Registration Dossier
Registration Dossier
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EC number: 282-850-4 | CAS number: 84434-51-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987/1988
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate
- EC Number:
- 282-850-4
- EC Name:
- Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate
- Cas Number:
- 84434-51-5
- Molecular formula:
- C40H30Cl4N14O20S6.6Na
- IUPAC Name:
- hexasodium 6,13-dichloro-3,10-bis({[2-({4-chloro-6-[(2,4-disulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)ethyl]amino})-5,12-dioxa-7,14-diazapentacene-4,11-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Procion Blue H-EXL
Blue Powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: ICI Colours and FIne Chemical
- Weight at study initiation: 250-396 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- treatment group
26% (w/v) Reactive Blue 198 of the test sample in deionised water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- treatment group
26% (w/v) Reactive Blue 198 of the test sample in deionised water
- No. of animals per dose:
- 20
- Challenge controls:
- 1% (w/v) preparation of the Reactive Blue 198 in deionised water to the left shorn flank
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Challenge with a 46% (w/v) preparation of the test sample in deionised water elicited a strong sensitisation response in previously-induced guinea pigs. Challenge with a 26% (w/v) preparation of the test sample in deionised water elicited a moderate sensitisation response in previously-induced guinea pigs. No sensitisation response was elicited following challenge with a 1% (w/v) preparation of the test sample in deionised water.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 26% (w/v) preparation of the test sample in deionised water
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 26% (w/v) preparation of the test sample in deionised water. No with. + reactions: 5.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 26% (w/v) preparation of the test sample in deionised water
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 26% (w/v) preparation of the test sample in deionised water. No with. + reactions: 10.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The present study has shown that after the release treatment 50% of the animals has given positive response.
According to the evaluation criteria of Directive 83/467/EEC, Reactive Blue 198 in the maximization test is a moderate sensitizer. - Executive summary:
The net response was calculated to be 67% and, therefore, when previously induced guinea pigs were challenged with a 46% (w/v) preparation of Reactive Blue 198, a strong sensitisation response was elicited. Following challenge with a 26% (w/v) preparation of the test sample in deionised water, moderate diffuse redness was observed in three test animals and scattered mild redness in seven test animals. None of the control animals showed a response.
The net response was calculated to be 50% and, therefore, when previously induced guinea pigs were challenged with a 26% (w/v) preparation of Reactive Blue 198, a moderate sensitisation response was elicited.
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