Androsta-1,4-diene-3,17-dione

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Mar 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1995

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

- 4 instead of 3 animals

GLP compliance:

yes

Remarks:

- but a QA check was not performed

Test material

Test material information

Constituent 1

Reference substance name:

Androsta-1,4-diene-3,17-dione

EC Number:

212-977-2

EC Name:

Androsta-1,4-diene-3,17-dione

Cas Number:

897-06-3

Molecular formula:

C19H24O2

IUPAC Name:

androsta-1,4-diene-3,17-dione

Constituent 2

Reference substance name:

1,4-Androstadiene-3,17-dione

IUPAC Name:

1,4-Androstadiene-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):

5 days

Number of animals or in vitro replicates:

4 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

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

reddening

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

conjunctivae score

Remarks:

swelling

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

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 (F)	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctiva (reddening)	0	0	0	0.0
	Conjunctiva (swelling)	0	0	0	0.0
2 (F)	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctiva (reddening)	0	0	0	0.0
	Conjunctiva (swelling)	0	0	0	0.0
3 (F)	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctiva (reddening)	0	0	0	0.0
	Conjunctiva (swelling)	0	0	0	0.0
4 (F)	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctiva (reddening)	0	0	0	0.0
	Conjunctiva (swelling)	0	0	0	0.0

The control eyes were without findings.

The single application of 0.1 ml ZK 4947 (corresponding to 70.6 - 76.4 mg) into the conjunctival sac of the right eye led to slight to moderate, transient irritations mainly on the application day. Only one animal showed severe secretion 30 minutes after application. From day 2 onwards, all animals were without findings

Applicant's summary and conclusion

Executive summary:

In a local tolerance test on the rabbit eye similar to OECD TG 405 a single application of the test substance into the conjunctival sac provoked transient slight to moderate irritations mainly on the application day. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters cornea, iris, conjunctival reddening and conjunctival swelling. According to EU classification criteria ZK 4947 (androstadiendion) need not be labelled as an eye irritant.