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EC number: 401-270-6 | CAS number: 122390-99-2
- 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
GLP guideline study according to OECD 404 and 405
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchil Ltd. Huntingdon, UK and Interfauna Uk Ltd.
- Age at study initiation: adult
- Weight at study initiation:
- Housing: individual wire mesh, Type III-high
- Diet (e.g. ad libitum): ssniff K 4, ad libitum
- Water (e.g. ad libitum): water from automatic water dispenser, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (+/-2)°C
- Humidity (%):45 - 65%
- Air changes (per hr): 10-fold
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h Light - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): in water
VEHICLE
- Amount(s) applied (volume or weight with unit): 500 mg in Water on Hansamed 'Hypoallergen' (Baiersdorf No. 2342) on a 6 cm² skin surface - Duration of treatment / exposure:
- 4 h
- Observation period:
- 24, 48 and 72 h after removal of the patches
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal region of the body
- % coverage: 6 cm²
- Type of wrap if used: test substance evenly distributed on sterile plaster. The plaster was fixed to the prepared skin area and then coverd with semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 h
SCORING SYSTEM: Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE - Irritation parameter:
- erythema score
- Basis:
- animal: 1-3
- Time point:
- other: 1, 24, 48 and 72 hours and 7 and 14 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: 1-3
- Time point:
- other: 1, 24, 48 and 72 hours and 7 and 14 days
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No abnormalities detected in any of the tested animals at different time points up to 72 h
- Other effects:
- None
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance was considered to be non-irritating to rabbit skin
- Executive summary:
A study was conducted to assess the skin irritation potential of test substance to the rabbit skin according to EU Method B.4. and OECD Guideline 404 in compliance with GLP.
Three animals were treated with 500 mg of the test substance pasted with water using semi-occlusive patches for 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with water. The skin was evaluated for erythema, eschar formation and edema numerically according to the score of Draize system for up to 72 h after patch removal.
No signs of irritation were observed during the whole observation period.
Under the test conditions, the test substance was considered to be non-irritating to rabbit skin.
Reference
No signs of irritations were observed during the whole observation period
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd. Huntington, UK and Interfauna UK Ltd.
- Age at study initiation: adult
- Housing: individual, wire mesh Type III-high
- Diet (e.g. ad libitum): ssniff K 4, ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 °C
- Humidity (%):45-65 %
- Air changes (per hr): 10-fold
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light - Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µg/l (= 70 mg)
- Concentration (if solution): mixed with water to obtain paste - Duration of treatment / exposure:
- single treatment / 4 h
- Observation period (in vivo):
- 24, 48, and 72 h after removal of patches
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, 24 h after administration the treated eyes were washed out thoroughly with isotonic saline (NaCl) solution
- Time after start of exposure: 24 h
SCORING SYSTEM: Lesions in cornea, iris or conjunctivae were graded numerically 'Scale for scoring ocular reactions'
TOOL USED TO ASSESS SCORE: 1%-fluorescein solution, UV-light - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Other effects:
- None
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance was considered to be non-irritating to the rabbit eye
- Executive summary:
In a primary eye irritation study, 70 mg of Reactive Blue FC 15353 was instilled into the conjunctival sac of the left eye of 3 New Zealand albino rabbits for 24 hours. Treated eyes were washed with isotonic saline at approx. 37 degrees C 24 hours after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place. Animals were then observed for 3 days. Irritation was scored by the Draize method.
In this study, the test item is not considered an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
A study was conducted to assess the skin and eye irritation potential of the test substance according to OECD Guideline 404 and 405 in compliance with GLP. Under the test conditions, the test substance was considered to be non-irritating to rabbit skin or eye.
Justification for selection of skin irritation / corrosion endpoint:
GLP guideline study
Justification for selection of eye irritation endpoint:
GLP guideline study
Justification for classification or non-classification
No effects reported in appropriate GLP guideline studies.
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