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EC number: 234-454-8 | CAS number: 12004-35-2
- 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:
- 0.05 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 520 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 7.5
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- NOAEC
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.024 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- other: NOAEL
Workers - Hazard for the eyes
Additional information - workers
Nickel aluminate CSR Table for Workers
Note 1. Exposures are always given in terms of mg nickel and NOT as mg substance.
Note 2. In cases where existing standards (OELs in case of workers, ambient air standards in case of general public) are used instead of DNEL/DMEL, the fields for Assessment factors and Dose descriptor were left blank. Further information on the air Standard derivation is contained in the documents referenced in the Table below.
Note 3. Acute systemic and local effects are relevant for short-term worker’s exposure (peak exposure of 15 minutes to a few hours). Long-term systemic and local effects are relevant to long-term worker’s exposure defined as 8 hours/day and 5 days per week for a working life.
Exposure pattern |
Route |
Descriptors [corrected] |
DNEL/DMEL/not quantifiable |
Most sensitive endpoint |
Acute-systemic effects |
Dermal (mg Ni/kg bw/day) |
Not relevant (negligible absorption) |
||
Inhalation (mg Ni/m3) |
NOAEC=3900 (MMAD=2.8 µm)
|
520 (MMAD = 2.8 µm)
|
Acute Toxicity (Death) |
|
Acute-local effects |
Dermal (mg Ni/cm2) |
Not relevant |
||
Inhalation (mg Ni/m3) |
NOAEC= 3.9 (MMAD=2.9 µm)
|
3.9 (MMAD=2.9 µm)a
|
Repeated Dose Toxicity (Lung inflammation) |
|
Long term -systemic |
Dermal (mg Ni/cm2) |
Not relevant (negligible absorption) |
||
Long term -systemic |
Inhalation (mg Ni/m3) |
SCOEL proposed nickel OEL = 0.01 “inhalable” |
OEL = 0.05b |
Developmental toxicity |
Long term - local effects |
Dermal (mg Ni/cm2) |
NOAEL= 0.024 |
DNEL=0.024c |
Sensitization (skin) |
Long term - local effects |
Inhalation (mg Ni/m3) |
SCOEL proposed nickel OEL=0.01 “inhalable” |
OEL = 0.05b |
Carcinogenicity and repeated toxicity (Respiratory tract-Inhalation) |
a. The DNEL for nickel aluminate based on acute toxicity-local effects (lung inflammation) corresponds to aerosols of MMAD = 2.9 µm. This value should be compared to workplace exposures comprised of particles of MMAD = 2.9 µm. The proper comparisons should take into account the equivalent deposited doses per unit surface area in the respiratory tract of rats exposed to experimental aerosols and of humans exposed to workplace aerosols. If this DNEL values are used in a direct comparison to workplace exposures with MMAD ≥ 30 µm, these values are likely to overestimate risk by ≥ 4-fold. For more details see Appendix in the CSR.
b. The justification for the use of an inhalable OEL of 0.05 mg Ni/m3is provided in the Appendix of the CSR. This value is based on the SCOEL proposed OEL for nickel of 0.01 mg Ni/m3(March 2009) with further adjustments for differences in particle size distributions between animal experiments and workplace exposures and differences in sampling efficiency between 37-mmm and inhalable samplers. The SCOEL value and the IND-revised value are based on toxicity local effects observed on the lungs of rats after inhalation and carcinogenicity effects in the respiratory tract observed in human studies. Both values consider nickel compounds to be genotoxic carcinogens with a practical threshold. These values are also protective against possible reproductive effects. When exposure are solely to metallic and nickel oxide dusts, without exposure to any other forms of nickel, and the mean particle size of the aerosol is greater than 10 µm aerodynamic equivalent diameter (≤ 10% of aerosol mass in respirable fraction), inhalable exposure levels up to 0.2 mg Ni/m3could be reasonably assumed to be safe (see Appendix). When handling powders of particle equivalent aerodynamic diameter below 10 µm, exposures (8h TWA) to these powders should be kept under 0.01 mg Ni/m3.
c. The DNEL for dermal sensitization/elicitation is based on a patch test study where exposure lasted for 48 hours under occlusion. Correction for differences in Ni release rates in sweat from nickel sulphate and oxide were applied.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 ng/m³
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 312 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 ng/m³
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- NOAEC
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Nickel Aluminate CSR Table for General Population
Note 1. Exposures are always given in terms of mg nickel and NOT as mg substance.
Note 2. In cases where existing standards (OELs in case of workers, ambient air standards in case of general public) are used instead of DNEL/DMEL, the fields for Assessment factors and Dose descriptor were left blank. Further information on the air Standard derivation is contained in the documents referenced in the Table below.
Note 3. Acute systemic and local effects are relevant for short-term exposure (peak exposure of 15 minutes to a few hours). Long-term systemic and local effects are relevant to long-term exposure defined as 24 hours/day and 7 days per week for a life-time.
Exposure pattern |
Route |
Descriptors [corrected] |
DNEL/DMEL/not quantifiablea |
Most sensitive endpoint |
|
Acute-systemic effects |
Dermal (mg Ni/cm2) |
Not relevant (negligible exposure and absorption) |
|||
Inhalation (mg Ni/m3) |
Not relevant – compliance with more conservative acute-local effects DNEL is also protective against acute systemic effects |
||||
Oral (mg Ni/kg bw/day) |
Not relevant (negligible exposure) |
||||
Acute-local effects |
Dermal (mg Ni/cm2) |
Not relevant (negligible exposure and absorption) |
|||
Inhalation (mg Ni/m3) |
NOAEC= 3.9
|
3.9
|
Repeated dose toxicity (lung inflammation) |
||
Long term-systemic effects |
Dermal (mg Ni/cm2) |
Not relevant (negligible absorption) |
|||
Inhalation (mg Ni/m3) |
Other: CSTEE (ambient air guidelines for Ni) = 0.00002 |
DNEL = 0.00002b |
Exacerbation of existing dermatitis |
||
Oral (mg Ni/kg bw/day) |
Not relevant (negligible exposure) |
||||
Long term-local effects |
Dermal (mg Ni/cm2) |
Not relevant (negligible exposure and absorption) |
|||
Inhalation (mg Ni/m3) |
Other: CSTEE (ambient air standard) = 0.00002 |
DNEL-DMEL = 0.00002b |
Repeated dose toxicity (lung inflammation) Carcinogenicity |
||
a. See Appendices of the CSR for more details on NOAEL identification and DNEL derivation.
b. We used the CSTEE, EU Scientific Committee on Toxicity, Ecotoxicity and the Environment (2001) ambient air recommended nickel value of 20 ng/m3instead of a DNEL based on long term-local respiratory effects. This value is also protective from the most sensitive of systemic effects: exacerbation of existing dermatitis (see Appendix).
Sensitive subpopulations. Sensitive subpopulations are not separately addressed as the inhalation DNEL-DMEL value used corresponds to the ambient air guidance value derived by CSTEE for the EU general public.
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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