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Diss Factsheets

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)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): adrostanolone acetate (5180)
- Lot/batch No.: 11630702

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye remained untreated and served as control
Duration of treatment / exposure:
once until end of study, test substance remained in eye
Observation period (in vivo):
observation before administration, 0.5, 1 and 2 hours thereafter and then every 23 to 24 hours until day 4 of test
Number of animals or in vitro replicates:
2/sex

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
>= 0.25
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: reddening
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
ca. 0.17
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: swelling
Other effects:
slight to moderate reddening and slight to severe swelling of the conjunctivae observed in all animals on administration day. On day 2 only slight conjunctival reddening and swelling were seen in three out of four animals. All animals were without any findings on day 3.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Androstanolone acetate is not irritating to the eye. Classification is not required
Executive summary:

After single administration of ZK 5180 into the conjuctival sac of the rabbit eye (2 male; 2 female rabbits) slight to moderate reddening and slight to severe swelling of the conjuctivae were observed in all animals on the application day, which was fully reversible by day 3 after administration.