potassium titanium oxide (K2Ti6O13)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 December 1989 to 31 January 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1987)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

432-240-0

EC Name:

-

Cas Number:

12056-51-8

Molecular formula:

K2Ti6O13

IUPAC Name:

Potassium hexatitanate

Details on test material:

- Name of test material (as cited in study report): Potassium titanate fibre
- Substance type: Light yellow / green, fine powder.
- Physical state: Solid
- Analytical purity: 100% (Ti 47.5, K 13.5 (wt%))
- Lot/batch No.: A249
- Storage condition of test material: Room temperature.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Slc:Wistar, Japan SLC Co., Ltd., Koto-cho, Hamamatsu-shi, Shizuoka, Japan.
- Age at study initiation: 6 weeks old.
- Weight at study initiation: 134 - 145 g for males, 109 - 112 g for females.
- Fasting period before study: Not reported.
- Housing: The animals were housed in groups of 5 in a hanging stainless cage (26 X 38 X 18 cm, Toyo Riko k.k.).
- Diet (e.g. ad libitum): MF (Oriental Yeast Industry k.k.), at libitum.
- Water (e.g. ad libitum): UV sterilised / filtred tap water, ad libitum.
- Acclimation period: 1 week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 2ºC.
- Humidity (%): 55 ± 10%.
- Air changes (per hr): 13 changes per hour.
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and 12 hours darkness.

IN-LIFE DATES: From: Day 0 To: Day 14.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Carboxymethyl Cellulose Sodium

Details on oral exposure:

VEHICLE
- Concentration in vehicle: (suspended in 0.5% Carboxymethyl Cellulose Sodium)
- Amount of vehicle (if gavage): 10 mg/kg

MAXIMUM DOSE VOLUME APPLIED: 2000 ml/kg (limited test).

Doses:

2000 mg/kg.

No. of animals per sex per dose:

5 animals per sex per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
(clinical signs and mortality) Immediately after and at 1, 3 and 6 hours after administration, and every 24 hours for 14 days.
(body weight gain) Day 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 14.

- Necropsy of survivors performed: yes. All animals were exsanguinated to death under ether anaesthesia after the 14-day observation period and postmortem pathological examinations were performed. Gross examination was performed for abnormal organs or tissues.

Statistics:

Not reported.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred in both sexes at the dose tested.
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No significant changes were observed. During the 14-day observation period, only mild soft stools were observed in one male rat from 50 minutes to 3 hours after the administration, and in one female rat at 3 hours post dose administration.

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study period.

Other findings:

Not reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It was concluded that the potassium titanate fibre has no toxic effects at the dose of 2000 mg/kg, and the minimum dose of potassium titanate fibre in rats was more than 2000 mg/kg. The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).

Executive summary:

To determine the acute toxicity of potassium titanate fiber, an oral dose limiting study in rats using 2000 mg/kg was conducted. The results were summarised as follows.

2000 mg/kg of the substance was dosed to 5 male and 5 female rats, being fasted from the previous night to 3 hours after the administration. No death has occurred in all male and female rats. In the observations of clinical signs, soft stools were found in one male rat from 50 minutes until 3 hours after the administration, and one female rat at 3 hours after the administration. No other significant changes were observed.

Both of all male and female rats gained body weight normally.

Any abnormal changes were not found at the postmortem pathological examinations following the 14-day observation period.

It was concluded that the minimum lethal dose of the substance was more then 2000 mg/kg.

The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).