Vinylene carbonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6-20 February 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Vinylene carbonate

EC Number:

212-825-5

EC Name:

Vinylene carbonate

Cas Number:

872-36-6

Molecular formula:

C3H2O3

IUPAC Name:

2H-1,3-dioxol-2-one

Details on test material:

- Name of test material (as cited in study report): Vinylene Carbonate
- Physical state: clear colourless liquid
- Analytical purity: 99.9%
- Purity test date: 7 January 2002
- Lot/batch No.: 011220
- Storage condition of test material: approx. 4 ºC in the dark, under nitrogen

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2-3.5 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hr

Observation period:

evidence of primary irritation: 1, 24, 48 and 72 hrs following the removal of the patches.
Additional observations: on days 7 and 14

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm^2
- % coverage: 100
- Type of wrap if used: cotton gauze patch, secured in position with a strip of surgical adhesive tape. The trunk was wrapped in an elasticated corset.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hrs


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hr

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: At 14 days, there was a reduced regrowth of fur and glossy skin.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hrs

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Well-defined erythema and slight to moderate oedema were noted at all treated skin sites 1, 24, 48 and 72 hours after patch removal.
The test material produced a primary irritation index of 4.3 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Other effects:

Other adverse reactions noted were light brown discolouration of the epidermis, blanching of the skin, loss of skin elasticity and flexibility, reduced regrowth of fur, glossy skin and hardened light brown-coloured scabs preventing accurate evaluation of erythema and oedema.

Applicant's summary and conclusion

Interpretation of results:

other: irritating

Conclusions:

The test material produced positive criteria in 3/3 rabbits and was also classified as irritant according to EU labelling regulations Commission Directive 93/21/EEC. The symbol Xi, the indication of danger ""Irritant"" and the risk phrase R38 (Irritating to skin) are therefore required.

Executive summary:

The skin irritancy potential of VC was tested in New Zealand White rabbit according to OECD 404. The test material produced a primary irritation index of 4.3 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material produced positive criteria in 3/3 rabbits and was classified as irritant for skin according to GHS and Regulation (EC) No 1272/2008.