Potassium tetrafluoroaluminate

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Aluminum potassium fluoride

EC Number:

262-153-1

EC Name:

Aluminum potassium fluoride

Cas Number:

60304-36-1

Details on test material:

Identification: KALIUMTETRAFLUOROALUMINAT
Description: colourless powder
Batch number: 0136A
Purity/Formulation: Assay of F 51.4% (47-53%), Al 17.7% (14-18%)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Test system: New Zealand White Rabbit, SpF
- Rationale: Recognized by the international guidelines as the recommended test system
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at start of treatment: 14 weeks (male), 14-16 weeks (females)
- Body weights at start of treatment: 2.7 to 3.1 kg
- Acclimatization: Seven days under laboratory conditions after health examination, only animals without any visual signs of illness were used for the study.
- Conditions: Standard Laboratory Conditions. The animal room was air-conditioned with 10-15 air changes per hour. The air was continuously monitored for temperature and relative humidity. The ranges for room temperature and relative humidity were 21-23.5 oC and approximately 39-75%, respectively. The animals were provided with an automatically controlled light cycle of 12 hours light and l2 hours dark. Music was played during the light cycle.
- Accommodation: Individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: right eye served as the reference control

Amount / concentration applied:

0.1 g (left eye only)

Duration of treatment / exposure:

single application

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, 17 and 21 days after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: primary irritation score

Time point:

other: 24, 48 and 72 hrs

Score:

4.33

Max. score:

13

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 17 days

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Diffuse corneal opacity was seen in all animals at the 1-hour examination and persisted through 72 hours before disappearing at 7 days (one animal), 10 days (one animal) or 21 days (one animal). Slight reduced light reflex of the iris was noted in one animal at the 1-hour examination. Hyperemic blood vessels of the conjunctivae and nictitating membrane were observed in all animals 1 hour after treatment and increased in severity through 72 hours before diminishing to clear by day 10 (one animal), 14 (one animal) or 17 (one animal).

Obvious swelling of the conjunctivae and nictitating membrane with partial eversion of lids or with lids about half-closed was observed in all animals at the 1-hour reading before diminishing by day 7 (one animal), 10 (one animal) or 14 (one animal).

A red ring of blood vessels was observed in all animals above the iris at the 7-day reading and persisted in two animals at the 10-day reading before disappearing in only one animal 14 days after treatment.

The sclera was not visible in all animals at 1 hour due to the swelling. A slightly reddened sclera was observed in all animals at the 24-hour reading and increased in severity in one animal at the 48-hour reading whereas the sclera was not visible in the two other animals due to the mucous production in the treated eye. When the sclera of one animal was not visible, a moderately reddened sclera was seen in the two other animals at 72 hours. Slightly to markedly reddened sclera was observed in all animals from 7 to 17 days after treatment and still persisting on test day 21 in two animals.

No staining of the treated eyes by the test item was observed.
No corrosion was observed at any of the measuring intervals.
All eye reactions were not clear 21 days after treatment.