Lithium potassium titanium oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 July-01 August 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(1996)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1996)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(1998)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium Potassium Titanium Oxide

EC Number:

445-620-6

Cas Number:

39318-30-4

Molecular formula:

Hill Empirical formula: K(0.5-0.7) Li(0.27) Ti(1.73) O(3.8-3.95) CAS Empirical formula: K(0.5-0.7) Li(0.27) Ti(1.73) O(3.8-3.95)

IUPAC Name:

Lithium Potassium Titanium Oxide

Details on test material:

Batch: 2D82A
White powder, crystal structure
Expiry date: 31 May 2003
Test substance storage: At room temperature in the dark
Stability in propylene glycol: at least 96 h

Test animals

Species:

rat

Strain:

other: Wistar strain Crl:(WI) BR (outbred, SPF-Quality)

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Charles River Deutschland, Sulzfeld, Germany
- Males/females. Females were nulliparous and non-pregnant.
- Age at study initiation: Young adult animals (approx. 8 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean.
- Housing: Group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm.) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany).
- Free access to pelleted animal diet (Altromin (code VRF 1), Lage, Germany).
- Free access to tap water.
- The acclimatization period was at least 5 days before the start of treatment under laboratory conditions.
- A health inspection was performed prior to treatment, to ensure that the animals were in a good state of health.

Results of analysis for diet (nutrients and contaminants), sawdust, paper and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All certificates and results of analysis are retained in the NOTOX archives.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3ºC
- Humidity (%): 30 - 70%
- Maximum level for relative humidity (with a maximum of 27%) occurred which might have been caused by cleaning procedures in the room. Based on laboratory historical data this protocol deviation was considered not to have affected the study integrity.
- Air changes (per hr): approximately 15 air changes per hour- Photoperiod (hrs dark / hrs light): 12 hours artificial
fluorescent light and 12 hours darkness per day.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Propylene glycol.

Details on oral exposure:

GAVAGE METHOD: stainless steel stomach tube.

FREQUENCY: single dosage, on Day 1.

VEHICLE : Propylene glycol (specific gravity 1.036)
The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.

DOSAGE PREPARATION: The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle.

Doses:

2000 mg/kg (10 mL/kg) body weight.

No. of animals per sex per dose:

3 males and 3 females.

Control animals:

no

Details on study design:

Animals were deprived of food overnight prior to dosing (max. 20 h) and until 3-4 hours after administration of the test substance. Water was available ad libitum.

OBSERVATION
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Mortality/Viability: twice daily
- Body weight: Day 1 (pre-administration), 8 and 15
- Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded.
- Necropsy of survivors performed: At the end of the observation period, all animals were sacrificed by asphyxiation using an oxygen/carbon dioxide procedure and subjected to necropsy
- 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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

Hunched posture was noted among the females between days 1 and 6. No clinical signs of systemic toxicity were noted in the males.

Body weight:

The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.

Gross pathology:

Effects on organs: No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

according to EC 1272/2008

Conclusions:

The acute oral LD50 of Terracess L in rat is > 2000 mg/kg bw.
TERRACESS L does not have to be classified and has no obligatory labelling requirement for oral toxicity.