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Toxicological information

Eye irritation

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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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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)