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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
4 instead of 3 animals
GLP compliance:
yes
Remarks:
- but a QA check was not performed

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-Androstadiene-3,17-dione, 2-Naphthol-Complex
EC Number:
600-487-5
Cas Number:
103799-56-0
Molecular formula:
C19 H24 O2 . C10 H8 O
IUPAC Name:
1,4-Androstadiene-3,17-dione, 2-Naphthol-Complex

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:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
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  0.0
 

 Iris

 0 0 0 0.0
 

 Conjunctiva (reddening)

 0 0 0 0.0
 

 Conjunctiva (swelling)

 0 0 0 0.0

 2 (M)

 Cornea

 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 0 0 0.3
   Conjunctiva (swelling) 0 0 0 0.0

 3 (F)

  Cornea 0 0 0 0.0
   Iris 0 0 0 0.0
   Conjunctiva (reddening) 1 0 0 0.3
   Conjunctiva (swelling) 0 0 0 0.0

 4 (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

The control eyes were without findings.

The single application of 0.1 ml ZK 134533 (corresponding to 82.2 - 86.7 mg) into the conjunctival sac of the right eye led to transient slight to severe secretion, slight to moderate reddening of the skin of the eye lids, slight to severe reddening and slight to moderate vascular injection of the conjunctivae in all animals while slight to moderate swelling was observed only in 2 animals on the application day. Two animals were without findings from day 2 onwards, whereas the other two animals showed slight reddening and blood vessel injection of the conjunctivae on day 2 and were without findings from day 3 onwards.

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 on the whole transient slight to moderate irritation mainly on the application day. 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 0.2 for conjunctival reddening. According to EU classification criteria ZK 134533 need not be labelled as an eye irritant.