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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 August 29 to September 01, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Chbb:NZW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH Chemisch-pharmazeutische Fabrik D-7950 Biberach/Riss
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: between 2950 to 2990 g
- Housing: animals were housed individually in metal cages, identified by ear tattoo
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

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

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 12-16 cm2
- Type of wrap if used: gauze patches covered with an aluminum foil (approx. 36 cm2 ) and held in place by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

OBSERVATION TIME POINTS (indicate if minutes, hours or days)
skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according

SCORING SYSTEM:
- Method of calculation: according to the OECD scoring system

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
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not skin irritant
Executive summary:

Method

The test was performed according to the OECD guideline 404, on 3 male rabbits.

0.5 g of the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank.

The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches.

Results

Not skin irritant