Ammonium trivanadium octaoxide

Endpoint summary

Description of key information

Acute oral toxicity: LD50 = 200 mg/kg bw (OECD 423; GLP; female rats)

Acute inhalation toxicity: LC50 = 0.67 mg/L air (analytical) (OECD 403; GLP, male rats)

Acute dermal toxicity: LD50 > 2000 mg/kg bw (OECD 402; GLP)

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:

2006-05-30 to 2006-06-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 17 December 2001

Deviations:

yes

Remarks:

see below

Principles of method if other than guideline:

Minor deviations:
- According to the guideline, when during the first step of dosing 2-3 animals die, then the next lower dose should be tested. In this study a dose of 300 mg/kg b.w. killed all animals. However, a second group was tested at this dose level, because the time selected interval between first and second step was too short (delayed onset of death of animals from the 1st dosing). This is not relevant for the results.
- According to the guideline, microscopic examination of organs showing evidence of gross pathology in animals survivng 24 or more hours may also be considered because it may yield useful information. In this study evidence of gross pathology were found, but no microscopic examination was carried out ad-hoc.
- According to the guideline, the details of food and water quality must be included in the test report. The study report only stated for the food that it was analysed. No further information in regard to food and water quality was mentioned.
The study report stated that there were problems measuring the temperature and humidity data for the environmental conditions continuously, which was assumed to be of no relevance for the results of this study.

GLP compliance:

yes

Remarks:

The study report stated that this study meets the requirements of the OECD Principles of GLP, OECD Environment Health and Safety Publications, Series on Principles of Good Laboratory Practice and Compliance Monitoring No. 1, Paris 1998.

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation: approx. 8 weeks at the time of the administration
- Weight at study initiation: 178 g - 200 g before administration
- Fasting period before study: Feed was withdrawn the evening before the administration of the test substance and was offered again about three h afterwards.
- Housing: Single caging in Makrolon cages type III (39 cm X 23 cm bottom area, 18 cm height). Wire mesh lids. Bedding material: Aspen wood chips, Fa ABEDD Dominik Mayr KEG, A-8580 Köflach, autoclaved.
- Diet (ad libitum): Altromin 1324 forte, gamma irradiated with 25 kGy60Co (Producer: Altromin GmbH, D-32791 Lage)
- Water (ad libitum): tap water from an automatic watering system
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: average of 22.5 °C
- Relative humidity: average of 66.2%
- Air exchanges: 12 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
A 0.1 % aqueous solution of Na-carboxymethylcellulose ("CMC" high viscosity, item No. C-5013, Lot. No. 98H0328 , Sigma) plus Tween 80 (Polyoxyethylensorbitanmonooleate, article No. 822187, Merck) was used as vehicle for the test substance.
- Justification for choice of vehicle: The test substance was not soluble in water. Aqueous CMC plus Tween 80 is a common vehicle for acute oral toxicity testing.

DOSE VOLUME APPLIED: 20 mL/kg b.w.. The individual dose volumes were calculated using the body weights determined on the day of the administration.

DOSAGE PREPARATION: The suspensions were prepared freshly before administration and were administered within 10 minutes after the preparation.

CLASS METHOD
- Rationale for the selection of the starting dose: As no prior information on the toxicity of the test substance was available, a starting dose of 300 mg of the test substance per kg body weight was chosen. The further proceeding was in accordance with the guidelin/directive. Due to the delayed onset of death in the animals of step 1 the test substance was also administered to another group with a dose of 300 mg/kg body weight (step 2).
No further significant information on details on oral exposure was stated.

Doses:

50 mg/kg b.w.
300 mg/kg b.w.

No. of animals per sex per dose:

Two groups of 3 females per dose level

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed within the periods 0 -0.5, 0.5 - 1, 1 -2, 2-4 and 4 - 6 hours after administration of the test substance and then at least once a day for a total of 2 weeks. Body weights were determined before administration, 7 days after administration and 14 days after administration. When early deaths occured the body weight was determined as soon as possible after finding.
- Necropsy of survivors performed: Yes, surviving animals were killed by inhalation of 80 % CO2 + 20 % air 14 days after administration and were also subjected to a necropsy including a gross pathological examination. Deceased animals were dissected and examined macroscopically in an attempt to identify the target organs.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Observations included but were not limited to changes in skin, fur, eyes, the occurence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions. Body weight gain was calculated for each week of the study, i.e. between 0 and 7 days after administration, and between 7 days and 14 days after administration.
No further significant information on details on study design was stated.

Statistics:

not stated

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

200 mg/kg bw

Based on:

test mat.

Mortality:

300 mg/kg b.w., step 1: All animals died 3 d after administration
300 mg/kg b.w., step 2: All animals died between 2 and 6 d after administration
50 mg/kg b.w., step 3: All animals survived until the scheduled termination of the study
50 mg/kg b.w., step 4: All animals survived until the scheduled termination of the study.

Clinical signs:

other: Only animals at the high dose (300 mg/kg b.w.) were affected. No symptoms of reduced well-being were observed at the does of 50 mg/kg b.w. The observed findings at 300mg/kg b.w. with an onset 2 d after administration and lasting until death (i.e. to a max

Gross pathology:

Abnormal findings were present only in deceased animals (animals died spontaneously):
- glandular stomach, mucosa, ulcera (step 1: 3/3 females; step 2: 2/3 females)
- glandualr stomach, mucosa, erosion (step 2: 1/3 females)
- stomach, blood in the lumen (step 2: 1/3 females)
- small intestine, blood in the lumen (step 1: 1/3 females; step 2: 1/3 females)
- small intestine, ulcera (step 2: 1/3 females)
- anus, soiled with faeces (step 1: 3/3 females; step 2: 3/3 females)
- liver, large white foci (step 2: 2/3 females)
All other animals were normal at the necropsy 14 d after administration.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The test substance caused gastrointestinal irritation and sings of discomfort at the dose of 300 mg/kg b.w. but no toxic effects at 50 mg/kg b.w. Shock from gastrointestinal lesions may have been the cause of death at the dose of 300 mg/kg bw.
The LD50 can be estimated at 200 mg/kg bw. according to annex 2 to OECD 423 (GHS: >50-300 mg/kg bw.; Category 3).
According to REGULATION (EC) No 1272/2008, a classification of "ammonium trivanadium octaoxide" is required (Acute toxicity Category 3; H301: Toxic if swallowed).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

200 mg/kg bw

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:

206-06-02 to 2006-08-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

adopted 12 May 1981

Deviations:

no

GLP compliance:

yes

Remarks:

According to the study report, this study was performed in compliance with the GLP of OECD (OECD Environment Health and Saftey Publications, Series on Principles of GLP and Compliance Monitoring No. 1, Paris 1998.

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633
- Age at study initiation: approx. 9 weeks at time of administration
- Weight at study initiation: 214 g - 252 g
- Housing: Single caging in Makrolon cages type III (39 cm X 23 cm X 18 cm). Wire mesh lids. Bedding material: Aspen wood chips, Fa, ABEDD Dominik Mayr KEG, A-8580 Köflach, autoclaved.
- Diet (ad libitum): Altromin diet No. 1324 forte. No feed was offered during the exposure.
- Water (e.g. ad libitum): Acidified water to pH 3 with HCl, from watering system. No water was offered during the exposure.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: Group High concentration : mean of 24.1 °C; group Mid and low concentration: mean of 22.0 to 23.2 °C
- Relative humidity: Group High concentration: mean of 82 %; group Mid and low concentration: mean of 69 to 73 %
- Air exchange: 12 /h
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

other: air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating particulates/aerosols: The test substance was ground in a ball mill for 5 minutes. In the dust generator (Technical & Scientific Equipment GmbH, Kronberg, Germany, article number 594203) it was trickled on to an adjustable metering system. From there it fell into the aerosol flask, was picked up by an air flow and transported to the lower centre of the inhalation chamber. The metering system was adjusted to get the desired dust concentration. Larger particles, the main part of the test substance , were caught in the inner chamber by sedimentation. Smaller particles reached the outer chamber and the inhalation tubes with the animals.

- Exposure apparatus and exposure chamber volume: The test substance was administreed in a "nose-only" inhalation aparatus (TSE, Technical & Scientific Equipment GmbH, Kronberg, Germany; article no. 504101). It consisted of a two chamber system. The aparatus was 30 cm in diameter and 27 cm in height, resulting in a total volume of 19 litres. In the twenty openings of the outer chamber, the inhalation tubes with the animals were situated. As only ten animals were administered, only the openings in the upper row were used. The inhalation chamber was situated in a fume cupboard.

- Source and rate of air: The air was obtained from a central pressure pump. The air flow was 700 liter per hour.

- Treatment of exhaust air: The air escaped via the upper central opening and via the animal tubes. The air was filtered oil-free and distributed within the Research center

- Temperature, humidity, air flow: The relative humidity was reduced to about 10 %. The humidity of the air inside the chamber was measured with a hygrometer (Hygrotest serie 55, type 0555 6020, Testoterm Ges.m.b.H, Vienna, Austria), the temperature with a glass-mercury thermometer. The air flow on the low pressure side (after the generator) was measured with a rotameter (Rota Apparatebau GmbH & Co KG, Wehr, Germany, type L 63/2400-9048, ranging till 2000 l/h) before starting the dust generator. During the exposure the air flow was checked by momentary interrupting the supply of the test substance and connecting the rotameter to the dust genereator. The air flow on the high pressure side (before the generator) was monitored by recording the pressure of the air.
The hygrometer was calibrated against the water vapour concentration of a saturated aqueous NaCl solution (76 % relative humidity) and a saturated LiCl solution (12 % relative humidity). The rotameter were calibrated against a gas meter (Experimentiergaszähler, Elster GesmbH, Vienna, Austria), which was calibrated by measuring the air displaced by a weighted volume water.
The temperature inside the chamber was 21.0 to 22.0 °C. The relative humidity ranged from 27 % to 35 %. The humidity was partly outside the recommeded range of 30 to 70 % but to prevent a possible agglomeration of the test substance, the air for the dust generation was not humidified.
- Other information: In the Toxicologiy Department the pressure was reduced to 1 bar.

TEST ATMOSPHERE (concentration of test substance)
- Brief description of analytical method used: The amount of test substance was measured by gravimetric analysis. The dust was collected 7 to 12 times during each exposure in plastic pipette- tips filled with cotton-wool which were inserted into the inhalation facility through a separate hole between two inhalation tubes. The site of collection was within the outer chamber. The inner diameter of the tips was 7 mm. Measured amounts of air with the dust were collected at a rate of 2.3 to 2.5 litres per minute which means a velocity of 1.0 to 1.1 m/sec in the tips. the exact amount of collected air was measured by a gas meter (Experimentiergaszähler, Elster GesmbH, Vienna, Austria).
Each filter-tip was dried and weighed before sampling. After sampling dry air (< 10 % humidity) was passed through them until the weight was constant. The difference in the weights before and after sampling divided by the volume of air sampled is the concentration of the dust.
The nominal chamber concentration was calculated as the weight of test substance used divided by the air flow through the chamber.
- Samples taken from breathing zone: no

- Method of particle size determination: The size if the dust particles was analysed with a cascade impactor (Berner-Impaktor Type LPI4/0,06/2 from Hauke KG, Gmunden, Austria). It contains nine steps with cut-off-diameters from 0.06 µm to 16 µm. The cut-off diameters were obtained from the manufacturer. The test substance - air mixture was passed through the impactor for 1 to 5 minutes at a rate of 5.7 L/min and the amount which sedimented in the individual steps was determined gravimetrically. The site of collection was the same as for the analysis

TEST ATMOSPHERE
- Particle size distribution for mid concentration group (1.23 mg/L) only : Fraction smaller that 5 µm: 86.5 %; fraction smaller than 4 µm: 77.2 %; fraction smaller than 2 µm: 35. 3%:
- MMAD (concentration of 0.47 mg/L): 2.5 (GSD: 1.8)
- MMAD (concentration of 1.23 mg/L): 2.5 µm (GSD: 1.9)
- MMAd (concentration of 2.67 mg/L): 2.6 µm (GSD: 1.8)
No further significant information on inhalation exposure was stated.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

see details on inhalation exposure

Duration of exposure:

4 h

Concentrations:

Mean Actual concentrations:
For the low concentration group: 0.47 mg/L
For the mid concentration group: 1.23 mg/L
For the high concentration group: 2.67 mg/L
Mean nominal concentration:
For the low concentration group: 3.6 mg/L
For the mid concentration group: 8.6 mg/L
For the high concentration group: 19.8 mg/L
The recovery of respirable dust was 13.1 to 14.3 %

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: Behaviour, reactions and physical signs of each of the animals were observed 1, 2, 3, 4, 5 and 6 hours after the start of the expsoure and then at least once a day for a total of 2 weeks. Individual body weights were determined before administration, 7 days after administration, 14 days after administration and of dead animals, that deceased 1 day after administration or later.
- Necropsy of survivors performed: yes, deceased animals were dissected and examined macroscopically in an attempt to identify the target organs. Surviving animals were killed by CO2-asphyxia (80 % CO2 and 20 % air) 14 days after administration and subjected to a necropsy including a gross pathological examination.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Body weight gain was calcualted for each week of the study i.e. between 0 and 7 days after administration and between 7 and 14 days after administration. Sex differences were evaluated.

Statistics:

For calculation of the mean particle size, the probit of the fraction of mass smaller than the cut-off diameters was plotted against the logarithm of the cut-off diameters and the linear regression of this graph was calculated, preferring the data points around 50 %. The diameter, where the regression gives a probit of 5 (corresponding to a fraction of 50 %) is the mass median aerodynamic diameter (MMAD). The proportion of the diameter at a probit of 6 (corresponding to a fraction of 84 %) to the mass median diameter is the geometric standard deviation (GSD).

Sex:

male/female

Dose descriptor:

LC50

Effect level:

0.84 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Sex:

female

Dose descriptor:

LC50

Effect level:

1.08 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

0.67 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

In the high (2.67mg/L) dose group, all animals died 2 hours to 1 days after the exposure.
In the mid (1.23 mg/L) dose group, all males and 3 of 5 females died 1 to 5 days after the exposure.
In the low (0.47 mg/L) dose group, one male but none of the females died 4 days after the exposure.

Clinical signs:

other: Dyspnoea and respiratory murmur were the most prominent findings in a dose-dependent severity. They indicate an adverse effect of the test substance to the lungs. Apathy and retention of faeces are interpreted as sequel of the bad condtions of the animals

Body weight:

The body weight loss in the first week after the exposure was test substance dependent. Males of the low-dose group lost 5.0 gram, in the mid- and high-dose groups, no male survived one week. Females of the low concentration group lost 9.2 gram, the two surviving females of the mid-dose group lost 5.5 gram. No female survived for one week in the high-dose group. In the second week, all survivng animals gained weight.

Gross pathology:

The most prominent findings were damages to the lungs (subpleural haemorrhages and oedema). Only decedents were affected.
Ulcer in the intestine and blood in the instestine lumen indicated that probably some of the test substance was also ingested orally. The intestine of some animals was autolytic at the time of necropsy as the animasl died during the night.
In 5 animals of the mid- and high-dose groups, the anus of the animals was soiled with faeces.
The other findings, white foci in the liver, a small thymus, and thymus petechiae, were observed in one animal each and are maybe random events. Also, blood in the nose was observed in two males.

Other findings:

Males and females responded similary to the test substance.

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The inhalation exposure of rats to "ammonium trivanadium octaoxide" leads to adverse effects in the lungs at elevated concentrations. Subsequently, the oxygen exchange is decreased to an extent that becomes lethal in some cases. The LC50- via inhalation for four hours of "ammonium trivanadium octaoxide" for rats is:
LC50, inhalation, 4 h, male rats: 0.67 mg/L
LC50, inhalation, 4 h, female rats: 1.08 mg/L
LC50, inhalation, 4 h, male and female rats: 0.84 mg/L
For the classification of the test substance, the lower LC50 value is considered.
According to REGULATION (EC) No 1272/2008, "ammonium trivanadium octaoxide" should be labelled (Acute toxicity Category 3; H331: Toxic if inhaled).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

670 mg/m³ air

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:

2006-06-20 to 2006-07-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Adopted February 1987

Deviations:

no

GLP compliance:

yes

Remarks:

The study report states that the study meets the requirements of the Principles of GLP of the OECD (Environment Health and Safety Publications, Series on Principles of GLP and Compliance Monitoring No. 1, Paris 1998.

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, D-97633 Sulzfeld
- Age at study initiation: approx. 8 weeks (males) and 12 weeks (females) at the time of administration
- Weight at study initiation: within the range of 223-246 g for females; within the range of 311-322 g for males
- Fasting period before study:
- Housing: Single caging in Makrolon cages type III (39 cm X 23 cm X 18 cm). Wire mesh lids. Bedding material: Aspen wood chips, type "ABEDD", (Fa. ABEDD Dominik Mayr KEG, A-8580 Köflach), autoclaved.
- Diet (ad libitum): Altromin 1324 forte, (Producer: Altromin GmbH, D- 32791 Lage) gamma irradiated with 25 kGy60Co
- Water (ad libitum): tap water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature: average of 22.2 °C
- Relative humidity: average of 53.0 %
- Air exchange: 12 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Health conditions: A health inspection was performed prior to the commencement of treatment to ensure, that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from any abnormality.

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
A single dermal administration was performed by spreading the test substance on an area of at least 10 % of the estimated body surface: The body surface was calculated using the formula: body surface (cm^2) = 10 X body weight (g)2/3. .The test site was located on the dorsal thoracal region. An area of 6.5 cm X 8 cm (52 cm^2) was marked on a relaxed animal. The hair of the dorsal trunk was clipped with an electrical hair clipper (Aesculap GH, 01 mm cutter head) one day before application of the test substance. A cellulose patch (Pehazell, HArtmann AG) with the calculated amount of the test substance on the surface and soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non irritating tape (Blenderm Wundpflaster, 3M). Patch and tape were covered semi-occlusiely by a dressing (Fixomull Stretch, Fa. Beiersdorf).

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: At the end of the exposure period the dressing, the tape and the patch were removed. Residual test substance was wiped off using wet cellulose tissue, if necessary.

TEST MATERIAL
- Amount(s) applied: The individual amounts of the test substance were calculated using the body weights determined on the day of the administration.

Duration of exposure:

24 hours

Doses:

400 (females), 894 (females), 2000 (females and males) mg/kg bw

No. of animals per sex per dose:

5 females / 5 males

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation were performed 0 - 0.5, > 0.5-1, > 1- 2, > 2-4 and > 4 - 6 hours after administration of the test substance (p.a.) and then at least once a day for a total of 2 weeks. No skin examination of the administration site was possible during the exposure period, while it was covered by the patch and wrappings. Body weight were determined before administration, 7 days p.a. and 14 days p.a.. Body weight gain was calculated for each week of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: Observations included but were not limitd to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions. All animals were killed by inhalation of 80 % CO2 + 20 % O2 14 days p.a. and subjected to a necropsy including a gross pathological examination.

Statistics:

not stated

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All animals survived until the scheduled termination of the study. No local or systemic test substancee related effects were noted at clinical observations or post-mortem examination at a dose of 2000 mg/kg b.w.

Clinical signs:

other: General findings: All animals were normal during the entire observation period. Observations of skin condition: A yellow staining of the skin was observed in all animals from 1 d until a maximum of 5 d p.a. This stain is attributed to a staining property

Gross pathology:

All animals were normal at terminal necropsy.

Other findings:

Sex differences: No noteworthy sex difference in the response to the test substance was derived from clinical observations or post-mortem findings.

It has to be pointed out, that in the separately performed dose finding study, mortality occured at a dose of 2000 mg/kg (1 female & 1 male animals were tested and died). However, none of the 5 male and 5 female rats in the main test were affected.

Interpretation of results:

GHS criteria not met

Conclusions:

No local or systemic test substancee related effects were noted at clinical observations or post-mortem examination at a dose of 2000 mg/kg bw.
No classifiaction of "ammonium trivanadium octaoxide" is derived from the results of this study according to REGULATION (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Justification for classification or non-classification

Ammonium trivanadium octaoxide requires classification as toxic if swallowed (Category 3) and toxic if inhaled (Category 3) according to Regulation (EC) 1272/2008. Classification of ammonium trivanadium octaoxide for acute toxicity via the dermal route is not required according Regulation (EC) 1272/2008.

Specific target organ toxicant (STOT) - single exposure (inhalation)

Dyspnoea and respiratory murmur were observed during the acute inhalation toxicity test, and observed post mortem findings in decedents were damages to the lungs, including subpleural haemorrhages and oedema (Werner, 2006). Effects below the Lethal threshold were also not observed in the acute oral and dermal toxicity tests. Nevertheless, ammonium trivanadium octaoxide has the potential to seriously damage the eyes (i.e. all observed effects were irreversible). According to EC Regulation No. 1272/2008, ammonium trivanadium octaoxide needs to be classified STOT SE 3 „Specific target organ toxicity after single exposure Category 3“ (H335: May cause respiratory irritation).