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Registration Dossier
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EC number: 254-413-8 | CAS number: 39318-18-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-06-23 to 2003-07-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Well documented, scientifically sound study that was conducted in accordance to GLP and OECD Guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tungsten oxide
- EC Number:
- 254-413-8
- EC Name:
- Tungsten oxide
- Cas Number:
- 39318-18-8
- Molecular formula:
- WOn (n=2.99 to 2.90)
- IUPAC Name:
- tungsten(6+) trioxidandiide
- Details on test material:
- - Name of test material (as cited in study report): Tungsten oxide blue
- Molecular formula (if other than submission substance): WO
- Physical state: Blue to black powder
- Analytical purity: 99.9%
- Purity test date: 2003-04-15
- Stability under test conditions: 5 years
- Storage condition of test material: Ambient temperature
- Other: Solubility in water- 118 mg/L at 20 degrees C
- pH: 6.9
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland
- Weight at study initiation: 2.1-2.6 kg
- Housing: Housed singly in metal wire cages (79 cm x 59 cm bottom area, 38 cm height)
- Diet: ad libitum (Altromin 2123 maintenance diet
- Water: ad libitum (tap water from an automatic water system)
- Acclimation period: 5 days (one animal), 12 days (two other animals)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19.4 °C
- Humidity (%): Average of 67.1%
- Photoperiod (hrs dark / hrs light): 12 dark/12 light; only artificial light from 6 am to 6 pm.
IN-LIFE DATES: From: 2003-06-23 To: 2003-07-04
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eyes remained untreated and served as control
- Amount / concentration applied:
- 100 mg of the test substance was instilled into the conjunctival sac of the right eye of each of three rabbits. The eyes were held closed for about one second to prevent a loss of test substance.
- Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM
Scoring scheme for ocular lesions- Draize, examined the cornea, iris, and conjunctivae
TOOL USED TO ASSESS SCORE: Otoscope lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Both the untreated eyes and the eyes treated with the test substance, for all three animals, were normal at each observation point.
- Other effects:
- No general toxic effects of the test substance were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The administration of 100 mg of the test substance to the eyes of three female rabbits resulted in no signs of eye irritation. No general toxic effects of the test substance were observed.
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