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EC number: 270-096-9 | CAS number: 68411-04-1
- 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
In a limited early acute oral toxicity study female rats were dosed with
5000 mg/kg bw C.I. Direct Blue 264. 2/10 animals died during the 14 days
observation period, consequently the oral LD50 is above 5000 mg/kg bw.
In an acute dermal toxicity study conducted according to OECD TG 402
C.I. Direct Blue 264 is regarded as non-toxic after dermal application.
The limit dose is 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Early study conducted according to scientifically accepted method
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 10 female Wistar rats were dosed by gavage with a single dose of C.I. Direct Blue 264. Animals were observed for 14 days and number of death and alive animals were recorded.
- GLP compliance:
- no
- Test type:
- other: Limit test
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Doses:
- 5
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- In a limited early acute oral toxicity study in female rats. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.
- Executive summary:
In a limited early acute oral toxicity study in female rats. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.
Reference
Single dose of 5000 mg/kg bw was used. 2/10 animals died during the 14 day observation period.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 6 females
- Control animals:
- not required
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- In an acute dermal toxicity study conducted according to OECD TG 402 C.I. Direct Blue 264 is regarded as non-toxic after dermal application.
- Executive summary:
Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg bw of C.I. Direct Blue 264 applied semiocclusively for 24 hours.
A dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities, toxicologically relevant clinical signs, toxicological effects on weight development and gross pathological findings.
Reference
Groups of 5 male and 5 female Wistar rats received a single dermal dose of 2000 mg/kg bw of C.I. Direct Blue 264 applied semiocclusively for 24 hours.
A dose of 2000 mg/kg bw was tolerated by male and female rats without mortalities, toxicologically relevant clinical signs, toxicological effects on weight development and gross pathological findings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
In a limited early acute oral toxicity study female rats were dosed with 5000 mg/kg bw C.I. Direct Blue 264. 2/10 animals died during the 14 days observation period, consequently the oral LD50 is above 5000 mg/kg bw.
In an acute dermal toxicity study conducted according to OECD TG 402 C.I. Direct Blue 264 is regarded as non-toxic after dermal application. The limit dose is 2000 mg/kg bw.
Justification for classification or non-classification
C.I. Direct Blue 264 is of low toxicity.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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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