Dipotassium hexafluorotitanate

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-11-26 to 1996-12-03

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992-07-17

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 1996-02-27

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.30 to 2.75 kg
- Housing: the animals were individually housed in suspended metal cages.
- Diet (ad libitum): STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water (ad libitum): mains drinking water
- Acclimation period: minimum acclimatisation period of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 19°C
- Relative humidity: 49 to 64%
- Air exchanges: approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a quantity of 0.5 g of the test material, moistened with distilled water was applied.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL of distilled water

Duration of treatment / exposure:

4 hours

Observation period:

approximately one hour following the removal of the patches, and 24,48 and 72 hours later as well as on Day 7

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure and type of wrap if used: on the day before the test each rabbit was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of the test material, moistened with distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: four hours after application

SCORING SYSTEM: according to the Draize scale
Any other skin reactions, if present, were also recorded.
If irreversible alteration of the dermal tissue is noted in any rabbit, which may include ulceration and clear necrosis or signs of scar tissue, the test material is classified as corrosive to rabbit skin.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight erythema was noted at two treated skin sites at the 24, 48 and 72 hour observations.
No signs of dermal irritation were noted at one treated skin site throughout the study.
No corrosive effects were noted.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material is non-irritating to the skin of rabbits.
According to 67/548/EC and subsequent regulations, dipotassium hexafluorotitanate is not classified as a skin irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, dipotassium hexafluorotitanate is not classified as a skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987-02-24

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 1996-02-27

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

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.

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:

24 h

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:

24 h

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:

24 h

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:

24 h

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

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Justification for classification or non-classification

According to a reliable, guideline conform study (OECD 404), dipotassium hexafluorotitanate is not irritating or corrosive to skin. No classification for skin irritation/corrosion is required.

According to a reliable, guideline conform study (OECD 405), dipotassium hexafluorotitanate causes serious damage to the eye. Consequently, dipotassium hexafluorotitanate is classified for irreversible effects on the eye (Category 1), according to Regulation (EC) No 1272/2008.