Ethisterone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Study period:

Feb 2010

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:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ethisterone

EC Number:

207-096-5

EC Name:

Ethisterone

Cas Number:

434-03-7

Molecular formula:

C21H28O2

IUPAC Name:

(1R,3aS,3bR,9aR,9bS,11aS)-1-ethynyl-1-hydroxy-9a,11a-dimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one

Details on test material:

- Name of test material (as cited in study report): ethisterone (ZK 4957)
- Analytical purity: 100.1%
- Lot/batch No.: 8115-13/08
- Expiration date of the lot/batch: 22 Oct 2011

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 eye and was not flushed out

Observation period (in vivo):

Observations were performed before administration, 0.5, 1 and 2 hours thereafter and then in the individual animal every 24 hours until day 4 of the test.

Number of animals or in vitro replicates:

2/sex

Results and discussion

In vivo

Results

Irritation parameter:

conjunctivae score

Remarks:

reddening

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.08

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Any other information on results incl. tables

Local findings after single administration of ZK 4957 into the conjunctival sac of the rabbit eye were slight to moderate reddening of the conjunctivae in all animals on administration day. On day 2 slight reddening of conjunctivae was noted in 1 out of 4 animals only. All animals were without findings on day 3 of the test.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Ethisterone is not eye irritant under the conditions of this study. Classification is not required

Executive summary:

The single administration of ethisterone (ZK 4957) to the right eye of male and female rabbits results in slight irritation on administration day which decreased in severity from day 2 onwards and were fully reversible on day 3. Ethisterone is not an eye irritant.