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EC number: 406-260-5 | CAS number: 58834-75-6 BTN; VPO CATALYST
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-10-1
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted to internationally recognised test methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Vanadyl pyrophosphate
- EC Number:
- 406-260-5
- EC Name:
- Vanadyl pyrophosphate
- Cas Number:
- 58834-75-6
- Molecular formula:
- V2P2O9
- IUPAC Name:
- divanadium(4+) (phosphonatooxy)phosphonate dioxidandiide
- Details on test material:
- - Name of test material (as cited in study report): BTN/A
- Chemical name: Vanadyl pyrophosphate
- Chemical formula: (VO)2P207
- Relative molar mass: 307.8
- Physical state Fine, dark-brown powder
- Lot/batch No.:0003
- Purity: Vanadium - 30.1%, phosphorous 21.0% by weight
- Storage condition of test material: Cool, dry, well ventilated room
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Olac Ltd, Bicester, England
- Age at study initiation: Not stated
- Weight at study initiation: 336 - 436 g
- Housing: Up to 5 animals/cage; stainless steel grid-bottomed cages
- Diet (e.g. ad libitum): FD1 guinea pig diet from SDS Ltd, Witham , Essex, ad libitum
- Water (e.g. ad libitum): Municipal tap water, ad libitum
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 21 deg C
- Humidity (%): 40 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 1990-04-10 To: 1990-05-18
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction - injection: 0.5% w/v
Induction - Epicutaneous: 50% w/v
Challenge - Epicutaneous: 10 and 50% w/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction - injection: 0.5% w/v
Induction - Epicutaneous: 50% w/v
Challenge - Epicutaneous: 10 and 50% w/v
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 20 - Details on study design:
- Selection of main study treatment regimes.
The concentrations chosen for use in induction and challenge were based on preliminary screens.
Constitution of main study groups
The test and control groups each consisted of twenty animals, evenly divided by sex. The control animals were treated identically to the test group during the induction and challenge procedures, except that during induction the test material was replaced by vehicle
Induction procedures
The induction procedures were primary induction by intradermal injection on Day 1 and secondary induction by occluded topical application on Day 8. Dermal responses to primary and secondary induction were assessed approximately 24 hours and 48 hours after injection or removal of the occlusive dressings.
Primary induction
Three pairs of injections (0.1 mL) were made deep into the dermis, such that on either side of the dorsal median line there were three injection sites in a row parallel to the spinal column. All injection sites lay near the periphery of a dermal test site 4 cm x 2 cm long, overlying the scapulae. The anterior and middle sites were positioned close together and distant from the posterior sites.
Secondary induction
On Day 8 the dermal areas treated on Day 1 were treated by topical application of 0.6 mL 50% w/v BTN/A in paraffin oil in test animals while controls received 0.6 ml of paraffin oil. Each dose was absorbed onto a 4 x 2.5 cm absorbent patch (Whatman No. 3 filter paper) which was applied to the skin and covered by an occlusive dressing (Blenderm, 3-M Co. and Elastoplast, Smith and Nephew Ltd) for 48 houres.
Challenge procedure
Both flanks of all animals were clipped to expose areas (5 x 5 cm) on either side of the trunk. On Day 22, the left site was treated by topical application of 0.03 mL paraffin oil while the right side received 0.03 mL 50% /v BTN/A in paraffin oil to one site and 10% w/v BTN/A in paraffin oil to a second site. The doses were absorbed onto 1 cm diameter absorbent patches and covered by an occlusive dressing for 24 hours.
The challenge sites were examined approximately 24 and 48 hours after removal of the occlusive dressings. The presence or absence of erythema or swelling of the treated skin was assessed without knowledge of the number or group identity of the animal under examination. The degree of reaction was scored on a five point scale:
o No response
+/- Barely perceptible erythema
I Slight erythema
2 Moderate erythema
3 Severe erythema
Bodyweight
The bodyweight of each animal was recorded at weekly intervals to detect treatment-related depression of growth or individual cases of ill-health. - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A total of eleven of the twenty test animals challenged with 50% w/v BTN/A in paraffin oil displayed a significant response (slight erythema or more marked reaction). No significant reaction was observed in similarly challenged controls nor amongst test or control animals challenged with 10% w/v BTN/A in paraffin oil or paraffin oil alone. It is therefore concluded that, under the conditions of this study, repeated administration of BTN/A caused delayed contact hypersensitivity in guinea-pigs.
- Executive summary:
Delayed dermal sensitisation has been investigated using the Maximisation test of Magnusson and Kligman and following OECD/EU test methods. 55% of animals challenged with the substance at a concentration of 50% w/v displayed a significant response. No such reaction was observed in similarly challenged controls. No significant response was observed amongst test or control animals challenged with the substance at a concentration of 10% w/v. It was concluded that the substance causes delayed contact hypersensitivity in guinea-pigs.
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