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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:
2009
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

Constituent 1
Chemical structure
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.

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- Fasting period before study: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.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.