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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
Study period:
Jun 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Acid Red 299

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Remarks:
HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: mean: 3.0 Kg
- Housing: individual cages
- Diet: standard diet "ssniff K" ad libitum
- Water: tab water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-60%
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml (max. 0.1g)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes the treated eye, with physiological NaCl solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize-Grade

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within:
Remarks:
72h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
72h
Irritant / corrosive response data:
No effects on Cornea or Iris were observed. A maximum score of 1 was noted for erythema and edema at 24 and 48-hour evaluations.

Any other information on results incl. tables

endpoint average score per observation time and endpoint*
24h 48h 72h
cornea opacity 0.0 0.0 0.0
iris value 0.0 0.0 0.0
conjuctiva redness 1.0 0.7 0.0
chemosis 0.3 0.3 0.0

* mean values of 3 animals

                    DRAIZE-GRADE (time after application)
     1h  24h  48h  72h  7d  14d, 21d
   Animal  A B C  A B C  A B C  A B C  A B C  A B C
    Cornea            
   opacity  0 0 0  0 0 0  0 0 0  0 0 0  0 0 0  n n n
   area  0 0 0  0 0 0  0 0 0  0 0 0  0 0 0  n n n
    Iris  0 0 0  0 0 0  0 0 0  0 0 0  0 0 0  n n n
    Conjunctivae            
   Erythem

superficial coloring

by test item

 1 1 1  1 0 1  0 0 0  0 0 0  n n n
   Chemosis  1 1 1  0 0 1  0 0 1  0 0 0  0 0 0  n n n
    Discharge  0 0 0  0 0 0  0 0 0  0 0 0  0 0 0  n n n

n: no evaluation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance does not have eye irritating effects.