Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1994-08-09 to 1994-08-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study followed the procedures indicated by internationally accepted guidelines and recommendations as Commission Regulation (EC) No 440/2008 (B.4: Acute Toxicity: Dermal Irritation / Corrosion).
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
directive 92/69/EEC
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: a pprox. 12 weeks
- Weight at study initiation: 2026 - 2195 grams
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 gram per day.
- Water: Free access to tap-water diluted with decalcified water.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 50 % rel. humidity
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The amount of test substance dose was 0.5 mL per animal.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: surgical gauze patch of 2x3 cm
- Type of wrap if used: patches were mounted on Micropore tape which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Four hours after the application, the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently a dry tissue

SCORING SYSTEM: As stated in the guidelines
TEST SITE
- Area of exposure: 2 x 3 cm
- % coverage: 100
- Type of wrap: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: with tissue moistened with tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
- according to the guidelines

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
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:
edema 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
Irritant / corrosive response data:
- no skin irritation after 4 hours
- no evidence of a corrosive effect
Other effects:
Colouration: No staining of the treated skin by the test substance was observed.
Toxicity symptoms/Mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was considered not irritating to the rabbit skin.
Executive summary:

The test item was tested for skin irritation/corrosion to the intact rabbit skin in a test with three New Zealand White albino rabbits according to OECD guideline 404/EU method B.4. 0.5 mL of the test substance was applied to the intact skin of the shaved area on one flank on the shaved skin of the animals. The test area was wrapped with surgical tape. After 4 hours the wrapping was removed, the remaining test substance washed off and the application site observed for any signs of irritation/corrosion for 72 hours. No skin irritation was caused by the test item after 4 hours of exposure in any of the three rabbits. There was no evidence of a corrosive effect on the skin. No staining of the treated skin by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

According to the results obtained in this study, the test item was considered not irritating to the rabbit skin.