Registration Dossier
Registration Dossier
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EC number: 245-322-4 | CAS number: 22914-58-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dimolybdenum trizinc nonaoxide
- EC Number:
- 245-322-4
- EC Name:
- Dimolybdenum trizinc nonaoxide
- Cas Number:
- 22914-58-5
- Molecular formula:
- Mo2O9Zn3
- IUPAC Name:
- dimolybdenum trizinc nonaoxide
- Reference substance name:
- Molybdenum zinc tetraoxide
- EC Number:
- 237-377-8
- EC Name:
- Molybdenum zinc tetraoxide
- Cas Number:
- 13767-32-3
- Molecular formula:
- MoO4Zn
- IUPAC Name:
- molybdenum zinc oxide
- Test material form:
- solid
Constituent 1
impurity 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: In house stock supply
- Age at study initiation: 39 to 40 weeks old
- Weight at study initiation: 3.34 to 4.35 Kg
- Housing: Each animal was housed individually in a plastic cage with perforated floors.
- Diet (e.g. ad libitum): 150 g of standard laboratory rodent diet per day. A dietary supplement of hay was offered during acclimatization and throughout the study observation period.
- Water (e.g. ad libitum): Provided ad libitum
- Acclimation period: 21 to 27 weeks prior to the start of study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20°C
- Humidity (%): 40 to 70%
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycles.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Duration of treatment / exposure:
- Three rabbits each received a singular ocular instillation of 0.1 g of the test substance
- Observation period (in vivo):
- Up to 1 week after instillation
- Number of animals or in vitro replicates:
- Three rabbits. A single animal was treated in advance; in the absence of a severe effect in this animal two further animals were committed to the study.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were flushed with saline to remove residual test substance at 24 and/or 48 hours after instillation as required per animal.
SCORING SYSTEM: Draize as per the OECD 405 guideline.
TOOL USED TO ASSESS SCORE: An ophthalmoscope or pencil beam torch was available for use to facilitate inspection of the eyes.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Iritis, a crimson-red conjunctival appearance, slight or moderate chemosis and moderate discharge were evident in the treated eye of all animals one hour after instillation. Injection of the conjunctival blood vessels or a crimson-red conjunctival appearance and slight or moderate chemosis were apparent during the next three days; slight discharge was evident in two animals 24 hours after instillation and in one animal at the 48 hour examination. The treated eye of all animals was overtly normal one week after instillation. Instillation of the test item gave no initial pain response.
- Other effects:
- There was no sign of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Mean values for ocular lesions:
24, 48 and 72 hours after instillation of Zinc Molybdate
Animal number |
Corneal Opacity |
Iridial Lesions |
Redness of Conjunctiva |
Chemosis |
1F# |
0.0 |
0.0 |
1.7 |
1.7 |
2F |
0.0 |
0.0 |
1.3 |
1.0 |
3F |
0.0 |
0.0 |
1.7 |
1.3 |
# Sentinel animal
F Female
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was shown to be negative for eye irritation and no classification under EU CLP (EC No. 1272/2008) is required.
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