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EC number: 233-071-3 | CAS number: 10028-18-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 15.8 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 12
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.46 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 2
- Dose descriptor starting point:
- LOAEC
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.001 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- other: NOAEL
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
Note 1. Exposures are always given in terms of mg nickel and NOT as mg substance
Note 2. All the values (including the dermal one) are provided in the table below.
Note 3. 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 Starting Points were left blank. Further information on the Standard derivation is contained in the documents referenced in the Table below.
Nickel sulfate Table for Workers
Exposure pattern |
Route |
Descriptors [corrected] |
DNEL/DMEL/not quantifiablea |
Most sensitive endpoint |
Acute-systemic effects |
Dermal (mg Ni/kg bw/day) |
Not relevant (negligible absorption) |
||
Inhalation (mg Ni/m3) |
NOAEC = 120 |
DNEL = 9.6 (MMAD =3 µm) |
Acute Toxicity (Death) |
|
Acute-local effects |
Dermal (mg Ni/cm2) |
Not irritant at concentration limit < 20% |
||
Inhalation (mg Ni/m3) |
LOAEC =0.7 (from 16 d study) |
DNEL= 0.28 (MMAD <4 µm)b |
Acute Toxicity (Lung inflammation) |
|
Long term-systemic effects |
Dermal (mg Ni/kg bw/day) |
Not relevant (negligible absorption) |
||
Inhalation (mg Ni/m3) |
SCOEL proposed nickel OEL = 0.01 “inhalable” |
OEL = 0.05c |
Developmental toxicity |
|
Long term -local effects |
Dermal (mg Ni/cm2) |
NOAEL= 0.00044 |
DNEL = 0.00044d |
Sensitization (skin) |
Inhalation (mg Ni/m3) |
SCOEL proposed nickel OEL = 0.01 “inhalable” |
OEL = 0.05c |
Carcinogenicity and repeated toxicity (Respiratory tract-Inhalation) |
|
a. See Appendix C1-C2 (CSR for Nickel Sulphate) for more details on NOAEL identification and DNEL derivation.
b. The DNEL based on acute toxicity-local effects (lung inflammation) corresponds to an aerosol of MMAD < 4 µm. This value is not directly comparable to workplace exposures comprised of particles of MMAD >> 4 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 value is used in a direct comparison to workplace exposures with MMAD ≥ 30 µm, this value is likely to overestimate risk by ≥ 4-fold. For more details see Appendix C3.
c. The justification for the use of an inhalable OEL of 0.05 mg Ni/m3is provided in Appendix C3 of CSR for Nickel Sulphate. 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-mm 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.
d. The DNEL for dermal sensitization/elicitation is based on a patch test study where exposure lasted for 48hs under occlusion. This value is likely to overestimate risk compared to workplace 8 h exposure without occlusion.
All data are converted into values suitable for Nickel fluoride by just correcting them with the different Molwculr weight. This approach is conservative as the effect is caused by Nickel and Nickel released by Nickel fluoride is lower ( see 7.1.1 NiF2 Kirby 2008 I and II)
Nickel fluorideTable for Workers
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 = 198 |
DNEL = 15.8 (MMAD =3 µm) |
Acute Toxicity (Death) |
|
Acute-local effects |
Dermal (mg Ni/cm2) |
Not irritant at concentration limit < 20% |
||
Inhalation (mg Ni/m3) |
LOAEC =1.15 |
DNEL= 0.46 (MMAD <4 µm) |
Acute Toxicity (Lung inflammation) |
|
Long term-systemic effects |
Dermal (mg Ni/kg bw/day) |
Not relevant (negligible absorption) |
||
Inhalation (mg Ni/m3) |
SCOEL proposed nickel OEL = 0.01 “inhalable” |
OEL = 0.08 |
Developmental toxicity |
|
Long term -local effects |
Dermal (mg Ni/cm2) |
NOAEL= 0.00044 |
DNEL = 0.00072 |
Sensitization (skin) |
Inhalation (mg Ni/m3) |
SCOEL proposed nickel OEL = 0.01 “inhalable” |
OEL = 0.08 |
Carcinogenicity and repeated toxicity (Respiratory tract-Inhalation) |
|
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 ng/m³
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 ng/m³
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.011 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.019 mg/kg bw/day
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- LOAEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Note 1. Exposures are always given in terms of mg nickel and NOT as mg substance
Note 2. All the values (including the inhalation one) are provided in the table below:
Note 3. 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 Starting Points were left blank. Further information on the Standard derivation is contained in the documents referenced in the Table below.
Nickel Sulphate Hexahydrate CSR Table for General Population (MvE)
Exposure pattern |
Route |
Descriptors [corrected] |
DNEL/DMEL/not quantifiablea |
Most sensitive endpoint |
Acute-systemic effects |
Dermal (mg Ni/cm2) |
Not relevant (negligible absorption) |
||
Inhalation (mg Ni/m3) |
Not relevant (negligible acute exposure) |
|||
Oral (mg Ni/kg bw/day) |
LOAEL = 0.012 |
DNEL= 0.01b |
Oral exacerbation of existing dermatitis |
|
Acute-local effects |
Dermal (mg Ni/cm2) |
Not relevant (negligible acute exposure) |
||
Inhalation (mg Ni/m3) |
Not relevant (negligible acute exposure) |
|||
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 = 0.00002c |
Reproductive Developmental toxicity |
|
Oral (mg Ni/kg bw/day) |
NOAEL =1.1 |
DNEL = 0.01b |
Reproductive Developmental toxicity |
|
Long term-local effects |
Dermal (mg Ni/cm2) |
Not relevant (negligible exposure) |
||
Inhalation (mg Ni/m3) |
Other: CSTEE (ambient air standard) = 0.00002 |
DNEL-DMEL = 0.00002c |
Repeated dose toxicity (lung inflammation) Carcinogenicity |
|
a. See Appendix C1-C2 (CSR for Nickel Sulphate) for more details on NOAEL identification and DNEL derivation.
b. This DNEL value was considered byWHO (World Health Organization, 2007. Background document for development of WHO Guidelines for Drinking-water Quality. © World Health Organization,)in the derivation of the Tolerable Daily Intake for nickel. This value was considered to be protective of sensitive subpopulations, including most nickel sensitive individuals, pregnant women and children.
c. We used the CSTEE, EU Scientific Committee on Toxicity, Ecotoxicity and the Environment (2001) ambient air recommended nickel value of 20 ng Ni/m3instead of a DMEL based on carcinogenicity or a DNEL based on long term-local respiratory effects. The CSTEE value is based on considerations of both respiratory toxicity and carcinogenicity (see Appendix C1),
Sensitive subpopulations. Sensitive subpopulations are not separately addressed as the oral DNEL values used correspond to the TDI calculated by WHO for the general public and the inhalation DNEL-DMEL value used corresponds to the ambient air guidance value derived by CSTEE for the EU general public.
All data are converted into values suitable for Nickel fluoride by just correcting them with the different Molwculr weight. This approach is conservative as the effect is caused by Nickel and Nickel released by Nickel fluoride is lower ( see 7.1.1 NiF2 Kirby 2008 I and II)
Nickel fluorideTable for General Population
Exposure pattern |
Route |
Descriptors [corrected] |
DNEL/DMEL/not quantifiable |
Most sensitive endpoint |
Acute-systemic effects |
Dermal (mg Ni/cm2) |
Not relevant (negligible absorption) |
||
Inhalation (mg Ni/m3) |
Not relevant (negligible acute exposure) |
|||
Oral (mg Ni/kg bw/day) |
LOAEL = 0.019 |
DNEL= 0.016 |
Oral exacerbation of existing dermatitis |
|
Acute-local effects |
Dermal (mg Ni/cm2) |
Not relevant (negligible acute exposure) |
||
Inhalation (mg Ni/m3) |
Not relevant (negligible acute exposure) |
|||
Long term-systemic effects |
Dermal (mg Ni/cm2) |
Not relevant (negligible absorption) |
||
Inhalation (mg Ni/m3) |
Other: CSTEE (ambient air guidelines for Ni) = 0.00003 |
DNEL = 0.00003 |
Reproductive Developmental toxicity |
|
Oral (mg Ni/kg bw/day) |
NOAEL =1.8 |
DNEL = 0.016 |
Reproductive Developmental toxicity |
|
Long term-local effects |
Dermal (mg Ni/cm2) |
Not relevant (negligible exposure) |
||
Inhalation (mg Ni/m3) |
Other: CSTEE (ambient air standard) = 0.00003 |
DNEL-DMEL = 0.00003 |
Repeated dose toxicity (lung inflammation) Carcinogenicity |
|
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