Registration Dossier
Registration Dossier
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EC number: 248-502-0 | CAS number: 27503-81-7
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well established clinical method with limited documentation
Data source
Reference
- Reference Type:
- other: summary letter
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
- Type of study / information:
- clinical study on skin tolerance in allergy laboratory
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- closed human patch test (48 h) in 50 subjects
Test material
- Reference substance name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid sodium salt
- EC Number:
- 924-712-4
- Molecular formula:
- C12 H9 O3 N2 S Na
- IUPAC Name:
- 2-phenyl-1H-benzimidazole-5-sulphonic acid sodium salt
Constituent 1
Method
- Details on study design:
- The test material was applied for 48 h under occlusive conditions to 50 subjects. Reading of skin reactions was performed after 48 and 72 h.
5% and 10% aqueous solution of sodium salt of the test item - Details on exposure:
- TYPE OF EXPOSURE: test item was applied with Finn chambers on Scanpore tape on normal back skin
TYPE OF EXPOSURE MEASUREMENT: observation of skin reactions after 48 and 72 h using the scale of the International Contact Dermatitis Research Group (0 negative, +/- uncertain positive reaction, + slight positive reaction, ++ strong positive reaction, +++ very strong positive reaction, IR irritant
EXPOSURE LEVELS: test item was applied as supplied
EXPOSURE PERIOD: 48 h
DESCRIPTION OF EXPOSURE GROUPS: 25 women and 25 men (aged between 20 and 88 years), who were tested in the allergy laboratory because of various dermatoses.
Results and discussion
- Results:
- No irritant reactions occurred in any of the 50 subjects.
Applicant's summary and conclusion
- Conclusions:
- The test item was well tolerated. No skin reactions occurred after 48 h epicutaneous occluded application in 50 subjects.
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