Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Start of experiment: September 27, 1988; End of experiment: September 30, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
This test was based on the OECD Guideline No. 404, adopted May 12, 1981, by the OECD council.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
Test article: FAT 92185/A
Batch No.: EN 27.86
Contents of active ingredients: approx. 55 %
Physical properties: solid/ solubility in water not determined
Storage conditions: room temperature
Stability: not determined
Safety precautions: gloves and face masks
Test material received: September 1, 1988








Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Breeder: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
Acclimatisation period: at least 5 days

Group size and husbandry
The test was performed on 3 female rabbits, checked for normal skin conditions, weighing between 2390 to 2500 g (approx. 12-14 weeks old). The animals were housed individually in metal cages, identified by individually numbered ear tags, kept at a
constant room temperature of 20±3 °C, at a relative humidity of 30-70 % and on a 12 hours light cycle day. The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water. All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer. Analytical results are available at the animal supply office. The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). Results of the routine chemical examination of water at source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschutz) are available to Ciba-Geigy Ltd. , as well as the results of inhouse chemical analysis by the analytical laboratories of the Pharmaceuticals Division, Ciba-Geigy Ltd. The body weight was recorded at start and on day 3 of the test.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Details on study design:
An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm ) bearing 0.5 g of the test article was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80 (prepared by Pharmaceuticals Division, Ciba-Geigy Ltd.). The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg). The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. The irritant/corrosive potency of FAT 92185/A was classified according to the EEC Council Directive 83/467.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation

Any other information on results incl. tables

The individual reaction scores of the control and treated flanks are summarised in Table 1 of the report, the individual body weights in Table 2 of the report. Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation. According to the EEC classification of the results obtained, FAT 92185/A can be classified as non-irritant in albino rabbits.

Body weights

animal no. 10/F, 11/F, 12/F

at start of test 2390, 2500, 2430

after 3 days (end) 2410, 2600, 2440

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions employed FAT 92185/A induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, FAT 92185/A can be classified as non-irritant according to the EEC Council Directive 83/467.
Executive summary:

Under the experimental conditions employed FAT 92185/A induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the

bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, FAT 92185/A can be classified as non-irritant according to the EEC Council Directive 83/467.