Potassium titanium oxide (K1.88-2.13Ti8O16.94-17.07)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP in accordance with an internationally recognised test guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Ministry of Agriculture, Forestry, and Fisheries (MAFF) (1985). 59 NohSan Number 4200, Acute Inhalation Toxicity Study. Testing Guidelines for Toxicity Studies

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Terracess TF

IUPAC Name:

Terracess TF

Details on test material:

- Name of test material (as cited in study report): Terracess TF-S
- Appearance: white powder
- Purity: 99.6%
- Lot/batch No.: 4D90
- Mass median aerodynamic diameter (for liq.+solid aerosol): 3.0 um

Test animals

Species:

rat

Strain:

other: Crl:CD®(SD)IGS BR

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: Substance as such

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.2 mg/l

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.2 mg/L air

Exp. duration:

4 h

Mortality:

Male: 5.2 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.2 mg/L; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Clinical signs of toxicity during exposure could not be visibly assessed due to the density of the test atmosphere and the fact that the rats were in nose-only restrainers. However, the normal response to an alerting response stimulus was determined duri

Body weight:

Female rats showed mainly slight (<9 g per day) to moderate (10 to 18 g per day) body weight losses over one to 3 days after exposure; male rats showed slight (<10 g per day) weight effects one day after exposure. These weight effects were followed by an essentially normal weight gain rate for the remainder of the recovery period in both sexes.

Gross pathology:

No gross lesions were present in the rats at necropsy.

Other findings:

One female rat had wet fur and a partially closed eye immediately after exposure; another female rat showed forelimb alopecia at the end of the recovery period.

Any other information on results incl. tables

The mean concentration of Terracess TF-S dust during the animal exposure was 5.2 ± 1.2 mg/L (mean ± S.D.). The mass median aerodynamic equivalent diameter, determined by cascade impactor measurement, was 3.0 μm with a geometric standard deviation of 1.6. The tested aerosol atmosphere was considered to be respirable in rats.

The chamber temperature during the animal exposure was 22 to 23°C, the relative humidity was 56 to 57%, the oxygen concentration was 20.9% and the airflow into the chamber was 24 L/min. These chamber environmental conditions were considered adequate for the conduct of the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC50) for Terracess TF-S in male and female rats was greater than 5.2 mg/L.