Sodium 4-vinylbenzenesulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 June to 7 July 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-vinylbenzenesulphonate

EC Number:

220-266-3

EC Name:

Sodium 4-vinylbenzenesulphonate

Cas Number:

2695-37-6

Molecular formula:

C8H8O3S.Na

IUPAC Name:

.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species: SPF bred New Zealand White albino rabbits
Supplier: Charles River Wiga FRG, Sulzfeld, Germany
Sex and age: males, young adult
Date of arrival: June 5, 1992
Body weight range at start of study: 2870-2900 g
Identification: earmarking: 320-322
Acclimatization period: 18 days
Caging: individually in suspended galvanized cages, fitted with wire-mesh floor and front
Lighting: 12 hours light/12 hours dark cycle
Temperature: 20 ± 3 °C
Humidity: 53-87% (upper limit incidentally higher than the intended 70%, because of meteorological circumstances or because of wet cleaning of the
animal room)
Ventilation: ca 10 air changes/hour
Diet: standard laboratory rabbit diet and tap water, ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

A plastic cup with a diameter of ca 2.5 cm was loaded with 0.75 g of the test mixture (0.5 g of the test material and 0.25 g water)

Duration of treatment / exposure:

4 hours

Observation period:

1, 24. 48 and 72 hours, then 7 and 14 days.

Number of animals:

3

Details on study design:

After the exposure period, the application site was cleaned with a paper tissue and water

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 7d

Score:

3.7

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 7d

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 14 d

Remarks on result:

positive indication of irritation

Results 11

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 14d

Score:

0

Max. score:

0

Results 12

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 14d

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

On the basis of the results obtained it was concluded that, under the conditions of this study, the substance is considered severely irritating for the skin of rabbits after a 4-hour dermal contact period.

Executive summary:

The skin irritation was assessed according to the OECD 404 test guideline in compliance with GLP using three New Zealand White rabbits.

The fur of the application was clipped and the substance applied in water for an expsure period of 4 hours with occluded dressing.

At 24 hours after removal, the skin effects observed in three rabbits consisted of moderate erythema, slight is chemic necrosis, and slight, moderate or severe oedema.

At 48 and 72 hours after removal, the three rabbits showed moderate erythema, very slight or slight ischemic necrosis, and moderate oedema. In addition, one rabbit showed slight incrustation at 72 hours after removal.

At 7 days after removal, well-defined erythema, very slight ischemic necrosis (one rabbit) and very slight oedema were observed in the three rabbits.

At 14 days after removal, all skin effects had cleared completely.

On the basis of the results obtained it was concluded that, under the conditions of this study, the substance is considered severely irritating for the skin of rabbits after a 4-hour dermal contact period.