Registration Dossier
Registration Dossier
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EC number: 234-744-4 | CAS number: 12030-85-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-12-12 to 2018-03-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted, 9th October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium niobate
- EC Number:
- 234-744-4
- EC Name:
- Potassium niobate
- Cas Number:
- 12030-85-2
- Molecular formula:
- K.NbO3
- IUPAC Name:
- niobium(5+) potassium trioxidandiide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Batch No.: 20171402
- CAS No.: 12030-85-2
- Purity: ≥ 99.8%
- Physical State: solid powder
- Colour: white
- Storage Conditions: room temperature, store in a tightly closed container
- Expiry Date: 2019-08-22
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, 97633 Sulzfeld, Germany
- Age at study initiation: animal no. 1 approximately 35 weeks old, animal no. 2 approximately 36 weeks old and animal no. 3 approximately 37 weeks old
- Weight at study initiation: 3.8 – 4.3 kg
- Housing: - Housed in ABS-plastic or Noryl rabbit cages, floor 4200 cm2
- Diet (e.g. ad libitum): Yes
- Water (e.g. ad libitum): Yes
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 + / - 3
- Humidity (%): 55 + / - 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material.
- Observation period (in vivo):
- up to 9 days
- Duration of post- treatment incubation (in vitro):
- N.A.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes with physiological saline 0.9% NaCl
- Time after start of exposure: 1 hour after the application
SCORING SYSTEM: Eye irritation scores according to Draze
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Remarks on result:
- positive indication of irritation
- 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:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9d
- Other effects:
- No systemic changes or body weight changes were observed. However, local changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In an in vivo acute eye irritation/corrosion study in rabbits, the test item was classified as an irritant under the GHS Criteria "Category 2."
- Executive summary:
In a primary eye irritation study, 0.1 g of the test item of purity ≥ 99.8% was instilled into the conjunctival sac of one eye of three male New Zealand White rabbits (obtained from Charles River Deutschland, 35, 36 and 37 weeks old respectively, 3.8 – 4.3 kg) for about one second. The treated eye was rinsed with physiological saline 1 hour after the application. The untreated eye served as control. Control and treated animals were observed for a period of 9 days. Irritation was scored by the method of Draize. All effects were reversible within 9 days after application.
Conjunctival redness, chemosis and iritis were observed with the highest score of 2, 1.33, and 1, respectively. 2 of 3 tested animals had an iritis score of ≥ 1, meeting the UN GHS for “Category 2A” for eye irritating effects.
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