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Diss Factsheets
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EC number: 268-519-7 | CAS number: 68110-30-5
- 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
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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 journals
Data source
Reference
- Reference Type:
- publication
- 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, 1996, 35, 313
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Patch test
- Principles of method if other than guideline:
- Patch tests were performed on 312 consecutive patients to determine the allergic potential of Reactive Red 198
- GLP compliance:
- not specified
- Type of study:
- 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: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): 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)
- Common Name: Reactive Red 198
- Molecular formula :
- Molecular weight : 984.2152 g/mol
- Substance type: organic
- Physical State: Solid (powder)
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 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)
- Common Name: Reactive Red 198
- Molecular formula : C27H22ClN7O16S5.Na
- Molecular weight : 984.2152 g/mol
- Substance type: organic
- Physical State: Solid (powder)
- Purchased from: Hoechst
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Department of Dermatology, University of Modena, Italy
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% and 10% in petrolatum
- Day(s)/duration:
- 3 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% and 10%
- Day(s)/duration:
- 3 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 312 consecutive patients
119 patients were tested with 5% concentration and remaining 193 with 10% concentration - Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: single exposure
- Exposure period: 3 days
- Test groups: 312
- Control group: number not mentioned
- Site: healthy skin of the back
- Frequency of applications: daily for 3 days
- Duration: 3 days
- Concentrations: 5% - 119 patients; 10% - 193 patients
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: no data available
- Exposure period: 3 days
- Test groups: 312
- Control group: no data available
- Site: healthy skin of the back
- Concentrations: 5% - 119 patients; 10% - 193 patients
- Evaluation (hr after challenge): no data available
OTHER: 312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential.
The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients. - 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 and 10%
- No. with + reactions:
- 0
- Total no. in group:
- 312
- Clinical observations:
- No positive allergic or irritant reactions were observed in the volunteers
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table: Reactive dyes used for patch testing
Color Index Name |
Commercial Name |
Structure |
Reactive Red 198 |
Red Remazol RB 133 |
Azo dye |
Reactive Red 180 |
Brilliant Red, Remazol F3B |
Azo dye |
Reactive Orange 16 |
Brilliant Orange, Remazol 3R |
Azo dye |
Reactive Orange 96 |
Gold Yellow, Remazol 3R |
Azo dye |
Reactive Blue 220 |
Brilliant Blue, Remazol BB |
Formazan dye |
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitoxing
- Conclusions:
- No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye.
Hence, Reactive Red 198 can be considered to not sensitizing to human skin. - Executive summary:
Patch tests were performed on 312 consecutive patients to determine the allergic potential of Reactive Red 198.
312 consecutive patients underwent patch tests with reactive dyes to determine the allergic contact dermatitis potential.
The dyes tested were provided as powder by Hoechst and were dispersed in petrolatum. The dyes were applied to the healthy sin of the back with Finn Chambers, on Scanpor tape for 3 days and read at 3 hours after removal and at 4 days according to ICDRG Scoring pattern. The concentration used was 5% in 119 patients and 10% in 193 patients.
No positive allergic or irritant reactions were observed in the volunteers when tested with 5% and 10% concentration of the dye.
Hence, Reactive Red 198 can be considered to not sensitizing to human skin.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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