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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 May 12 to15, 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test conducted according to internationally accepted testing guidelines.

Data source

Reference
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted May 12, 1981
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

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: approx. 12-14 weeks old.
- Weight at study initiation: between 2190 t o 2470 g.
- Housing: individually housed in metal cages.
- Diet: ad libitum, standard rabbit pellet NAFAG, N. 814 Gossau. All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer.
- Water: ad libitum. The quality of the drinking water was according to the specification of the "Schweizerisches Lebensmittelbuch" (Edition 1972).
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: constant room temperature of 20 ± 3 °C
- Humidity: relative humidity of 30-70 %
- Photoperiod: 12 hrs light cycle day.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
A gauze patch (20 cm2) bearing 0.5 g of the test substance was applied to the flank.
A control gauze patch was applied to the contra-lateral flank. Both gauze patches were moistened before application with distilled water.
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches.
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: an area of at least 6 cm2 was shaved on both flanks of the animals approximately 24 hours before treatment.
- Type of wrap if used: the patches were loosely covered with an aluminium foil (36 cm2 ) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

OBSERVATION
The animals were checked daily for systemic symptoms and mortality.

SCORING SYSTEM
According to the OECD scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 3/3
Time point:
other: mean 24, 48 and 72 hours
Score:
< 2.3
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
other: mean 24, 48 and 72 hours
Score:
< 2.3
Reversibility:
fully reversible
Irritant / corrosive response data:
Because no reactions were observed at 24 hours to 7 2 hours after removing the bandages, the test was ended after the 72 hours evaluation.
It can be concluded that test item has no primary skin irritant potency in albino rabbits.

Any other information on results incl. tables

Evaluation of skin reaction

Animal no. Erythema Oedema
25/M 26/M 27/M 25/M 26/M 27/M
CF/TF CF/TF CF/TF CF/TF CF/TF CF/TF
After 1 hr 0/0 0/0 0/0 0/0 0/0 0/0
After 24 hrs 0/0 0/0 0/0 0/0 0/0 0/0
After 48 hrs 0/0 0/0 0/0 0/0 0/0 0/0
After 72 hrs 0/0 0/0 0/0 0/0 0/0 0/0
mean 24-72 hrs 0/0 0/0 0/0 0/0 0/0 0/0

CF = control flank; TF = test flank

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Not irritating.
Executive summary:

Method

The skin irritation potential was assessed according to the OECD guideline No. 404, adopted May 12, 1981, by the OECD council.

Results

Under the experimental conditions employed test item did not induce skin irritation when applied to the clipped albino rabbit skin. Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation.

Conclusion

It can be concluded that test item has no primary skin irritant potency in albino rabbits.