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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics" Division of Pharmacology, FDA. According to Draize, 1959
Principles of method if other than guideline:
Draize Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: single
- Diet (ad libitum): Hoeing 222
- Water (ad libitum): not specified


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12:12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: 1 eye untreated: control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
Single instillation of 0.1 ml into the left eye, eyes were left unwashed
Observation period (in vivo):
24, 48 and 72 hrs, 4, 5, 6, and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not performed

SCORING SYSTEM: according to the OECD/ Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: slight to moderate erythema was observed 1 to 8 h after application (before the relevant reading points).
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: slight to moderate chemosis 1 to 8 h after application (before the relevant reading points).
Other effects:
Slight to moderate discharge was observed 1 to 8 h after application.

Any other information on results incl. tables

Raw data

Animal  Reading  Opacity Cornea area Iritis Redness Chemosis Discharge Symptoms
1 1 h 0 0 0 2 2 1  
2 1 h 0 0 0 2 1 1  
3 1 h 0 0 0 1 0 0  
4 1 h 0 0 0 2 2 1  
5 1 h 0 0 0 2 2 1  
6 1 h 0 0 0 2 2 1  
1 2 h 0 0 0 2 2 1  
2 2 h 0 0 0 2 1 2  
3 2 h 0 0 0 1 0 0  
4 2 h 0 0 0 2 2 1  
5 2 h 0 0 0 2 1 2  
6 2 h 0 0 0 2 2 2  
1 8 h 0 0 0 2 1 2  
2 8 h 0 0 0 2 1 2  
3 8 h 0 0 0 1 0 0  
4 8 h 0 0 0 2 2 2  
5 8 h 0 0 0 2 2 2  
6 8 h 0 0 0 2 2 2  
1 24 h 0 0 0 0 0 0  
2 24 h 0 0 0 0 0 0  
3 24 h 0 0 0 0 0 0  
4 24 h 0 0 0 0 0 0  
5 24 h 0 0 0 0 0 0  
6 24 h 0 0 0 0 0 0  
1 48 h 0 0 0 0 0 0  
2 48 h 0 0 0 0 0 0  
3 48 h 0 0 0 0 0 0  
4 48 h 0 0 0 0 0 0  
5 48 h 0 0 0 0 0 0  
6 48 h 0 0 0 0 0 0  
1 72 h 0 0 0 0 0 0  
2 72 h 0 0 0 0 0 0  
3 72 h 0 0 0 0 0 0  
4 72 h 0 0 0 0 0 0  
5 72 h 0 0 0 0 0 0  
6 72 h 0 0 0 0 0 0  
1 4 d 0 0 0 0 0 0  
2 4 d 0 0 0 0 0 0  
3 4 d 0 0 0 0 0 0  
4 4 d 0 0 0 0 0 0  
5 4 d 0 0 0 0 0 0  
6 4 d 0 0 0 0 0 0  
1 5 d 0 0 0 0 0 0  
2 5 d 0 0 0 0 0 0  
3 5 d 0 0 0 0 0 0  
4 5 d 0 0 0 0 0 0  
5 5 d 0 0 0 0 0 0  
6 5 d 0 0 0 0 0 0  
1 6 d 0 0 0 0 0 0  
2 6 d 0 0 0 0 0 0  
3 6 d 0 0 0 0 0 0  
4 6 d 0 0 0 0 0 0  
5 6 d 0 0 0 0 0 0  
6 6 d 0 0 0 0 0 0  
1 24 - 72 h 0.00   0.00 0.00 0.00    
2 24 - 72 h 0.00   0.00 0.00 0.00    
3 24 - 72 h 0.00   0.00 0.00 0.00    
4 24 - 72 h 0.00   0.00 0.00 0.00    
5 24 - 72 h 0.00   0.00 0.00 0.00    
6 24 - 72 h 0.00   0.00 0.00 0.00    
mean  24 - 72 h 0.00   0.00 0.00 0.00    

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met