Lithium titanium oxide (Li4Ti5O12)

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

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- Fasting period before study: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.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