Registration Dossier
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EC number: 240-245-2 | CAS number: 16090-02-1
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human patch test.
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
- EC Number:
- 240-245-2
- EC Name:
- Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
- Cas Number:
- 16090-02-1
- Molecular formula:
- C40H38N12Na2O8S2
- IUPAC Name:
- disodium 5-{[4-(morpholin-4-yl)-6-(phenylamino)-1,3,5-triazin-2-yl]amino}-2-[(E)-2-(4-{[4-(morpholin-4-yl)-6-(phenylamino)-1,3,5-triazin-2-yl]amino}-2-sulfonatophenyl)ethenyl]benzene-1-sulfonate
Constituent 1
Method
- Type of population:
- general
- Subjects:
- Number of subjects exposed: 102
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED
Patch test (epicutaneous test).
ADMINISTRATION
- Type of application: occlusive.
- Application: for a total of 10 applications (3 per week).
- Exposure: dressing for 48 hours (72 hours on the weekend).
- Vehicle / solvent: petrolatum.
- Concentrations: 1 % and 5 %.
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 102
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
There was no evidence of allergenic skin contact sensitization at both concentrations tested.
Applicant's summary and conclusion
- Conclusions:
- No evidence of allergenic skin contact sensitization at both concentrations tested.
- Executive summary:
Procedures
A repeated insult patch test was performed on 102 volunteers. The test substance was dissolved in petrolatum to concentrations of 1 % and 5 % and was applied for a total of 10 applications (3 per week) under occlusive dressing for 48 hours (72 hours on the weekend). This was followed by a rest period and final elicitation on a fresh application site.
Results
There was no evidence of allergenic skin contact sensitization at both concentrations tested.
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