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EC number: 200-539-3 | CAS number: 62-53-3
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- The identification of contact allergens by human assay. II. The maximization test: a procedure for screening and rating contact sensitizers
- Author:
- Kligman AM
- Year:
- 1 966
- Bibliographic source:
- J. Invest. Dermatol. 12, 393-409
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human maximization test on 25 volunteers.
- GLP compliance:
- no
Test material
- Reference substance name:
- Aniline
- EC Number:
- 200-539-3
- EC Name:
- Aniline
- Cas Number:
- 62-53-3
- Molecular formula:
- C6H7N
- IUPAC Name:
- aniline
- Details on test material:
- - Name of test material (as cited in study report): aniline
- Analytical purity: no data
Constituent 1
Method
- Type of population:
- other: institutional volunteeers = prisoners
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 25
- Sex: male
- Age: no data
- Race: black americans (90%) - Route of administration:
- dermal
- Details on study design:
- ADMINISTRATION
- Type of application: occlusive
- Description of patch: Webril (non-woven, highly absorbent cloth)
- Concentrations: 20% for induction/10% for challenge
- Volume applied: 1 mL
- Testing/scoring schedule: Induction was performed five times (24 h with 5% sodium lauryl suphate (SLS) followed by 48 h with 20% aniline solution). Challenge consisted of pre-treating the skin with 0.4 mL 10% SLS for one hour followed by 48-h occlusive treatment with 10% aniline solution. The challenge reaction is read directly after removal of the 48 hour patch and again in another two days.
EXAMINATIONS
- Grading/Scoring system: 0-2/25 = weak sensitizer; 3-7/25 = mild sensitizer; 8-13/25 = moderate sensitizer; 14-20/25 = strong sensitizer; 21-25/25 = extreme sensitizer
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 7; sensitization grade 2
- Number of subjects with negative reactions: 18
- Number of subjects with irritating reactions: no data
The test material was judged as mild sensitizer.
Applicant's summary and conclusion
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