Registration Dossier
Registration Dossier
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EC number: 228-770-5 | CAS number: 6358-36-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Fluorescent Whitening Agents Tests for Skin-Sensitizing Potential.
- Author:
- John F. Griffith, PhD, Cincinnati
- Year:
- 1 973
- Bibliographic source:
- Archives of Dermatology, 107(5):728-733,
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Test material disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate were examined in Human by Repeated Insult Patch Test.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- Not specified.
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:
- C40H40N12O8S2.2Na
- IUPAC Name:
- disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
Constituent 1
- Specific details on test material used for the study:
- Details on test material
- Name of test material (as cited in study report): disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate
- Molecular formula: C26H26N2O2S
- Molecular weight: 926.0 g/mol
- Substance type: Organic
- Physical state: Solid
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Remarks:
- Not applicable
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.5% of Detergent
- Concentration / amount:
- 10%
- Day(s)/duration:
- 2weeks
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.5% of Detergent
- Concentration / amount:
- 10%
- Day(s)/duration:
- 7days
- No. of animals per dose:
- 70 humans subjects.
- Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 2 weeks
- Test groups: no data
- Control group: no data
- Site: human skin
- Frequency of applications: 9 applications in 2 week
- Duration: 24 hrs
- Concentrations: 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 24-hour exposures
- Day(s) of challenge: 2 weeks later
- Exposure period: 7days
- Test groups: no data
- Control group: no data
- Site: human skin
- Concentrations: 10%
- Evaluation (hr after challenge): no data - Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 168
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 70
- Clinical observations:
- No sensitization reactions was observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- A skin sensitization test was conducted for the test material.The disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate observed to be non- sensitizing to human.
- Executive summary:
The sensitization test was performed on 70 human by repeated insult patch test.10% of disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate in 0.5% vehicle was applied to 70 human subjects.For this test, the materials were applied under occlusive patches in a series of nine applications, each of 24 hours' duration, during a three-week period. Challenge applications were made two weeks later.Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate tested did not reveal any tendency to produce skin sensitization among the human subjects who were exposed to the test material. Therefore Disodium 4,4'-bis [(4-anilino-6-morpholino- 1,3,5-triazin-2-yl) amino]stilbene-2,2'-disulphonate was considered to be non sensitizing to the human .
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