Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-113-5 | CAS number: 7440-03-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-08-06 to 2009-11-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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
- EC Number:
- 231-113-5
- EC Name:
- Niobium
- Cas Number:
- 7440-03-1
- Molecular formula:
- Nb
- IUPAC Name:
- Niobium
- Test material form:
- solid: compact
- Details on test material:
- - Name of test material (as cited in study report): Niobium metal (Nb)
- Substance type: Metal
- Physical state: solid
- Analytical purity: > 98.5%
- Lot/batch No.: AD/4202
- Stability under test conditions: stable
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 15 weeks
- Weight at study initiation: > 2 kg
- Diet (ad libitum): ad libitum
- Water (ad libitum):ad libitum
- Acclimation period: 5 days
- Sex: females
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+-3
- Humidity (%): 55+-10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 2009-09-07 To: 2009-09-11
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 applied: 0.5 g moistened with water ad injectionem
VEHICLE
Aqua ad injectionem
- Lot/batch no. (if required): 749A191 - Duration of treatment / exposure:
- 4 h
- Observation period:
- Reading time points: 1, 24, 48 and 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm² of the left dorsal trunk
- Type of wrap if used: gauze patch held in place with non-irritating tape
SCORING SYSTEM: according to OECD 404 (Draize scoring)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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:
- other: CLP/EU GHS criteria not met, no classification according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
