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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects observed.
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
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
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
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
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
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)