Slags, ilmenite electrothermal smelting

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-02-11 to 2008-02-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: conducted according to guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Slags, ilmenite electrothermal smelting

EC Number:

293-671-6

EC Name:

Slags, ilmenite electrothermal smelting

Cas Number:

91081-64-0

Molecular formula:

M3O5

IUPAC Name:

Slags, ilmenite electrothermal smelting

Details on test material:

- Name of test material (as cited in study report): Titanium Slag "Exxaro Sulphate Slag“
- Substance type: technical product
- Physical state: solid, black brown granular
- Composition of test material, percentage of components: 100 % UGI
- Purity test date: 14 December 2006
- Lot/batch No.: MKT_SUL_061207_0000
- Receipt No.: 38606
- Expiration date of the lot/batch: December 2026
- Storage condition of test material: at room temperature
No further details are given.

Test animals

Species:

rat

Strain:

other: CD

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH
- Age at study initiation: 59 - 60 days
- Weight at study initiation: 181 - 191 g
- Fasting period before study: Feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum.
- Housing: During the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages (type III) with granulated wood bedding.
- Diet: Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, Germany) served as food.
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Photoperiod: 12 hours dark/light cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.8% aqueous hydroxypropylmethylcellulose

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg b.w.

CLASS METHOD
- Rationale for the selection of the starting dose: The dose used is selected from a series of defined dose levels. Due to the small number of animals used with this method, there is no need to perform a range finding test.

No further details are given.

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

6

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 minutes, as well as 3, 6 and 24 hours after administration.
- Necropsy of survivors performed: yes; At the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. No histopathology was carried out as no macroscopical findings were noted at autopsy.
- Other examinations performed: During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity, as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Observations on mortality were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.

Statistics:

no data

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.
See attached table.

Clinical signs:

No clinical signs occurred.
See attached table.

Body weight:

All animals gained the expected body weight.
See attached table.

Gross pathology:

No pathological changes were observed at necropsy.
See attached table.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

other: requires no classification

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the present test conditions, a single oral administration of 2000 mg Titanium Slag "Exxaro Sulphate Slag"/kg b.w. to rats did not reveal any signs of toxicity.