Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non-GLP study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985
Reference Type:
other: TSCA 8e
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bismuth vanadium tetraoxide
EC Number:
237-898-0
EC Name:
Bismuth vanadium tetraoxide
Cas Number:
14059-33-7
Molecular formula:
Bi O4 V
IUPAC Name:
bismuth vanadium tetraoxide
Details on test material:
- Name of test material (as cited in study report): Sicopal-Gelb L-1110
- Physical state: solid
- Composition of test material, percentage of components: 57% BiVO4, 43% BiMoO6

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
head only
Vehicle:
other: Aerosil E 200
Details on inhalation exposure:
A head-nose inhalation system INA 20 with a volume of ca. 55 L was used during exposure. The substance was dispersed with Aerosil E 200 (5% m/m) to ensure better flowability and the dust-aerosol was generated with a Vibratomat. A variable oscillation amplitude and slit were used to obtain different concentrations. A volumetric flow of 1500 L/h was used during the four hour exposure of the animals. A 10% overpressure in the exposure chamber ensured that the substance-air mixture was not diluted by external air. Determination of the concentration was done gravimetrically. Particle size determination was carried out using an Andersen Stack Sampler Mark III.10 male and 10 female Wistar rats, ca. 8 weeks of age at the beginning of the study, were exposed to 5.15 mg/L of a dust-aerosol of the test substance.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5.42 +/- 0.093 mg/L
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.15 mg/L air (analytical)
Exp. duration:
4 h
Remarks on result:
other: No mortality occured
Mortality:
Mortality did not occur.
Clinical signs:
other: Clinical symptoms during exposure included an increased breathing rate. Following exposure, the animals exhibited accelerated or intermittent breathing and scrubby fur. These symptoms had disappeared by day six of exposure.
Body weight:
At the beginning of the study, a mean body weight of 263 g and 179 g of the male and female animals, respectively, was recorded. At the end of the study (day 14), the mean body weight of the male and female animals was 334 g and 208 g, respectively. There was no substance related effect on the body weight development of the animals.
Gross pathology:
Gross pathology revealed slightly yellow lungs in the sacrificed animals.

Any other information on results incl. tables

The mean analytical concentration was 5.42 mg/L ± 0.093 mg/L (single values: 5.50, 5.33, 5.49, 5.34 mg/L). After deduction of the Aerosol, the mean concentration was 5.15 mg/L.

Particle size determination yielded a mass median aerodynamic diameter 50% of 2.6 µm. The respirable fraction (particles ≤ 5.5 µm) was 88.5%.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the results of this study, the LC50 following four hour inhalation exposure to the test substance was > 5.15 mg/L for male and female Wistar rats.