Registration Dossier

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:
From June 13th, 1989 to June 16th, 1989.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to the OECD TG 404 and to GLP, however with following deviation: testing was conducted under occlusive conditions instead of semiocclusive as recommended by the guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Physical properties: yellow liquid, insoluble in water
Storage conditions: room temperature
Validity: May 1992

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approximately 12-14 weeks
- Weight at study initiation: 2290-2380 g
- Housing: individually in metal cages (and identified by individually numbered ear tags)
- Diet (e.g. ad libitum): standard rabbit pellet (Nafag No. 814, Gossau, Switzerland) ad libitum
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h / 12h

All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer.
The drinking water quality fulfilled the critical parameters in the specification of the "Schweizerisches Lebensmittelbuch" (Edition 1972).

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: A control gauze patch moistened with distilled water was applied to the contralateral flank.
Amount / concentration applied:
A gauze patch (approx. 12-16 cm ) bearing 0.5 mL of the test substance was applied to the right flank of each animal. The patches were loosely covered with an aluminum foil and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches; skin reaction was assessed according to the OECD scoring system. Moreover, the animals were checked daily for systemic symptoms and mortality.
Number of animals:
3 male animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(mean)
Basis:
animal: 1, 2 and 3
Time point:
other: 24-48-72 h
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Erythema graded 1 was seen in all 3 animals at reading time point 1 hour and persisted until 24 hours in only one case. After 48 hours, recovery was complete.
Irritation parameter:
edema score
Remarks:
(mean)
Basis:
animal: 1, 2, 3
Time point:
other: 24-48-72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: None of the animals showed edema
Irritant / corrosive response data:
The substance applied for 4 hours to the skin of rabbit under occlusive conditions induced very slight erythema in all 3 animals but no edema. Erythema was seen at reading time point 1 hour following removal of the dressing and was graded 1(max. 4). At reading time point 24 hour, very slight erythema persisted in one of the 3 animals. At reading time point 48 hour, reversibility was completed in all 3 animals.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU 67/548/EEC and EC/1271/2008
Conclusions:
Under the experimental conditions employed the test article induced minimal erythema reactions well below the threshold of significance when applied to the clipped albino rabbit skin.
Executive summary:

The substance was applied for 4 hours to the skin of 3 male rabbits according to the OECD TG 404, but under occlusive conditions. The treatment induced very slight erythema in all 3 animals but no edema. Erythema was seen at reading time point 1 hour following removal of the dressing and was graded 1(max. 4). At reading time point 24 hour, very slight erythema persisted in one of the 3 animals. At reading time point 48 hour, reversibility was completed in all 3 animals. Based on the scoring of the skin findings as recommended by the OECD guideline, the test item was not irritating to the skin of rabbit.