Registration Dossier
Registration Dossier
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EC number: 231-141-8 | CAS number: 7440-31-5
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not reported.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Although not sufficient for assessing tin contact sensitivity, the study fulfils it's objectives in studying cross sensitisation.
Data source
Reference
- Reference Type:
- publication
- Title:
- Tin: an overlooked contact sensitiser
- Author:
- Menne T, Andesen KE, Kaaber K, Osmundsen PE, Andersen JR, Yding F & Valeur G
- Year:
- 1 987
- Bibliographic source:
- Contact dermatitis: 16:9-10
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Patch tests were performed with metallic tin in 73 nickel-sensitive patients.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Tin
- EC Number:
- 231-141-8
- EC Name:
- Tin
- Cas Number:
- 7440-31-5
- Molecular formula:
- Sn
- IUPAC Name:
- tin
- Details on test material:
- Tin pure metal coated on to copper discs
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 73
- Sex: Both male and female
- Age: Various ages
No further details reported - Clinical history:
- - History of allergy or casuistics for study subject or populations: Nickel sensitivity
- Controls:
- No data
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusion provided by the solid tin disc.
- Description of patch: A copper disc (12 mm diameter 1 mm thick) plated with pure tin metal was fixed in place on the upper back with Scanpor tape
- Vehicle / solvent: Not applicable
- Testing/scoring schedule: readings were taken at 48, 72 and in some cases 120 hours.
- Removal of disc: After 48 hours of exposure
EXAMINATIONS
- Grading/Scoring system: Reactions were graded by severity.
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 6 with strong positive reactions
- Number of subjects with equivocal reactions 4 doubtful reactions
Any other information on results incl. tables
Table 1: Reactions to tin in 6 nickel-sensitive patients
Age (years) |
Sex |
History of nickel dermatitis |
Hand eczema |
Reaction to tin |
7 |
M |
+ |
- |
++ |
23 |
F |
+ |
- |
++ |
29 |
F |
+ |
- |
+++ |
30 |
F |
+ |
- |
++ |
63 |
M |
- |
- |
++ |
74 |
F |
+ |
+ |
++ |
EDAX analysis confirmed the surface composition of the tin discs, and the corrosion test established that not even minute amounts of nickel were released after prolonged exposure, 6 of the 73 nickel-sensitive patients had a + + or + + + reaction to the tin discs. The 7-year-old boy was sensitized from metal spectacle frames, 4 patients had a doubtful (? + ) positive reaction and the test was negative in 63 patients. All 73 patients had at least 2 other positive tests at the same time. The patient with the + + + reaction was retested with tin alone 3 months later on the upper arm and again developed a strong positive reaction.
EDAX analysis confirmed the surface composition of the tin discs, and the corrosion test established that not even minute amounts of nickel were released after prolonged exposure, 6 of the 73 nickel-sensitive patients had a + + or + + + reaction to the tin discs. The 7-year-old boy was sensitized from metal spectacle frames, 4 patients had a doubtful (? + ) positive reaction and the test was negative in 63 patients. All 73 patients had at least 2 other positive tests at the same time. The patient with the + + + reaction was retested with tin alone 3 months later on the upper arm and again developed a strong positive reaction.
Applicant's summary and conclusion
- Conclusions:
- In 73 nickel sensitive patients, 6 strong and 4 doubtful reactions were induced in patients exposed to tin.
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