Sodium 4-vinylbenzenesulphonate

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

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

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

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

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

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

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

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

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

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

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

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

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 14d

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 14d

Score:

0

Max. score:

0

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 June 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes

Species:

chicken

Strain:

other: ROSS, spring chickens

Details on test animals or tissues and environmental conditions:

Approximately 7 week old, male or female chickens (ROSS, spring chickens), bodyweight range approximately 2.5 -3.0 kg, were used as eye-donors. Twelve heads of these animals were obtained from poultry slaughter house v.d.Bor, Amersfoortseweg 118, Nijkerkerveen, the Netherlands. Heads of the animals were severed immediately after sedation of the animals by electric shock and incision of the neck for bleeding, and before they reached the next station or the process line.
The heads were placed in small plastic boxes (3 heads per box) on a bedding of paper tissues moistened with isotonic saline.
Next, they were transported to the testing facility. During transportation, the heads were kept at ambient temperature.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

The test substance was applied in amounts of 0.03g, by powdering the entire surface of the cornea.

Duration of treatment / exposure:

total exposure period of 10 seconds

Duration of post- treatment incubation (in vitro):

The control eye and test eyes were examined at 30, 75, 120, 180 and 240 minutes after treatment

Number of animals or in vitro replicates:

The test substance was tested on five out of the six eyes; the sixth eye was treated in a similar way with isotonic saline only and served as a control.

Details on study design:

Within 2 hours after kill, eyes were carefully dissected and placed in a superfusion apparatus using the following procedure:
First the eye-lids were carefully removed without damaging the cornea and a small drop of Fluorescein sodium BP 2%w/v was applied to the corneal surface for a few seconds and subsequently rinsed off with isotonic saline of ambient temperature.
Next, the head with the fluorescein-treated cornea was examined with a slit-lamp microscope (Slit-lamp 900BM), to ensure that the cornea was not damaged. If undamaged, the eye was further dissected from the head without damaging the eye or cornea. Care was taken to remove the eye-ball from the orbit without cutting off the optic nerve too short.

The enucleated eye was placed in a stainless steel clamp with the cornea positioned vertically and transferred to a chamber of the superfusion apparatus. The clamp holding the eye was positioned in such a way that the entire cornea was supplied with isotonic saline from a bent, stainless steel tube, at a rate of ca 0.10 -0.15ml/min. The six chambers of the superfusion apparatus as well as the saline were temperature controlled at 32± 1.5°C.

Six eyes were selected and after placing in the superfusion apparatus, the eyes were examined again with the slit-lamp microscope to ensure that they were not damaged. Corneal thickness was measured using the Depth Measuring Attachment no.II for the Haag-Streit slit-lamp microscope. Thickness of the cornea was expressed in instrument units. An accurate measurement was taken at the corneal apex of each eye. Eyes with a corneal thickness deviating more than 10% of the average corneal thickness of the six eyes, or eyes that were unacceptably stained with fluorescein (score higher than 0.5), indicating the cornea to be permeable, or eyes that showed any other signs of damage, were rejected as test eyes and were replaced.

After an equilibration period of 45 -60 minutes, the corneal thickness of the six eyes was measured again to determine the zero reference value for corneal swelling calculations. At time t=0, i.e.immediately after the zero reference measurement, the test substance was applied to the eye. For this purpose, the clamp holding the eye was placed on a paper tissue outside the chamber with the cornea facing upwards. The test substance was applied in amounts of 0.03g, by powdering the entire surface of the cornea. After a total exposure period of 10 seconds, the corneal surface was rinsed thoroughly with 20ml of isotonic saline of ambient temperature. Next, the eye in the holder was returned to its chamber. This procedure was repeated for each test eye. The test substance was tested on five out of the six eyes; the sixth eye was treated in a similar way with isotonic saline only and served as a control. The control eye and test eyes were examined at 30, 75, 120, 180 and 240 minutes after treatment. All examinations were carried out with the slit-lamp microscope.

Irritation parameter:

cornea opacity score

Run / experiment:

Timepoint: 30 min

Value:

1

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Irritation parameter:

cornea opacity score

Run / experiment:

Timepoint: 75 min

Value:

> 1.3 - < 1.5

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Irritation parameter:

cornea opacity score

Run / experiment:

Timepoint: 120 min

Value:

> 1.3 - < 1.5

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Irritation parameter:

cornea opacity score

Run / experiment:

Timepoint: 180 min

Value:

> 1.3 - < 1.5

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Irritation parameter:

cornea opacity score

Run / experiment:

Timepoint: 240 min

Value:

> 19.4 - < 24.1

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Irritation parameter:

percent corneal swelling

Run / experiment:

Timepoint: 30 min

Value:

> 12.1 - < 15.5

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Irritation parameter:

percent corneal swelling

Run / experiment:

Timepoint: 75 min

Value:

> 14.5 - < 19

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Irritation parameter:

percent corneal swelling

Run / experiment:

Timepoint: 120 min

Value:

> 18 - < 24.1

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Irritation parameter:

percent corneal swelling

Run / experiment:

Timepoint: 180 min

Value:

> 18.7 - < 22.4

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Irritation parameter:

percent corneal swelling

Run / experiment:

Timepoint: 240 min

Value:

> 19.4 - < 24.1

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

On the basis of the results obtained with this ex vivo bioassay and according to the scheme for EC classification applied it can be concluded that Spinomar NaSS is irritating, but not corrosive to eyes.

Executive summary:

The eye irritation was assessed in vitro (ex vivo) by means of the Chicken Enucleated Eye Test according to a method equivalent to the OECD Guideline 438 Isolated Chicken Eye Test Method) in compliance with GLP. Five enucleated eyes were treated with the undiluted substance and one control eye was treated in the same manner except without the application of test material.

Application of the substance caused moderate coreneal swelling, slight to moderate corneal opacity and moderate fluorescein retention in the test eyes.

On the basis of the results obtained with this ex vivo bioassay and according to the scheme for EC classification applied it can be concluded that Spinomar NaSS is irritating, but not corrosive to eyes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:

The study is a GLP compliant in vivo test designed to measure the skin irritation of the substance.

Justification for selection of eye irritation endpoint:

The study is a GLP compliant ex vivo test designed to measure the eyye irritation of the substance.

Effects on skin irritation/corrosion: highly irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

In vivo skin irritation

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

In vitro (ex vivo) eye irritation

The eye irritation was assessed in vitro (ex vivo) by means of the Chicken Enucleated Eye Test according to a method equivalent to the OECD Guideline 438 Isolated Chicken Eye Test Method) in compliance with GLP. Five enucleated eyes were treated with the undiluted substance and one control eye was treated in the same manner except without the application of test material.

Application of the substance caused moderate coreneal swelling, slight to moderate corneal opacity and moderate fluorescein retention in the test eyes.

On the basis of the results obtained with this ex vivo bioassay and according to the scheme for EC classification applied it can be concluded that Spinomar NaSS is irritating, but not corrosive to eyes.