Sodium prop-2-enesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium prop-2-enesulphonate

EC Number:

219-676-5

EC Name:

Sodium prop-2-enesulphonate

Cas Number:

2495-39-8

Molecular formula:

C3H6O3S.Na

IUPAC Name:

sodium prop-2-ene-1-sulfonate

Details on test material:

- Name of test substance: Golpanol ALS wasserfrei
- Test-substance No.: 09/0505-1
- Batch identification: 04749356P0
- Purity: Golpanols ALS = 71.3%; NaCI = 26.0%
- Homogeneity: The homogeneity of the test substance was provided after shaking the test-substance container.
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
ADDITIONAL TEST-SUBSTANCE INFORMATION
- pH-value: Ca. 5.5 (undiluted test substance, moistened with water)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation: 6 - 7 months
- Weight at study initiation: 4.06 kg – 4.18 kg
- Housing: Single housing
- Diet (e.g. ad libitum): Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water (e.g. ad libitum):Tap water ad libitum
- Acclimation period: for at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated left eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (about 34 mg of the comminuted test substance)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

28 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: No effects observed.

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

2

Reversibility:

other: No effects observed.

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 - 48 - 72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 - 48 - 72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24 - 48 - 72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 - 48 - 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24 - 48 - 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: No effects were observed.

Other effects:

Discharge (see table 1)

Any other information on results incl. tables

Table 1: irritant response, data for each individual animal at each observation time as well as calculation of the means.

Exposition:	24 h
Animal	Reading	Opacity	Cornea area	Iritis	Redness	Chemosis	Discharge	Symptoms
1	1 h	0	0	0	2	3	3	scleral vessels injected, circular
2	1 h	0	0	0	2	2	3	scleral vessels injected, circular
3	1 h	0	0	0	2	2	2	scleral vessels injected, circumscribed area
1	24 h	0	0	0	2	2	1	scleral vessels injected, circular
2	24 h	0	0	0	2	1	1	scleral vessels injected, circumscribed area
3	24 h	0	0	0	2	0	1	scleral vessels injected, circumscribed area
1	48 h	0	0	0	2	1	0	scleral vessels injected, circumscribed area
2	48 h	0	0	0	1	0	1	scleral vessels injected, circumscribed area
3	48 h	0	0	0	1	0	1	scleral vessels injected, circumscribed area
1	72 h	0	0	0	1	0	0	scleral vessels injected, circumscribed area
2	72 h	0	0	0	1	0	0	scleral vessels injected, circumscribed area
3	72 h	0	0	0	1	0	0	scleral vessels injected, circumscribed area
1	7 d	0	0	0	0	0	0
2	7 d	0	0	0	0	0	0
3	7 d	0	0	0	0	0	0
1	24 - 72 h	0,00		0,00	1,67	1,00
2	24 - 72 h	0,00		0,00	1,33	0,33
3	24 - 72 h	0,00		0,00	1,33	0,00
mean	24 - 72 h	0,00		0,00	1,44	0,44

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP (1272/2008/EC)