Magnesium potassium titanium oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 October 2000-16 November 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: 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:

2001

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)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1996)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

436-900-9

EC Name:

-

Cas Number:

39290-90-9

Molecular formula:

Hill Empirical formula: K(0.2-0.7) Mg(0.4) Ti(1.6) O(3.7-3.95) CAS Empirical formula: K(0.2-0.7) Mg(0.4) Ti(1.6) O(3.7-3.95)

IUPAC Name:

Magnesium Potassium Titanium Oxide

Details on test material:

Batch: 0G99
White powder
Specific gravity: 3.38
Expiry date: 21 August 2001
Test substance storage: At room temperature in the dark
Stability in 1% aq. carboxymethyl cellulose: at least 4 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. 11 weeks old).
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean
- Housing: Group housing of 3 animals per sex per cage in labelled polycarbonate cages (Macrolon, type IV; height 15 cm.) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany)
- Free access to standard pelleted laboratory animal diet (Altromin (code VRF 1), Lage, Germany)
- Free access to tap water
- The acclimation period was at least 5 days before the start of treatment under laboratory conditions.
- A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health.

Results of analysis for diet (nutrients and contaminants), sawdust 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%
- 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: 1% Aqueous carboxymethyl cellulose.

Details on oral exposure:

GAVAGE METHOD: stainless steel stomach tube.

FREQUENCY: single dosage, on Day 1.

VEHICLE : 1% Aqueous carboxymethyl cellulose
The vehicle was selected based on a pretest performed at NOTOX

DOSAGE PREPARATION: The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.

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:

other: No clinical signs of toxicity were noted.

Gross pathology:

Effects on organs: Reduced size of testes was observed in one male. No abnormalities were found at macroscopic post mortem examination of the other anaimals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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