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Diss Factsheets

Toxicological information

Eye irritation

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
110
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.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
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.