Reaction mass of toluene and 2-vinyl-1,3-dioxolane

Skin irritation / corrosion

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-vinyl-1,3-dioxolane

EC Number:

223-626-8

EC Name:

2-vinyl-1,3-dioxolane

Cas Number:

3984-22-3

Molecular formula:

C5H8O2

IUPAC Name:

2-vinyl-1,3-dioxolane

Constituent 2

Reference substance name:

Toluene

EC Number:

203-625-9

EC Name:

Toluene

Cas Number:

108-88-3

Molecular formula:

C7H8

IUPAC Name:

toluene

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Reversibility:

not specified

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

0

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

not specified

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 1h

Score:

1

Reversibility:

not specified

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 7

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

not specified

Results 8

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: day 5

Score:

1

Reversibility:

not specified

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 10

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Remarks on result:

other:

Remarks:

Mean result

Results 11

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Remarks on result:

other:

Remarks:

Mean result

Results 12

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Remarks on result:

other:

Remarks:

Mean result

Results 13

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Remarks on result:

other:

Remarks:

Mean result

Results 14

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

other:

Remarks:

Mean result

Results 15

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.