Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Nov to Dec 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
- 4 instead of 3 animals

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye, which remained untreated, served as control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
test substance remained in the eye (eye was not rinsed)
Observation period (in vivo):
4 days
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:
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:
0.67
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Table 1: Results of the study

    

 Irritant effects (score)         

Animal no. (sex)

 Irritation parameter

24 h 48 h  72 h  Mean scores

 1 (M)

 Cornea

0 0.0
 

 Iris

0 0 0 0.0
 

 Conjunctiva (reddening)

1 1 0 0.67
 

 Conjunctiva (swelling)

0 0 0 0.0

 2 (M)

 Cornea

0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 1 0 0.67
   Conjunctiva (swelling) 0 0 0 0.0

 3 (F)

 Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 0 0 0 0.0
   Conjunctiva (swelling) 0 0 0 0.0

 4 (F)

 Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 2 2 0 1.33
   Conjunctiva (swelling) 0 0 0 0.0

The control eyes were without findings.

The single administration of 0.1 mL test substance (56.1-72.2 mg ZK 30367) into the conjunctival sac of the right eye led to slight to moderate reddening of the conjunctivae in all animals on administration day and on day 2 and 3. Slight swelling of the conjunctivae in one animal of each gender was observed on administration day. All animals were without findings 72 hours after treatment.

Applicant's summary and conclusion

Executive summary:

In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight irritation which was fully reversible 72 hours after treatment. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters cornea, iris and conjunctival swelling as well as 0.67 for conjunctival reddening. According to EU classification criteria ZK 30367 need not be labelled as an eye irritant.