Reaction Mass of Dialuminium Titanium Pentoxide and Strontium Calcium Aluminosilicate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Remarks:

Sako, 2007

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1st August - 15th August 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other:

Remarks:

English translation of good quality study for a read-across substance; reported in Japanese; no indication of GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

not specified

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Dialuminium titanium pentaoxide

EC Number:

234-456-9

EC Name:

Dialuminium titanium pentaoxide

Cas Number:

12004-39-6

Molecular formula:

Al2O5Ti

IUPAC Name:

Dialuminum titanium pentaoxide

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Aluminium titanium oxide.
- Molecular formula (if other than submission substance): Al2TiO5
- Molecular weight (if other than submission substance): 181.83
- Physical state: White powder

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc.
- Age at study initiation: 7 weeks
- Weight at study initiation: 161 - 178 g
- Fasting period before study: Animals were fasted for 20 hours before administration.
- Housing: Animals were housed in a suspended aluminium cage, with 2 or 3 animals per cage.
- Diet (e.g. ad libitum): Allowed ad libitum access to a pellet diet (CRF-1, Oriental Yeast Co., Ltd.) except during fasting periods.
- Water (e.g. ad libitum): Ad libitum access to filtered tap water from Osaka city.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 26°C
- Humidity (%): 40 - 70%
- Air changes (per hr): More than 10 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.

IN-LIFE DATES: From: August 1st 2007 To: August 15th, 2007.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Methylcellulose solution

Details on oral exposure:

The test animals were administered a dose of 2000 mg/kg bw test substance. They were administered a volume of 10 mL/kg bw in 0.5% methyl cellulose solution.

Doses:

2000 mg/kg bw.

No. of animals per sex per dose:

5 female animals per group.

Control animals:

not specified

Details on study design:

The test animals were observed for 14 days after treatment. Clinical signs were recorded at 10 and 30 minutes and 1, 2 and 4 hours after administration and once daily for 14 days. Body weights were recorded on the day of administration and on Days 7 and 14. Necropsy was performed at the end of the 14-day observation period.

Statistics:

Not required for evaluation of results

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality at the Limit Dose

Mortality:

There were no mortalities observed at the dose tested.

Clinical signs:

other: No abnormal clinical signs were observed in the animals tested at 2000 mg/kg bw throughout the observation period.

Gross pathology:

No abnormal findings were observed in the animals at 2000 mg/kg bw.

Other findings:

No other abnormal results reported.

Any other information on results incl. tables

No additional results or findings reported.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

Under the conditions of the study, the acute oral LD50 in the rat was found to be greater than 2000 mg/kg bw.

Executive summary:

This study was conducted to determine the acute oral toxicity of aluminium magnesiun titanium oxide when adminstered by gavage to Crl:CD(SD) female rats at the limit dose level of 2000 mg/kg bw. The rats were observed for 14 days following administration. No mortalities were observed; no abnormal clinical findings were reported and body weights did not show any treatment-related effects. Gross pathology performed at the end of the 14-day observation period did not show abnormal findings in the organs examined. Based on these results under the conditions of this study, the acute oral LD50 was found to exceed 2000 mg/kg bw.