Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-12-09 to 1996-12-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable with restrictions - the purity and the stability of the test material were missing in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987-02-24
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
signed 1996-02-27

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): POTASSIUM HEXAFLUOROTITANATE (IV) FINE POWDER PURE
- Physical state: white granular solid
- Storage condition of test material: ambient temperature (< 25°C), under artificial light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 3.02 kg
- Housing: the animal was housed in a suspended metal cage.
- Diet (ad libitum): STANRAB SQC Rabbit Diet, Special Diets Services, Witham, Essex, UK
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 to 19°C
- Relative humidity: 49 to 56%
- Air exchanges: approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a volume of 0.06 mL of the test material, which was found to weigh approximately 100 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 immediately after application, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes.
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
approximately 1 and 24 hours following treatment
Number of animals or in vitro replicates:
one rabbit
Details on study design:
Immediately before the start of the test, both eyes of the provisionally selected test rabbit were examined for evidence of ocular irritation or defect with the aid of a light source from as standard ophthalmoscope.

SCORING SYSTEM: according to the Draize scale
Any other ocular effects were also recorded.
Immediately after administration of the test material, an assessment of the initial pain reaction was made.
If the rabbit shows irreversible ocular damage the test material will be classified as corrosive to the eye.

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Opacity of cornea covered an area greater than three quarters, up to whole area.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 hours
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal killed immediately after 24-hour observation. Opacity of cornea covered an area greater than three quarters, up to whole area.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Pupil abnormally small in appearance.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Animal killed immediately after 24-hour observation. Pupil abnormally small in appearance.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Petachial haemorrhage of nictitating membrane and conjunctival membrane of lower eyelid; pale appearance of nictitating membrane.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 hours
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Animal killed immediately after 24-hour observation. Pale appearance of nictitating membrane; haemorrhage of the nictitating and lower conjunctival membranes.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Discharge with moistening of the lids and hairs a considerable area around the eye.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal killed immediately after 24-hour observation. Discharge with moistening of the lids and hairs a considerable area around the eye.
Irritant / corrosive response data:
Diffuse corneal opacity was noted in the treated eye one hour after treatment with translucent corneal opacity noted at the 24-hour observation.
Iridial inflammation was noted in the treated eye one hour after treatment and at the 24-hour observation.
Conjunctival irritation was noted in the treated eye one hour after treatment with severe conjunctival irritation noted at the 24-hour observation.
Haemorrhage of the nictitating membrane was noted in the treated eye at the 1 and 24-hour observations. The nictitating membrane was pale in appearance at these times.
Haemorrhage of the conjunctival membrane of the lower eyelid was noted at the 24-hour observation.
The pupil of the treated eye appeared abnormally small at the 1 and 24-hour observations.
Due to showing signs of pain and discomfort the animal was killed for humane reasons in accordance with company policy and current UK Home office guidelines

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is considered to cause serious damage to the eyes of rabbits.
According to 67/548/EC and subsequent regulations, dipotassium hexafluorotitanate is classified as being a risk of causing serious damage to the eyes (R41) .
According to the EC Regulation No. 1272/2008 and subsequent regulations, dipotassium hexafluorotitanate is classified as Category 1.