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EC number: 619-916-2 | CAS number: 12031-95-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- tetralithium(1+) 3,3-di{[oxido(oxo)titanio]oxy}-1,5-dioxotrititanoxane-1,5-bis(olate)
- EC Number:
- 619-916-2
- Cas Number:
- 12031-95-7
- Molecular formula:
- Li4Ti5O12
- IUPAC Name:
- tetralithium(1+) 3,3-di{[oxido(oxo)titanio]oxy}-1,5-dioxotrititanoxane-1,5-bis(olate)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Appearance: white powder.
- Lot No. 0171AV037
- Content: Ti: 51.5 %. Li: 6.2 %.
- Storage conditions: room temperature.
- Stability at storage conditions: unlimited.
- Bulk density: 688 g/L.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, CRl:CD(SD)
- Age at study initiation: ca. 8 weeks.
- Weight at study initiation: ca. 195 g
- Fasting period before study: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
- Housing: Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids.
- Diet (e.g. ad libitum): Ssniff R/M-H maintenance diet for rats and mice (item V1534-300) ad libitum.
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 22.3 °C
- Humidity (%): average of 54.9 %
- Air changes (per hr): 12.
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: variable.
- Justification for choice of vehicle: The test substance was not soluble in water. Aqueous CMC is a common vehicle for acute oral toxicity testing.
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg.
DOSAGE PREPARATION: The suspensions were prepared freshly before administration and were administered within 15 minutes after the preparation.
Rationale for the selection of the starting dose: As no prior information on the toxicity of the test substance was available, a starting dose of 300 mg of the test substance per kg body weight was chosen. - Doses:
- 300 and 2000 mg/kg bw.
- No. of animals per sex per dose:
- 2 steps à 3 rats = 6.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observations were performed within the periods 0 - 0.5, 0.5 - 1, 1 - 2, 2 - 4 and 4 - 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
- Body weights were determined before administration, 7 days p.a. and 14 days p.a.
- Necropsy of survivors performed: yes. - Statistics:
- no.
Results and discussion
- Preliminary study:
- n.a.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- other: All animals did not show any clinical signs during the entire observation period.
- Gross pathology:
- No abnormal findings were made in all animals at the necropsy 14 d p.a.
- Other findings:
- none.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
An acute oral toxicity study according to the Acute Toxic Class method was performed with rats.
The LD50oral,14d is >2000 mg/kg bw.
No relevant signs of toxicity were observed up to 2000 mg/kg bw.
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