Registration Dossier
Registration Dossier
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3-{5-[3-(4-{1-[3-(dimethylammonio)propyl]-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo}benzamido)phenylazo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-1-pyridyl}propyl(dimethyl)ammonium di(acetate); 3-{5-[4-(3-{1,6-dihydro-2-hydroxy-4-methyl-1-[3-(methylammonio)propyl]-6-oxo-3-pyridylazo}benzamido]phenylazo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-1-pyridyl}propyl(dimethyl)ammonium di(acetate); reaction mass of: 3-{5-[3-(4-{1,6-dihydro-2-hydroxy-4-methyl-1-[3-(methylammonio)propyl]-6-oxo-3-pyridylazo}benzamido)phenylazo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-1-pyridyl}propyl(methyl)ammonium di(acetate)
EC number: 431-440-5 | CAS number: -
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This in vivo study was conducted in 1999, before publication of Commission Regulation (EU) 2017/706.
Test material
- Reference substance name:
- -
- EC Number:
- 431-440-5
- EC Name:
- -
- IUPAC Name:
- (3-{5-[(E)-2-(3-{4-[(E)-2-{1-[3-(dimethylazaniumyl)propyl]-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl}diazen-1-yl]benzamido}phenyl)diazen-1-yl]-6-hydroxy-4-methyl-2-oxo-1,2-dihydropyridin-1-yl}propyl)dimethylazanium (3-{6-hydroxy-5-[(E)-2-(3-{4-[(E)-2-{2-hydroxy-4-methyl-1-[3-(methylazaniumyl)propyl]-6-oxo-1,6-dihydropyridin-3-yl}diazen-1-yl]benzamido}phenyl)diazen-1-yl]-4-methyl-2-oxo-1,2-dihydropyridin-1-yl}propyl)(methyl)azanium (3-{6-hydroxy-5-[(E)-2-(4-{3-[(E)-2-{2-hydroxy-4-methyl-1-[3-(methylazaniumyl)propyl]-6-oxo-1,6-dihydropyridin-3-yl}diazen-1-yl]benzamido}phenyl)diazen-1-yl]-4-methyl-2-oxo-1,2-dihydropyridin-1-yl}propyl)dimethylazanium hexaacetate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Concentration / amount:
- intradermal: 0.1 ml/site
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saline
2) test substance diluted to 5 % (w/w) in PEG 400
3) test substance diluted to 3 % (w/w) by emulsion in a
1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saline
epidermal:
test substance 50 % in PEG 400
Concentration of test material and vehicle used for each challenge:
epidermal:
test substance 1 % in PEG 400
Challenge
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- intradermal: 0.1 ml/site
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saline
2) test substance diluted to 5 % (w/w) in PEG 400
3) test substance diluted to 3 % (w/w) by emulsion in a
1:1 (v/v) mixture of Freund's Complete Adjuvant and
physiological saline
epidermal:
test substance 50 % in PEG 400
Concentration of test material and vehicle used for each challenge:
epidermal:
test substance 1 % in PEG 400
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 1 %
Signs of irritation during induction:
Possible erythema reaction could not be determined due to
substance-related orange staining of the skin. However, no
oedema was observed.
Evidence of sensitisation of each challenge concentration:
1 %: 0/10 animals showed sensitization.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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