Blend of Magneli suboxides of titanium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-02-21 to 1995-03-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 92/69/EEC, B1-bis

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

416-390-4

EC Name:

-

IUPAC Name:

Blend of Magneli suboxides of titanium

Details on test material:

Ebonex Powder, Batch Composite 01, Composition: 2% Ti3O5, 49% Ti4O7, 36% Ti5O9, 5% Ti6O11, 7% Ti7O13, 1% Ti8O15. The Ebonex Powder used in this experiment differed from the Substance listed in Section 1 in that it contained less Ti4O7 and Ti6O11 and more Ti5O9. It also contained small proportions of Ti3O5, Ti7O13 and Ti8O15. However, the Ebonex Powder used for this study was still a blend of Magneli suboxides of titanium, primarily based upon the same three titanium oxides, Ti4O7, Ti5O9 and Ti6O11 as in the current Ebonex Powder listed in Section 1. As such the results from the Ebonex Powder used in this experiment are considered to be applicable for the current Ebonex Powder as listed in Section 1.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

A group of 10 rats (5 males/5 females) in the weight range 91-107g prior to dosing were housed in cages of 5 rats (same sex) per cage. Standard laboratory rodent diet (Biosure LAD1) and drinking water were available ad libitum. The animals were fasted overnight and for 4 hours after dosing. Room temperature was 22+/- 3C with 12 hours artificial light.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Ebonex Powder was prepared at a concentration of 20% w/v in distilled water and administered at a volume of 10 ml/kg bodyweight.

Details on oral exposure:

Single oral dose

Doses:

Preliminary dose 0.5 g/kg bodyweight.
Main study 2.0 g/kg bodyweight

No. of animals per sex per dose:

Preliminary sighting study: 0 (male)
Preliminary sighting study: 1 (female)
Main study: 5 (male)
Main study: 5 (female)

Control animals:

no

Details on study design:

Preliminary sighting study:
One female rat was dosed at 500 mg/kg bodyweight.

Main study:
A group of ten rats (five males and five females) were
treated at 2000 mg/kg bodyweight.
All animals were killed on Day 15 by cervical dislocation prior to macroscopic examination

Results and discussion

Preliminary study:

Species/strain: Rat (Sprague-Dawley (CD))
500 mg/kg bw: Evident toxicity: N; Mortality: N
mg/kg bw: Evident toxicity: ; Mortality:

Observations:
None

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Dose descriptor:

other: 2000 mg/kg bw (fixed dose initial)

Remarks on result:

other: No. with evident toxicity: 5; No. of deaths: 0; No. of animals used: 5

Mortality:

None

Clinical signs:

Signs of toxicity:
Clinical signs of reaction to treatment were confined to piloerection and abnormal body carriage in all rats within five minutes of dosing. These signs persisted and were accompanied at later intervals on Day 1 by pallor of the extremities in all rats. Recovery of rats, as judged by external appearance and behaviour, was complete by Day 3 (males) and Day 4 (females).

Body weight:

A slightly low bodyweight gain was recorded for one male rat on both Day 8 and Day 15. All other animals achieved satisfactory bodyweight gains throughout the study.

Gross pathology:

Effects on organs:
No macroscopic abnormalities were observed for animals killed on Day 15.

Other findings:

A slightly low bodyweight gain was recorded for one male on both Day 8 and Day 15. All other animals achieved satisfactory bodyweight gains throughout the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information

Conclusions:

The discriminating dosage of the test substance when administered orally to rats was established to be greater than 2.0 g/kg bodyweight.

Executive summary:

A group of ten fasted rats (5 male/5 female) was given a single dose by oral gavage of the test substance formulated in distilled water, at a dose of 2.0 g/kg bodyweight. All animals were killed on Day 15 by cervical dislocation prior to macroscopic examination. There were no deaths. Clinical signs of reaction to treatment were confined to piloerection and abnormal body carriage in all rats within five minutes of dosing seen in all rats. Recovery of rats was complete by Day 3 (males) and Day 4 (females). A slightly low bodyweight gain was recorded for one male on both Day 8 and Day 15. All other animals achieved satisfactory bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The discriminating dosage of the test substance when administered orally to rats was established to be greater than 2.0 g/kg bodyweight.