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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Oct 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:
5-Hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androst-6-en-17-one
EC Number:
617-345-3
Cas Number:
82543-14-4
Molecular formula:
C25 H36 O4
IUPAC Name:
5-Hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androst-6-en-17-one
Details on test material:
- Name of test material (as cited in study report): ZK 90504
- Batch No.: 21608604

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 eye was not rinsed
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:
0.3
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
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)  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  1  0  0.7
    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)  1  0  0  0.3
    Conjunctivae (swelling)  0  0  0  0.0

A slight to moderate reddening and slight swelling of the conjunctivae were seen in all animals on administration day.

Applicant's summary and conclusion

Executive summary:

The single administration of Enpivalat into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 47.3 -54.0 mg) results in slight to moderate reddening and slight swelling of the conjunctivae in all animals on administration day. On day 2 (24 h after administration) only slight conjunctival reddening was seen in three out of 4 animals and in 1 out of 4 animals on day 3. All animals were without findings on day 4 (72 hours after administration).

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 0.3 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.

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