3'H-Cyclopropa[1,2]pregna-1,4,6-triene-3,20-dione, 1,2-dihydro-17-hydroxy-, (1.alpha.,2.alpha.)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987-02-24

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

17-Hydroxy-1 alpha,2 alpha-methylene-4,6-pregnadiene-3,20-dione

EC Number:

606-682-1

Cas Number:

2098-65-9

Molecular formula:

C22 H28 O3

IUPAC Name:

17-Hydroxy-1 alpha,2 alpha-methylene-4,6-pregnadiene-3,20-dione

Test material form:

solid: bulk

Remarks:

???

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Controls:

other: left eye served as control

Duration of treatment / exposure:

test substance remained in the eye, eye was not rinsed

Observation period (in vivo):

5 d

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:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.8

Max. score:

2

Reversibility:

fully reversible within: 5 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Any other information on results incl. tables

Results of the study after 24, 48 and 72 h:

		Irritant Effects (Score)
Animal		24 h	48 h	72 h			Mean scores
1 (M)	Cornea	0	0	0			0.0
	Iris	0	0	0			0.0
	Conjunctivae (reddening)	1	0	0			0.33
	Conjunctivae (swelling)	0	0	0			0.0
2 (M)	Cornea	0	0	0
	Iris	0	0	0			0.0
	Conjunctivae (reddening)	2	1	1			1.33
	Conjunctivae (swelling)	2	1	0			1.0
1 (F)	Cornea	0	0	0			0.0
	Iris	0	0	0			0.0
	Conjunctivae (reddening)	2	1	0			1.0
	Conjunctivae (swelling)	0	0	0			0.0
2 (F)	Cornea	0	0	0			0.0
	Iris	0	0	0			0.0
	Conjunctivae (reddening)	1	0	0			0.33
	Conjunctivae (swelling)	0	0	0			0.0

A single application of 0.1 ml ZK 12126 into the conjunctival sac of the rabbit eye led to slight secretion, swelling and reddening of the outer eye lids as weil as eye lid closure and to moderate to severe reddening, swelling and blood vessel injection of the conjunctivae mainly on the application day. These effects gradually subsided and from day 3 (2 animals), 4 or 5 onwards, all animals were without findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The single administration of 1,2 -Methylen-4,6 -dien into the right eye of 2 male and 2 female rabbits with a volume of 0.1 ml/eye (corresponding to 50.3 -56.4 mg) resulted in slight secretion, swelling and reddening of the outer eye lids as weil as eye lid closure and to moderate to severe reddening, swelling and blood vessel injection of the conjunctivae mainly on the application day. These effects gradually subsided and from day 3 (2 animals), 4 or 5 onwards, all animals were without findings.

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 and iris, 0.3 for conjuntival swelling and 0.8 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.