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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
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- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
skin sensitisation: not sensitising (OECD 406; GLP; read-across from vanadium oxide sulphate pentahydrate and sodium metavanadate)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-05-18 to 2010-09-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- Deviations:
- yes
- Remarks:
- , guinea pigs were housed at a temperature of 22°C +/- 3°C instead at a temperature of 20 +/- 3°C
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-11-12
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Since the LLNA is prone to false negative results with metals and false positive results due to skin irritation, which could not be completely excluded for vanadium substances, it was decided to conduct the more appropriate and metal-sensitive Magnusson and Kligman study (OECD 406) instead of the LLNA with the selected vanadium substance.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services Germany GmbH, Stolzenseeweg 32 – 36, 88353 Kißlegg, Germany
- Age at study initiation: 32 days
- Weight at study initiation: 323 - 360 g (excluding positive control group); Positive control group: 312 - 381 g
- Housing: The animals were kept in pairs in MAKROLON cages (MZK 80/25). Granulated textured wood (Granulat A2, J. BRANDENBURG, 49424 Goldenstedt, Germany) was used as bedding material in the cages.
- Diet (ad libitum): Commercial diet, ssniff® Ms-H V2233 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C (maximum range)
- Relative humidity: 55% ± 15% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Concentration / amount:
- 0.01 % of Freund's complete adjuvant (diluted 1:1 with 0.9 % NaCl)
- Day(s)/duration:
- Day 0
- Route:
- intradermal
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- 0.1 mL of 0.01 % vanadium oxide sulphate pentahydrate
- Day(s)/duration:
- Day 0
- Route:
- intradermal
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- 0.1 mL of vanadium oxide suphate pentahydrate in a 1:1 mixture (v/v) FCA/physiological saline
- Day(s)/duration:
- Day 0
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- 10 % solution of vanadium oxide sulphate pentahydrate
- Day(s)/duration:
- Day 7 (exposure: 48 hours)
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- 0.5 % solution of vanadium oxide sulphate pentahydrate
- Day(s)/duration:
- Day 21 (exposure period: 24 hours)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary test: 10 animals
Main study: 10 animals (treatment group) plus 5 animals (vehicle control group)
Positive control group: 20 - Details on study design:
- RANGE FINDING TESTS:
The aim of the preliminary study was to determine the appropriate dose level of the test item following intracutaneous and topical administration. The concentration used in the main study following the induction procedure should produce mild to moderate (grade 1 or grade 2) skin reactions following topical application and be adjusted to the highest level that can be well tolerated locally and generally following intracutaneous injection. For the challenge exposure a subirritating concentration was used which produced no evidence of skin irritation in non-sensitised animals.
The shoulder and the flank region of the animals were shaved or shaved and depilated (approx. 5 cm x 5 cm).
(a) intracutaneous: 0.1 mL of the prepared test item was administered intracutaneously (shoulder region).
Three concentrations of the test item were injected intradermally into four animals, respectively. In all, twelve concentrations were tested intracutaneously.
(b) topical: The test area of 6 animals was shaved (3 animals) or shaved and depilated (3 animals). 2 mL of the test preparation was spread over a filter paper (2 cm x 4 cm) and applied to the test area and held in contact by an occlusive dressing.
Two concentrations each were applied to the shaved or shaved and depilated flanks of 6 animals each.
The occlusive dressing and the filter paper containing the test item were removed after 24 or 48 hours and the application sites were assessed immediately, 24 and 48 (depilated) or immediately and 24 hours (non-depilated) after removal of the filter paper for erythema and oedema using the grading scale of MAGNUSSON/KLIGMAN..
Results:
Twelve concentrations of vanadium oxide sulphate pentahydrate were tested by intracutaneous injection: 0.00001, 0.00005, 0.0001, 0.0005, 0.001, 0.005, 0.01, 0.1, 0.5, 1, 5 or 10% solutions in aqua ad iniectabilia.
Concentrations up to 0.005% did not reveal any skin reaction. A concentration of 0.01% revealed a moderate and confluent erythema 24 hours and an intense erythema and swelling 48 and 72 hours after administration. Concentrations of 0.1% and above revealed an intense erythema and swelling 24 to 72 hours after administration.
Six concentrations of vanadium oxide sulphate pentahydrate were tested by topical application: 0.5, 1, 5, 10, 25 and 50% concentrations in aqua ad iniectabilia.
- Non-depilated skin: A concentration of 0.5% did not reveal any skin reactions. Concentrations of 1 or 5% revealed a discrete or patchy erythema, concentrations of 10% and above a moderate and confluent erythema 48 and 72 hours after start of administration.
- Depilated skin: A concentration of 0.5% did not reveal any skin reactions. A concentration of 1% revealed a discrete or patchy erythema 24 hours after administration. A concentration of 5% revealed an intense erythema and swelling 24 hours and a moderate and confluent erythema 48 and 72 hours after start of administration. Concentrations of 10% and above revealed an intense erythema and swelling 24, 48 and 72 hours after start of administration.
It was decided to use a 0.01% solution for the 1st (intracutaneous) induction stage, a concentration of 10% for the 2nd (topical) induction stage and a 0.5% concentration for the challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injection and topical administration)
- Test groups:
Stage 1:
Day 0
Three pairs of intradermal injections of 0.1 mL were given in the shoulder region which was cleared of hair so that one of each pair lay on each side of midline.
(1) Freund's complete adjuvant (Batch no. 049K8700; SIGMA-ALDRICH Chemie GmbH, 82024 Taufkirchen, Germany)(diluted 1 : 1 with 0.9% NaCl (Batch no. 005632; Delta Select GmbH, 63303 Dreieich, Germany))
(2) the test item (vanadium oxide sulphate pentahydrate) (0.01 % in aqua ad injectabilia)
(3) the test item in a 1:1 mixture (v/v) FCA/physiological saline
In injection 3, the final concentration of the test item was equal to that in injection 2.
Stage 2:
Day 7
7 days after the intracutaneous injection, the shoulder region of the same animals was shaved again but not depilated and treated topically using the patch-test technique (as described above under "Range finding tests") (exposure time: 48 hours). The patch was removed after 48 hours. No cleaning of the skin was necessary.
- Control group:
The vehicle control animals were treated in the same way as the animals of the test group, but received aqua ad iniectabilia instead of the test item.
- Skin observations and scoring: The skin reaction results of the first induction exposure (intradermal injection) were evaluated at 24 and 48 hours, of the second induction (topical administration) at 48 and 72 hours after start of exposure.
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (topical administration)
- Test groups:
Stage 3:
Two weeks (Day 21) after the topical application (corresponds to a monitoring period of 21 days) the flanks of the same animals were shaved and depilated for a further topical application using the patch-test technique (as described above under "Range finding tests"). The filter paper containing the test item was applied to the left flank, the filter paper with the vehicle to the right flank of the animal (exposure time: 24 hours). 21 hours after the filter paper had been removed the treated skin was cleaned and fur removed, if necessary.
- Control group:
The left flank was treated with the test item, the right flank with the vehicle i.e. in the same way as the test group.
- Evaluation (hr after challenge):
21 hours after removing the filter paper the challenge area was cleaned and cleared of hair if necessary. Three hours later (at 48 hours from the start of challenge application) the skin reaction was observed and recorded. 24 hours after this observation a second observation (72 hours) was made and recorded. The skin reactions were graded following the grading scale of MAGNUSSON/KLIGMAN.
OTHER OBSERVATIONS:
Mortality: daily during the observation period
Clinical signs: daily during the observation period
Body weight: at start of study and at study termination
Pathology: No necropsy was performed. No animal was found dead in the main study or was sacrificed in extremis.
POSITIVE CONTROL GROUP:
The animals of the positive control group (same origin (strain) as those used in the study) were treated with a 2% (w/v) benzocaine solution intracutaneously in stage 1, a 5% (w/v) benzocaine solution topically in stage 2 and in stage 3.
The positive control data are obtained from the historical background of the laboratory that conducted this test. The study was performed during March 2010. - Challenge controls:
- Vehicle control group: Aqua ad iniectabilia
5 males were used for the vehicle control group. - Positive control substance(s):
- yes
- Remarks:
- Benzocaine (dissolved in 40% ethanolic 0.9% NaCl solution)
- Positive control results:
- Animals of this strain treated with benzocaine in 40% ethanolic 0.9% NaCl solution exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema or an intense erythema and swelling.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5% solution of vanadium oxide sulphate pentahydrate in aqua ad iniectabilia
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin irritation was observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5% solution of vanadium oxide sulphate pentahydrate in aqua ad iniectabilia
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin reaction was observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5% solution of vanadium oxide sulphate pentahydrate in aqua ad iniectabilia
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The vehicle control revealed no skin reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5% solution of vanadium oxide sulphate pentahydrate in aqua ad iniectabilia
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The vehicle control revealed no skin reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5% (w/v) benzocaine solution (Benzocaine was dissolved in 40% ethanolic 0.9% NaCl solution)
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Animals exhibited a sensitising reaction in form of a moderate and confluent erythema or an intense erythema and swelling.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5% (w/v) benzocaine solution (Benzocaine was dissolved in 40% ethanolic 0.9% NaCl solution)
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Animals exhibited a sensitising reaction in form of a moderate and confluent erythema or an intense erythema and swelling.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the Regulation (EC) 1272/2008 and subsequent adaptations, the substance is not sensitising to the skin.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-05-18 to 2010-09-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- Deviations:
- yes
- Remarks:
- , guinea pigs were housed at a temperature of 22°C +/- 3°C instead at a temperature of 20 +/- 3°C
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-11-12
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Since the LLNA is prone to false negative results with metals and false positive results due to skin irritation, which could not be completely excluded for vanadium substances, it was decided to conduct the more appropriate and metal-sensitive Magnusson and Kligman study (OECD 406) instead of the LLNA with the selected vanadium substance.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services Germany GmbH, Stolzenseeweg 32 – 36, 88353 Kißlegg, Germany
- Age at study initiation: 32 days
- Weight at study initiation: 325 - 361 g (excluding positive control group); Positive control group: 312 - 381 g
- Housing: The animals were kept in pairs in MAKROLON cages (MZK 80/25). Granulated textured wood (Granulat A2, J. BRANDENBURG, 49424 Goldenstedt, Germany) was used as bedding material in the cages.
- Diet (ad libitum): Commercial diet, ssniff® Ms-H V2233 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C (maximum range)
- Relative humidity (%): 55% ± 15% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Concentration / amount:
- 0.1 mL of Freund's complete adjuvant (diluted 1:1 with 0.9 % NaCl)
- Day(s)/duration:
- Day 0
- Route:
- intradermal
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- 0.1 mL of 0.01 % sodium metavanadate
- Day(s)/duration:
- Day 0
- Route:
- intradermal
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- 0.1 mL of sodium metavanadate in a 1:1 mixture (v/v) FCA/physiological saline
- Day(s)/duration:
- Day 0
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- 1 % solution of sdium metavanadate
- Day(s)/duration:
- day 7 (exposure: 48 hours)
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: aqua ad iniectabilia
- Concentration / amount:
- 0.05 % solution of sodium metavanadate
- Day(s)/duration:
- Day 21 (exposure period: 24 hours)
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary test: 16 animals
Main test: 10 animals (treatment group) plus 5 animals (vehicle control group)
Positive control group: 20 animals - Details on study design:
- RANGE FINDING TESTS:
The aim of the preliminary study was to determine the appropriate dose level of the test item following intracutaneous and topical administration. The concentration used in the main study following the induction procedure should produce mild to moderate (grade 1 or grade 2) skin reactions following topical application and be adjusted to the highest level that can be well tolerated locally and generally following intracutaneous injection. For the challenge exposure a subirritating concentration was used which produced no evidence of skin irritation in non-sensitised animals.
The shoulder and the flank region of the animals were shaved or shaved and depilated (approx. 5 cm x 5 cm).
(a) intracutaneous: 0.1 mL of the prepared test item was administered intracutaneously (shoulder region).
Three concentrations of the test item were injected intradermally into four animals, respectively. In all, twelve concentrations were tested intracutaneously.
(b) topical: The test area of 12 animals was shaved (6 animals) or shaved and depilated (6 animals). 2 mL of the test preparation was spread over a filter paper (2 cm x 4 cm) and applied to the test area and held in contact by an occlusive dressing.
Two concentrations each were applied to the shaved or shaved and depilated flanks.
The occlusive dressing and the filter paper containing the test item were removed after 24 or 48 hours and the application sites were assessed immediately, 24 and 48 (depilated) or immediately and 24 hours (non-depilated) after removal of the filter paper for erythema and oedema using the grading of MAGNUSSON/KLIGMAN.
Results:
Twelve concentrations of sodium metavanadate were tested by intracutaneous injection: 0.00001, 0.00005, 0.0001, 0.0005, 0.001, 0.005, 0.01, 0.1, 0.5, 1, 5 or 10% solutions in aqua ad iniectabilia.
Concentrations up to 0.005% did not reveal any skin reaction. A concentration of 0.01% revealed a moderate and confluent erythema 24, 48 and 72 hours after administration. A concentration of 0.1% revealed a moderate and confluent erythema 24 hours and an intense erythema and swelling 48 and 72 hours after administration. A concentration of 0.5% revealed an intense erythema and swelling 24, 48 and 72 hours after administration. The animal employed with the concentrations of 1, 5 and 10% died prematurely within 24 hours after administration.
Twelve concentrations of sodium metavanadate were tested by topical application: 0.0005, 0.001, 0.005, 0.01, 0.05, 0.1 0.5, 1, 5, 10, 25 and 50% concentrations in aqua ad iniectabilia.
Non-depilated skin: Concentrations up to 0.05% did not reveal any skin reactions. Concentrations of 0.1 or 0.5% revealed a discrete or patchy erythema, a concentrations of or 5% revealed a moderate and confluent erythema, concentrations of 10% and above revealed an intense erythema and swelling 48 and 72 hours after start of administration, respectively.
Depilated skin: Concentrations up to of 0.05% did not reveal any skin reactions. A concentration of 0.1% revealed a discrete or patchy erythema 24, 48 and 72 hours after start of administration. A concentration of 0.5% revealed a moderate and confluent erythema 24 hours and an intense erythema 48 and 72 hours after start of administration. Concentrations of 1% and above revealed an intense erythema and swelling 24, 48 and 72 hours after start of administration.
It was decided to use a 0.01% solution for the 1st (intracutaneous) induction stage, a concentration of 1% for the 2nd (topical) induction stage and a 0.05% concentration for the challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injection and topical administration)
- Test groups:
Stage 1:
Day 0
Three pairs of intradermal injections of 0.1 mL were given in the shoulder region which was cleared of hair so that one of each pair lay on each side of midline.
(1) Freund's complete adjuvant (Batch no. 049K8700; SIGMA-ALDRICH Chemie GmbH, 82024 Taufkirchen, Germany)(diluted 1 : 1 with 0.9% NaCl (Batch no. 005632; Delta Select GmbH, 63303 Dreieich, Germany))
(2) the test item (sodium metavanadate) (0.01 % in aqua ad iniectabilia)
(3) the test item in a 1:1 mixture (v/v) FCA/physiological saline
In injection 3, the final concentration of the test item was equal to that in injection 2.
Stage 2
Day 7
7 days after the intracutaneous injection, the shoulder region of the same animals was shaved again and treated topically using the patch-test technique (as described above under "Range finding tests)(exposure time: 48 hours). The patch was removed after 48 hours. No cleaning of the skin was necessary.
- Control group:
The vehicle control animals were treated in the same way as the animals of the test group, but received aqua ad iniectabilia instead of the test item.
Skin observations and scoring: The skin reaction results of the first induction exposure were evaluated at 24 and 48 hours, of the second induction at 48 and 72 hours after start of exposure. The skin reactions were graded following the grading scale of MAGNUSSON/KLIGMAN.
B. CHALLENGE EXPOSURE
- No. of exposures:
- Test groups:
Two weeks (Day 21) after the topical application (corresponds to a monitoring period of 21 days) the flanks of the same animals were shaved and depilated for a further topical application using the patch-test technique (as described above under "Range finding tests). The filter paper containing the test item was applied to the left flank, the filter paper with the vehicle to the right flank of the animal (exposure time: 24 hours). 21 hours after the filter paper had been removed the treated skin was cleaned and fur removed, if necessary.
- Control group:
The left flank was treated with the test item, the right flank with the vehicle i.e. in the same way as the test group.
- Evaluation (hr after challenge): 21 hours after removing the filter paper the challenge area was cleaned and cleared of hair if necessary. Three hours later (at 48 hours from the start of challenge application) the skin reaction was observed and recorded. 24 hours after this observation a second observation (72 hours) was made and recorded. The skin reactions were graded following the grading scale of MAGNUSSON/KLIGMAN.
OTHER OBSERVATIONS:
Mortality: daily during the observation period
Clinical signs: daily during the observation period
Body weight: at start of study and at study termination
Pathology: No necropsy was performed. No animal was found dead in the main study or was sacrificed in extremis.
POSITIVE CONTROL GROUP:
The animals of the positive control group (same origin (strain) as those used in the study) were treated with a 2% (w/v) benzocaine solution intracutaneously in stage 1 , a 5% (w/v) benzocaine solution topically in stage 2 and in stage 3. The positive control data are obtained from the historical background of the laboratory that conducted this study. The study was performed during March 2010. - Challenge controls:
- Vehicle control group: aqua ad iniectabilia
5 males were used for the vehicle control group. - Positive control substance(s):
- yes
- Remarks:
- Benzocaine (dissolved in 40% ethanolic 0.9% NaCl solution)
- Positive control results:
- Animals of this strain treated with benzocaine in 40% ethanolic 0.9% NaCl solution exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema or an intense erythema and swelling.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.05% solution of sodium metavanadate in aqua ad iniectabilia
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin irritation was observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.05% solution of sodium metavanadate in aqua ad iniectabilia
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No skin irritation was observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.05% solution of sodium metavanadate in aqua ad iniectabilia
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The vehicle control revealed no skin reactions.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.05% solution of sodium metavanadate in aqua ad iniectabilia
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- The vehicle control revealed no skin reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5% (w/v) benzocaine solution (benzocaine was dissolved in 40% ethanolic 0.9% NaCl solution)
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Animals exhibited a sensitising reaction in form of a moderate and confluent erythema or an intense erythema and swelling.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5% (w/v) benzocaine solution (benzocaine was dissolved in 40% ethanolic 0.9% NaCl solution)
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Animals exhibited a sensitising reaction in form of a moderate and confluent erythema or an intense erythema and swelling.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the Regulation (EC) 1272/2008 and subsequent adaptations, the substance is not sensitising to the skin.
Referenceopen allclose all
A 0.01% solution of vanadium oxide sulphate pentahydrate in aqua ad iniectabilia chosen for the 1st (intracutaneous) induction stage revealed in all 10 animals a moderate and confluent erythema 24 hours and a discrete or patchy erythema 48 hours after administration.
2 mL of a 10% concentration of vanadium oxide sulphate pentahydrate in aqua ad iniectabilia/animal chosen for the 2nd (topical) induction stage revealed in all 10 animals a discrete or patchy erythema 48 and 72 hours after start of exposure.
The challenge with 2 mL of a 0.5% solution of vanadium oxide sulphate pentahydrate inaqua ad iniectabilia/animal revealed no skin irritation in any animal and, thus, the test item had no sensitising properties.
The body weight gain of the animals treated with vanadium oxide sulphate pentahydrate was within the range of the vehicle control during the experiment.
Behaviour remained unchanged.
A 0.01% solution of sodium metavanadate i naqua ad iniectabilia chosen for the 1st (intracutaneous) induction stage revealed in all 10 animals a moderate and confluent erythema 24 hours and a discrete or patchy erythema 48 hours after administration.
2 mL of a 1% concentration of sodium metavanadate in aqua ad iniectabilia/animal chosen for the 2nd (topical) induction stage revealed in all 10 animals a discrete or patchy erythema 48 and 72 hours after start of exposure.
The challenge with 2 mL of a 0.05% solution of sodium metavanadate in aqua ad iniectabilia/animal revealed no skin irritation in any animal and, thus, the test item had no sensitising properties.
The body weight gain of the animals treated with sodium metavanadate was within the range of the vehicle control during the experiment.
Behaviour remained unchanged.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Soluble tetra- and pentavalent vanadium substances failed to elicit any skin sensitising response in sensitisation studies according to Magnusson and Kligman (OECD 406).
A justification for using the Magnusson and Kligman design instead of the LLNA is provided as attached.
The studies by Haferkorn (2010a,b) are considered key studies on skin sensitisation and are used for classification.Positive human experience with any vanadium substance have not been reported. Based on read-across, ammonium trivanadium octaoxide is not assumed to have a potential for skin sensitisation.
Read across
Upon dissolution, vanadium substances transform inartificial body fluids, including PBS, sweat, gastric juice and lung fluid, predominantlyto the pentavalent form,except in artificial lysosomal fluid; here, even pentavalent forms are converted almost completely to tetravalent species already after a short period of time (for more information on in vitro bioaccessibility testing, please refer IUCLID section 7.1). Thus, it can be assumed that vanadium speciation in body fluids is controlled by the conditions of the respective medium but not by the vanadium source. Thus, read-across of skin sensitisation data from soluble tetra- and pentavalent vanadium substances is justified.
Ammonia/ammonium (i) is ubiquitous in the environment (air, soil and water) and as part of the natural nitrogen cycle intrinsically present in the human body due to a natural background in all dietary sources, and (ii) ammonia/ammonium is a normal constituent of all body fluids. The sources of endogenous ammonium include bacterial hydrolysis of urea and other nitrogenous compounds in the intestine, the purine-nucleotide cycle, amino acid transamination in skeletal muscle, and other metabolic processes in kidneys and liver. At physiological pH, it exists mainly as ammonium ion with reference serum levels just below 35 µmol/L. Any excess ammonia is excreted as urea, which is synthesised in the liver through the urea cycle. In consequence, because of its intrinsic nature as an endogenous physiological compound, any skin sensitising effect of ammonium is not to be expected.Therefore, only the potential of the respective vanadium anion was addressed by testing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Exposure to ammonium trivanadium octaoxide has not been reported to induce immune responses in vanadium industry workers, and occupational asthma or reduced lung function has not been diagnosed in vanadium and vanadium substances producing facilities.
Justification for classification or non-classification
Based on the outcome of sensitisation studies with soluble tetra- and pentavalent vanadium forms according to Magnusson and Kligman, it can be concluded that ammonium trivanadium octaoxide does not have a sensitisation potential and therefore must not need to be classified and labelled according to Regulation (EC) 1272/2008.
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