Androst-4-ene-3,17-dione, 1-methyl-, (1.alpha.)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Study period:

Sep 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

- 4 instead of 3 animals

Test material

Test material information

Constituent 1

Reference substance name:

1 alpha-Methyl-4-androstene-3,17-dione

EC Number:

609-915-5

Cas Number:

4136-62-3

Molecular formula:

C20 H28 O2

IUPAC Name:

1 alpha-Methyl-4-androstene-3,17-dione

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the left eye, which remained untreated, served as control.

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

test substance remained in the eye (eye was not rinsed)

Observation period (in vivo):

6 days

Number of animals or in vitro replicates:

2 males and 2 females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.25

Max. score:

2

Reversibility:

fully reversible within: 5 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

reddening

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

conjunctivae score

Remarks:

swelling

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Any other information on results incl. tables

Table 1: Results of the study

		Irritant effects (score)
Animal no. (sex)	Irritation parameter	24 h	48 h	72 h	Mean scores
1 (M)	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
2 (M)	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctiva (reddening)	1	0	0	0.33
	Conjunctiva (swelling)	1	1	1	1.0
3 (F)	Cornea	0	0	0	0.0
	Iris	1	1	1	1.0
	Conjunctiva (reddening)	3	2	2	2.67
	Conjunctiva (swelling)	4	2	2	2.67
4 (F)	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctiva (reddening)	1	0	0	0.33
	Conjunctiva (swelling)	1	0	0	0.33

The control eyes were without findings.

The single administration of 0.1 mL test substance (45.7- 51.5 mg ZK 62096) into the conjunctival sac of the right eye led in 3 of the 4 rabbits to slight reddening and/or swelling of the conjunctivae from day 1 or 2 to day 2 to 4. In the 4th rabbit more severe findings were observed. This animal showed severe reddening and swelling of the conjunctivae and slight hyperemia or vessel injection of the iris on day 2. The findings in the iris vanished by day 5 and the conjunctival findings vanished by day 6.

Applicant's summary and conclusion

Executive summary:

In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight irritation in 3 out of 4 rabbits and clear-cut irritation in 1 out of 4 rabbits. The findings were fully reversible by day 3 to 6 after administration. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameter cornea, 0.25 for iris as well as 1.0 for conjunctival reddening and swelling. According to EU classification criteria ZK 62096 need not be labelled as an eye irritant.