Registration Dossier
Registration Dossier
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EC number: 235-117-8 | CAS number: 12069-94-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2000-07-25 to 2000-12-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. Niobium pentoxide data are used in a read-across approach for the assessment of niobium carbide.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- niobium pentoxide
- IUPAC Name:
- niobium pentoxide
- Reference substance name:
- Diniobium pentaoxide
- EC Number:
- 215-213-6
- EC Name:
- Diniobium pentaoxide
- Cas Number:
- 1313-96-8
- Molecular formula:
- Nb2O5
- IUPAC Name:
- diniobium pentaoxide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Nb2O5 NIOBIUM PENTOXIDE GRADE LN
- Physical state: A white powder
- Lot/batch No: 20000103
- Analytical purity: 99.99%
- Intended use: optical industry, electro ceramics, single crystals
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd., Bicester, Oxon, England.
- Age at study initiation: at least 12 weeks
- Weight at study initiation: 2.4 – 2.8 kg
Housing:
- Diet (e.g. ad libitum): standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet)
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 12 days
- Sex: males
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 2
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with electrical clipper
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g moistened with water ad injectionem
VEHICLE
Aqua ad injectionem - Duration of treatment / exposure:
- 4h
- Observation period:
- 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- Approximately 0.5 g of the test substance was applied under a 2-ply 25mm x 25mm gauze pad, which had been moistened with 0.5 mL distilled water, to one intact skin on each animal.
Each treatment site was covered with “Electroplast” elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (36 °C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
SCORING SYSTEM: according to OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- At all evaluation time points the individual scores for erythema and oedema were 0.
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a primary dermal irritation study according to OECD 404 niobium pentoxide was not irritating.
- Executive summary:
In a primary dermal irritation study according to OECD 404, 3 young adult New Zealand White rabbits were dermally exposed to 0.5 g niobium pentoxide (99.99%) moistened with water ad injectionem for 4 hours under a 2-ply 25x25 mm gauze pad covered with “Electroplast” elastic adhesive. Animals then were observed after 24, 48 and 72 hours after patch removal. Irritation was scored according to OECD guideline 404. No irritation was observed.
In this study, niobium pentoxide is not a dermal irritant.
The information for niobium pentoxide is used in a read-across approach in the assessment of niobium carbide.
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