Pyridinium toluene-4-sulphonate

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Number and sex: 3 males
- Bodyweights (at the start and at the termination of the study):
Animal No. 61: 2.1 kg and 2.2 kg
Animal No. 62: 2.2 kg and 2.4 kg
Animal No. 63: 2.1 kg and 2.3 kg
- Cages: individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height.
- Room temperature: 19.0 °C
- Relative humidity: average of 48.8 %
- Light: artificial light from 6 a.m. to 6 p.m.
- Feed: altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum. Hay-briquettes (supplied by SSNIGG, D-59494 Soes) were offered additionally as a dietary supplement
- Water: tap water from an automatic watering system, ad libitum
- Acclimatisation: 5 days (animal No. 61) and 12 days (animal No. 62 and 63)

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

other: The surrounding of the administration area served as a negative control

Amount / concentration applied:

0.5 g test substance (the weighed amount of the individual dose was 505 mg) was moistened with 1.0 mL deionised water and were placed on gauze patches in a size of about 2.5 cm x 2.5 cm.

Duration of treatment / exposure:

4 hours

Observation period:

The skins were examined for local alterations one day before the administration of the test substance and immediately before the administration. The treated areas of the animals were examined approximately 1, 24, 48 and 72 hours after patch removal.

Number of animals:

3

Details on study design:

An electric hair clipper, Aesculap GH 204 with a 1 mm cutterhead, was used for clipping of the hair.
Patches were held in place by fixing them marginally with non irritating tapes. The application sites were covered semi-occlusively by a dressing. Access by the animals to the application sites was prevented by a plastic collar.
At the end of the exposure period the dressings, the tapes with the patches and the collars were removed.
The treated areas of the animals were examined for erythema/eschar and oedema as well as for other local alterations (such as hyperplasia, scaling, discolouration, fissures, scabs and alopecia).
The surrounding of the administration area, i.e. the untreated skin, served as a negative control.
The skin was examined using a cold light source KL 1500 electronic.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.

Other effects:

no symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Interpretation of results:

other: not irritating

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Supplier: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Number and sex: 3 males
- Bodyw eights (at the start and at the termination of the study):
Animal No. 61: 2.2 kg and 2.5 kg
Animal No. 62: 2.3 kg and 2.6 kg
Animal No. 63: 2.0 kg and 2.4 kg
- Cages: individual caging in metal wire cages, Ehret GmbH, D-79312 Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height.
- Room temperature: 19.0 °C
- Relative humidity: 48.4 %
- Light: artificial light from 6 a.m. to 6 p.m.
- Feed: Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum. Hay-briquettes (supplied by SSNOFF, D-59494 Soest) were offered additionally as a dietary supplement.
- Water: tap water from an automatic watering system, ad libitum
- Acclimatisation: 5 days (animal No. 61) and 12 days (animal No. 62 and 63)

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as a negative control.

Amount / concentration applied:

The test substance consisted of a crystalline and a viscous part. Before the instillation into the eyes the test substance was given into a mortar for grinding the crystals. 0.1 ml of the resulting viscous mass was administered per animal into the conjunctival sacs of the right eyes. The left eyes remained untreated and served as control.
Firstly, the test substance was given to one animal. As no evidence for a serious damage to the eye of this animal wa found during the initial 72 hours observation period, the test substance was administered to the other two animals subsequently.

Duration of treatment / exposure:

Not specified

Observation period (in vivo):

1, 24, 48 and 72 hours and 7 days after the administration of the test substance

Number of animals or in vitro replicates:

3 males

Details on study design:

Both eyes of the animals were examined 24 hours before the instillation and approximately 1, 24, 48 and 72 h p.a.
Further examination was performed in all animals 24 h after administration by instillation of a fluorescein solution (Minims Fluorescein Sodium 2%) onto the cornea. The whole eyes, especially the corneae, the irises and the conjunctivae were examined using an otoscope lamp.
Calculation of the MMAS (Modified Maximum Average Score) was performed according to the ECETOC Technical Report No.48(2), 1998 (Eye Irritation Reference Chemicals Data Bank, 2nd ed.)

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48 h

Score:

1

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

48 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

48 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

48 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48 h

Score:

2

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24 h

Score:

3

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

48 h

Score:

2

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24 h

Score:

2

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

48 h

Score:

1

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Other effects:

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.

Interpretation of results:

other: not irritating

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In the in vivo skin and eye irritation studies no significant effects were observed in the presence of the test substance. Therefore, classification of WS400304 for skin or eye irritation is not required [REGULATION (EC) 1272/2008].