Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 273-729-7 | CAS number: 69012-29-9 By-product from the production of ferronickel from a complex ore. Consists primarily of oxides of aluminum, iron, magnesium and silicon.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/m³
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
-
The study in question is a chronic study so no assessment factor higher than 1 is chosen.
-
Interspecies difference: The default assessment factor for interspecies differences for local effects on the respiratory tract is 2.5 (ECHA Guidance Document R.8 p. 38).
-
Intraspecies difference: The default assessment factor for intraspecies differences for workers is 5 and for general population is 10 (ECHA Guidance Document R.8 p. 38).
-
Inhalable fraction: NOAEC calculated on fine nickel dust (MMAD=1.8μm, GSD=2.4). Ferronickel slags' inhalable dust (<100μm) consists of only about 5% with dust of the granulometry of the tested substance and about 17% of total respirable fraction (<10μm). All dust that was examined in the study had a MMAD <2μm, so it is thought that an adjustment must be made on the DNEL value. Using a conservative approach, a factor of 0.25 will be applied to reach a DNELrespand an additional (conservative) factor of 0.25 will be applied to that in order to reach a DNELinh.
The final DNEL for local effects was determined at around 5.53mg/m3 for respirable dust and around 22mg/m3 for inhalable dust.
The OEL for total respirable dust is 5mg/m3 and that for total inhalable dust is 10mg/m3. They are both lower than the respective DNELs, so these will be the final values.Systemic effects
From the available data the most appropriate choice is the result of NTP, 2006a on subchronic toxicity of nickel oxide.
The descriptor has been corrected according to ECHA Guidance Document R.8 p 27
-
Duration of exposure: The default assessment factor for extrapolation of exposure duration from sub-chronic to chronic exposure is 2 (ECHA Guidance Document R.8 p. 38).
-
Interspecies difference: The default assessment factor for interspecies differences for systemic effects is 2.5 ECHA Guidance Document R.8 p. 38).
-
Intraspecies difference: The default assessment factor for intraspecies differences for workers is 5 and for general population is 10 (ECHA Guidance Document R.8 p. 38).
-
Inhalable fraction: NOAEC calculated on fine nickeloxide dust) mass median aerodynamic diameters ranged from 1.89 to 3.29μm) Ferronickel slags' inhalable dust (<100μm) consists of only about 4.5% with dust of the granulometry of the tested substance and about 17% of total respirable fraction (<10μm). All dust that was examined in the study had a MMAD <2μm, so it is thought that an adjustment must be made on the DNEL value. Using a conservative approach, a factor of 0.25 will be applied to reach a DNELrespand an additional (conservative) factor of 0.25 will be applied to that in order to reach a DNELinh.
The final DNEL for systemic effects was determined at 103mg/m3 for the respirable fraction and 414mg/m3 for the inhalable fraction.
The OEL for total respirable dust is 5mg/m3 and that for total inhalable dust is 10mg/m3. They are lower than the respective DNEL, so these will be the final values.
-
The DNELs that were calculated were for inhalation exposure. Two starting points were chosen, one for local and one for systemic effects.
Local effects
From the available data the most appropriate choice is the result of Oller et al, 2008 on chronic toxicity of nickel metal.
The descriptor has been corrected according to ECHA Guidance Document R.8 p 27.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 µg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
-
The study in question is a chronic study so no assessment factor higher than 1 is chosen.
-
Interspecies difference: The default assessment factor for interspecies differences for local effects on the respiratory tract is 2.5 (ECHA Guidance Document R.8 p. 38).
-
Intraspecies difference: The default assessment factor for intraspecies differences for the general population is 10 (ECHA Guidance Document R.8 p. 38).
-
Inhalable fraction: NOAEC calculated on fine nickel dust (MMAD=1.8μm, GSD=2.4). Ferronickel slags' inhalable dust (<100μm) consists of only about 4.5% with dust of the granulometry of the tested substance and about 17% of total respirable fraction (<10μm). All dust that was examined in the study had a MMAD <2μm, so it is thought that an adjustment must be made on the DNEL value. Using a conservative approach, a factor of 0.25 will be applied to reach a DNELrespand an additional (conservative) factor of 0.25 will be applied to reach a DNELinh.
The final DNEL for local effects was determined at around 2.8 mg/m3 for respirable dust and around 11mg/m3 for inhalable dust.
The concentration limit for total dust in the atmosphere is 50μg/m3 which is lower than the respective DNEL, so this will be the final valueSystemic effects
From the available data the most appropriate choice is the result of NTP, 2006a on subchronic toxicity of nickel oxide.
The descriptor has been corrected according to ECHA Guidance Document R.8 p 27
-
Duration of exposure: The default assessment factor for extrapolation of exposure duration from sub-chronic to chronic exposure is 2 (ECHA Guidance Document R.8 p. 38).
-
Interspecies difference: The default assessment factor for interspecies differences for systemic effects is 2.5 ECHA Guidance Document R.8 p. 38).
-
Intraspecies difference: The default assessment factor for intraspecies differences for workers is 5 and for general population is 10 (ECHA Guidance Document R.8 p. 38).
-
Inhalable fraction: NOAEC calculated on fine nickeloxide dust) mass median aerodynamic diameters ranged from 1.89 to 3.29μm) Ferronickel slags' inhalable dust (<100μm) consists of only about 5% with dust of the granulometry of the tested substance and about 17% of total respirable fraction (<10μm). All dust that was examined in the study had a MMAD <2μm, so it is thought that an adjustment must be made on the DNEL value. Using a conservative approach, a factor of 0.25 will be applied to reach a DNELrespand an additional (conservative) factor of 0.25 will be applied to reach a DNELinh.
The final DNEL for systemic effects was determined at 51 mg/m3 for the respirable fraction and 207mg/m3 for the inhalable fraction.
The OEL for total respirable dust is 50μg/m3 which is significantly lower than the respective DNEL, so this will be the final value.
-
The DNELs that were calculated were for inhalation exposure. Two starting points were chosen, one for local and one for systemic effects.
Local effects
From the available data the most appropriate choice is the result of Oller et al, 2008 on chronic toxicity of nickel metal.
The descriptor has been corrected according to ECHA Guidance Document R.8 p 27.
It must be noted however that the potential for dispersion of dust from slags, ferronickel-manufg is low, due to its coarseness, so exposure of local population to airbourne ferronickel slags' dust is unlikely.
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.
