Registration Dossier
Registration Dossier
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EC number: 263-000-1 | CAS number: 61788-71-4
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
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., B. Belletti, L. Mantovani, and P. Pepe.
- Year:
- 1 996
- Bibliographic source:
- Contact Dermatitis. 35:260-261.
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 24 hour occluded patch testing
- GLP compliance:
- no
Test material
- Reference substance name:
- Nickel sulphate
- EC Number:
- 232-104-9
- EC Name:
- Nickel sulphate
- Cas Number:
- 7786-81-4
- Molecular formula:
- NiSO4
- IUPAC Name:
- nickel(2+) sulfate
Constituent 1
Method
- Type of population:
- other: healthy subjects (no metal intolerance or eczema)
- Subjects:
- 25 subjects patch tested (ages 22-50)
- Route of exposure:
- dermal
- Reason of exposure:
- other: experimental patch testing
- Details on exposure:
- 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.
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 the skin of non-nickel-sensitive subjects."
Applicant's summary and conclusion
- Executive summary:
STUDY RATED BY AN INDEPENDENT REVIEWER.
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