Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Dec 1994
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:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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 10882
- Batch No.: 15002811, 15002812

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):
72 hours
Number of animals or in vitro replicates:
4 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:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.42
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 48 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  Cornea 0 0.0
   Iris 0 0 0 0.0
   Conjunctivae (reddening) 2 0 0 0.67
   Conjunctivae (swelling) 1 0 0 0.33
 2  Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
  Conjunctivae (reddening) 1 0 0 0.33
   Conjunctivae (swelling) 1 0 0 0.33
 3  Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctivae (reddening) 1 0 0 0.33
   Conjunctivae (swelling) 0 0 0 0.0
 4  Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctivae (reddening) 1 0 0.33
   Conjunctivae (swelling) 0 0 0 0.0

On the day of administration slight to moderate transient reddening and swelling of the conjunctivae and the outer eye lids were observed in all animals. All animals were without findings after 48 hours.

Applicant's summary and conclusion

Executive summary:

The single administration of 6 -Chlor-Chlormethyldien (ZK 10882) into the right eye of four female rabbits with a volume of 0.1 ml/eye (corresponding to 71.5 -76.5 mg) results in slight to moderate transient reddening and swelling of the conjunctivae and the outer eye lids in all animals on administration day. Afterwards slight to moderate conjunctival reddening (in all animals) and slight swelling (in two animals) were seen up to 24 hours after application . All animals were without findings 48 hours after application.

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, iris, 0.17 for conjuntival swelling and 0.42 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.