Registration Dossier
Registration Dossier
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EC number: 419-500-9 | CAS number: 171599-85-2 RED REN 363
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- bidistilled water
- Amount / concentration applied:
- Duration
- Duration of treatment / exposure:
- 4 h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1 d
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1 d
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1 d
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1 d
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not fully reversible within: 1 d
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1 d
- Remarks on result:
- other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 1 days
- Other effects:
- - COLORATION:
The test article caused light pink staining of the treated
skin.
- CLINICAL SIGNS:
No systemic symptoms were observed.
- BODY WEIGHTS:
The body weight gain was within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- not classified
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