Registration Dossier
Registration Dossier
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EC number: 414-100-0 | CAS number: 154336-20-6 SUMIFIX BRILLIANTBLAU GL KONZENTRAT
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: SNIF
- Title:
- Unnamed
- Year:
- 2 021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- other: migration from SNIF
- Justification for non-LLNA method:
- migration from SNIF
Test material
- Reference substance name:
- Potassium sodium 6,13-dichloro-3,10-bis{2-[4-[3-(2-hydroxysulphonyloxyethanesulfonyl)phenylamino]-6-(2,5-disulfonatophenylamino)-1,3,5-triazin-2-ylamino]ethylamino}benzo[5,6][1,4]oxazino[2,3-b]phenoxazine-4,11-disulfonate
- EC Number:
- 414-100-0
- EC Name:
- Potassium sodium 6,13-dichloro-3,10-bis{2-[4-[3-(2-hydroxysulphonyloxyethanesulfonyl)phenylamino]-6-(2,5-disulfonatophenylamino)-1,3,5-triazin-2-ylamino]ethylamino}benzo[5,6][1,4]oxazino[2,3-b]phenoxazine-4,11-disulfonate
- Cas Number:
- 154336-20-6
- Molecular formula:
- C56H42Cl2K4N16Na4O32S10
- IUPAC Name:
- potassium sodium 6,13-dichloro-3,10-bis{2-[4-[3-(2-hydroxysulphonyloxyethanesulfonyl)phenylamino]-6-(2,5-disulfonatophenylamino)-1,3,5-triazin-2-ylamino]ethylamino}benzo[5,6][1,4]oxazino[2,3-b]phenoxazine-4,11-disulfonate
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Details on test animals and environmental conditions:
- Number of animals in test group: 20
Number of animals in negative control group: 10
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25 %
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 1 %
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25 %
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 1 %
- No. of animals per dose:
- test group: 20; negative control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 3
- Total no. in group:
- 20
Any other information on results incl. tables
Signs of irritation during induction: None.
Evidence of sensitisation of each challenge concentration: 3 at 25 %.
Other observations:
One animal in the test group died prior to application. Bladder stone and intestinal intussusception were observed in this animal. It was assumed that the death was not due to administration of the test material.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not classified
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