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Description of key information

The in vivo skin irritation potential of magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) was assessed in an FDA guideline study (Primary irritation study method) in three female albino rabbits. There was no evidence of a skin irritation reaction when the test substance (0.5 g) was applied to the intact and abraded skin of the test animals for 24 hours under occlusive conditions (with observation for up to 72 hours after patch removal).


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.

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:
25 May 1992 - 29 May 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: FDA Primary Irritation Study Method
Version / remarks:
Federal Register 43, 163, 1978
Deviations:
no
GLP compliance:
not specified
Specific details on test material used for the study:
Nonswellable mica MK (Micromica), supplied by Co-op Chemical Co., Ltd.
Species:
rabbit
Strain:
not specified
Remarks:
"Albino"
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Clean Jikken-Dohbutsu Center, Saitama, Japan.
- Age at study initiation: Not specified.
- Weight at study initiation: About 2.3 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 ºC ± 2 ºC
- Humidity (%): 50% ± 10%
- Air changes (per hr): 17 changes/hour.
- Photoperiod (hrs dark / hrs light): 12 hours (light from 06.00 to 18.00)

IN-LIFE DATES: Not specified.
Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
Abraded sites were also tested.
Vehicle:
unchanged (no vehicle)
Remarks:
Solid substance, wetted with drops of water.
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of solid test substance, wetted with drops of water.
Duration of treatment / exposure:
24 hours.
Observation period:
72 hours.
Number of animals:
3 (females).
Details on study design:
TEST SITE
- Area of exposure: 4 cm x 4 cm.
- Type of wrap if used: Double wrapping with non-permeable adhesive tape (Brenderm, 3M) and elastic bandage (Silkytex, Alcare).

OBSERVATION TIME POINTS: 3, 24, 48 and 72 hours after removal of the patches.

SCORING SYSTEM:
- Erythema and eschar formation:
-- No erythema: 0
-- Very slight (barely discernible) erythema: 1
-- Well-defined erythema: 2
-- Moderate erythema: 3
-- Severe erythema with slight eschar formation: 4

- Oedema formation:
-- No oedema: 0
-- Very slight (barely discernible) oedema: 1
-- Slight oedema (edges of area well-defined by definite raising): 2
-- Moderate oedema (raised approximately 1 mm): 3
-- Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4

- Primary irritation index (PII) is the sum of the erythema and oedema scores:
-- Not irritating: 0 ≤ PII < 0.5
-- Slightly irritating: 0.5 ≤ PII < 2.0
-- Moderately irritating: 2.0 ≤ PII < 5.0
-- Severely irritating: 5.0 ≤ PII < 6.0
-- "Erosive" [Corrosive]: 6.0 ≤ PII < 8.0
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Other effects:
No abnormalities in gross appearance, behaviour or appetite were noted in the tested animals during the study period.
Interpretation of results:
GHS criteria not met
Conclusions:
In a guideline in vivo study, magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) was found to be non-irritating to the skin of rabbits.
Executive summary:

The in vivo skin irritation potential of magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2) was assessed in an FDA guideline study (Primary irritation study method) in three female albino rabbits. There was no evidence of a skin irritation reaction when the test substance (0.5 g) was applied to the intact and abraded skin of the test animals for 24 hours under occlusive conditions (with observation for up to 72 hours after patch removal).

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:
28 November 1994 - 05 December 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
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
Specific details on test material used for the study:
Nonswellable mica MK (Micromica), supplied by Co-op Chemical Co., Ltd.
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.
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No skin irritation reactions were observed in an in vivo test. In an in vivo eye irritation study, all observed irritation reactions were found to be fully reversible within 24 hours. Thus, under the GHS/CLP criteria, no classification for skin or eye irritation is required for magnesium potassium fluoride silicate (Mg2.7K0.7Si4O10F2).