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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from Aug. 27, 1984 to Nov. 15, 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Test substance: FAT 20'306/B
Batch No.: HT 2025/50
Physical properties: powder
Stability: guaranted by the sponsor for 30 years (2014)
Safety precautions: gloves and face masks
Test material received: July 5, 1984

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
The albino rabbit is the recommended species for skin irritation / corrosion studies.
-Animal Strain: New Zealand white rabbits (KFM-NZW)
-Breeder: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
-Acclimatization period: 5 days
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 degree centigrade
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): on a 12 hours light cycle day.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
dist. water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5 g of the test substance was applied to the flank.
Duration of treatment / exposure:
4 hours
Observation period:
viability/mortality: Daily;
Body weights: At the start and end of the test
Number of animals:
3 male rabbits
Details on study design:
An area of about 6 sq.cm was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch bearing 0.5 g of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with dest. water.

The patches were covered with an occlusive membrane and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No reactions were observed at 24 hours to 72 hours after removing the bandages. So the test was ended after the 72 hours evaluation without the need for an observation period.
Other effects:
The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animal during the test period, and no morality occured due to the results obtained.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
It can be concluded that FAT 20'306/B has no primary skin irritant potency in albino rabbits.
Executive summary:

The test was performed to access the primary skin irritation potential when single doses of test substance are placed on the skin of rabbits. The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article. No reactions were observed at 24 hours to 72 hours after removing the bandages. The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animal during the test period, and no morality occured due to the results obtained. Based on the results of this test, it indicates that the test substance shall not be classified in accordance with CLP (Regulation EC No.1272/2008).