Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Oct 1998
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:
1998
Report Date:
1998

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 34517
- Batch No.: 27002001-07

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 and eye was not rinsed
Observation period (in vivo):
96 hours
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
Remarks:
reddening
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 96 hours
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 72 hours

Any other information on results incl. tables

Results of the study

      Irritant Effects (Score)         
 Animal    24 h 48 h   72 h  Mean scores
 1 (male)  Corneal Opacity 0 0.0
   Iris (redness, swelling, reaction of pupillary reflex etc.) 0 0 0 0.0
   Conjunctivae (reddening) 2 1 1 1.3
   Conjunctivae (swelling) 1 1 0 0.7
 2 (male)  Corneal Opacity 0 0 0 0.0
   Iris (redness, swelling, reaction of pupillary reflex etc.) 0 0 0 0.0
    Conjunctivae (reddening) 1 0 0 0.3
    Conjunctivae (swelling) 0 0 0 0.0
 3 (female)   Corneal Opacity 0 0 0 0.0
    Iris (redness, swelling, reaction of pupillary reflex etc.) 0 0 0 0.0
    Conjunctivae (reddening) 1 1 0 0.7
    Conjunctivae (swelling) 0 0 0 0.0
 4 (female)   Corneal Opacity 0 0 0 0.0
    Iris (redness, swelling, reaction of pupillary reflex etc.)  0 0 0 0.0
    Conjunctivae (reddening) 1 0 0 0.3
    Conjunctivae (swelling) 0 0 0 0.0

Injection of blood vessels in the iris were seen in one animal and slight to moderate reddening and slight swelling of the conjunctivae in all animals until 24 hours after administration. On day 5 (96 hours after administration) all animals were without findings.

Applicant's summary and conclusion

Executive summary:

The single administration of Dimethylenketon into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 28.1 -37.4 mg) results in an injection of blood vessels in the iris in one animal and slight to moderate reddening and slight swelling of the conjunctivae in all animals until 24 h after administration. On days 3 and 4 (48 and 72 h after administration) only slight conjunctival reddening and/or swelling was seen in two out of four animals and on day 5, 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, 0.2 for conjuntival swelling and 0.7 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.

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