Magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 November 1994 - 05 December 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Standard eye irritation test method. 50 mg of test substance was instilled into the conjunctival sac of three female rabbits. The contra-lateral eye served as the control. Treated animals were observed for 7 days.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2)

EC Number:

949-694-5

Molecular formula:

Mg2.7K0.7Si4O10F2

IUPAC Name:

Magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2)

Test material form:

solid: crystalline

Specific details on test material used for the study:

Nonswellable mica MK (Micromica), supplied by Co-op Chemical Co., Ltd.

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Remarks:

"Albino"

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Saitama Jikken-Dohbutsu Kyohkyusho, Saitama, Japan.
- Age at study initiation: Not specified.
- Weight at study initiation: About 2.4 kg.
- Housing: Individually in Natsume aluminium cages.
- Diet (e.g. ad libitum): Commercial diet ad libitum.
- Water (e.g. ad libitum): Drinking water ad libitum.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 °C ± 2 °C
- Humidity (%): 50% ± 10%
- Air changes (per hr): 17 changes/hour.
- Photoperiod (hrs dark / hrs light): 12 hours (light 06.00 - 18.00).

IN-LIFE DATES: Not specified.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

50 mg.

Duration of treatment / exposure:

Not specified. Eyes were not washed following instillation of test substance.

Observation period (in vivo):

7 days.

Number of animals or in vitro replicates:

3 (females).

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Eyes not washed.

SCORING SYSTEM: Draize. Interpretation of Draize scores according to criteria of Kay JH and Calandra JC (1962). J. Soc. Cosm. Chem. 13, 281.

TOOL USED TO ASSESS SCORE: sodium fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

110

Results 2

Irritation parameter:

other: I.A.O.I. (Max., mean score)

Remarks:

Index of acute ocular irritation

Basis:

mean

Time point:

other: 1 hour.

Score:

7.3

Max. score:

110

Reversibility:

fully reversible within: 24 hours.

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 8

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 12

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 13

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 14

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Kay and Calandra scheme for interpretation considers the maximum mean score (essentially an acute reading) combined with the persistence of the effect. The I.A.O.I. score of 7.3 combined with the mean score of 0 after 48 hours places the test substance in Class 3, "minimally irritating".

Other effects:

No abnormalities in gross appearance, behaviour or appetite were noted in the tested animals during the study period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an in vivo study, magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) was found to be non-irritating to the eyes of rabbits.

Executive summary:

The in vivo eye irritation potential of magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) was assessed in a non-guideline study in three female albino rabbits. Following instillation of the test substance (50 mg), mild conjunctival redness and discharge were observed in all three treated animals, and mild chemosis was observed in 2/3 animals. All observed irritation reactions were found to be fully reversible within 24 hours. Thus, under the GHS/CLP criteria, the test substance was concluded to be non-irritating.