Dipotassium titanate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 May 2012 - 15 August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

30 May 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

2002

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147

Version / remarks:

November 2000, including the most recent partial revisions.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dipotassium titanate(2-)

EC Number:

261-919-2

EC Name:

Dipotassium titanate(2-)

Cas Number:

59766-31-3

Molecular formula:

K2O17Ti8

IUPAC Name:

dipotassium titanate(2-)

Test material form:

solid: particulate/powder

Details on test material:

Appearance: White powder
Storage conditions: Room temperature

Test animals

Species:

rat

Strain:

other: CD (Crl:CD 'SD')

Sex:

female

Details on test animals or test system and environmental conditions:

- Source: Charles River (UK) Ltd.
- Age at study initiation: Young adult animals (approx. 8-12 weeks old)
- Weight at study initiation: 220 to 244 gram
- Fasting period before study: overnight prior to and approximately four hours after dosing
- Housing: Group housing of 3 animals per cage in labeled Macrolon cages
- Diet: Free access to pelleted rodent diet (Rat and Mouse No. 1 Maintenance Diet).
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 23
- Humidity (%): 40 - 70
- Air changes (per hr): Not indicated
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 14 June 2012 to 05 July 2012

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

GAVAGE METHOD: plastic feeding tubes.

Frequency: single dosage, on Day 1.

VEHICLE
- Justification for choice of vehicle: The vehicle (water) was selected based on trial formulations performed at Huntingdon Life Sciences and on test substance data supplied by the sponsor.

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg (10 mL/kg) body weight.

DOSAGE PREPARATION: Test substance was frmulated at a concentration of 200 mg/mL in de vehicle.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6 (2 groups of three females in a stepwise manner)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: At least twice daily
Body weights: Days 1 (prior to dosing), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and twice daily thereafter, until Day 15.
- Necropsy of survivors performed: All animals on day 15
- 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

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths during the study

Clinical signs:

There were no clinical signs of reaction to treatment throughout the study

Body weight:

All animals were considered to have achieved satisfactory bodyweight gains throughout the study.

Gross pathology:

No abnormalities were noted in any animal at the macroscopic examination.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

according to Regulation (EC) No 1272/2008

Conclusions:

In an acute oral toxicity study with rats, performed according to OECD 423 test guideline, an LD50 >2000 mg/kg bw was determined.

Executive summary:

An acute oral toxicity study in rats was performed according to the OECD 423 test guideline and in accordance with GLP principles. TISMO D, formulated in water, was administired by oral gavage to two subsequent groups of three female CD rats at 2000 mg/kg bw. There were no deaths and no clinical signs of reaction to treatement or effects on bodyweight gains throughout the study. The LD50 value of TISMO D was established to exceed 2000 mg/kg bw. Based on these results, according to Regulation (EC) 1272/2008, TISMO D does not have to be classified and has no obligatory labelling required for oral toxicity.