Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA Primary Irritation Study Method
Version / remarks:
Federal Register 43, 163, 1978
Deviations:
no
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

Species:
rabbit
Strain:
not specified
Remarks:
"Albino"
Details on test animals or test system 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.

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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).

Categories Display