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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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.
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.