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EC number: 231-869-6 | CAS number: 7773-01-5
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study not to GLP or guideline, but follows basic scientific principles. The study was conducted on MnSO4. Readacross from MnSO4 to MnCl2 is justified because both have Mn2+ ion, and both have anions that are not considered to be sensitisers.
- Justification for type of information:
- See the read-across report attached in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- other: read-across target
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- See the read-across report attached in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- other: Not reported
- Dose level:
- 75 - 80 % w/v solution
- Remarks on result:
- no indication of skin sensitisation
Data source
Reference
- Reference Type:
- publication
- Title:
- Interactions of sulphates of divalent metals in nickel-sulphate-sensitive patients
- Author:
- Santucci B, Cannistrachi C, Cristando A and Picardo M
- Year:
- 1 996
- Bibliographic source:
- Experimental Dermatology. 5:79-83
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 82 subjects who previously gave a positive patch test result to nickel sulphate (5%) were patch retested with 10 µl of nickel sulphate (0.1M) and to aqueous solutions of magnesium sulphate (0.3M), zinc sulphate (0.3M and 0.5M), manganese sulphate (0.3M and 0.5M), cadmium sulphate (0.3M) and iron sulphate (0.3M).
70 subjects (64 female and 6 male, mean age 34 and mean duration of dermatitis 4.2 years) who gave positive reactions (scores 2 or 3: ICRDG nomenclature) to only nickel sulphate, were randomly divided in two groups of 30 and 40 subjects respectively.
The 1st group were tested a week later, on the opposite side on the back with 10 µl of the following solutions:
TEST 1: nickel sulphate (0.1M)
TEST 2: nickel sulphate (0.1M) + zinc sulphate (0.3M)
TEST 3: nickel sulphate (0.1M) + zinc sulphate (0.5M)
TEST 4: nickel sulphate (0.1M) + magnesium sulphate (0.3M)
TEST 5: nickel sulphate (0.1M) + manganese sulphate (0.3M)
TEST 6: nickel sulphate (0.1M) + manganese sulphate (0.5M)
TEST 7: cadmium sulphate (0.3M)
TEST 8: nickel sulphate (0.1M) + cadmium sulphate (0.3M)
TEST 9: iron sulphate (0.3M)
TEST 10: nickel sulphate (0.1M) + iron sulphate (0.3M)
The subjects in the 2nd group were tested with the following:
TEST 1: nickel sulphate (0.1M)
TEST 2: nickel sulphate (0.1M) + zinc sulphate (0.3M)
TEST 3: nickel sulphate (0.1M) + zinc sulphate (0.5M)
TEST 4: nickel sulphate (0.1M) + magnesium sulphate (0.3M)
TEST 5: nickel sulphate (0.1M) + manganese sulphate (0.3M)
TEST 6: nickel sulphate (0.1M) + manganese sulphate (0.5M)
TEST 7: cadmium sulphate (0.1M)
TEST 8: nickel sulphate (0.1M) + cadmium sulphate (0.1M)
TEST 9: iron sulphate (0.1M)
TEST 10: nickel sulphate (0.1M) + iron sulphate (0.1M)
Patch tests were read at days 2 and 3. visual scoring was used to compare the differences between positive responses found to nickel sulphate and
those found to the solution tested. As a control we evaluated the patch test reactions to all the solutions in 50 healthy subjects. The pH of the solutions varied between 4.7-5.8. - GLP compliance:
- not specified
- Type of study:
- patch test
Test material
- Reference substance name:
- Mix of NiSO4(20% w/v) and MnSO4 (80% w/v)
- IUPAC Name:
- Mix of NiSO4(20% w/v) and MnSO4 (80% w/v)
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Group 1:
TEST 1: nickel sulphate (0.1M)
TEST 2: nickel sulphate (0.1M) + zinc sulphate (0.3M)
TEST 3: nickel sulphate (0.1M) + zinc sulphate (0.5M)
Group 2:
TEST 1: nickel sulphate (0.1M)
TEST 2: nickel sulphate (0.1M) + zinc sulphate (0.3M)
TEST 3: nickel sulphate (0.1M) + zinc sulphate (0.5M)
TEST 4: nickel sulphate (0.1M) + magnesium sulphate (0.3M)
TEST 5: nickel sulphate (0.1M) + manganese sulphate (0.3M)
TEST 6: nickel sulphate (0.1M) + manganese sulphate (0.5M)
TEST 7: cadmium sulphate (0.1M)
TEST 8: nickel sulphate (0.1M) + cadmium sulphate (0.1M)
TEST 9: iron sulphate (0.1M)
TEST 10: nickel sulphate (0.1M) + iron sulphate (0.1M)
TEST 4: nickel sulphate (0.1M) + magnesium sulphate (0.3M)
TEST 5: nickel sulphate (0.1M) + manganese sulphate (0.3M)
TEST 6: nickel sulphate (0.1M) + manganese sulphate (0.5M)
TEST 7: cadmium sulphate (0.3M)
TEST 8: nickel sulphate (0.1M) + cadmium sulphate (0.3M)
TEST 9: iron sulphate (0.3M)
TEST 10: nickel sulphate (0.1M) + iron sulphate (0.3M)
Challenge
- Concentration / amount:
- Group 1:
TEST 1: nickel sulphate (0.1M)
TEST 2: nickel sulphate (0.1M) + zinc sulphate (0.3M)
TEST 3: nickel sulphate (0.1M) + zinc sulphate (0.5M)
Group 2:
TEST 1: nickel sulphate (0.1M)
TEST 2: nickel sulphate (0.1M) + zinc sulphate (0.3M)
TEST 3: nickel sulphate (0.1M) + zinc sulphate (0.5M)
TEST 4: nickel sulphate (0.1M) + magnesium sulphate (0.3M)
TEST 5: nickel sulphate (0.1M) + manganese sulphate (0.3M)
TEST 6: nickel sulphate (0.1M) + manganese sulphate (0.5M)
TEST 7: cadmium sulphate (0.1M)
TEST 8: nickel sulphate (0.1M) + cadmium sulphate (0.1M)
TEST 9: iron sulphate (0.1M)
TEST 10: nickel sulphate (0.1M) + iron sulphate (0.1M)
TEST 4: nickel sulphate (0.1M) + magnesium sulphate (0.3M)
TEST 5: nickel sulphate (0.1M) + manganese sulphate (0.3M)
TEST 6: nickel sulphate (0.1M) + manganese sulphate (0.5M)
TEST 7: cadmium sulphate (0.3M)
TEST 8: nickel sulphate (0.1M) + cadmium sulphate (0.3M)
TEST 9: iron sulphate (0.3M)
TEST 10: nickel sulphate (0.1M) + iron sulphate (0.3M)
- No. of animals per dose:
- Group 1: 30
Group 2: 40
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: Not reported
- Dose level:
- 75 - 80 % w/v
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
RESULTS
70 out of 82 tested subjects showed patch test positive responses to only 10µl of nickel sulphate 0.1M. The majority (75%) of nickel sulphate positive patch test reactions were reduced or inhibited by the sulphates of divalent metals. Mg, Zn and Mn at 0.3M concentrations.
No effects were observed when testing with cadmium sulphate and iron sulphate at both concentrations. The 50 healthy subjects gave negative reactions to all the tested solutions.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- Manganese sulphate did not cause sensitisation even when present at 75-80% w/v solution. This provides support that the structural analogue, manganese dichloride is not a skin sensitiser.
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