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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 618-920-1 | CAS number: 93280-40-1
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Divanadyl pyrophosphate
- EC Number:
- 407-130-0
- EC Name:
- Divanadyl pyrophosphate
- Cas Number:
- 65232-89-5
- Molecular formula:
- (VO)2P2O7
- IUPAC Name:
- Divanadyl pyrophosphate
- Details on test material:
- - Name of test material (as cited in study report): E-326 Catalyst
- Physical state: grey/green powder
- Analytical purity: 96%
- Lot/batch No.: 104
- Storage condition of test material: at 13 °C protected from light.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK)
- Age at study initiation: 32-40 days
- Weight at study initiation: 73-86 g
- Housing: 5 animals per cage
- Diet: LAD1 complete, pelleted laboratory rodent diet (Biosure, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 25 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% methylcellulose in distilled water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Formulations of the test material were prepared for administration as a series of graded concentrations in 1% w/v methylcellulose in distilled water to provide the required dosages at a constant volume-dosage. Control rats received the vehicle alone at the same volume-dosage. All formulation were prepared freshly each day.
VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg bodyweight - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Homogeneity was determined by atomic absorption spectrophotometric analysis of total Vanadium content of the trial formulations for the high and low dosage groups immediately following their preparation. Stability was assessed by analysis of the infra-red spectra of evaporated samples after 24 and 48 hours storage at room temperature. In addition, duplicate samples (2 ml each) of each formulation prepared for administration on the first day of treatmentand on one occasion in Week 4 of treatment were retrospectively analysed by atomic absorption spectrophotometry for achieved concentration.
- Duration of treatment / exposure:
- 30 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 20, 100, 500 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
Four groups of three male and three female rats were given E-326 catalyst in 1% w/v methyl cellulose in distilled water once daily by oral gavage for seven days at dosages of 30, 100, 250 or 500 mg/kg/day, at a volume-dosage of 10 ml/kg bodyweight. Serial examinations were confined to observation of clinical signs and bodyweight recordings. No test substance related signs of toxicity were reported. Thus, dosages of 20, 100 and 500 mg/kg/day were selected for the main study. Based on toxicity data provided by the Sponsor, the high dosage of 500 mg/kg/day was considered to be the maximum that could be administered without significant risk of death from acute effects of treatment.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule for examinations: twice weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: day 29
- Anaesthetic used for blood collection: Yes
- Animals fasted: Yes, overnight
- How many animals: all
- Parameters examined: packed cell volume, haemoglobin concentration, erythrocyte count, total and differential leucocyte count, platelet count, mean cell haemoglobin, mean cell volume.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 29
- Animals fasted: Yes, overnight
- How many animals: all
- Parameters examined: alkaline phosphatase, alanine amino-transferase, aspartate amino-transferase, urea, creatinine, glucose, bilirubin, total protein, sodium, potassium, chloride, calcium, inorganic phosphorus.
URINALYSIS: Yes
- Time schedule for collection of urine: day 25
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters examined: appearance, volume, pH, specific gravity, protein, glucose, ketones, bilirubin, urobilinogen, nitrite, blood - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, detailed examination of the external features and orifices, the neck and the subcutaneous structures and the cranial, thoracic, pelvic and abdominal cavities and their viscera. Organ weight from adrenals, heart, kidneys, liver, spleen, testes was recorded.
HISTOPATHOLOGY: Yes, abnormalities, adrenals, heart, kidneys, liver, spleen. - Statistics:
- The following test were used: student`s t-test, Dunnett´s or Fisher-Behrens tests and Fisher Exact Probability test.
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
500 mg/kg bw: One male rat showed bodyweight loss and was found dead on day 20. One female showed bodyweight loss from the beginning of the study, loose faeces, hunched posture and piloerection on Day 3 and was killed on Day 4 for humanity reasons. A further female was hunched, thin and had reduced body temperature and muscle tone, muscle tremor, rapid respiration, piloerection and pallor on Day 21, and was killed for humanity reasons on the same day. Three females showed salivation.
100 mg/kg bw: Salivation of a single female
BODY WEIGHT AND WEIGHT GAIN
500 mg/kg bw: slighly lower body weight gain (females)
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
500 mg/kg bw: Slighly lower food consumption, particularly during the first week of treatment (females)
HAEMATOLOGY
500 mg/kg/day: lowered mean red cell-volumes, haemoglobin concentrations and packed cell volumes slightly reduced and red cell numbers slightly elevated. slightly reduced lymphocyte and corresponding total leucocyte numbers and slightly higher platelet counts (females)
CLINICAL CHEMISTRY
500 mg/kg bw: Elevated plasma amino-transferase activities, elevated plasma ure concentrations (males), reduced plasma alkaline phosphatase activity (females)
100 mg/kg bw: elevated plasma amino-transferase activities (females)
URINALYSIS
No test substance- related effects
ORGAN WEIGHTS
No test substance- related effects
GROSS PATHOLOGY
No test substance- related effects
HISTOPATHOLOGY:
Histopathology of the male that died revealed diminished glycogen and congestion in the liver. Histopathology of one female that was sacrificed revealed papillary mineralisation in the right kidney, plasmocytosis and parafollicular hyperplasia in the mesenteric lymph nodes and diminished glycogen and congestion in the liver. The second female that was sacrificed, showed hydronephrosis and vacuolation or degeneration of the right kidney tubules, hepatocytic degeneration and inflammation, diminished glycogen and congestion in the liver and atrophy of the splenic white pulp. In the surviving animals there were no other microscopic changes which were attributed to treatment.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: clinical signs; mortality;
- Dose descriptor:
- NOEL
- Effect level:
- 20 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: clinical chemistry;
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
In conclusion, the oral administration at a dosage of 500 mg/kg/day for four consecutive weeks caused the death of three rats, haematological alterations and changes in blood chemistry. The no observed adverse effect level (NOAEL) under the conditions of the present study was 100 mg/kg bw/day for both sexes.
Applicant's summary and conclusion
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.