Vinyl chloroacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2001

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:

Vinyl chloroacetate

EC Number:

219-834-3

EC Name:

Vinyl chloroacetate

Cas Number:

2549-51-1

Molecular formula:

C4H5ClO2

IUPAC Name:

ethenyl 2-chloroacetate

Test material form:

liquid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Lts, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks old
- Weight at study initiation: 2.69 - 2.82 kg
- Housing: suspended metal cages
- Diet (e.g. ad libitum): free access to STANRAB SQC Rabbit Diet allowed throughout the day
- Water (e.g. ad libitum): free access to mains tap water allowed throughout the day
- Acclimation period: minimum 5 days

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

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm cotton gauze patch
- Type of wrap if used: each patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approx size 2.5 x 4.0 cm), and to prevent the rabbit interfering with the patches, the trunk of the rabbit was wrapped in elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material was removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits

OBSERVATION TIME POINTS
1 hour, 24 hours, 48 hours and 72 hours. Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions.

SCORING SYSTEM:
Draize classification scheme

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

2

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

2

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

2

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

2.33

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

2

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

1.67

Irritant / corrosive response data:

Well defined erythema was noted at all treated skin sites one hour after patch removal and at subsequent 24, 48 and 72 hour observations.

Slight oedema was noted at all treated skin sites one hour after patch removal. Moderate oedema was noted at one treated skin site with slight oedema at two treated skin sites at the 24 hr observation. Slight oedema was noted at all treated skin sites at the 48 hr observation. Slight oedema was noted at all treated skin sites with very slight oedema at the remaining treated skin site at the 72 hr observation. Slight oedema persisted at one treated skin site with very slight oedema at one other treated skin site at the 7 day observation.

Light brown discolouration of the epidermis was noted at two treated skin sites at the 24, 48 and 72 hr observations with loss of skin elasticity noted at the remaining treated skin site at the 48 and 72 hr observations. Crust formation was noted at all treated skin sites at the 7 day observation and precluded the evaluation of erythema at two treated skin sites at this time. Reduced regrowth of fur was noted at one treated skin site at the 14 day observation.

Two treated skin sites appeared normal at the 14 day observation.

Other effects:

- Other adverse local effects: light brown discolouration of the epidermis, loss of skin elasticity, crust formation, reduced regrowth of fur observed at some treated sites

Any other information on results incl. tables

see 'attached background material'

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test material produced positive criteria in 3/3 rabbits. It produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. The test substance meets the criteria for classification as Skin Irrit. 2; H315 according to Regulation (EC) No.1272/2008.

Executive summary:

 A GLP study was performed according to the OECD Guideline 404, to assess the irritancy potential of Vinyl Chloroacetate to the skin of the New Zealand White rabbit. A single 4 hr semi-occluded application of the test material to the intact skin of 3 rabbits produced well defined erythema and slight to moderate oedema. Light brown discolouration of the epidermis, loss of skin elasticity, reduced regrowth of fur and crust formation were also noted. Two treated skin sites appeared normal at the 14 day observation. 3 min and 1 hr semi-occluded applications of the test material produced no corrosive effects.

 

The test material produced positive criteria in 3/3 rabbits. It produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. The test substance meets the criteria for classification as Skin Irrit. 2; H315 according to Regulation (EC) No.1272/2008.