Registration Dossier
Registration Dossier
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EC number: 208-933-7 | CAS number: 547-67-1
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Abstract only.
Data source
Reference
- Reference Type:
- publication
- Title:
- Nickel sulfate 5-20% aq. does not evoke irritation on the skin of non-nickel-sensitive subjects.
- Author:
- Seidenari S, Belletti B, Mantovani L, and Pepe P
- Year:
- 1 996
- Bibliographic source:
- Contact Dermatitis, 35: 260-261
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Individuals with no pre-existing history of Ni intolerance underwent patch testing with 5, 10, and 20% nickel sulphate solutions. In addition, a distilled water and a blank test chamber control were included. Patches were removed after 24 hours. Individuals were re-tested 30 days later.
- 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
- IUPAC Name:
- nickel(2+) sulfate
- Details on test material:
- - Name of test material (as cited in study report): Nickel sulphate
- Molecular formula (if other than submission substance): NiSO4
- Molecular weight (if other than submission substance): 154.768
- Smiles notation (if other than submission substance): S(=O)(=O)([O-])[O-].[Ni+2]
- InChl (if other than submission substance): InChI=1/Ni.H2O4S/c;1-5(2,3)4/h;(H2,1,2,3,4)/q+2;/p-2
- Substance type: no data
- Physical state: no data
- Analytical purity: no data
Constituent 1
Method
- Subjects:
- - Number of subjects exposed: 25
- Route of administration:
- dermal
- Details on study design:
- Patch-Test (Finn Chambers on Scanpor tape)
5, 10, and 20% nickel sulphate solution. Individuals with no pre-existing history of Ni intolerance underwent patch testing with nickel sulphate. Patch test concentrations: 5, 10, and 20% nickel sulphate solution, distilled water, and a blank test chamber. Patches were removed after 24 hours. Individuals were re-tested 30 days later.
STATISTICAL METHOD:
- Student's t test. The level of significance was 0.05.
Results and discussion
- Results of examinations:
- The authors reported that no papular or vesicular reactions were observed at nickel patch test sites. Slight erythematous reactions were observed
at control and nickel test sites. The authors reported that "nickel sulfate solutions at concentrations up to 20% are not irritant to theskin of non-nickel-sensitive subjects."
Applicant's summary and conclusion
- Conclusions:
- Nickel sulfate solutions at concentrations up to 20% are not irritant to the skin of non-nickel-sensitive subjects.
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