Registration Dossier
Registration Dossier
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EC number: 221-409-2 | CAS number: 3087-16-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source .
Data source
Reference
- Reference Type:
- secondary source
- Title:
- SIDS Initial Assessment Report For SIAM 13, CAS no: 16470-24-9(Fluorescent Brightener 220)
- Author:
- OECD SIDS SIAM 13
- Year:
- 2 001
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 13, Bern, Switzerland, 6-9 November 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Repeated insult patch test
- Principles of method if other than guideline:
- The skin sensitization study of Fluorescent Brightener 220 was performed by repeated insult patch test.
- GLP compliance:
- not specified
- Type of study:
- other: Repeated insult patch test
- Justification for non-LLNA method:
- No data available
Test material
- Reference substance name:
- Tetrasodium 4,4'-bis[[4-[bis(2-hydroxyethyl)amino]-6-(4-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate]
- EC Number:
- 240-521-2
- EC Name:
- Tetrasodium 4,4'-bis[[4-[bis(2-hydroxyethyl)amino]-6-(4-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate]
- Cas Number:
- 16470-24-9
- Molecular formula:
- C40H44N12O16S4.4Na
- IUPAC Name:
- tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[bis(2-hydroxyethyl)amino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
- Test material form:
- solid
- Details on test material:
- Name of the test chemical:C.I. Fluorescent Brightener 220
Molecular Formula: C40H44N12O16S4.4Na
Molecular Weight:1165.048 g/mol
Substance Type: Organic
Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- Details on test material
Name of the test chemical:C.I. Fluorescent Brightener 220
Molecular Formula: C40H44N12O16S4.4Na
Molecular Weight:1165.048 g/mol
Substance Type: Organic
Physical State: Solid
In vivo test system
Test animals
- Species:
- other: human
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- 48hr
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- 48 hr
- No. of animals per dose:
- 103 female
- Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:10
- Exposure period:48hr per application
- Test groups:103
- Control group: No data available
- Site: back
- Frequency of applications: After 48hr for 10 application
- Duration:20 days
- Concentrations: 0.1%
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: After 14 days of last induction patch test
- Exposure period:48 hr
- Test groups:103
- Control group: No data available
- Site: back
- Concentrations: 0.1%
- Evaluation (hr after challenge):48hr
OTHER: No data available - Challenge controls:
- No data available
- Positive control substance(s):
- no
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 103
- Clinical observations:
- no indication of skin sensitization after the challenge
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Not skin sensitizing in human
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The skin sensitization study of Fluorescent Brightener 220 (16470-24-9) was performed by repeated insult patch test in human was determined to be not skin sensitizing
- Executive summary:
The skin sensitization study of Fluorescent Brightener 220(16470-24-9) was performed by repeated insult patch test in 103 female volunteers using 0.1% aqueous solution.
In induction phase, 10 repeated patch applications was done using 0.1% test solution for 48hr per application at back of the volunteers.
In challenge phase, After 14 days rest period challenge application of 0.1% test solution was applied on back of the subject for 48hr.No skin sensitizing reaction observed after 48hr of challenge application .Hence it is considered thatFluorescent Brightener 220(16470-24-9) was not skin sensitizing in human
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