Registration Dossier
Registration Dossier
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EC number: 224-548-7 | CAS number: 4404-43-7
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
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.
