Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
