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EC number: 282-850-4 | CAS number: 84434-51-5
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987/1988
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: ICI Colours and FIne Chemical
- Weight at study initiation: 250-396 g
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- treatment group
26% (w/v) Reactive Blue 198 of the test sample in deionised water - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- treatment group
26% (w/v) Reactive Blue 198 of the test sample in deionised water - No. of animals per dose:
- 20
- Challenge controls:
- 1% (w/v) preparation of the Reactive Blue 198 in deionised water to the left shorn flank
- Positive control substance(s):
- no
- Positive control results:
- Challenge with a 46% (w/v) preparation of the test sample in deionised water elicited a strong sensitisation response in previously-induced guinea pigs. Challenge with a 26% (w/v) preparation of the test sample in deionised water elicited a moderate sensitisation response in previously-induced guinea pigs. No sensitisation response was elicited following challenge with a 1% (w/v) preparation of the test sample in deionised water.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 26% (w/v) preparation of the test sample in deionised water
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 26% (w/v) preparation of the test sample in deionised water. No with. + reactions: 5.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 26% (w/v) preparation of the test sample in deionised water
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 26% (w/v) preparation of the test sample in deionised water. No with. + reactions: 10.0. Total no. in groups: 20.0.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The present study has shown that after the release treatment 50% of the animals has given positive response.
According to the evaluation criteria of Directive 83/467/EEC, Reactive Blue 198 in the maximization test is a moderate sensitizer. - Executive summary:
The net response was calculated to be 67% and, therefore, when previously induced guinea pigs were challenged with a 46% (w/v) preparation of Reactive Blue 198, a strong sensitisation response was elicited. Following challenge with a 26% (w/v) preparation of the test sample in deionised water, moderate diffuse redness was observed in three test animals and scattered mild redness in seven test animals. None of the control animals showed a response.
The net response was calculated to be 50% and, therefore, when previously induced guinea pigs were challenged with a 26% (w/v) preparation of Reactive Blue 198, a moderate sensitisation response was elicited.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The net response was calculated to be 67% and, therefore, when previously induced guinea pigs were challenged with a 46% (w/v) preparation of Reactive Blue 198, a strong sensitisation response was elicited. Following challenge with a 26% (w/v) preparation of the test sample in deionised water, moderate diffuse redness was observed in three test animals and scattered mild redness in seven test animals. None of the control animals showed a response.
The net response was calculated to be 50% and, therefore, when previously induced guinea pigs were challenged with a 26% (w/v) preparation of Reactive Blue 198, a moderate sensitisation response was elicited.
Justification for selection of skin sensitisation endpoint:
According to the evaluation criteria of Directive 83/467/EEC, Reactive Blue 198 in the maximization test is a moderate sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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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