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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 July - 18 July 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 17 Dec 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in a cold dark place (prefabricated refrigerator, 8.6 to 11.4°C), protected from light, in a well-closed container.
- Stability of test article: stable for one year, at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was dissolved in water at 200 mg/mL just before dosing.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Slc:Wistar [SPF]
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC Inc., Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: 133 - 137 g
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: individual in wire-mesh cages with an automatic water flushing breeding rack (Toyoriko). The cages were exchanged every two weeks and the feeders once a week.
- Diet: pellet diet CRF-1 (Oriental Yeast, lot No. 131108), ad libitum
- Water: tap water, ad libitum (analysis was performed)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.7 - 23.2
- Humidity (%): 49.4 to 57.7
- Air changes (per hr): ≥ 12
- Photoperiod (hrs dark / hrs light): 12/ 12
IN-LIFE DATES: From: 4 July To: 18 July 2014
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 1.0 mL/ 100 g bw
- Lot/batch no.: K3K81(Otsuka Pharmaceutical Factory, Inc.; Japan)
MAXIMUM DOSE VOLUME APPLIED: 1.0 mL per 100 g bw
- Rationale for the selection of the starting dose:
The acute oral toxicity of the test substance was predicted to be very low and the LD50 was estimated to be > 2000 mg/kg bw (information from sponsor). Therefore, 2000 mg/kg bw, the upper limit level described in the test guideline, was set for the dose level of the sighting study.
As a result of the sighting study, no animal died. Therefore, the dose of 2000 mg/kg bw was selected as a dose of the main study. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females (including one female in the sighting study)
- Control animals:
- no
- Remarks:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On Day 0, all animals were observed once within 30 minutes and once each at 1, 2, 3 and 4 hours after dosing. From the next day of dosing (from Day 1 to Day 14), the animals were observed once daily. All animals were weighed on Days 0 (before dosing), 7 and 14.
- Necropsy of survivors performed: yes
- The following organs and tissues were examined macroscopically: external surfaces, orifices, the organs and tissues in the abdominal, thoracic, pelvic and cranial cavities - Statistics:
- Statistical analysis was not used.
Results and discussion
- Preliminary study:
- No mortality or clinical signs indicative for systemic toxicity were observed during the sighting study.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- On Day 1, diarrhea was observed in 4 of 5 animals. From Day 2 to Day 14, no clinical signs were observed in any of the animals.
- Body weight:
- All animals showed normal body weight gains during the observation period.
- Gross pathology:
- All animals showed no abnormal gross findings in the examined organs and tissues.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- CLP: not classified
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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