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EC number: 274-356-2 | CAS number: 70161-20-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Title: A study of 5 newly patch-tested reactive textile dyes.
- Author:
- Bianca Maria Manzini, Massimo Donini , Alberico Motolese and Stefania Seidenari
- Year:
- 1 996
- Bibliographic source:
- Contact Dermatitis volume 35 page no. 313 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To evaluate skin sensitization potential of 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino] -4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl] sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) on 312 patients
- GLP compliance:
- not specified
- Type of study:
- other: Human patch test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)
- EC Number:
- 604-452-5
- Cas Number:
- 145017-98-7
- Molecular formula:
- C27H22ClN7O16S5.4Na
- IUPAC Name:
- 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)
- Test material form:
- solid
- Details on test material:
- - Name of test material : Reactive Red 198
-IUPAC name: 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4 -[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)
- Molecular formula (if other than submission substance): C27H22ClN7O16S5.4Na
- Molecular weight (if other than submission substance): 984.2152 g/mol
- Substance type: organic
- Physical state: solid
InChI::1S/C27H22ClN7O16S5.4Na/c28-25-31-26(29-16-2-1-3-18(12-16)53(39,40)41)33-27(32-25)30-20-13-19(54(42,43)44)10-14-11-21(55(45,46)47)23(24(36)22(14)20)35-34-15-4-6-17(7-5-15)52(37,38)9-8-51-56(48,49)50;;;;/h1-7,10-13,36H,8-9H2,(H,39,40,41)(H,42,43,44)(H,45,46,47)(H,48,49,50)(H2,29,30,31,32,33);;;;/q;4*+1/p
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : Reactive Red 198
-IUPAC name: 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy- 3-[2-[4-[[2-(sulfooxy)ethyl] sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)
- Molecular formula (if other than submission substance): C27H22ClN7O16S5.4Na
- Molecular weight (if other than submission substance): 984.2152 g/mol
- Substance type: organic
- Physical state: solid
InChI::1S/C27H22ClN7O16S5.4Na/c28-25-31-26(29-16-2-1-3-18(12-16)53(39,40)41)33-27(32-25)30-20-13-19(54(42,43)44)10-14-11-21(55(45,46)47)23(24(36)22(14)20)35-34-15-4-6-17(7-5-15)52(37,38)9-8-51-56(48,49)50;;;;/h1-7,10-13,36H,8-9H2,(H,39,40,41)(H,42,43,44)(H,45,46,47)(H,48,49,50)(H2,29,30,31,32,33);;;;/q;4*+1/p
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- - Source: 312 patients admitted to Allergological Services
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% on 119 patients and 10% on 193 patients
- Day(s)/duration:
- 3 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% on 119 patients and 10% on 193 patients
- Day(s)/duration:
- 3 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 312 patients
- Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: no data
- Exposure period: 3 days
- Test groups: 312 patients
- Control group: no data
- Site: back
- Frequency of applications: no data
- Duration: 3 days
- Concentrations: 5% on 119 patients and 10% 0n 193 patients
B. CHALLENGE EXPOSURE
- No. of exposures: no data
- Exposure period: 3 days
- Test groups: 312 patients
- Control group: no data
- Site: back
- Concentrations: 5% on 119 patients and 10% on 193 patients
- Evaluation (hr after challenge): 3 hrs - Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- test chemical
- Dose level:
- 5% on 119 patients and 10% on 193 patients
- No. with + reactions:
- 0
- Total no. in group:
- 312
- Clinical observations:
- No positive allergic reactions were observed
- Remarks on result:
- no indication of skin sensitisation
In vivo (LLNA)
- Cellular proliferation data / Observations:
- No positive allergic reactions were observed
Any other information on results incl. tables
The test material was installed in Finn chambers on Scanpor tape for the patch test
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) when applied as a patch test on healty skin of 321 patients in the concentration 5% on 119 patients and 10% on 193 patients in petrolatum produced no skin allergic reaction. Hence, 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) was considered to be not skin sensitizing.
- Executive summary:
2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino]- 1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[2-[4-[[2-(sulfooxy) ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) was used as a test material to evaluate skin sensitization potential on healty skin of 321 patientsadmitted to Allergological Services.
The test material was applied on the back of the patients which was installed in Finn chambers on Scanpor tape for the patch test in the concentration 5% on 119 patients and 10% on 193 patients diluted in petrolatum.
The exposure duration was 3 days and the observations were made 3 hrs after removal of the test material on day 4
The test material produced no skin allergic reaction. Hence, 2,7-Naphthalenedisulfonic acid, 5-[[4-chloro-6-[(3-sulfophenyl)amino] -1,3,5-triazin-2-yl]amino]-4-hydroxy- 3 - [2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) was considered to be not skin sensitizing.
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