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EC number: 232-261-3 | CAS number: 7803-55-6
- 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
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- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- Explosiveness
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
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- Dissociation constant
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Specific investigations
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![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-02-25 to 2013-03-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 2012-10-02
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-11-12
Test material
- Reference substance name:
- Ammonium trioxovanadate
- EC Number:
- 232-261-3
- EC Name:
- Ammonium trioxovanadate
- Cas Number:
- 7803-55-6
- Molecular formula:
- H4N.O3V
- IUPAC Name:
- ammonium trioxovanadate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Ammonium trioxovanadate
- Molecular weight: 116.98 g/mol
- Physical state: white-yellow powder, odourless
- Storage condition of test material: keep dry in closed containers at room temperature.
- Water solubility: soluble
- Relative density: 2.32 [20°C; Vanadium Consortium, 2012]
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: approximately 7 months
- Weight at study initiation: 2.70 - 3.08 kg
- Housing: for 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine. During the acclimatisation period and after the 8-hour period in restrainers, the animals were kept singly in cages with dimensions of 380 mm x 425 mm x 600 mm (manufacturer: Dipl.Ing. W. EHRET GmbH, 16352 Schönwalde, Germany).
- Diet (ad libitum; before and after the exposure period): commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum; before and after exposure period): tap water
- Acclimation period: at least 20 adaptation days
ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 3°C (maximum range)
- Relative humidity: 30% - 70% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item were administered into one eye each of three animals. The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control. - Duration of treatment / exposure:
- One hour
- Observation period (in vivo):
- Prior to the administration and 1, 24, 48, 72 hours and 4 to 7 days after the administration
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- USE OF TOPICAL ANAESTHETICS AND SYSTEMIC ANALGESICS
Sixty minutes prior to test item administration, 0.01 mg Buprenovet®/kg b.w. were administered by subcutaneous injection to all animals to provide a therapeutic level of systemic analgesia to avoid or minimize pain and distress.
Five minutes prior to the test item administration, one or two drops of Ophtocain®, a topical anaesthetic, was applied to each eye of all animals, to the right eye, in which the test item was to be applied, and to the left eye, which served as control.
In addition, 8 hours after administration of the test item all animals were treated with 0.01 mg Buprenovet®/kg b.w. in conjunction with 0.5 mg Metacam®/kg b.w., subcutaneously.
INITIAL TEST AND CONFIRMATORY TEST
The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.
REMOVAL OF TEST SUBSTANCE
- Washing: each eye was rinsed with 20 mL of 0.9% aqueous NaCl solution.
- Time after start of exposure: one hour after instillation
SCORING SYSTEM: according to the Draize scale
Any further lesions are listed.
TOOL USED TO ASSESS SCORE: the eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, 72 hours and 4 to 7 days after the administration. The eye reactions were observed and registered.
24 hours and 7 days after administration, fluorescein (Fluorescein SE Thilo drops (ALCON PHARMA GmbH, 79108 Freiburg, Germany)) was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.
OBSERVATIONS:
General criteria: body weight of all animals was measured at the beginning and at the end of the study. Behaviour and food consumption were monitored.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Corneal staining (1/4 to 1/2 of the surface) was observed during the 24 hours fluorescein test.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: Corneal staining (3/4 to whole surface) was observed during the 24 hours fluorescein test.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: Corneal staining (3/4 to whole surface) was observed during the 24 hours fluorescein test.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritant / corrosive response data:
- A single instillation of 100 mg Ammonium trioxovanadate per animal into the conjunctival sac of the right eye of three rabbits caused the following changes:
Cornea opacity was observed in all animals:
- one animal: 24 and 48 hours (grade 2), 72 hours (grade 1) after instillation;
- second animal: 24 and 48 hours (grade 2), 72 hours and 4 days (grade 1) after instillation;
- third animal: 24 hours to 5 days (grade 1) after instillation.
Conjunctivae redness was observed in all animals:
- one animal: 24 and 48 hours (grade 3), 72 hours (grade 2), 60 minutes and 4 days (grade 1) after instillation;
- second animal: 24 and 48 hours (grade 3), 60 minutes and 72 hours (grade 2), 4 to 6 days (grade 1) after instillation;
- third animal: 24 hours (grade 3), 48 and 72 hours (grade 2), 60 minutes and 4 to 6 days (grade 1) after instillation.
Chemosis was observed in all animals:
- one animal: 60 minutes (grade 1), 24 and 72 hours (grade 2), 48 hours (grade 3) after instillation;
- second animal: 24 and 48 hours (grade 4), 72 hours and 4 days (grade 1) after instillation;
- third animal: 24 hours (grade 4), 48 and 72 hours (grade 2), 4 days (grade 1) after instillation.
The irises were not affected by instillation of the test item. - Other effects:
- There were not any systemic intolerance reactions concerning behaviour, body weight and food consumption.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (irritating to eyes)
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Ammonium trioxovanadate oxide is irritating to the eyes.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, ammonium trioxovanadate is classified as irritating to the eyes.
According to the EC-Regulation 1272/2008 and subsequent regulations, ammonium trioxovanadate is classified in Category 2.
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