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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Dec 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported 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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test material

Constituent 1
Reference substance name:
3,3-Ethylenedioxy-17 alpha-hydroxy-5-androstene-17beta-carbonitrile
IUPAC Name:
3,3-Ethylenedioxy-17 alpha-hydroxy-5-androstene-17beta-carbonitrile
Details on test material:
- Name of test material (as cited in study report): ZK 233744
- Batch No.: 1366
- Purity: 92.3%

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:
2 (3) 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:
0.59
Max. score:
3
Reversibility:
fully reversible within: 72 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: 72 hours
Other effects:
The treatment did not result in any effect on body weight.

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)  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 (male)  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 (female)   Cornea 0 0 0 0.0
    Iris 0 0 0 0.0
    Conjunctiva (reddening) 1 1 0 0.67
    Conjunctiva (swelling) 1 1 0 0.67
 4 (female)   Cornea 0 0 0 0.0
    Iris 0 0 0 0.0
    Conjunctiva (reddening) 1 0 0 0.33
    Conjunctiva (swelling) 0 0 0 0.0

A slight reddening of the conjunctivae were observed in all animals and a slight to moderate swelling of the conjunctivae was observed in both male animals and one female animal on administration day.

Applicant's summary and conclusion

Executive summary:

The single administration of Diketon into the right eye of 2 (3) males and 2 female rabbits with a volume of 0.1 ml/eye (corresponding to 61.5 -65.2 mg) resulted in slight reddening of the conjunctivae observed in all animals on the administration day and on days 2 and 3 (except one female animal only until day 2). Slight to moderate swelling of the conjunctivae was observed in two male animals and one female animaion the administration

day. In one female animal slight swelling was seen until day 3. All animals were without findings on day 4.

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, 0.17 for conjuntival swelling and 0.59 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.

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