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
- Study period:
- 2005
- 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:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 84/449/EWG, B.6 (Meerschweinchen-Maximierungstest (GPMT)); OECD 406
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not reported
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:
- tetrapotassium tetrasodium 6,13-dichloro-3,10-bis({[2-({4-[(2,5-disulfonatophenyl)amino]-6-({3-[2-(sulfonatooxy)ethanesulfonyl]phenyl}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
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: a) Intradermal: 1% in water b) Topical application: 25% in petrolatum
- Concentration / amount:
- a) 25% in petrolatum
b) Not feasible - Day(s)/duration:
- not reported
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: a) Intradermal: 1% in water b) Topical application: 25% in petrolatum
- Concentration / amount:
Concentration of test material and vehicle used for each challenge:
a) 25% in petrolatum
b) Not feasible- Day(s)/duration:
- not reported
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 3.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Signs of irritation during induction: No
Evidence of sensitization of each challenge concentration: 3 at 25%
Other observations:
One animal in the test group died before application. bladder stone
and intussusception of the intestine were observed in this animal.
It was assumed that death was not due to the administration
of the test material.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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