Registration Dossier
Registration Dossier
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EC number: 237-487-6 | CAS number: 13814-97-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Potassium tetrafluoroborate
- EC Number:
- 237-928-2
- EC Name:
- Potassium tetrafluoroborate
- Cas Number:
- 14075-53-7
- IUPAC Name:
- potassium tetrafluoroborate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): potassium tetrafluoroborate
- Physical state: white crystalline solid
- Lot/batch No.: 2281A
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: ca. 12-16 weeks
- Weight at study initiation: 2.69-2.89 kg
- Housing: individually in suspended metal cages
- Diet: Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, U.K., ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19
- Humidity (%): 49-65
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as a negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (ca. 99 mg) - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 + 48 + 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 + 48 + 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 + 48 + 72 hours
- Score:
- 0.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 + 48 + 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Residual test material was noted around the treated eye of two animals one hour after treatment. No corneal or iridial effects were noted during the study. Chemosis was noted in all treated eyes one hour after treatment (score 1). Minimal conjunctival redness (score 1) persisted in one treated eye at the 24-hour observation. Treated eyes appeared normal 24-48 hours after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not irritating to the eye.
- Executive summary:
In a GLP-compliant OECD Guideline 405 study, rabbits were exposed to potassium tetrafluoroborate to test the eye irritation properties. 0.1 mL of the test material (ca. 99 mg) was instilled in one eye of three rabbits and the eyes were observed after 1, 24, 48 and 72 hours. Untreated eyes served as negative control. Residual test material was noted around the treated eye of two animals one hour after treatment. No corneal or iridial effects were noted during the study. Chemosis was noted in all treated eyes one hour after treatment (score 1). Minimal conjunctival redness persisted in one treated eye at the 24-hour observation (score 1; mean score at 24 + 48 + 72 hours for three animals 0.11). Treated eyes appeared normal 24-48 hours after treatment. Based on the results of the study, potassium tetrafluoroborate was concluded to be not irritating to eyes.
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