Registration Dossier
Registration Dossier
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EC number: 202-409-1 | CAS number: 95-31-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable, well-documented study report which meets basic sientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeated Insult Patch test (modified Shelanski (4 x 4 method))
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N-tert-butylbenzothiazole-2-sulphenamide
- EC Number:
- 202-409-1
- EC Name:
- N-tert-butylbenzothiazole-2-sulphenamide
- Cas Number:
- 95-31-8
- Molecular formula:
- C11H14N2S2
- IUPAC Name:
- N-(1,3-benzothiazol-2-ylsulfanyl)-2-methylpropan-2-amine
- Details on test material:
- purity: 97.4 %
Constituent 1
Method
- Type of population:
- general
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- sensitising
Any other information on results incl. tables
Forty-five subjects completed the study. During the induction period, eleven subjects demonstrated intense irritation consisting of erythema and induration. These responses were considered indicative of an allergic reaction. due to the severity of reaction during the induction period, these eleven subjects were not tested during the portion of the induction phase which followed their response. Following the single 24 hour challenge application, six subjects demonstrated slight to moderate erythema. Twenty-four hours after removal of the test material, mild to intense inflammatory changes were observed in 15 individuals. At 48 hours after removal, responses were still noted in 13 subjects. These responses were considered characteristic for allergic contact dermatitis.
In conclusion, the test substance, tested as a 60 % preparation in petrolatum, produced sensitization in 13/54 subjects who completed the study. No evidence of primary irritation was observed.This chemical was considered to be a strong skin 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.
