Registration Dossier
Registration Dossier
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EC number: 215-231-4 | CAS number: 1314-35-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-06-24 to 2002-08-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tungsten trioxide
- EC Number:
- 215-231-4
- EC Name:
- Tungsten trioxide
- Cas Number:
- 1314-35-8
- Molecular formula:
- O3W
- IUPAC Name:
- trioxotungsten
- Details on test material:
- - Name of test material (as cited in study report): Tungsten oxide
- Supplier: Sponsor
- Physical state: Yellow to greenish powder
- Analytical purity: 99.88%
- Purity test date: 2002-05-28
- Stability under test conditions: 5 years
- Storage condition of test material: Ambient temperature, dry
- Melting point: Approx. 1473 degrees C
- pH: 6.1 (aqueous suspension, 100 g/L)
- Solubility: < 10 mg/L WO3
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 Wiga, D-97633
- Weight at study initiation: 1.8-2.0 kg
- Housing: Animals were housed singly in metal wire cages, type KK 016R
- Diet: Altromin 2023 diet for rabbits - ad libitum. Hay briquettes were offered additionally as a dietary supplement.
- Water: Tap water from an automatic watering system - ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19.6 °C
- Humidity (%): Average of 70.3%
- Air changes (per hr): 12/hr
- Photoperiod (hrs dark / hrs light): 12 dark/12 light (6 am to 6 pm)
IN-LIFE DATES: From: 2004-06-24 To: 2004-06-28
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: deionised water
- Controls:
- other: surrounding untreated skin
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/ 2.5 cm X 2.5 cm patch
VEHICLE
- Amount(s) applied (volume or weight with unit): 1.0 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm X 2.5 cm on the clipped dorsal areas of the trunk of the rabbits.
- Type of wrap if used: cellulose patches and self adhesive non woven, hypoallergenic fabric
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was wiped off with wet Kleenex tissues after 4 hour exposure period, if necessary.
SCORING SYSTEM: Erythema/Eschar and Oedema
- The skin was examined using a cold light source KL 1500 electronic
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.
- Other effects:
- No general toxic effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- All areas to be treated with the test substance and all control areas were normal before the application and at each observation time. The mean scores for three of the animals at 24, 48 and 72 hrs. post application were 0.0 when observing for Erythema/Eschar and Oedema.
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