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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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
yes
Remarks:
only 7 d observation time
GLP compliance:
no
Remarks:
GLP was not mandatory at the time of the study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
no washing
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.39
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks:
one animal showed grade-1 opacity at D7
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.39
Max. score:
2
Reversibility:
fully reversible within: 3 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.61
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks:
4 animals showed erythema (grade 1-3) at D7
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2.11
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks:
1 animal showed grade 1 chemosis on D7
Irritant / corrosive response data:
see table below for individual animal data

Any other information on results incl. tables

Rabbit # Time [h] cornea iris conjunctivae  
        redness swelling
1 24 1 1 3 4
  48 1 1 3 4
  72 1 1 3 4
  average 1.00 1.00 3.00 4.00
2 24 1 1 3 2
  48 0 0 3 2
  72 0 0 2 0
  average 0.33 0.33 2.67 1.33
3 24 0 0 3 4
  48 0 0 3 1
  72 0 0 2 0
  average 0.00 0.00 2.67 1.67
4 24 0 0 3 4
  48 1 1 3 2
  72 0 0 2 0
  average 0.33 0.33 2.67 2.00
5 24 1 1 3 4
  48 0 0 3 1
  72 0 0 2 1
  average 0.33 0.33 2.67 2.00
6 24 1 1 3 4
  48 0 0 2 1
  72 0 0 1 0
  average 0.33 0.33 2.00 1.67
Time [h] cornea iris conjunctivae  
      redness swelling
average 24 0.67 0.67 3.00 3.67
score 48 0.33 0.33 2.83 1.83
72 0.17 0.17 2.00 0.83
24+48+72 0.39 0.39 2.61 2.11

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
GDMA should be classified as Eye Irrit 2 - H319.