Registration Dossier
Registration Dossier
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EC number: 419-500-9 | CAS number: 171599-85-2 RED REN 363
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 92/69/EEC, B.6 Maximization test
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- N,N'-bis{6-chloro-4-[6-(4-vinylsulfonylphenylazo)-2,7-disulfonicacid 5-hydroxy-napht-4-ylamino]-1,3,5-triazin-2-yl}-N-(2-hydroxyethyl)-ethane-1,2-diamine, sodium salt
- EC Number:
- 419-500-9
- EC Name:
- N,N'-bis{6-chloro-4-[6-(4-vinylsulfonylphenylazo)-2,7-disulfonicacid 5-hydroxy-napht-4-ylamino]-1,3,5-triazin-2-yl}-N-(2-hydroxyethyl)-ethane-1,2-diamine, sodium salt
- Cas Number:
- 171599-85-2
- Molecular formula:
- C46H38Cl2N14O19S6
- IUPAC Name:
- tetrasodium 5-[(4-chloro-6-{[2-({4-chloro-6-[(7-{2-[4-(ethenesulfonyl)phenyl]diazen-1-yl}-8-hydroxy-3,6-disulfonatonaphthalen-1-yl)amino]-1,3,5-triazin-2-yl}(2-hydroxyethyl)amino)ethyl]amino}-1,3,5-triazin-2-yl)amino]-3-{2-[4-(ethenesulfonyl)phenyl]diazen-1-yl}-4-hydroxynaphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Concentration
Concentration of test material and vehicle used at induction:
- intradermal: 0.1 ml
A) 1:1 mixture of Freund's Complete Adjuvant
and physiological saline
B) test substance diluted to 5 % with bidistilled
water.
C) test substance diluted to 5 % by emulsion
in a 1:1 mixture of Freund's C. Adj. and physiological
saline.
- epidermal:
test substance 50 % in bidistilled water
Concentration of test material and vehicle used for each challenge:
- 1. challenge:
test substance 25 % in bidistilled water
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino guinea pig (HYMALIAN)
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Route:
- epicutaneous, occlusive
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10
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:
- 20
- Clinical observations:
- not reported
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- not reported
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- not reported
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 25 %
Signs of irritation during induction:
- Test group :
- The experimental animals showed no oedema after the 48
hours occluded epidermal induction exposure. Determination
of erythema was not possible due to red discoloration of
the treated skin.
- Control group :
Neither erythema nor edema were observed.
Evidence of sensitisation of each challenge concentration:
- CHALLENGE CONCENTRATION 25%:
9/20 (=45%) of the animals showed sensitization
Other observations:
- MORTALITY:
No mortality occured during the study.
- CLINICAL SIGNS:
No clinical signs noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- irritant
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