Tris(pentane-2,4-dionato-O,O')vanadium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed data

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed data

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

no details given

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

The animals used were Sprague Dawley rats (Lippische Versuchstierzucht Hagemann GmbH. Extertal, Germany) weighing between 250g and 290g. Rats were provided with standard rat diet and water ad libitum. The diet was withdrawn approx. 16 hours before application. At the onset of the main experiment animals were randomly divided into group of 5.

Type of coverage:

occlusive

Vehicle:

other: 0.8% aqueous hydroxypropyl-methyl-cellulose gel

Details on dermal exposure:

The hair on the site of application was clipped with hair-clippers, without causing injury, approximately 24 hours before application.
The site was situated on the animal's back between the fore and hind extremitites and had an area of approx. 5 x 6 cm (=1/10 body surface).
The test substance was applied to 8 layers of gauze and then to the application site. The patch was covered with a plastic sheet and secured with adhesive plaster.

Duration of exposure:

24 hours

Doses:

2500 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: immediately, 5, 15, 30 and 60 min, as well as 3 h, 6 h and 24 h after administration; then twice daily for a period of 14 days
- Frequency of body weights: before administration, then weekly for a period of 14 days
- Necropsy of survivors performed: yes

Statistics:

The LD50 was calculated according to Finney D.J., Probit Analysis, 3rd Edition, Cambridge University Press, Cambridge, 1971

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Sex:

not specified

Dose descriptor:

other: no-effect level

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no signs of toxicity were observed

Mortality:

Mortality did not occur in treated animals.

Clinical signs:

other: No signs of toxicity were observed following dermal application.

Other findings:

No signs of toxicity were observed following dermal application.

Conclusions:

No mortality occurred at a tested level of 2500 mg/kg bw. The LD50 is considered to be more than 2500 mg/kg bw.

Executive summary:

In an acute dermal toxicity study (limit test similar to OECD Guideline 402), groups of Sprague-Dawley rats (5/group) were given a single dermal dose of vanadium pentoxide, at 2500 mg/kg bw and observed for 14 days. No mortality occurred in this test; therefore an exact LD50 has not been determined. The test article vanadium pentoxide, when administered dermally as received to 5 Sprague Dawley rats had an acute dermal LD50 of greater than 2.5 g/kg bw. No evidence of systemic toxicity was observed.

Cross-reference 2

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed data

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

not specified

GLP compliance:

not specified

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals used were Sprague Dawley rats (Lippische Versuchstierzucht Hagemann GmbH. Extertal, Germany) weighing between 250g and 290g. Rats were provided with standard rat diet and water ad libitum. The diet was withdrawn approx. 16 hours before application. At the onset of the main experiment animals were randomly divided into group of 5.

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

> 7.22 - < 13.26 µm

Remark on MMAD/GSD:

An analysis of the particle size distribution was carried out twice during the exposure period using a cascade impactor according to May (May K. R. (1975) J. Aerosol. Sei. 6: 413).
The dust from the exposure chamber was sucked through the cascade impactor for 1.5 to 5 min at a constant flow rate of 5 l/min. The slides covered with adhesive tape were removed from the impactor and were weighted on an analytical balance (precision 10 µg). The mass median aerodynamic diameter (MMAD) was estimated by means of nonlinear regression analysis (Litchfield and Wilcoxon, (1949) J. Pharmacol. 95: 99).

Details on inhalation exposure:

Analysis of the Dust Concentration:
The dust concentration in the inhalation chamber was measured with an air sample filter (Sartorius Minisart SM 17598). Dust samples were taken during the first half and during the second half of the exposure. For that purpose, Minisart SM 17598 filters were placed close to the animals' nose and sucked through with a constant flow of air of 300 l/h for 1 to 3 min. The filters were weighed before and after sampling. Concentration of the test substance in the air was calculated as mg/l.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Control animals:

not specified

Details on study design:

The study was carried out using a dynamic inhalation apparatus with a nose only exposure of the animals. The apparatus consists of a cylindrical exposure chamber (volume 40 l) which holds a maximum of 20 animals in pyrex tubes at the edge of the chamber in a radial position.
The dust was generated with a dust generator and dosing apparatus. The generator was fed with compressed air from a compressor. At the bottom of the exposure chamber the air was sucked off at a similar rate as created by the dust generator, in order to produce a homogeneous distribution in the exposure chamber. At least 12 air changes per hour were carried out. Air-flow meters were used to control the constant supply of compressed air and vacuum. Flow rates were checked at least once hour and corrected if necessary. Exposure time was 4 hours.

Statistics:

The LD50 was calculated according to Finney D.J., Probit Analysis, 3rd Edition, Cambridge University Press, Cambridge, 1971

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

2.61 mg/L air

Based on:

not specified

Key result

Sex:

female

Dose descriptor:

LC50

Effect level:

2.43 mg/L air

Based on:

not specified

Sex:

male

Dose descriptor:

other: No-effect level

Effect level:

0.72 mg/L air

Based on:

not specified

Sex:

female

Dose descriptor:

other: No-effect level

Effect level:

1.21 mg/L air

Based on:

not specified

Mortality:

Animals died up to 8 days after the inhalative exposure.

Other findings:

Histopathological examination of the lungs of the animals that received inhalative exposure revealed haemorrhage, vascular congestion and oedema in the lungs and bronchopneumonia.

Conclusions:

LC50 = 2.61 mg/L (male rats), 2.43 mg/L (female rats)

Executive summary:

Rats were exposed to dust of ammonium vanadate (NH₄VO₃, CAS 7803 -55 -6) for 4 hours (nose only). Animals died up to 8 days after the inhalative exposure. Histopathological examination of the lungs of the animals that received inhalative exposure revealed haemorrhage, vascular congestion and oedema in the lungs and bronchopneumonia. The LC50-values for V₂O₃(analytical grade, powder) is 6.65 mg/L in female rats. The LC50-values for the NH₄VO₃ test-substance following inhalative exposure were 2.61 mg/L for male and 2.43 mg/L for female rats.

Cross-reference 3

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed data

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

not specified

GLP compliance:

not specified

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals used were Sprague Dawley rats (Lippische Versuchstierzucht Hagemann GmbH. Extertal, Germany) weighing between 250g and 290g. Rats were provided with standard rat diet and water ad libitum. The diet was withdrawn approx. 16 hours before application. At the onset of the main experiment animals were randomly divided into group of 5.

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

> 15.14 - < 19.48 µm

Remark on MMAD/GSD:

An analysis of the particle size distribution was carried out twice during the exposure period using a cascade impactor according to May (May K. R. (1975) J. Aerosol. Sei. 6: 413).
The dust from the exposure chamber was sucked through the cascade impactor for 1.5 to 5 min at a constant flow rate of 5 l/min. The slides covered with adhesive tape were removed from the impactor and were weighted on an analytical balance (precision 10 µg). The mass median aerodynamic diameter (MMAD) was estimated by means of nonlinear regression analysis (Litchfield and Wilcoxon, (1949) J. Pharmacol. 95: 99).

Details on inhalation exposure:

Analysis of the Dust Concentration:
The dust concentration in the inhalation chamber was measured with an air sample filter (Sartorius Minisart SM 17598). Dust samples were taken during the first half and during the second half of the exposure. For that purpose, Minisart SM 17598 filters were placed close to the animals' nose and sucked through with a constant flow of air of 300 l/h for 1 to 3 min. The filters were weighed before and after sampling. Concentration of the test substance in the air was calculated as mg/l.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

Control animals:

not specified

Details on study design:

The study was carried out using a dynamic inhalation apparatus with a nose only exposure of the animals. The apparatus consists of a cylindrical exposure chamber (volume 40 l) which holds a maximum of 20 animals in pyrex tubes at the edge of the chamber in a radial position.
The dust was generated with a dust generator and dosing apparatus. The generator was fed with compressed air from a compressor. At the bottom of the exposure chamber the air was sucked off at a similar rate as created by the dust generator, in order to produce a homogeneous distribution in the exposure chamber. At least 12 air changes per hour were carried out. Air-flow meters were used to control the constant supply of compressed air and vacuum. Flow rates were checked at least once hour and corrected if necessary. Exposure time was 4 hours.

Statistics:

The LD50 was calculated according to Finney D.J., Probit Analysis, 3rd Edition, Cambridge University Press, Cambridge, 1971

Sex:

male

Dose descriptor:

LC50

Remarks on result:

not determinable

Key result

Sex:

female

Dose descriptor:

LC50

Effect level:

> 6.65 mg/L air

Based on:

not specified

Sex:

male

Dose descriptor:

other: No-effect level

Remarks on result:

not determinable

Sex:

female

Dose descriptor:

other: No-effect level

Effect level:

> 6.65 mg/L air

Based on:

not specified

Mortality:

Animals died up to 8 days after the inhalative exposure.

Other findings:

Histopathological examination of the lungs of the animals that received inhalative exposure revealed haemorrhage, vascular congestion and oedema in the lungs and bronchopneumonia.

Conclusions:

LC50 > 6.65 mg/l (female rats)

Executive summary:

Rats were exposed to dust of vanadium (III) oxide (V₂O₃,CAS 1314 -34 -7) for 4 hours (nose only). Animals died up to 8 days after the inhalative exposure. Histopathological examination of the lungs of the animals that received inhalative exposure revealed haemorrhage, vascular congestion and oedema in the lungs and bronchopneumonia. The LC50-values for V₂O₃ (analytical grade, powder) is > 6.65 mg/L in female rats.

Cross-reference 4

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed data

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

Oral Toxicity:
The test substance was suspended in 0.8 % aqueous hydroxypropyl-methyl-cellulose gel and administered by gavage. The volume of application was 20 ml/kg b.w.
Clinical Evaluation:
Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed immediately, 5, 15, 30 and 60 min, as well as 3 h, 6 h and 24 h after administration. Then twice daily for a period of 14 days. The time of death was recorded as precisely as possible. Individual body weights were recorded before administration of the substance, thereafter in weekly intervals up to the end of the study, and at death. At the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. Autopsy and macroscopic inspection of rats which died prematurely were carried out as soon as possible after exitus.

GLP compliance:

not specified

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals used were Sprague Dawley rats (Lippische Versuchstierzucht Hagemann GmbH. Extertal, Germany) weighing between 250g and 290g. Rats were provided with standard rat diet and water ad libitum. The diet was withdrawn approx. 16 hours before application. At the onset of the main experiment animals were randomly divided into group of 5.

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 20 ml/kg b.w.

Statistics:

The LD50 was calculated according to Finney D.J., Probit Analysis, 3rd Edition, Cambridge University Press, Cambridge, 1971

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

218 mg/kg bw

Based on:

not specified

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

141 mg/kg bw

Based on:

not specified

Sex:

male

Dose descriptor:

other: No-effect level

Effect level:

100 mg/kg bw

Based on:

not specified

Sex:

female

Dose descriptor:

other: No-effect level

Effect level:

46.4 mg/kg bw

Based on:

not specified

Mortality:

Animals died up to 8 days after the oral exposure.

Clinical signs:

other: Following oral administration reduced motility, ataxia, muscular hypotonia, dyspnoea, reduced body weight gain and death were observed as toxic signs.

Gross pathology:

Macrosopic inspection revealed haemorrhagic intestinal mucosa and a dark liver following oral exposure in the animals that died prematurely.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

LD50 = 218 mg/kg bw(male rats), 141 mg/kg bw (female rats)

Executive summary:

The acute oral toxicity of ammonium metavanadate (CAS 7803 -55 -6) was studies similar to OECD Guideline 401. Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed immediately, 5, 15, 30 and 60 min, as well as 3 h, 6 h and 24 h after administration. Then twice daily for a period of 14 days. The time of death was recorded as precisely as possible. Individual body weights were recorded before administration of the substance, thereafter in weekly intervals up to the end of the study, and at death. At the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. Autopsy and macroscopic inspection of rats which died prematurely were carried out as soon as possible after exitus. The LD50-values for the NH₄VO₃ test-substance (analytical grade, powder) following oral administration were 218 mg/kg bw for male and 141 mg/kg bw for female rats.

Cross-reference 5

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed data

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

not specified

GLP compliance:

not specified

Limit test:

no

Specific details on test material used for the study:

no details given

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals used were Sprague Dawley rats (Lippische Versuchstierzucht Hagemann GmbH. Extertal, Germany) weighing between 250g and 290g. Rats were provided with standard rat diet and water ad libitum. The diet was withdrawn approx. 16 hours before application. At the onset of the main experiment animals were randomly divided into group of 5.

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

> 2.01 - < 2.44 µm

Remark on MMAD/GSD:

An analysis of the particle size distribution was carried out twice during the exposure period using a cascade impactor according to May (May K. R. (1975) J. Aerosol. Sei. 6: 413).
The dust from the exposure chamber was sucked through the cascade impactor for 1.5 to 5 min at a constant flow rate of 5 l/min. The slides covered with adhesive tape were removed from the impactor and were weighted on an analytical balance (precision 10 µg). The mass median aerodynamic diameter (MMAD) was estimated by means of nonlinear regression analysis (Litchfield and Wilcoxon, (1949) J. Pharmacol. 95: 99).

Details on inhalation exposure:

Analysis of the Dust Concentration:
The dust concentration in the inhalation chamber was measured with an air sample filter (Sartorius Minisart SM 17598). Dust samples were taken during the first half and during the second half of the exposure. For that purpose, Minisart SM 17598 filters were placed close to the animals' nose and sucked through with a constant flow of air of 300 l/h for 1 to 3 min. The filters were weighed before and after sampling. Concentration of the test substance in the air was calculated as mg/l.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

4 h

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

The study was carried out using a dynamic inhalation apparatus with a nose only exposure of the animals. The apparatus consists of a cylindrical exposure chamber (volume 40 l) which holds a maximum of 20 animals in pyrex tubes at the edge of the chamber in a radial position.
The dust was generated with a dust generator and dosing apparatus. The generator was fed with compressed air from a compressor. At the bottom of the exposure chamber the air was sucked off at a similar rate as created by the dust generator, in order to produce a homogeneous distribution in the exposure chamber. At least 12 air changes per hour were carried out. Air-flow meters were used to control the constant supply of compressed air and vacuum. Flow rates were checked at least once hour and corrected if necessary. Exposure time was 4 hours.

Statistics:

The LD50 was calculated according to Finney D.J., Probit Analysis, 3rd Edition, Cambridge University Press, Cambridge, 1971

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

11.09 mg/L air

Based on:

not specified

Key result

Sex:

female

Dose descriptor:

LC50

Effect level:

4.3 mg/L air

Based on:

not specified

Sex:

male

Dose descriptor:

other: No-effect level

Effect level:

0.9 mg/L air

Based on:

not specified

Sex:

female

Dose descriptor:

other: No-effect level

Effect level:

2.42 mg/L air

Based on:

not specified

Mortality:

Animals died up to 8 days after the inhalative exposure.

Other findings:

Histopathological examination of the lungs of the animals that received inhalative exposure revealed haemorrhage, vascular congestion and oedema in the lungs and bronchopneumonia

Conclusions:

LC50 = 11.09 mg/l (male rats), 4.3 mg/l (female rats)

Executive summary:

Rats were exposed to dust of vanadium pentoxide (V₂O₅, CAS 1314 -62 -1) for 4 hours (nose only). Animals died up to 8 days after the inhalative exposure. Histopathological examination of the lungs of the animals that received inhalative exposure revealed haemorrhage, vascular congestion and oedema in the lungs and bronchopneumonia. The LC50-values for the V₂O₅ test-substance (analytical grade, powder) were 11.09 mg/L for male and 4.3 mg/L for female rats.

Cross-reference 6

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed data

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

Oral Toxicity:
The test substance was suspended in 0.8 % aqueous hydroxypropyl-methyl-cellulose gel and administered by gavage. The volume of application was 20 ml/kg b.w.
Clinical Evaluation:
Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed immediately, 5, 15, 30 and 60 min, as well as 3 h, 6 h and 24 h after administration. Then twice daily for a period of 14 days. The time of death was recorded as precisely as possible. Individual body weights were recorded before administration of the substance, thereafter in weekly intervals up to the end of the study, and at death. At the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. Autopsy and macroscopic inspection of rats which died prematurely were carried out as soon as possible after exitus.

GLP compliance:

not specified

Limit test:

no

Specific details on test material used for the study:

no details given

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals used were Sprague Dawley rats (Lippische Versuchstierzucht Hagemann GmbH. Extertal, Germany) weighing between 250g and 290g. Rats were provided with standard rat diet and water ad libitum. The diet was withdrawn approx. 16 hours before application. At the onset of the main experiment animals were randomly divided into group of 5.

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 ml/kg bw

Doses:

not specified

No. of animals per sex per dose:

not specified

Control animals:

not specified

Details on study design:

no details given

Statistics:

The LD50 was calculated according to Finney D.J., Probit Analysis, 3rd Edition, Cambridge University Press, Cambridge, 1971

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

8 713 mg/kg bw

Based on:

test mat.

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

5 639 mg/kg bw

Based on:

test mat.

Sex:

male

Dose descriptor:

other: No-effect level

Effect level:

4 640 mg/kg bw

Based on:

test mat.

Sex:

female

Dose descriptor:

other: No-effect level

Effect level:

4 640 mg/kg bw

Based on:

test mat.

Mortality:

Animals died up to 8 days after the oral exposure.

Clinical signs:

other: Following oral administration reduced motility, ataxia, muscular hypotonia, dyspnoea, reduced body weight gain and death were observed as toxic signs.

Gross pathology:

Macrosopic inspection revealed haemorrhagic intestinal mucosa and a dark liver following oral exposure in the animals that died prematurely.

Conclusions:

LD50 = 8713 mg/kg (male rats), 5639 mg/kg (female rats)

Executive summary:

The acute oral toxicity of vanadium (III) oxide (CAS 1314 -34 -7) was studies similar to OECD Guideline 401. Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed immediately, 5, 15, 30 and 60 min, as well as 3 h, 6 h and 24 h after administration. Then twice daily for a period of 14 days. The time of death was recorded as precisely as possible. Individual body weights were recorded before administration of the substance, thereafter in weekly intervals up to the end of the study, and at death. At the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. Autopsy and macroscopic inspection of rats which died prematurely were carried out as soon as possible after exitus.

The LD50-values for the V₂O₃ test-substance (analytical grade, powder) following oral administration were 8713 mg/kg for male and 5639 mg/kg for female rats.

Cross-reference 7

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed data

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

The animals used were Sprague Dawley rats (Lippische Versuchstierzucht Hagemann GmbH. Extertal, Germany) weighing between 250 g and 290 g. Rats were provided with standard rat diet and water ad libitum. The diet was withdrawn approx. 16 hours before application. At the onset of the main experiment animals were randomly divided into group of 5.

Type of coverage:

occlusive

Vehicle:

other: 0.8% aqueous hydroxypropyl-methyl-cellulose gel

Details on dermal exposure:

The hair on the site of application was clipped with hair-clippers, without causing injury, approximately 24 hours before application.
The site was situated on the animal's back between the fore and hind extremitites and had an area of approx. 5 x 6 cm (=1/10 body surface).
The test substance was applied to 8 layers of gauze and then to the application site. The patch was covered with a plastic sheet and secured with adhesive plaster.

Duration of exposure:

24 hours

Doses:

2500 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: immediately, 5, 15, 30 and 60 min, as well as 3 h, 6 h and 24 h after administration; then twice daily for a period of 14 days
- Frequency of body weights: before administration, then weekly for a period of 14 days
- Necropsy of survivors performed: yes

Statistics:

The LD50 was calculated according to Finney D.J., Probit Analysis, 3rd Edition, Cambridge University Press, Cambridge, 1971

Preliminary study:

not performed

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Sex:

not specified

Dose descriptor:

other: no-effect level

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no signs of toxicity were observed

Mortality:

Mortality did not occur in treated animals.

Clinical signs:

other: No signs of toxicity were observed following dermal application.

Gross pathology:

not performed

Other findings:

No signs of toxicity were observed following dermal application.

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality occurred at a tested level of 2500 mg/kg bw. The LD50 is considered to be more than 2500 mg/kg bw.

Executive summary:

In an acute dermal toxicity study (limit test similar to OECD Guideline 402), groups of Sprague-Dawley rats (5/group) were given a single dermal dose of ammonium metavanadate, at 2500 mg/kg bw and observed for 14 days. No mortality occurred in this test; therefore an exact LD50 has not been determined. The test article, when administered dermally as received to 5 Sprague Dawley rats had an acute dermal LD50 of greater than 2.5 g/kg bw. No evidence of systemic toxicity was observed.

Cross-reference 8

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: peer-reviewed data

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

no details given

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

The animals used were Sprague Dawley rats (Lippische Versuchstierzucht Hagemann GmbH. Extertal, Germany) weighing between 250 g and 290 g. Rats were provided with standard rat diet and water ad libitum. The diet was withdrawn approx. 16 hours before application. At the onset of the main experiment animals were randomly divided into group of 5.

Type of coverage:

occlusive

Vehicle:

other: 0.8% aqueous hydroxypropyl-methyl-cellulose gel

Details on dermal exposure:

The hair on the site of application was clipped with hair-clippers, without causing injury, approximately 24 hours before application.
The site was situated on the animal's back between the fore and hind extremities and had an area of approx. 5 x 6 cm (=1/10 body surface).
The test substance was applied to 8 layers of gauze and then to the application site. The patch was covered with a plastic sheet and secured with adhesive plaster.

Duration of exposure:

24 hours

Doses:

2500 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: immediately, 5, 15, 30 and 60 min, as well as 3 h, 6 h and 24 h after administration; then twice daily for a period of 14 days
- Frequency of body weights: before administration, then weekly for a period of 14 days
- Necropsy of survivors performed: yes

Statistics:

The LD50 was calculated according to Finney D.J., Probit Analysis, 3rd Edition, Cambridge University Press, Cambridge, 1971

Preliminary study:

not performed

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Sex:

not specified

Dose descriptor:

other: no-effect level

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no signs of toxicity were observed

Mortality:

Mortality did not occur in treated animals.

Clinical signs:

other: No signs of toxicity were observed following dermal application.

Gross pathology:

not performed

Other findings:

No signs of toxicity were observed following dermal application.

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality occurred at a tested level of 2500 mg/kg bw. The LD50 is considered to be > 2500 mg/kg bw.

Executive summary:

In an acute dermal toxicity study (limit test similar to OECD Guideline 402), groups of Sprague-Dawley rats (5/group) were given a single dermal dose of vanadium pentoxide, at 2500 mg/kg bw and observed for 14 days. No mortality occurred in this test; therefore an exact LD50 has not been determined. The test article vanadium pentoxide, when administered dermally as received to 5 Sprague Dawley rats had an acute dermal LD50 of greater than 2.5 g/kg bw. No evidence of systemic toxicity was observed.

Data source

Reference

Reference 1

Reference Type:

review article or handbook

Title:

Vanadium and its inorganic compounds (inhalable fraction)

Year:

2009

Bibliographic source:

The MAK-Collection Part I: MAK Value Documentations, Vol. 25. DFG, Deutsche Forschungsgemeinschaft

Reference 2

Reference Type:

publication

Title:

New Investigations on Acute Toxicities of Vanadium Oxides

Author:

J. Leuschner et al.

Year:

1994

Bibliographic source:

Monatshefte für Chemie 125. 623-646

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

Oral Toxicity:
The test substance was suspended in 0.8 % aqueous hydroxypropyl-methyl-cellulose gel and administered by gavage. The volume of application was 20 ml/kg b.w.
Clinical Evaluation:
Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed immediately, 5, 15, 30 and 60 min, as well as 3 h, 6 h and 24 h after administration. Then twice daily for a period of 14 days. The time of death was recorded as precisely as possible. Individual body weights were recorded before administration of the substance, thereafter in weekly intervals up to the end of the study, and at death. At the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. Autopsy and macroscopic inspection of rats which died prematurely were carried out as soon as possible after exitus.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Divanadium pentaoxide

EC Number:

215-239-8

EC Name:

Divanadium pentaoxide

Cas Number:

1314-62-1

Molecular formula:

O5V2

IUPAC Name:

dioxovanadiooxy(dioxo)vanadium

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

no details given

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The animals used were Sprague Dawley rats (Lippische Versuchstierzucht Hagemann GmbH. Extertal, Germany) weighing between 250g and 290g. Rats were provided with standard rat diet and water ad libitum. The diet was withdrawn approx. 16 hours before application. At the onset of the main experiment animals were randomly divided into group of 5.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

methylcellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 ml/kg bw

Doses:

not specified

No. of animals per sex per dose:

not specified

Control animals:

not specified

Details on study design:

no details given

Statistics:

The LD50 was calculated according to Finney D.J., Probit Analysis, 3rd Edition, Cambridge University Press, Cambridge, 1971

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

470 mg/kg bw

Based on:

not specified

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

467 mg/kg bw

Based on:

not specified

Effect levels 3

Sex:

male

Dose descriptor:

other: No-effect level

Effect level:

215 mg/kg bw

Based on:

not specified

Effect levels 4

Sex:

female

Dose descriptor:

other: No-effect level

Effect level:

215 mg/kg bw

Based on:

not specified

Mortality:

Animals died up to 8 days after the oral exposure.

Clinical signs:

other: Following oral administration reduced motility, ataxia, muscular hypotonia, dyspnoea, reduced body weight gain and death were observed as toxic signs.

Gross pathology:

Macrosopic inspection revealed haemorrhagic intestinal mucosa and a dark liver following oral exposure in the animals that died prematurely.

Applicant's summary and conclusion

Conclusions:

LD50 = 470 mg/kg (male rats), 467 mg/kg (female rats)

Executive summary:

The acute oral toxicity of vanadium pentoxide (CAS 1314 -62 -1) was studies similar to OECD Guideline 401. Following administration, observations were made and recorded systematically with individual records being maintained for each animal. Observations were performed immediately, 5, 15, 30 and 60 min, as well as 3 h, 6 h and 24 h after administration. Then twice daily for a period of 14 days. The time of death was recorded as precisely as possible. Individual body weights were recorded before administration of the substance, thereafter in weekly intervals up to the end of the study, and at death. At the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. Autopsy and macroscopic inspection of rats which died prematurely were carried out as soon as possible after exitus.The LD50-values for the V₂O₅ test-substance (analytical grade, powder) following oral administration were 470 mg/kg for male and 467 mg/kg for female rats.