5) does not always have to be applied for local effects. In this case the local effect is minimal inflammation, which is caused by the increased removal of activated carbon particles from the lung. In an article on inhalation of carbon black in three species (Elder et al., 2005), it appeared that rats are more sensitive to lung inflammation and histopathology than mice and hamsters. The particle surface area was also of concern and increased particle retention significantly. Based on the high sensitivity of rats to lung inflammatory changes associated with removal of particles in the lung, it is deemed justified to reduce the assessment factor for remaining differences to 1.
- AF for intraspecies differences:
- 1
- Justification:
- In December 2013 ECETOC prepared an extensive evaluation of the scientific literature on Poorly Soluble Particles (PSP) and lung overload (ECETOC TR122, 2013). In this document ECETOC concludes that using an assessment factor of 1 for intraspecies differences is reaonable for PSP. In this case the ECETOC guidance is justified, because: (1) AC-HDS may be considered a PSP of low toxicity; (2) only minimal lung inflammatory changes within the physiological range were seen in a 90-day inhalation toxicity study in rats; (3) AC-HDS appears not to give any significant systemic bioavailability; (4) the minimal lung effects were "port-of-entry" effects. The ECETOC report concludes that for concentration dependent local effects for PSP, an intraspecies AF of 1 is considered sufficient. Therefore, an assessment factor for intraspecies variation of 1 is proposed for the derivation of the DNEL for AC-HDS and AC-LDS.
- AF for the quality of the whole database:
- 1
- Justification:
- Based on the availability of a study performed in accordance with OECD-guidelines and GLP, no assessment factor for quality of the database has to be taken into account.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties were identified.
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
The DNEL (respirable) was derived using the results of the 90 -d repeated dose inhalation toxicity study in which a NOAEL of 7.29 mg/m3 was derived (see endpoint summary for repeated dose toxicity). To derive the inhalation DNEL for worker, the NOAEL of 7.29 mg/m3 should be corrected for the difference between respiratory rates under standard conditions and under conditions of light activity, in accordance with the ECHA Guidance on Information Requirements R.8. Furthermore, as the rats in the study were exposed to 6h per day, a correction factor of 1.33 (8h compared to 6h) should be applied: NOAELcorrected = (7.29 mg/m3/1.33) x 6.7 m3/10 m3 = 3.67 mg/m3. Several assessment factors were taken into account in accordance with the ECHA Guidance on Information Requirements R.8, the ECETOC Guidance on Assessment Factors to Derive a DNEL (2010) and ECETOC TR122 Poorly Soluble Particles/Lung overload (2013).
General Population - Hazard via inhalation 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: ECHA Guidance on Information Requirements R8, ECETOC Guidance on Assessment Factors to Derive a DNEL (2010) and ECETOC TR122 Poorly Soluble Particles/Lung overload (2013)
- Overall assessment factor (AF):
- 2
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- The default assessment factor when the starting point is a NOAEL, in accordance with the ECHA Guidance on Information Requirements R.8.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default assessment factor from sub-chronic to chronic is 2, in accordance with the ECHA Guidance on Information Requirements R.8, as the effect is due to the removal of accumulated particles by macrophages.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No assessment factor for allometric scaling is necessary as the study is an inhalation study.
- AF for other interspecies differences:
- 1
- Justification:
- The default assessment factor for remaining interspecies differences (i.c. by default 2.5) does not always have to be applied for local effects. In this case the local effect is minimal inflammation, which is caused by the increased removal of activated carbon particles from the lung. In an article on inhalation of carbon black in three species (Elder et al., 2005), it appeared that rats are more sensitive to lung inflammation and histopathology than mice and hamsters. The particle surface area was also of concern and increased particle retention significantly. Based on the high sensitivity of rats to lung inflammatory changes associated with removal of particles in the lung, it is deemed justified to reduce the assessment factor for remaining differences to 1.
- AF for intraspecies differences:
- 1
- Justification:
- In December 2013, ECETOC prepared an extensive evaluation of the scientific literature on Poorly Soluble Particles (PSP) and lung overload (ECETOC TR122, 2013). In this document ECETOC concludes that using an assessment factor of 1 for intraspecies differences is reaonable for PSP. In this case the ECETOC guidance is justified, because: (1) AC-HDS may be considered a PSP of low toxicity; (2) only minimal lung inflammatory changes within the physiological range were seen in a 90-day inhalation toxicity study in rats; (3) AC-HDS appears not to give any significant systemic bioavailability; (4) the minimal lung effects were "port-of-entry" effects. The ECETOC report concludes that for concentration dependent local effects for PSP, an intraspecies AF of 1 is considered sufficient. Therefore, an assessment factor for intraspecies variation of 1 is proposed for the derivation of the DNEL for AC-HDS and AC-LDS.
- AF for the quality of the whole database:
- 1
- Justification:
- Based on the availability of a study performed in accordance with OECD-guidelines and GLP, no assessment factor for quality of the database has to be taken into account.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining differences expected.
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
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
General Population - Hazard via oral 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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.