Registration Dossier
Registration Dossier
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EC number: 201-325-2 | CAS number: 81-11-8
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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Skin sensitization potential of the test chemical
- Author:
- Griffith et al
- Year:
- 1 972
- Bibliographic source:
- Arch Derm. 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Skin Sensitisation study was conducted by using the given test chemical.
- GLP compliance:
- not specified
- Type of study:
- other: Human Patch Test
- Justification for non-LLNA method:
- The study was performed on Human subjects to assess the sensitizing potential of the test chemical.
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 4,4'-bis((4-(bis(2-hydroxyethyl)amino)-6-(4-sulphonatoanilino)-1,3,5-triazin-2-yl)amino)stilbene-2,2'-disulphonate)
- Test material form:
- solid: granular
- Details on test material:
- - Name of the test chemical : Fluorescent Brightener 220
- Molecular formula: C40H40N12O16S4.4Na
- Molecular weight: 1165.048 g/mol
- Substance type: Organic
- Smiles: [Na+].[Na+].[Na+].[Na+].OCCN(CCO)c1nc(Nc2ccc(cc2)S(=O)(=O)[O-])nc(Nc3ccc(\C=C\c4ccc(Nc5nc(Nc6ccc(cc6)S(=O)(=O)[O-])nc(n5)N(CCO)CCO)cc4S(=O)(=O)[O-])c(c3)S(=O)(=O)[O-])n1
Constituent 1
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: 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: soap plus borate solution
- Concentration / amount:
- 3% of the test chemical
- Day(s)/duration:
- 21 Days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: soap plus borate
- Concentration / amount:
- Not Specifed
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 72 subjects
- Details on study design:
- No Data Available
- Challenge controls:
- Soap plus borate
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No Data Available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3% of the test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 72
- Clinical observations:
- No Clinical observations were seen in the subjects.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Sensitizing
- Conclusions:
- Based on all the observations and results, it was concluded that the test chemical was not considered to be sensitizing to the human subject, and is thus not likely to be classified for sensitization as per CLP.
- Executive summary:
A skin sensitization study was performed using the test chemical on human subjects so as to identify the sensitizing potential of the test chemical. The test material (3% of the test chemical in a soap plus borate solution was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 72 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The test application sites were graded for primary irritation at various intervals. The material did not appear to cause irritation. None of the subjects were sensitized. Hence, based on all the observations and results, it was concluded that the test chemical was not considered to be sensitizing to the human subject, and is thus not likely to be classified for sensitization as per CLP.
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