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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
(no informations if untreated skin served as control).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted May 12, 1981)
Deviations:
yes
Remarks:
(no informations if untreated skin was used as control)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Lot no. 057249.28
Test item stability garantueed by sponsor
Test material received April 18, 1983
- Storage: Room temperature
Specific details on test material used for the study:
- Lot/batch No.: 057249.28
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf / Switzerland
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2410-2530 g
- Housing: Individually
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: moistened with water before application
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3 female animals
Details on study design:
TEST SITE
- Area of exposure: at least 6 cm²
- Type of wrap if used: The gauze patch with the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, Brugg / Switzerland).

REMOVAL OF TEST SUBSTANCE
- Washing: no washing conducted

SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 48 - 72 h
Remarks on result:
other: see table below for details
Irritation parameter:
edema score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritant / corrosive response data:
Due to intensive staining by the test compound scoring after 1 h was not possible. Erythema (score 1) were detected 24 h after treatment in 2 animals. One animal recovered within the next 24 h, whereas the other animal still showed erythema (score 2). This animal recovered 72 h after treatment. No edema were observed.
Other effects:
The body weight development was not affected by the application of the test article.

Any other information on results incl. tables

Table 1: Scoring of erythema and edema formation

Exposition:  4 h, semiocclusive
Animal  Reading  Erythema Edema
1 1 h na 0
2 1 h na 0
3 1 h na 0
1 24 h 1 0
2 24 h 0 0
3 24 h 1 0
1 48 h 0 0
2 48 h 0 0
3 48 h 2 0
1 72 h 0 0
2 72 h 0 0
3 72 h 0 0
1 7 d 0 0
2 7 d 0 0
3 7 d 0 0
1 24/48/72 hrs 0.3 0
2 24/48/72 hrs 0 0
3 24/48/72 hrs 1 0
mean 24 - 72 h 0.44 0.00

na = not assessable due to staining produced by the test item.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met