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EC number: 240-521-2 | CAS number: 16470-24-9
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 publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Fluorescent Whitening Agents. Tests for skin-sensitizing potential.
- Author:
- Griffith et al.
- Year:
- 1 973
- Bibliographic source:
- Arch. Dermatol. 107, 728-733
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- see details in remarks on material and methods: human repeat insult patch test (HRIPT)
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 4,4'-bis[[4-anilino-6-[(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- EC Number:
- 241-883-4
- EC Name:
- Disodium 4,4'-bis[[4-anilino-6-[(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- Cas Number:
- 17958-73-5
- IUPAC Name:
- disodium 2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
- Details on test material:
- - Name of test material (as cited in study report): FWA-8
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 66 with 1% and 73 with 10%
- Controls:
- The vehicle also was applied as a negative control. No positive control was applied.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: 0.5% aqueous solution of a detergent mixture
- Concentrations: 10%
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: 66 or 73
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
The material did not appear to cause irritation. None of the subjects was sensitized.
Applicant's summary and conclusion
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