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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: oral
Administrative data
- 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
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 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
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:
- 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
Administration / exposure
- 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
Results and discussion
Effect levels
- 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.
Applicant's summary and conclusion
- 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).
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