Registration Dossier
Registration Dossier
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EC number: 232-089-9 | CAS number: 7785-87-7
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
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:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10µl of nickel sulphate 0.1M
- No. with + reactions:
- 70
- Total no. in group:
- 82
- Clinical observations:
- Not specified
- Remarks on result:
- positive 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:
- GHS criteria not met
- Conclusions:
- Manganese sulphate reduced the sensitisation effect of nickel sulphate and did not cause sensitisation even when present at 75-80% w/v solution. This supports non-classification of MnSO4 as a skin sensitiser.
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