Registration Dossier

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other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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.