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EC number: 407-130-0 | CAS number: 65232-89-5 BP AMOCO IV; E-326 CATALYST; KAT MSA; MSA-KATALYSATORTABLETTEN
- 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:
- (phosphonooxy)phosphonic acid dihydrate vanadium
- Details on test material:
- 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
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- by atomic adsorption spectrophotometry
- Duration of treatment / exposure:
- 30 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
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: on basis of a preliminary study
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
OPHTHALMOSCOPIC EXAMINATION: No
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
NEUROBEHAVIOURAL EXAMINATION: No - 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.
HISTOPATHOLOGY: Yes, abnormalities, adrenals, heart, kidneys, liver, spleen. - Other examinations:
- Organ weight from adrenals, heart, kidneys, liver, spleen, testes was recorded.
- 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
One male rat treated at 500 mg/kg/day 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 on humane grounds. 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 on humane grounds on the same day.
Salivation was observed on days 20 to 28 in three females at 500 mg/kg bw and on day 20 in one female at 100 mg/kg bw.
BODY WEIGHT AND WEIGHT GAIN
Females treated with 500 mg/kg bw showed slighly lower body weight gain.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Females treated with 500 mg/kg bw showed slighly lower food consumption, particularly during the first week of treatment.
HAEMATOLOGY
The mean red cell-volumes of rats treated at 500 mg/kg/day were lower than those of the controls. In addition, haemoglobin concentrations and packed cell volumes were slightly lower and red cell numbers slightly higher than those of the controls. Females treated at this dosage had slightly lower lymphocyte and corresponding total leucocyte numbers and slightly higher platelet counts than the female controls.
CLINICAL CHEMISTRY
The plasma alanine amino-transferase activities of male and female rats treated at 500 mg/kg/day and female rats treated at 100 mg/kg/day were slightly higher than those of the controls. The plasma urea concentration of male rats treated at 500 mg/kg/day was marginally higher than that of the male controls and the plasma alkaline phosphatase activity of females treated at this dosage was slightly lower than that of the female controls.
URINALYSIS
Urine was considered to have been unaffected by treatment with.
ORGAN WEIGHTS
There were no differences in organ weight between treated and control animals that could be unequivocally attributed.
Slightly higher liver, kidney and spleen weights relative to bodyweight recorded for female rats treated at 500 mg/kg/bw/day, when compared with control values, were considered to have more likely reflected a difference in growth performance than a direct effect of the test material.
GROSS PATHOLOGY
There were no microscopic findings attributable to treatment. Enlarged lymph nodes were observed in some animals treated at 500 mg/kg bw/day but these were considered unlikely to be related to treatment.
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 diet
- 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. Effects at 100 mg/kg/day were essentially confined to a marginal increase in plasma alanine aminotransferase activity in females. 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
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