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Mixture of hexa(sodium,lithium) 4-{[1,7-disulfonato-5-hydroxy-6-({4-[(6-methoxy-5-sulfonatobenzoheteromonocycle-2-yl)diazenyl]-5-alkyl-2-(3-sulfonatopropoxy)phenyl}diazenyl)naphthalen-2-yl]diazenyl}-5-hydroxy-1-(4-sulfonatophenyl)heteromonocycle-3-carboxylate and hexa(sodium,lithium) 4-{[1,7-disulfonato-5-hydroxy-6-({4-[(6-methoxy-7-sulfonatobenzoheteromonocycle-2-yl)diazenyl]-5-alkyl-2-(3-sulfonatopropoxy)phenyl}diazenyl)naphthalen-2-yl]diazenyl}-5-hydroxy-1-(4-sulfonatophenyl)heteromonocycle-3-carboxylate
EC number: - | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 21 - August 19, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to current OECD test guidelines and GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): E-BK105
- Physical state: Black powder, solid
- Lot/batch No.: MB-1
- Expiration date of the lot/batch: July 6, 2015
- Storage condition of test material: Room temperature, dark place
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc. (Hino breeding center)
- Age at study initiation: 9 weeks
- Weight at study initiation: 187.9-210.5 g
- Fasting period before study: From the evening on the day before the administration (approx 18 hours predose) to about 3 hours postdose.
- Housing: Stainless steel cages (W226xD346xH198 mm), stainless steel racks and feeders, one animal per cage
- Diet (ad libitum): Pellet diet (CRF-1, Oriental Yeast Co., Ltd.) (each lot analysed: contaminants confirmed to be within acceptable limits of the test facility)
- Water (ad libitum): Well water admixed with NaClO (about 2 ppm) (analysed every 6 months: contaminants confirmed to be in compliance with the waterworks law of Japan)
- Acclimation period: 6 days for experiment 1 and 8 days for experiment 2
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.6-24.6
- Humidity (%): 44.9-61.3
- Air changes (per hr): 10 to 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: test substance solved to make a dosing solution at a concentration of 100 mg/ml
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg
DOSAGE PREPARATION (if unusual): The dosing volumes for individual animals were calculated on the basis of the body weight measured just before administration.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The lethal dose of a similar substance was reported to be 2000 mg/kg or above. Therefore, the dose level for the first administration was set at 2000 mg/kg, which is the maximum dose recommended in the guideline applied to this study. As a result, as no death or moribundity was observed on the day after the first administration the dose level for the second administration was also set at 2000 mg/kg. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females in each of 2 experiments
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical signs were observed before the dosing (Day 1, day of initial administration), 30 min, 1, 3, and 5 hours postdose on Day 1 and once daily for 14 days thereafter. Body weight was measured just before the administration (Day 1) and on Days 4, 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: none - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths were noted in any animal in experiment 1 and 2.
- Clinical signs:
- other: Test substance mixed feces was observed in all animals from 0.5 or 1 hours on Day 1 (administration day) to Day 3 or 4, and chromaturia (blackish) was observed in all animals from Day 2 to Day 4 or 5 in experiment 1 and 2. These changes were attributed to
- Gross pathology:
- No abnormalities were noted in any animal in experiment 1 or 2.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of E-BK105 in rats was determined to be above 2000 mg/kg bw under the conditions of this study (OECD 423).
- Executive summary:
A single oral administration of E-BK105 (dissolved in water) by gavage was conducted to female Crl:CD(SD) rats aged 9 weeks to evaluate its acute oral toxicity in accordance with the OECD test guideline 423. A dose of 2000 mg/kg bw was employed for the first and second administration to each three rats. As a result, there was no mortality, body weight gain effects, or necropsy findings. Clinical signs were restricted to test substance mixed feces and chromaturia (blackish). In conclusion, the LD50 of E-BK105 in rats is determined to be above 2000 mg/kg bw under the conditions of this study.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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