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EC number: 215-204-7 | CAS number: 1313-27-5
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-07-16 to 1990-07-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, conducted and documented in accordance with GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 February 1987
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- The study report states that the study was conducted in compliance with Good Laboratory Practice Standards, e.g. by the United Kingdom Compliance Programme, Department of Health & Social Security 1986 and subsequent revision, Department of Health, 1989.
Test material
- Reference substance name:
- Molybdenum trioxide
- EC Number:
- 215-204-7
- EC Name:
- Molybdenum trioxide
- Cas Number:
- 1313-27-5
- Molecular formula:
- MoO3
- IUPAC Name:
- molybdenum trioxide
- Details on test material:
- - Name of test material (as cited in study report): Pure molybdic oxide
- Physical state: light grey powder
- Analytical purity: > 99.9% (calculated based on molybdenum content of 66.63 %)
- Impurities (identity and concentrations): no relevant impurities were stated (> 1.0%)
- Purity test date: 1990-06-06
- Stability under test conditions: not determined
- Storage condition of test material: at ambient temperature
No further significant information on test material was stated.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: aprroximately 11 to 13 weeks
- Weight at study initiation: weight range 2.6 to 3.0 kg
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet: free access to SDS Standard Rabbit Diet
- Water: free access to tap water
- Acclimation period: the rabbits were acclimated, but the acclimatisation period is not stated
ENVIRONMENTAL CONDITIONS
- Temperature: maintained at approximately 19 °C
- Relative humidity: maintained at 30-70%
- Air exchanges: maintained at approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hr / 12 hr
No further significant details on test animals were stated.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye remained untreated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: A 100 mg amount of Pure molybdic oxide, the weight occupying a volume of 0.1 ml, was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing.
VEHICLE: Test substance was administered as supplied by the Sponsor.
No further significant information on Amount/concentration applied was stated. - Duration of treatment / exposure:
- not stated
- Observation period (in vivo):
- Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and 7 days after instillation.
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- SCORING SYSTEM:
Grading and scoring of the ocular lesions were performed using the prescribed numerical scoring system as follows:
Cornea:
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity = 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible = 1
Easily discernible translucent areas, details of iris slightly obscured = 2
Nacrous areas, no details of iris visible, size of pupil barely discernible = 3
Opaque cornea, iris not discernible through the opacity = 4
Area of cornea involved:
One quarter (or less) but not zero = 1
Greater than one quarter, but less than half = 2
Greater than half, but less than three quarters = 3
Greater than three quarters, up to whole area = 4
Iris:
Normal = 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) = 1
No reaction to light, haemorrhage, gross destruction (any or all of these) = 2
Conjunctivae:
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)
Blood vessels normal = 0
Some blood vessels definitely hyperaemic (injected) = 1
Diffuse, crimson colour, individual vessels not easily discernible = 2
Diffuse, beefy red = 3
Chemosis (lids and/or nictitating membranes)
No swelling = 0
Any swelling above normal (includes nictitating membranes) = 1
Obvious swelling with partial eversion of lids = 2
Swelling with lids about half-closed = 3
Swelling with lids more than half-closed = 4
TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by the use of a handheld torch.
OTHER OBSERVATIONS: All animals were observed daily for signs of ill health or toxic signs.
No further significant information was stated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 2
- Other effects:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Instillation of molybdic trioxide into the rabbit eye elicited transient mild conjunctival inflammation only.
Molybdenum trioxide does not require classification as an eye irritant according to directive 67/548/EEC or regulation 1272/2008/EC, respectively. A pdf document including the calculation of mean irritation scores according to both guidelines is attached to this endpoint study record.
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