Disodium hexatitanate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 October 2011 - 22 November 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau, November 24, 2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Disodium hexatitanate

EC Number:

815-182-4

Cas Number:

12058-75-2

Molecular formula:

Na2Ti6O13

IUPAC Name:

Disodium hexatitanate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

- Analytical purity: 100%
- Purity test date: 11 August 2011
- Lot/batch No.: IC96
- Expiration date of the lot/batch: 24 March 2014
- Storage: room temperature

Test animals

Species:

rat

Strain:

other: Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 209-235 g
- Housing: housed in groups of 3 rats of the same sex, in solid bottomed polycarbonate cages with a stainless steel mesh lid
- Diet (e.g. ad libitum): free access to a standard rodent diet (Rat and Mouse No.1 Maintenance Diet), except the overnight prior to and approximately 4 hours after dosing. The diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
- Water (e.g. ad libitum): freely available via polycarbonate bottles fitted with sipper tubes
- Acclimation period: at least 5 days before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -23 °C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

DOSAGE PREPARATION: formulations were stirred before and after the dosing procedure.
- formulations were prepared on the day of dosing.

Doses:

The test substance was formulated at a concentration of 200 mg/ml in the vehicle and administered at a volume of 10 mL/kg bodyweight

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed soon after dosing and at frequent intervals for the remainder of Day1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

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:

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

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute median lethal oral dose (LD50) to rats of test substance was demonstrated to be greater than 2000 mg/kg bodyweight.