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EC number: 239-198-0 | CAS number: 15137-09-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- The chelating effect of sodium EDTA in nickel-allergic patients was investigated. It could be shown how EDTA has a blocking effect for skin irritant reaction (eczema) on humans.
Data source
Reference
- Reference Type:
- publication
- Title:
- Chelating effect of EDTA on nickel
- Author:
- Van Ketel, W.G. and Bruynzeel, D.P.
- Year:
- 1 984
- Bibliographic source:
- Contact dermatitis, 11/5, 311-314
Materials and methods
- Principles of method if other than guideline:
- Study on humans in order to investigate an EDTA effect which prevent the dermatitis-provoking potential of nickel.
- 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(2+) sulfate
1
- Specific details on test material used for the study:
- aqueous nickel sulphate (prepared by the hospital pharmacist)
In vitro test system
- Test system:
- human skin model
- Remarks:
- upper back of 17 nickel-allergic female patients
- Source species:
- human
- Cell type:
- other: human skin cells
- Vehicle:
- water
- Details on test system:
- The right half of the upper back was lightly rubbed with a cream containing 10% EDTA (w/w) (disodium salt of ethylenediamine tetra acetate) in cetomacrogol cream FNA. After 15 min, when the cream was no longer visible, 3 concentrations of aqueous nickel sulphate were patch tested in the pretreated area. The left upper back was pretreated in a similar way with cetomacrogol cream FNA without EDTA. The same concentrations of nickel sulphate were patch tested in this area. Patch testing was performed with the Silver Patch Testers. The reactions were graded according to the ICDRG after 48 and 72 h.
- Control samples:
- yes, concurrent positive control
- other: 10% EDTA in cetomacrogol cream
- Amount/concentration applied:
- 0.01% (24.4 ppm), 0.1% (244 ppm), 1% (2440 ppm)
- Duration of treatment / exposure:
- The reactions were graded after 48 and 72 h
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Remarks:
- After 2880 and 4320 min
- Run / experiment:
- 1-6, 8-14 and 16
- Positive controls validity:
- not specified
- Remarks on result:
- no indication of irritation
- Remarks:
- at 2440 ppm nickel sulphate
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Remarks:
- After 2880 and 4320 min
- Run / experiment:
- 7, 15 and 17
- Positive controls validity:
- not specified
- Remarks on result:
- positive indication of irritation
- Remarks:
- slight reaction was observed
Applicant's summary and conclusion
- Conclusions:
- The blocking effect of the 10% EDTA cream appeared to be significant in comparison with that of the cream base only (p < 0.01). In most patients, 10% EDTA does chelate nickel sulphate in 0.01% (24.2 ppm), 0.1% (244 ppm) and 1% (2440 ppm) by reducing the dermatitis-provoking potential of nickel. A barrier cream with 10% EDTA might be of help in nickel-allergic patients with eczema of the hands.
- Executive summary:
In the area pretreated with 10% EDTA in cetomacrogol cream FNA, only 3 of 17 patients showed a + positive reaction to 1% (2440 ppm) nickel sulphate. 3 patients showed no reaction to any concentration of nickel sulphate in either area. The reactivity to nickel sulphate in the area pretreated with 10% EDTA appeared to be far less than in the control area (rank sum test p < 0.01). No irritant reactions to the 10% EDTA cream were observed.
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