Registration Dossier
Registration Dossier
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EC number: 939-382-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Maximisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- A 2:1 mixture of: tris(3,5,5-trimethylhexylammonium)-4-amino-3-(4-(4-(2-amino-4-hydroxyphenylazo)anilino)-3-sulfonatophenylazo)-5,6-dihydro-5-oxo-6-phenylhydrazononaphthalene-2,7-disulfonate; tris(3,5,5-trimethylhexylammonium)-4-amino-3-(4-(4-(4-amino-2-hydroxyphenylazo)anilino)-3-sulfonatophenylazo)-5,6-dihydro-5-oxo-6-phenylhydrazononaphthalene-2,7-disulfonate
- EC Number:
- 406-000-0
- EC Name:
- A 2:1 mixture of: tris(3,5,5-trimethylhexylammonium)-4-amino-3-(4-(4-(2-amino-4-hydroxyphenylazo)anilino)-3-sulfonatophenylazo)-5,6-dihydro-5-oxo-6-phenylhydrazononaphthalene-2,7-disulfonate; tris(3,5,5-trimethylhexylammonium)-4-amino-3-(4-(4-(4-amino-2-hydroxyphenylazo)anilino)-3-sulfonatophenylazo)-5,6-dihydro-5-oxo-6-phenylhydrazononaphthalene-2,7-disulfonate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Intradermal: 0.1% w/v deionised water.
Topical: 31% w/v deionised water. - Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.3%, 1%, 3%, 10% (w/v) deionised water
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- Not specified
- Challenge controls:
- Not specified
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Not specified
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Not specified
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not specified
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 10 %
Signs of irritation during induction:
No information was given in the test report
Evidence of sensitisation of each challenge concentration:
0
Other observations:
Black staining occurred at 1-10% (topical concentrations) but did not obscure the site. No reactions at challenge were observed with concentrations of 1% and 0.3% (data not in table).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not classified as skin sensitizer.
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