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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No information on test method (although it appears to be similar to OECD TG 403), experimental study published in the peer review literature. Limitations in design and /or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
The full materials and methods are not provided so we assumed that deviations occurred either in implementation and or reporting.
Principles of method if other than guideline:
Groups of five animals were randomly divided into each dose. The animals were exposed for 4 hours and were monitored for 14 days twice daily.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): V2O5 Technical grade, powder
- The material was provided by Gesellschaft fur Elecktrometallurgie GmbH (Nurnberg, Germany)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH, Exterttal, Germany)
- Age at study initiation: No data
- Weight at study initiation: 250 g to 290 g
- Fasting period before study: 16 hours
- Housing: No data
- Diet (e.g. ad libitum): standard rat diet ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- None provided

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Dynamic inhalation apparatus with nose only exposure of the animals and the apparatus consisted of a cylindrical exposure chamber which holds a maximum of 20 animals in pyrex tubes at the edge of the chamber in a radial position.
- Exposure chamber volume: 40 litres
- Source and rate of air: Compressed air from a compressor
- Method of conditioning air:
- System of generating particulates/aerosols: A dust generator and dosing apparatus was used. The generator used compressed air from a compressor and air was sucked from the bottom of the chamber at a similar rate as the generator. Air flow meters were used to control the supply of air and vacuum. Flow rates were checked at least once an hour and corrected if necessary.
- Method of particle size determination: Particle size distribution analysis was carried out twice during the exposure period using a cascade impactor. Dust from the exposure chamber was sucked for 1.5 to 5 minutes at a rate of 5 L/min through the cascade impactor. The slides were covered with adhesive tape, removed from the impactor, weighed and the mass median aerodynamic diameter estimated using the Litchfield and Wilcoxon non-linear regression analysis.
- Treatment of exhaust air: No data
- Temperature, humidity, pressure in air chamber: No data

TEST ATMOSPHERE
- Dust concentration was measured with an air sample filter (Sartorius Minsart SM 17598)
- Samples were taken twice (first half and secon half exposure)
- Filters were placed close to the animals' nose and sucked through with a constant flow of air of 100 L/hour for 1 to 3 minutes.
- The filters were weighed before and after sampling and the concentration of the substance calculated in mg/L

VEHICLE
- Compressed air



Analytical verification of test atmosphere concentrations:
yes
Remarks:
Dust was collected from the chambers and anlysed.
Duration of exposure:
4 h
No. of animals per sex per dose:
5 rats per sex and dose
Control animals:
other: There isno data provided
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: immediately, 5 min, 15 min, 30 min, 60 min, 3h, 6h, and 24h after administration. Then twice daily for a period of 14 days.
- Necropsy of survivors performed: yes- All gross pathological changes were recorded and macroscopic inspection.
- No other information is provided in the publication.
Statistics:
The mass median aerodynamic diameter estimated using the Litchfield and Wilcoxon non-linear regression analysis.
The LD50 was calculated according to Finney.

Results and discussion

Preliminary study:
No data
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LC50
Effect level:
4.4 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: The 95% CL were not provided in the publication.
Sex:
male
Dose descriptor:
other: NOEC
Effect level:
1.62 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: The 95% CL were not provided in the publication.
Sex:
female
Dose descriptor:
LC50
Effect level:
2.2 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: The 95% CL were not provided in the publication.
Sex:
female
Dose descriptor:
other: NOEC
Effect level:
1.11 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: The 95% CL were not provided in the publication.
Mortality:
According to the paper animals died up to 8 days after inhalation exposures. However, no live/dead ratios were provided.
Clinical signs:
other: There were no clinical signs reported although in the materials and method of the paper it clearly states the scheduled clinical evaluations.
Body weight:
The paper indicates that body weights were recorded before the administration of the substance and at weekly intervals up to the end of the study. However this information is not presented.
Gross pathology:
Histopathological examination of the lungs revealed haemorrhage, vascular congestion and oedema in the lungs and bronchopneumonia. The paper identifies a “no-effect level” of 1.11 and 1.62 mg/l for females and males respectively, so presumably these lung effects were seen at higher concentrations only.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results of the inhalation toxicity study with V2O5 indicate that according to the Classification, Labelling and Packaging Regulations (EC 1272/2008) V2O5 would be classified as 'harmful' via the inhalation route.