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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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EC number: 224-699-9 | CAS number: 4454-16-4
- 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
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Dermal absorption
Administrative data
- Endpoint:
- dermal absorption
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- In vitro permeation of nickel salts through human stratum corneum.
- Author:
- Tanojo, H., Hostynek, J.J., Mountford, H.S. and Maibach, H.I.
- Year:
- 2 001
- Bibliographic source:
- Acta Derm Venereol. Suppl 212:19-23.
Materials and methods
- Principles of method if other than guideline:
- Measures of the permeation of these salts through the stratum corneum (SC). No standard guideline followed. Test methods are described in the following sections.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Nickel sulphate
- EC Number:
- 232-104-9
- EC Name:
- Nickel sulphate
- Cas Number:
- 7786-81-4
- Molecular formula:
- H2O4S.Ni
- IUPAC Name:
- Nickel sulfate
- Details on test material:
- - Name of test material (as cited in study report): Nickel sulphate hexahydrate
- Molecular formula (if other than submission substance): not different than submission substance
- Molecular weight (if other than submission substance): not different than submission substance
- Smiles notation (if other than submission substance): not different than submission substance
- InChl (if other than submission substance): not different than submission substance
- Structural formula attached as image file (if other than submission substance): not different than submission substance
- Substance type: Pure solution
- Physical state: liquid
- Composition of test material, percentage of components: 1% w/v nickel
- Other details on test material not reported or not applicable
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: human stratum corneum
Administration / exposure
- Details on study design:
- Heat-separated human stratum corneum sheets from cadavers were placed in a continuous flow-through diffusion cell system
maintained at 37 deg. C. Aqueous donor solutions of nickel salts (nitrate, sulfate, and chloride) were prepared containing 1% w/v Ni
(10 mg/ml Ni2+). HPLC-grade water was used as the receptor fluid, which was pumped at a rate of 4-5 ml/hr through the receptor side of the
diffusion cells. The receptor water was collected every 4 hours up to 96 hours. Donor solutions were collected from each diffusion cell. The
stratum corneum sheets were boiled in 10 ml of a 30% hydrogen peroxide solution for 4 hours and cooled. Analyses were conducted by ICP-MS.
The percentage of Ni compound recovered from the applied dose was determined.
The 96-h in vitro permeation profile of each nickel salt was plotted against time using Microcal Origin,
and the permeability constant of each salt was calculated from the permeation rate during steady state.
Data were analyzed using the paired Student t-test on Microcal Origin
Results and discussion
- Absorption in different matrices:
- The permeation of various nickel salts across human skin was relatively minute. One percent or less of the nickel salts penetrated the stratum corneum at 96 hours, and less than 1% of the salts was retained. Retention in the stratum corneum was highest for the nitrate (0.95%) and lowest for the acetate (0.10%). Percent retentions in the stratum corneum of the chloride and sulfate salts were 0.18 and 0.56%,respectively.
The highest rate of permeation for all salts tested occurred within the first 24 hours. The chloride and acetate salts reached peak penetration
within 4 hours. Nickel nitrate peaked at ca. 8 hours, while nickel sulfate peaked after 12 hours post-application. Steady state was
obtained after 24 hours for all the nickel salts tested.
The permeability constants (standard deviation) of nickel salts across human stratum corneum in vitro were reported as:
nickel sulfate: 8.5 (5.5) cm/h x 10e-7
nickel chloride: 6.8 (1.2) cm/h x 10e-7
nickel nitrate: 5.2 (1.6) cm/h x 10e-7
nickel acetate: 5.2 (1.1) cm/h x 10e-7
Any other information on results incl. tables
The permeation of various nickel salts across human skin was relatively minute. One percent or less of the nickel salts penetrated the stratum corneum at 96 hours, and less than 1% of the salts was retained. Retention in the stratum corneum was highest for the nitrate (0.95%) and lowest for the acetate (0.10%). Percent retentions in the stratum corneum of the chloride and sulfate salts were 0.18 and 0.56%,respectively.
The highest rate of permeation for all salts tested occurred within the first 24 hours. The chloride and acetate salts reached peak penetration
within 4 hours. Nickel nitrate peaked at ca. 8 hours, while nickel sulfate peaked after 12 hours post-application. Steady state was obtained after 24 hours for all the nickel salts tested. The permeability constants (standard deviation) of nickel salts across human stratum corneum in vitro were reported as:
nickel sulfate: 8.5 (5.5) cm/h x 10e-7
nickel chloride: 6.8 (1.2) cm/h x 10e-7
nickel nitrate: 5.2 (1.6) cm/h x 10e-7
nickel acetate: 5.2 (1.1) cm/h x 10e-7
Applicant's summary and conclusion
- Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
ROBUST SUMMARY DEVELOPED BY AN INDEPENDENT REVIEWER.
Robust Summary for Tanojo et al. (2001):
Human skin was obtained from cadavers and the stratum corneum was prepared using a modification of the method of Tanojo et al (1997).
Heat-separated human stratum corneum sheets were placed in a continuous flow-through diffusion cell system maintained at 37 deg. C. Aqueous donor solutions of nickel salts (nitrate, sulfate, and chloride) were prepared containing 1% w/v Ni (10 mg/ml Ni2+). HPLC-grade water was used as the receptor fluid, which was pumped at a rate of 4-5 ml/hr through the receptor side of the diffusion cells. The receptor water was collected every 4 hours up to 96 hours.
Donor solutions were collected from each diffusion cell. The stratum corneum sheets were boiled in 10 ml of a 30% hydrogen peroxide solution for 4 hours and cooled. Analyses were conducted by ICP-MS. The percentage of Ni compound recovered from the applied dose was determined. The 96-h in vitro permeation profile of each nickel salt was plotted against time using Microcal Origin, and the permeability constant of each salt was calculated from the permeation rate during steady state. Data were analyzed using the paired Student t-test on Microcal Origin.
The permeation of various nickel salts across human skin was relatively minute. One percent or less of the nickel salts penetrated the stratum corneum at 96 hours, and less than 1% of the salts was retained. Retention in the stratum corneum was highest for the nitrate (0.95%) and lowest for the acetate (0.10%). Percent retentions in the stratum corneum of the chloride and sulfate salts were 0.18 and 0.56%,respectively.
The highest rate of permeation for all salts tested occurred within the first 24 hours. The chloride and acetate salts reached peak penetration
within 4 hours. Nickel nitrate peaked at ca. 8 hours, while nickel sulfate peaked after 12 hours post-application. Steady state was
obtained after 24 hours for all the nickel salts tested.
The permeability constants (standard deviation) of nickel salts across human stratum corneum in vitro were reported as:
nickel sulfate: 8.5 (5.5) cm/h x 10e-7
nickel chloride: 6.8 (1.2) cm/h x 10e-7
nickel nitrate: 5.2 (1.6) cm/h x 10e-7
nickel acetate: 5.2 (1.1) cm/h x 10e-7
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