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EC number: 408-210-8 | CAS number: 124605-82-9 C.I. DIRECT BLUE 301; DIRECT BLUE 301
- 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
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- Flash point
- Auto flammability
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- 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

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 9, 1990 - January 30, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline 401 study, GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene
- EC Number:
- 408-210-8
- EC Name:
- Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene
- Cas Number:
- 124605-82-9
- Molecular formula:
- C33 H26 N8 O14 S4 .x Li .x Na
- IUPAC Name:
- dilithium(1+) disodium 5-amino-3-{2-[4-(2-{4-[2-(8-amino-1-hydroxy-3,6-disulfonatonaphthalen-2-yl)diazen-1-yl]-2-methylphenyl}diazen-1-yl)phenyl]diazen-1-yl}-4-hydroxynaphthalene-2,7-disulfonate
- Details on test material:
- - Physical state: powder
- Stability under test conditions: stable for at least 2 hours
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., CH-4414 Fuellinsdorf
- Age at study initiation: males: 9 weeks, females: 11 weeks
- Weight at study initiation: males: 200 - 222 g, females: 164 - 183 g
- Fasting period before study: 12 to 18 hours (access to water was not interrupted)
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding
- Diet: Pelleted standard Kliba 343, Batch 61/89 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum.
- Water: Community tap water from Itingen, available ad libitum.
- Acclimation period: One week under laboratory conditions, after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark, music/light period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: bi-distilled water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED:
Application Volume/ kg body weight: 10 ml at 2000 mg/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations: Four times during test day 1, and daily during days 2 - 15
- Frequency of weighing: Test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- The LOGIT-Model could not be applied to the observed rates of death, toxicity was estimated without use of a statistical model.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- Lungs: discoloration, dark red (5 animals).
Kidneys: discoloration, black (1 animal).
No macroscopical organ changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- The acute oral toxicity of the test substance in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg body weight.
- Executive summary:
In an oral toxicity study according to OECD guideline 401, 5 male and 5 female rats were dosed once with the test article by gastric intubation at a dose level of 2000 mg/kg body weight and observed for 15 days. The vehicle used was bi-distilled water. There were no deaths and none of the animals showed clinical signs. All rats gained weight normally. The following organ findings were observed: discoloration of lungs (dark red) in five animals, discolored kidneys (black) in one animal. No macroscopical organ changes were observed. Under the conditions of this study, the LD50 is greater than 5000 mg/kg body weight in male and female rats when applied orally.
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