Registration Dossier
Registration Dossier
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EC number: 406-260-5 | CAS number: 58834-75-6 BTN; VPO CATALYST
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study conducted in accordance with 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, England
- Age at study initiation: circa 13 wees
- Weight at study initiation: 2.71 - 2.93 kg
- Housing: Individually housed in stainless steel cages
- Diet (e.g. ad libitum): SQC rabbit diet from Special Diet Services, ad libitum
- Water (e.g. ad libitum): Municipal tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 23 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: 1990-03-19 To: 1990-03-22
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): .05 g
- Concentration (if solution): n/a - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1h, 24h, 48h and 72h
- Number of animals:
- 3 male
- Details on study design:
- TEST SITE
- Area of exposure: 3 x 2 cm
- Type of wrap if used: Unmedicated gauze patch held in place by strips of Blenderm adhesive tape. Pads of cotton wool placed over tst sites and trunk wrapped in elasticated bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated sites washed with warm water and dried using paper towels
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Black staining from the test substance was observed at the test site of two animals until the 24 hour examination and in the other rabbit until the 72 hour examination. The discolouration did not affect the assessment of any potential erythematous response. There was no irritant response to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There was no irritation response to treatment.
Under the conditions of this test, BTN/A was designated 'non-irritant' to skin. - Executive summary:
Skin irritation has been investigated using OECD/EU test methods. Exposure to the substance for 4 hours did not result in any irritant response.
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