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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Nov 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:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
7 beta-Hydroxy-3 beta,15 alpha-dipivaloyloxy-5-androsten-17-one
EC Number:
617-708-6
Cas Number:
85390-94-9
Molecular formula:
C29 H44 O6
IUPAC Name:
7 beta-Hydroxy-3 beta,15 alpha-dipivaloyloxy-5-androsten-17-one
Details on test material:
- Name of test material (as cited in study report): ZK 92136
- Batch No.: 21604812

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 was not flushed out
Observation period (in vivo):
72 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:
0.16
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Other effects:
Single application of ZK 92136 led to slight to moderate reddening and swelling of the conjunctivae in all animals on administration day. On day 2 (24 h after administration) slight conjunctival reddening was seen in two out of four animals and on day 3, all animals were without findings.
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)  Corneal Opacity  0 0.0
   Iris (redness, swelling, reaction of pupillary reflex etc.)  0  0  0  0.0
   Conjunctivae (reddening)  0  0  0 0.0
   Conjunctivae (swelling)  0  0  0  0.0
 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  0  0  0.3
    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)  0  0  0  0.0
    Conjunctivae (swelling)  0  0  0  0.0

Applicant's summary and conclusion

Executive summary:

The single administration of Dipivalat into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 51.2 -52.4 mg) results in slight to moderate reddening and swelling of the conjunctivae in all animals on administration day. On day 2 (24 h after administration) slight conjunctival reddening was seen in two out of four animals and on day 3, 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, iris and conjuntival swelling and 0.2 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.

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