Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 July to 23 July 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Study conducted in compliance with OECD 404 without any deviation and not under GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Details on test material:
Batch No.: LF-238-042-F3
Name of test material (as cited in study report): 2-VINYL-1,3-DIOXOLANE
Physical state: colourless liquid
Storage conditions: ambient temperature, protected from light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: VIVALIS (49450 Roussay, France)
- Weight at study initiation: higher than 1.8 kg on day before the application of the preparation
- Number and sex : 3 males
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3°C
- Humidity: 50 +/- 20%
- Dark/light: 12h light / 12h dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
4 hours
Observation period:
Obervation at 1, 24, 48 and 72h after the removal of the patch.
Number of animals:
The substance was test tested with one animal. No corrosive or irritant effects were observed after 4hours.
The test was completed with the two others animals during 4 hours with only one patch on each animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48 h
Score:
1
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1h
Score:
1
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: day 5
Score:
1
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Remarks on result:
other:
Remarks:
Mean result
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Remarks on result:
other:
Remarks:
Mean result
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Remarks on result:
other:
Remarks:
Mean result
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
other:
Remarks:
Mean result
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
other:
Remarks:
Mean result
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
other:
Remarks:
Mean result
Irritant / corrosive response data:
At 24 and 48h, a slight erythema was observed. They were totally reversible.
A slight edema was observed only 1h after the application and was totally reversible from hour 24 of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with Regulation EC No. 1272/2008, the test substance has not to be classified as skin irritant.
Executive summary:

An in vivo skin irritation test on rabbit was conducted according to Guideline OECD 404 to predict the acute skin irritation potential of the test substance.

At 24 and 48h, a slight erythema was observed. They were totally reversible.

A slight edema was observed only 1h after the application and was totally reversible from hour 24 of the study.

Therefore, in accordance with Regulation EC No. 1272/2008, the test substance has not to be classified as skin irritant.