Titanium dioxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study, however basic data of test item (purity, stability) are missing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Titanium dioxide

EC Number:

236-675-5

EC Name:

Titanium dioxide

Cas Number:

13463-67-7

Molecular formula:

O2Ti

IUPAC Name:

dioxotitanium

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK)
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 227-243 g (males) and 200-214 g (females)
- Fasting period before study:
- Housing: The animals were housed in groups of up to 5 by sex in solid-floor polypropylene cages furnished with woodflakes.
- Diet: ad libitum; with the exception of an overnight fast immediately before dosing
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 50-56
- Air changes (per hr): 15
- Photoperiod: 12 hours dark/light cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

The volume administered to each animal was calculated according to its fasted body weight at the time of dosing.

Doses:

Based on the results of a range-finding study a group of animals was treated as follows:
Dose level: 2000 mg/kg
Concentration: 200 mg/ml
Dose volume: 10 ml/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded prior dosing on day 0 and on days 7 and 14. At the end of the study the animals were killed and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic carvities for examination of major organs. The appearance of any macroscopic abnormalities was recoded. No tissues were retained.

Statistics:

no data

Results and discussion

Preliminary study:

There were no daeths or clinical signs of toxicity. Based on this information, a dose level of 2000 mg/kg body weight was selected for the main study.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

There were no deaths

Clinical signs:

other: No signs of systemic toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

no

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information at the tested dose Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose of the test material was found to be greater than 2000 mg/kg body weight. No symbol and risk phrase are required according to EU labelling regulations.