Registration Dossier
Registration Dossier
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EC number: 419-720-5 | CAS number: 182061-89-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- according to EU method B.6
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 92/69/EEC
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study was performed in 1995
Test material
- Reference substance name:
- -
- EC Number:
- 419-720-5
- EC Name:
- -
- Cas Number:
- 182061-89-8
- Molecular formula:
- C25H26N9Na3O12S3
- IUPAC Name:
- trisodium 6-amino-5-{2-[4-({4-[bis(2-hydroxyethyl)amino]-6-[(2-sulfonatoethyl)amino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazen-1-yl}-4-hydroxynaphthalene-2-sulfonate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 10 %
- Adequacy of induction:
- other: highest concentration not giving rise to irritation effects in the preliminary test
- Route:
- other: topical application
- Vehicle:
- physiological saline
- Concentration / amount:
- 10 %
- Adequacy of induction:
- other: highest concentration not giving rise to irritation effects in the preliminary test
Challengeopen allclose all
- No.:
- #1
- Route:
- other: no information available
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 %
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- other: no information available
- Vehicle:
- physiological saline
- Concentration / amount:
- 1 %
- Adequacy of challenge:
- other: highest concentration not giving rise to irritation effects in the preliminary test
- No. of animals per dose:
- 20 animals treatment group
10 animals control goup
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs recorded
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs recorded
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs recorded
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs recorded
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- no signs of sensitization observed
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