Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Feb 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ZK 12126
- Batch No.: 608/2

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye served as control
Duration of treatment / exposure:
test substance remained in the eye, eye was not rinsed
Observation period (in vivo):
5 d
Number of animals or in vitro replicates:
2 males and 2 females

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:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.8
Max. score:
2
Reversibility:
fully reversible within: 5 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 72 hours

Any other information on results incl. tables

Results of the study after 24, 48 and 72 h:

      Irritant Effects (Score)              
 Animal   24 h 48 h  72 h     Mean scores
 1 (M) Cornea 0  0.0
  Iris 0 0 0  0.0 
  Conjunctivae (reddening) 1 0 0  0.33
  Conjunctivae (swelling) 0 0 0    0.0
 2 (M) Cornea 0  
  Iris 0   0.0
Conjunctivae (reddening)   1.33
  Conjunctivae (swelling) 2 1 0 1.0
 1 (F) Cornea 0 0 0 0.0
  Iris 0   0.0 
  Conjunctivae (reddening) 2 1 0 1.0
  Conjunctivae (swelling) 0 0 0   0.0
 2 (F) Cornea  0 0 0   0.0
  Iris  0 0 0 0.0 
  Conjunctivae (reddening) 1 0 0   0.33 
  Conjunctivae (swelling) 0 0.0 

A single application of 0.1 ml ZK 12126 into the conjunctival sac of the rabbit eye led to slight secretion, swelling and reddening of the outer eye lids as weil as eye lid closure and to moderate to severe reddening, swelling and blood vessel injection of the conjunctivae mainly on the application day. These effects gradually subsided and from day 3 (2 animals), 4 or 5 onwards, all animals were without findings.

Applicant's summary and conclusion

Executive summary:

The single administration of 1,2 -Methylen-4,6 -dien into the right eye of 2 male and 2 female rabbits with a volume of 0.1 ml/eye (corresponding to 50.3 -56.4 mg) resulted in slight secretion, swelling and reddening of the outer eye lids as weil as eye lid closure and to moderate to severe reddening, swelling and blood vessel injection of the conjunctivae mainly on the application day. These effects gradually subsided and from day 3 (2 animals), 4 or 5 onwards, all animals were without findings.

According to the system of evaluation recommended for EU, the mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after administration were 0 for the cornea and iris, 0.3 for conjuntival swelling and 0.8 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.