Dialuminium titanium pentaoxide

Endpoint summary

Description of key information

A study is available for the read-across substance aluminium magnesium titanium oxide

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1st August - 15th August 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Reason / purpose for cross-reference:

reference to same study

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

Limit test:

no

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.

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

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.

No additional results or findings reported.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

A good quality, guideline-compliant study is available for this endpoint.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

No study is available.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

No study is available.

Additional information

A study is available for the read-across substance aluminium magnesium titanium oxide. The read-across substance and the registered substance are comparable insoluble ceramic substances. The read-across substance additionally contains magnesium which is not predicted to confer significant acute oral toxicity. Acute oral toxicity is dependent on systemic exposure to the substance. Given the fact that the registered substance is an insoluble ceramic, its acute oral toxicity can be reliably predicted to be very low, as clearly shown for the read-across substance. Additionally the component ions of the substance (i.e. Al, Ti) are not associated with marked acute toxicity.

Justification for selection of acute toxicity – oral endpoint
Only one study is available for this endpoint.

Justification for selection of acute toxicity – inhalation endpoint
No study is available; a waiver is proposed for this endpoint based on the absence of acute oral toxicity and the absence of dermal absorption.

Justification for selection of acute toxicity – dermal endpoint
No study is available; a waiver is proposed for this endpoint based on the absence of exposure.

Justification for classification or non-classification

A study available for the read-across substance aluminium magnesium titanium oxide does not trigger classification for acute oral toxicity according to the criteria of the DSD or the CLP Regulation.