Registration Dossier
Registration Dossier
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EC number: 211-190-1 | CAS number: 633-03-4
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)
- Rationale for reliability incl. deficiencies:
- other: Non-Guideline and non-GLP study
Data source
Reference
- Reference Type:
- publication
- Title:
- Contact-Group Sensitization to Triphenylmethane Dyes
- Author:
- Bielicky T. and Novak M.
- Year:
- 1 969
- Bibliographic source:
- Arch Dermatol 1969, Issue: Nov. 100(5), Page: 540-3
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Patch test on skin with a concentration of 2 %
- GLP compliance:
- no
Test material
- Reference substance name:
- Basic Green 1 sulphate
- IUPAC Name:
- Basic Green 1 sulphate
- Details on test material:
- Please refer to IUCLID section 1.
Constituent 1
Method
- Type of population:
- other: patients with observed signs of contact sensitivity towards triphenylmethane
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 11
- Clinical history:
- - History of allergy or casuistics for study subject or populations: patients with observed signs of contact sensitivity towards triphenylmethane
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: patch test ADMINISTRATION- Vehicle / solvent: in water- Concentrations: 2 % - Testing/scoring schedule: treatment for 20 - 24 h, evaluation for 6 to 7 daysEXAMINATIONS- Grading/Scoring system: Due to skin colouring erythematous reaction could not be evaluated. Therefore itching; isolated papules; edema, confluent papules, infiltration; vesicular reaction were recorded.
Results and discussion
- Results of examinations:
- SYMPTOMSPatients showed itching, isolated papules, edema, confluent papules, infiltration and vesicular reaction within 7 days after treatment.NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions: 11- Number of subjects with no reactions: 0Type of reaction: Patients showed symptoms ranging from isolated papules to edema, confluent papules, infiltration and vesicular reaction.
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.
