Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 235-384-0 | CAS number: 12207-63-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: inhalation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Ammonium trivanadium octaoxide
- EC Number:
- 235-384-0
- EC Name:
- Ammonium trivanadium octaoxide
- Cas Number:
- 12207-63-5
- Molecular formula:
- NH4V3O8
- IUPAC Name:
- trivanadium(5+) ammonium octaoxidandiide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Ammoniumpolyvanadate ((NH4)2V6O16)
- Physical state: yellow powder
- Stability at conditions of storage: Stable
- Stability in aqueous solutions: Stable
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- 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
Administration / exposure
- 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).
Results and discussion
Effect levelsopen allclose all
- 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.
Applicant's summary and conclusion
- 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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.