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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1992-11-18 to 1992-11-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study relibale with restrictions - The purity and stability of the test substance were not stated.

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)
Version / remarks:
, adopted 1987-02-24
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
signed 1992-06-11

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Potassium tetrafluoroborate
- Physical state: White crystalline solid
- Storage condition of test material: Room temperature
- Container: White plastic jar
No further information on the test substance was stated.

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: Twelve to sixteen weeks old
- Weight at study initiation: 2.69 - 2.89 kg (3 animals: 2.70 kg, 2: 2.57 kg, and 2.57 kg, respectively)
- Housing: The animals were individually housed in suspended metal cages.
- Diet (ad libitum): Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol, U.K.)
- Water (ad libitum): Mains drinking water
- Acclimation period: Minimum acclimatisation period of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 16 - 19 °C
- Relative humidity: 49 - 65%
- Air exchange: approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml of the test material, which was found to weigh approximately 99 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediatley after application, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purpose.
No further information on the amount/concentration applied was stated.
Duration of treatment / exposure:
Not applicable
Observation period (in vivo):
Immediately after administration of the test material, an assessment of the inital pain reaction was made.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
3 rabbits (1 male/2 females)
Details on study design:
One rabbit was initially treated. Initial pain reaction had been observed in this animal.
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. In order to minimise pain on instillation of the test material, one drop of local anaesthetic ("Ophthaine", 0.5% proxymetacaine hydrochloride, E.R. Squibb & Sons, Limited Hounslow, Middlesex, U.K.) was instilled into both eyes of these animals 1 -2 minutes before treatment.

SCORING SYSTEM: Draize scoring system
Any other adverse ocular effects were also noted.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.

OBSERVATIONS:
Immediately after administration of the test material, an assessment of the inital pain reaction was made.
No further information on the study design was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
Initial pain reaction had been observed in the first treated animal.
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.
Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Minimal conjunctival redness 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:
According to the Directive 67/548/EEC and its subsequent amendments, potassium tetrafluoroborate is non-irritating to the eye.
Also, according to the Regulation (EC) No. 1272/2008 and subsequent amendments, potassium tetrafluoroborate is non-irritatng to the eye.