Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

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

Test material

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males 14 weeks, female 15 weeks
- Weight at study initiation: males 2.4 - 2.9 kg, female 2.9 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, rabbit maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen, ad libitum
- Acclimation period: Four days under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): relative humidity 40-70%,
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 mg / animal
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: the test article was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The
dressing was wrapped around the abdomen and anchored with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was flushed with lukewarm tap water
- Time after start of exposure: 4h

SCORING SYSTEM: ERYTHEMA AND ESCHAR FORMATION score 0-4, EDEMA FORMATION score 0-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 71
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
erythema score
Basis:
animal: # 72
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
erythema score
Basis:
animal: # 73
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
edema score
Basis:
animal: # 71
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
edema score
Basis:
animal: # 72
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritation parameter:
edema score
Basis:
animal: # 73
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effects occured
Irritant / corrosive response data:
no signs of irritaion at any time point
Other effects:
In the area of application orange staining of the treated skin attributed to the pigment or coloring of the test article was observed in all animals at any of the examination intervals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All calculated scores (mean of 24, 48 and 72 h) were of grade 0.00.
The test item is not subject to classification and labelling.
Executive summary:

The test item was tested for primary skin irritation according to OECD TG 404.

Under the conditions of this experiment, the test item was found to cause a primary irritation score of 0.00, when applied to intact rabbit skin. Local signs (mean of 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. In the area of application, orange staining of the treated skin by pigment or co1oring ef the test article was observed in all animals at any of the examination intervals. No corrosive effect had occurred on the skin at any measuring interval.