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EC number: 261-919-2 | CAS number: 59766-31-3
- 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:
- 30 May 2012 - 15 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147
- Version / remarks:
- November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Dipotassium titanate(2-)
- EC Number:
- 261-919-2
- EC Name:
- Dipotassium titanate(2-)
- Cas Number:
- 59766-31-3
- Molecular formula:
- K2O17Ti8
- IUPAC Name:
- dipotassium titanate(2-)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Appearance: White powder
Storage conditions: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD (Crl:CD 'SD')
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River (UK) Ltd.
- Age at study initiation: Young adult animals (approx. 8-12 weeks old)
- Weight at study initiation: 220 to 244 gram
- Fasting period before study: overnight prior to and approximately four hours after dosing
- Housing: Group housing of 3 animals per cage in labeled Macrolon cages
- Diet: Free access to pelleted rodent diet (Rat and Mouse No. 1 Maintenance Diet).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 23
- Humidity (%): 40 - 70
- Air changes (per hr): Not indicated
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14 June 2012 to 05 July 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- GAVAGE METHOD: plastic feeding tubes.
Frequency: single dosage, on Day 1.
VEHICLE
- Justification for choice of vehicle: The vehicle (water) was selected based on trial formulations performed at Huntingdon Life Sciences and on test substance data supplied by the sponsor.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg (10 mL/kg) body weight.
DOSAGE PREPARATION: Test substance was frmulated at a concentration of 200 mg/mL in de vehicle. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6 (2 groups of three females in a stepwise manner)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: At least twice daily
Body weights: Days 1 (prior to dosing), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and twice daily thereafter, until Day 15.
- Necropsy of survivors performed: All animals on day 15
- Other examinations performed: None. - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study
- Clinical signs:
- There were no clinical signs of reaction to treatment throughout the study
- Body weight:
- All animals were considered to have achieved satisfactory bodyweight gains throughout the study.
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- according to Regulation (EC) No 1272/2008
- Conclusions:
- In an acute oral toxicity study with rats, performed according to OECD 423 test guideline, an LD50 >2000 mg/kg bw was determined.
- Executive summary:
An acute oral toxicity study in rats was performed according to the OECD 423 test guideline and in accordance with GLP principles. TISMO D, formulated in water, was administired by oral gavage to two subsequent groups of three female CD rats at 2000 mg/kg bw. There were no deaths and no clinical signs of reaction to treatement or effects on bodyweight gains throughout the study. The LD50 value of TISMO D was established to exceed 2000 mg/kg bw. Based on these results, according to Regulation (EC) 1272/2008, TISMO D does not have to be classified and has no obligatory labelling required for oral toxicity.
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