Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-08-08 to 1989-08-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant; Guideline Study (OECD 404; adopted 1981). deviation from OECD Guideline adopted 2002: occlusive treatment. This deviation has no influence on the reliability of the study.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May 12, 1981
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
April 25, 1984
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical properties: solid;
- Storage conditions: room temperature;

Test animals

Species:
rabbit
Strain:
New Zealand White
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;
- Weight at study initiation: 2550 - 2750 gr;
- Housing: individually in metal cages;
- Diet: standard rabbit pellet diet - Nafag No. 814, Gossau, Switzerland; ad libitum;
- Water: fresh water ad libitum;
- Acclimation period: at least 5 days;

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C;
- Humidity: relative humidity of 30-70 %
- Air changes (per hr): no information available;
- Photoperiod: 12 hours light cycle per day.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: moistened with water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g;

VEHICLE
- Patches were moistened with distilled water before application;
Duration of treatment / exposure:
4 hours
Observation period:
72 hours (skin reactions were scored at 1, 24, 48 and 72 hours after patch removal)
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 12 - 16 cm² at the flank of the animals
- Type of wrap: patch covered with aluminium foiul and hold in place with adhesive plast (Isoplast) wrapping

REMOVAL OF TEST SUBSTANCE
- Washing: none

SCORING SYSTEM: OECD guideline No. 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation.
It can be concluded that the test item has no primary skin irritant potency in albino rabbits.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU