Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Divanadium trioxide is not acutely toxic via the oral, dermal, or inhalation route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-08-19 to 1991-09-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study with acceptabel restrictions Minor deviations: - According to the guideline, the volume of an aqueous solution administered to rodents should not exceed 2 ml/100g. In this study an aqueous solution of 50 ml/kg b.w. was administered to the rats. - According to the guideline, the individual weights should be determined before the application of the test substance , which was done in this study. The individual weights were not provided in the report but only the average weight of the males and females per dose. - According to the guideline, the relative humidity should be between 30 - 70 %. In this study the relative humidity was slightly higher (60 +/- 20 %). - According to the guideline, a stomach tube or a suitable intubation cannula should be used when the test substance is administered by gavage. The study report does not stated what was used in order to administered the test substance by gavage. -According to the guideline, after the substance has been administered, food may be withheld for a further 3 -4 hours. In the study report it was not stated if food was withheld after the administration of the test substance. According to the guideline, the 95 per cent confidence interval for the LD50 should be included in the test report. In this test report the 95 per cent confidence interval was not stated.
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 24 February 1987
Deviations:
yes
Remarks:
see rational for reliability
GLP compliance:
yes (incl. QA statement)
Remarks:
The study states that the study was performed according to eg. "Good Laboratory Practice" Regulations of the EEC enacted in Germany in the "Chemikaliengesetz" dated March 14th, 1990, BGBL.I, pp. 521, 1990.
Test type:
standard acute method
Limit test:
no
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 D-4923 Extertal 1
- Age at study initiation: approx. 40 - 60 days
- Weight at study initiation: 161 g - 200 g
- Fasting period before study: approx. 16 hours
- Housing: Animals were kept in groups of two or three in MAKROLON cages (type III). Granulated textured wood was used as bedding material (Granulat Typ A2, supplier: Messrs. BRANDENBURG, Inh. H.Brandenburg, D-2849 Goldenstedt).
- Diet: Standardized diet for rats ALTROMIN 1324 (supplied by: ALTROMIN GmbH, D-4937 Lage/Lippe)
- Water (ad libitum): tap water
- Quarantine period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C +/- 3 °C (maximum range)
- Relative humidity: 60 % +/- 20 % (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
No further significant information on test animals was stated.
Route of administration:
oral: gavage
Vehicle:
other: hydroxypropyl-methylcellulose gel
Details on oral exposure:
VEHICLE
V2O3 technical grade pulverised was suspended in 0.8 % aqueous hydroxypropyl-methylcellulose gel (Methocel E 4 M).
Batch No.(Vehicle): MM 84097413
MAXIMUM DOSE VOLUME APPLIED: The volume of application was 50 ml/kg b.w. for all groups. (The dose interval factors were 1.21 and 1.47,)
No further significant information on details on oral exposure was stated.
Doses:
4640, 6810, 10000 and 14700 mg V2O3 technical grade pulverised/kg b.w.; 5620 mg/kg b.w. (only 5 females)
No. of animals per sex per dose:
5 males / 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed immediately, 5, 15, 30 and 60 min, as well as 3 h, 6 h and 24 h after administration. During the follow-up period, changes of skin and fur, eyes and mucous membranes, respiratory and circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, and thereafter each working day. Observations on mortality were made at least once daily with appropriate actions taken to minimize loss of animals during the study. Individual body weights were recorded before administration of the substance, thereafter in weekly intervals up to the end of the study, and at death.
- Necropsy of survivors performed: Yes, at the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. From animals which survived 24 hours or longer a microscopic examination of all organs which show evident lesions is performed. Autopsy and macroscopic inspection of rats which died prematurely were carried out as soon as possible after exitus.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Attention was also paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Changes in weight were calculated and recorded when survival exceeds one day.
No further significant information on details on study design was stated.
Statistics:
The LD50 was calculated by regression analysis.
Sex:
male
Dose descriptor:
LD50
Effect level:
8 713.1 mg/kg bw
Remarks on result:
other: Slope: 17.95; No estimation of the confidence limits possible, due to low number of animals employed and the steepness of the mortality curve.
Sex:
female
Dose descriptor:
LD50
Effect level:
5 639 mg/kg bw
Remarks on result:
other: Slope: 59.92; No estimation of the confidence limits possible, due to the low number of animals employed and the steepness of the mortality curve.
Mortality:
Lowest lethal dose: 5620 mg/kg b.w. p.o. for females and 6810 mg/kg b.w. p.o. for males. Animals died between 4 hours and 48 hours, where observed in abdominal position and comatose condition. Animals died between 4 hours and 48 hours.
Dose level and number of dead animals:
4640 mg/kg b.w. p.o.: 0/5 males; 0/5 females
5620 mg/kg b.w. p.o. (only females): 2/5 females
6810 mg/kg b.w. p.o.: 1/5 males; 5/5 females
10000 mg/kg b.w. p.o.: 1/5 males; 5/5 females
14700 mg/kg b.w. p.o.: 5/5 males; 5/5 females
Clinical signs:
other: Animals showed symptoms between 60 minutes and day 2. 5620 mg/kg b.w. p.o. (only females): slightly reduced motility (5/5 females), slight ataxia (5/5 females) and slight dysnoea (5/5 females) 6810 mg/kg b.w. p.o.: slightly reduced motility (5/5 males; 5/
Gross pathology:
Autopsy of deceased animals:
6810 mg/kg b.w. p.o: stomach distended (1/1 male; 2/5 females); stomach and intestine distended (3/5 females)
10000 mg/kg b.w. p.o.: stomach and intestine distended ( 1/1 male, 4/5 females); liver pale (1/1 male; 1/5 females); intestinal wall reddened (1/5 females)
Autopsy of survivng animals: no pathological findings
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the EEC-Commission directive of July 29th, 1983 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (83/467/EEC) and the results obtained under the present test conditions the test substance can be classified as relatively non-toxic (not classified) (LD50: > 2000 mg/kg b.w. p.o.) in the acute oral toxicity study in the rat.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 639 mg/kg bw
Quality of whole database:
The GLP study is reliable with acceptabel restrictions.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-10-01 to 1991-11-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study without restrictions Minor deviations: - One concentration besides the limit dose was measured. -According to the guideline, the weight variation in animals or between groups used in a test should not exceed +/- 20 per cent of the mean weight. In the males there was a slightly larger weight variation. - According to the guideline, the relative humidity in the animal room should be between 30 - 70 % . In this study the relative humidity was slightly higher (60 +/- 20 %). -According to the guideline, animals should be tested with inhalation equipment designed to sustain a dynamic air flow of 12 to 15 air changes per hour. In this study in the high concentration group the air flow was 19.5 changes per hour. - According to the guideline, the duration of exposure should be at least 4 hours after equilibration of the chamber concentration. It was not stated if the 4 hours started after equilibration of the chamber concentration. - According to the guideline, body weight changes should be calculated and recorded when survival exceeds one days. This is missing in this study. -The GSD for the MMAD is missing.
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes (incl. QA statement)
Remarks:
The study report stated that the study was performed according to "Good Laboratory Practice" Regulations of the EEC enacted in Germany in the "Chemikaliengesetz" dated March 14th, 1990, BGBL I, pp. 521, 1990.
Test type:
standard acute method
Limit test:
yes
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, D-4923 Extertal 1
- Age at study initiation: 49 - 61 days
- Weight at study initiation: 197 - 270 g (males); 180 - 219 g (females)
- Fasting period before study: approx. 16 hours
- Housing: Animales were kept in groups of two or three in Makrolon cages (type III). Granulated textured wood (type 2, supplied by Johannes Brandenburg, D-4937 Goldenstedt) was used as bedding material.
- Diet (ad libitum): Standardized diet for rats ALTROMIN 1324 (supplied by: ALTROMIN GmbH, D- 4937 Lage/Lippe)
- Water (ad libitum): tap water
- Quarantine period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C +/- 3 °C (maximum range)
- Relative humidity: 60 % +/- 20 % (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
No further significant information on test animals was stated.
Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
other: air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus & Exposure chamber volume: The study was carried out using a dynamic inhalation apparatus with a nose only exposure of the animals according to KIMMERLE & TREPPER (Rhema-Labortechnik, D-6238 Hofheim/Taunus). 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.

- Source and rate of air: At the bottom of the exposure chamber the air was sucked off at the similar rate as created by the dust generator in order to produce a homogenous distribution in the exposure chamber. Air-flow meters (Rotameter, ROTA Apparate- und Maschinenbau, D-7867 Wehr 2/Baden) were used to control the constant supply of compressed air and vacuum. Flow rates were checked at least once/hour and corrected if necessary. Air flow was 480 l/h for the low concentration, and 780 l/h for the high concentration. The air change was 12.0 changes per hour for the low concentration, and 19.5 changes per hour for the high concentration.

- System of generating particulates/aerosols: The dust was generated with a dust generator and dosing apparatus (BURGHART, D-2000 Wedel/Holstein). The generator was fed with compressed air from a compressor.

- Method of particle size determination: An analysis of the particle size distribution was carried out twice during the exposure period using a cascade impactor according to MAY (1975).
The impactor is a device that classifies particles present in a sample of air or gas into known size ranges. It does this by drawing the air sample through a cascade of progressively finer nozzles. The air jets from these impact on plane sampling surfaces (slides) covered with adhesive tape. Each stage represents an aerodynamic size range. The dust from the exposure chamber was sucked through the cascade impactor for 1 0r 2 minutes at a constant flow rate of 5 l/min. The slides were removed from the impactor and were weighed on an analytical balance (SARTORIUS, type 1601004, precision 10µg).
Respirable amount (particle size <= 4 µm)
Dose level 1.58 mg/l air: 0.30 mg/l air
Dose level 6.65 mg/l air: 0.74 mg/l air

- Temperature, humidity: The temperature (GTH 1200 Digital Thermometer, Fa. Greisinger Electronic GmbH, D-8413 Regenstauf) and humidity (Sekunden -Hygrometer Typ 6100, Testoterm) was continuously monitored close to the animals' nose in the inhalation chamber. The temperature was 19 °C - 21 °C and the relative humidity was 60 % - +/- 20 %.

TEST ATMOSPHERE (Test substance concentration)
- Brief description of analytical method used: The dust concentration in the inhalation chamber was measured with an air sample filter (Minisart SM 17598) and pump (water jet air pump controlled by a rotameter). Dust samples were taken during the first half and during the second half of the exposure. The 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 or 2 minutes with a water jet air pump controlled by a rotameter. The filters were weighed before and after sampling (accuracy 0.01 mg).
- Samples taken from breathing zone: yes/no

TEST ATMOSPHERE
- Particle size distribution: The sample supplied had a particle size distribution of 70.6 % in the particle size range of 23.7 to 54.9 µm measured with a Malvern particle sizer.
Particle size (µm) and mean (concentration 1.58 mg/l air):
<0.5 µm: 0.06 %
0.5 µm: 2.59 %
1 µm: 5.73 %
2 µm: 9.78 %
4 µm: 19.19 %
8 µm: 32.69 %
16 µm: 56.71 %
>= 32 µm: 100.0 %
Particle size (µm) and mean (concentration 6.65 mg/l air):
<0.5 µm: 0.67 %
0.5 µm: 2.34 %
1 µm: 4.71 %
2 µm: 9.43 %
4 µm: 11.10 %
8 µm: 21.75 %
16 µm: 60.62 %
>= 32 µm: 100.0 %
- MMAD:
Dose level 1.58 mg/l air: 15.14 µm
Dose level 6.65 mg/l air: 19.48 µm
No further significant information on inhalation exposure was stated.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
see "details on inhalation exposure" above
Duration of exposure:
4 h
Remarks on duration:
Exposition started by locating the rats into the exposure chamber.
Concentrations:
Mean actual concentration: 1.58 +/- 0.11 mg/l air (nominal concentration: 8.1 mg/l air) and 6.65 +/- 2.11 mg/l air (nominal concentration: 35.1 mg/l air). 6.65 mg/l air was the highest concentration that could be generated in the inhalation chamber. Since neither mortalitiy nor toxic symptoms were observed up to the concentration of 6.65 mg/l air for 4 hours, no higher dosage was applied.
No. of animals per sex per dose:
5 males / 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During and following exposure, observations were made. A careful clinical examination was made at least once each day until all symptoms subsided, thereafter each working day. Observations on mortality were made at least once daily with appropriate actions taken to minimize loss of animals to the study. Individual body weights of the animals were determined before the exposure, after 1 week and at study termination.
- Necropsy of survivors performed: Yes, necropsy of all animals was carried out and all gross pathological changes were recorded. From animals which survived 24 hours or longer a microscopic examination of all organs which showed evident lesions was performed after preparation of paraffin sections and HE-staining.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Cageside observations included, but were not limited to, changes in the skin and fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, and somatomotor activity and behaviour pattern. Particluar attention was directed to observation of tremors, convulsions, salivation, diarrhoea. lethargy, sleep and coma.
No further significant information on study design was stated.
Statistics:
The mass median aerodynamic diameter (MMAD) was estimated by means of nonlinear regression analysis (LITCHFIELD & WILCOXON). The 32 µm particle size range was not included in the determination of the MMAD in order not to give undue weight to this value.The LC50 could not be calculatedbecause no mortality occurred.
Sex:
male
Dose descriptor:
LC50
Effect level:
> 6.65 mg/L air
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC0
Effect level:
> 6.65 mg/L air
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
> 6.65 mg/L air
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC0
Effect level:
> 6.65 mg/L air
Exp. duration:
4 h
Mortality:
Under the present test conditions no mortalitiy was observed up to 6.65 mg V2O3 technical grade pulverised/l air for 4 hours.
Clinical signs:
other: Dose level & toxic signs: 1.58 mg/l air: No signs of systemic intolerance 6.65 mg/l air: No signs of systemic intolerance 5.2 mg/l air: except for mortality, no signs of systemic intolerance
Body weight:
There was no inhibition of body weight gain in either males or females.

 1.58 mg/l air   1.58 mg/l air   6.65 mg/l air   6.65 mg/l air     
Lungs  male female  male  female  
macroscopic-number examined 5 5 5 5
 white foci 0 0 1 0
 haemorrhagic 1 2 0 2
microscopic-number examined 1 1 1 1
 vascular congestion 0 1 1 1
 initial haemorrhagic bronchopneumania 1 1 0 0

The histopathological changes found in the lung were regarded as unspecific effects, which usually occur after an inhalative exposure to a dust.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No acute toxicity was observed in an 4-h acute toxicity inhalation test of V2O3 in rats (LD50 > 6.65 mg/L), Thus, according to Regulation 83/467/EEC, V2O3 (technical grade pulverised) will not be classified for acute toxicity via inhalation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
6 650 mg/m³ air
Quality of whole database:
The GLP study is reliable with acceptabel restrictions.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-08-21 to 1991-09-4
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study without restrictions Minor deviations: - According to the guideline, a limit test of at least 2000 mg/kg bw can be carried out. In this study one additional concentration above the limit dose was also tested. - The guideline suggested that the rats should be in the weight range of 200 to 300 g at the beginning of the study but in this study the rats were in the weight range of 160 -199 g. - According to the guideline, the rats should be housed individually. In this study they were housed in groups of two or three rats. - According to the guideline, the relative humidity should be between 30 - 70 %. In this study the relative humidity was slightly higher (60 +/- 20 %). - According to the guideline, the test substance should be applied to the skin. In this study the test substance was applied first to the patch and the patch was placed onto the skin. - According to the guideline, the individual weights should be determined before the application of the test substance, which was done in this study. The individual weights were not provided in the report but only the average weight of the males and females per dose.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 24 February 1987
Deviations:
yes
Remarks:
see rational for reliability
GLP compliance:
yes (incl. QA statement)
Remarks:
The study states that the study was performed according to eg. "Good Laboratory Practice" Regulations of the EEC enacted in Germany in the "Chemikaliengesetz" dated March 14th, 1990, BGBL.I, pp. 521, 1990.
Test type:
standard acute method
Limit test:
yes
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, D- 4923 Extertal 1
- Age at study initiation: approx. 40 - 60 days
- Weight at study initiation: 160 - 199 g
- Fasting period before study: approx. 16 hours
- Housing: Animals were kept in groups of two or three in MAKROLON cages (type III). Gradulated textured wood was used as bedding material (Granulat Typ A2, supplier: Messrs. BRANDENBURG, Inh. H.Brandenburg, D-2849 Goldenstedt)
- Diet: Standardized diet for rats ALTROMIN 1324 (supplied by: ALTROMIN GmbH, D-4937 Lage/Lippe)
- Water (ad libitum): tap water
- Quarantine period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C +/- 3 °C (maximum range)
- Relative humidity: 60 % +/- 20 % (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
No further information was stated on test animals.
Type of coverage:
occlusive
Vehicle:
other: hydroxypropyl-methylcellulose gel
Details on dermal exposure:
TEST SITE
The test substance was applied on the shaved intact dorsal skin of rats (5 X 6 cm, 1/10 of body surface). 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.
The test substance was applied to 8 layers of gauze and to the application site. The patch was covered with a plastic sheet and secured with adhesive plaster.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: At the end of the exposure period, residual substance was removed with tepid tap water.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The volume of application was 20 ml/kg b.w.. The dose interval factor was 1.25.

VEHICLE
0.8 % aqueous hydroxypropyl-methylcellulose gel (Methocel E 4 M) served as vehicle for V2O3 technical grade pulverised.
Batch No.(Vehicle): MM 84097413
No further significant information on details on dermal exposure was stated.
Duration of exposure:
24 hours
Doses:
2000 mg and 2500 mg V2O3 technical grade pulverised/kg b.w.
No. of animals per sex per dose:
5 males / 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed immediatly, 5, 15, 30 and 60 min, as well as 3 h, 6 h and 24 h after administration. During the follow-up period changes in skin and fur, eyes and mucous membranes, and the respiratory, circulatory, autonomic and central nervous system and somatomotor activity and behaviour pattern were observed at least once a day until all symptoms have subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Observations on mortality were made at least once daily with appropriate actions taken to minimise loss of animals during the study.
Individual body weights were recorded before administration of the substance, thereafter in weekly intervals up to the end of the study, and at death.
- Necropsy of survivors performed: yes, at the end of the experiments all surviving animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded. From animals which survive 24 hours or longer a microscoic examination of all organs which show evident lesions was performed. Autopsy and macroscopic inspection of the animals which died prematurely were carried out as soon as possible after exitus.
- Other examinations performed: Changes in weight were calculated and recorded when survival exceeds one day. The skin was observed for the development of erythema and oedema and was rated as follows:
Erythema
0 = no erythema
1 = very slight erythema (barely perceptible)
2 = well-defined erythema
3 = moderate to severe erythema
4 = severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema
0 = no oedema
1 = very slight oedema (barely perceptible)
2 = slight oedema (edges of area well defined by definite raising)
3 = moderate oedema (raised approx. 1 mm)
4 = severe oedema (raised more than 1 mm and extending beyond the area of exposure)
No further significant information on study design was stated.
Statistics:
The LD50 could not be calculated because none of the animals died prematurely.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
None of the animals died prematurely.
Clinical signs:
other: Under the present test conditions no local or systemic intolerance reactions were observed up to the highest tested dose-level of 2500 mg V2O3 technical grade pulverised/kg b.w. by dermal administration to rats.
Gross pathology:
There were no pathological findings in male or female rats.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the present test conditions dermal administration of up to 2500 mg V2O3 technical grade pulverised/kg b.w. did not cause any toxic effects in rats. According to directive 83/467/EEC, V2O3 technical grade pulverised can be classified as relatively non-toxic (not classified) in the acute dermal toxicity study in the rat.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 500 mg/kg bw
Quality of whole database:
The GLP study is reliable with acceptable restrictions.

Additional information

Acute oral toxicity:

Divanadium trioxide is non-toxic if swallowed as the LD50 for rats is > 2000 mg/kg bw.

Acute inhalation toxicity: 

Divanadium trioxide is non-toxic if inhaled as the LC50 for rats is > 6.65 mg/L air.

Acute dermal toxicity:

Divanadium trioxide is non-toxic in contact with skin as the LD50 for rats is > 2500 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint

There is only one reliable study available.

Justification for selection of acute toxicity – inhalation endpoint

There is only one reliable study available.

Justification for selection of acute toxicity – dermal endpoint

There is only one reliable study available.

Justification for classification or non-classification

The available information indicates that divanadium trioxide is not acutely toxic or harmful. Therefore, classification of divanadium trioxide for acute toxicity is not required according to Regulation (EC) 1272/2008.

Specific target organ toxicant (STOT) – single exposure

The classification criteria according to Regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral, inhalation, or dermal are not met since adverse health effects, including reversible and irreversible, were not observed immediately or delayed after exposure.