Pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-chloro-1-(chloromethyl)-, (1.alpha.)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(1R,3aS,3bR,9S,9aS,9bS,11aS)-1-acetyl-5-chloro-9-(chloromethyl)-9a,11a-dimethyl-7-oxo-1H,2H,3H,3aH,3bH,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl acetate

EC Number:

605-617-4

Cas Number:

17183-98-1

Molecular formula:

C24 H30 Cl2 O4

IUPAC Name:

(1R,3aS,3bR,9S,9aS,9bS,11aS)-1-acetyl-5-chloro-9-(chloromethyl)-9a,11a-dimethyl-7-oxo-1H,2H,3H,3aH,3bH,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl acetate

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):

72 hours

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:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.42

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Any other information on results incl. tables

Results of the study:

		Irritant Effects (Score)
Animal		24 h	48 h	72 h	Mean scores
1	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctivae (reddening)	2	0	0	0.67
	Conjunctivae (swelling)	1	0	0	0.33
2	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctivae (reddening)	1	0	0	0.33
	Conjunctivae (swelling)	1	0	0	0.33
3	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
4	Cornea	0	0	0	0.0
	Iris	0	0	0	0.0
	Conjunctivae (reddening)	1	0		0.33
	Conjunctivae (swelling)	0	0	0	0.0

On the day of administration slight to moderate transient reddening and swelling of the conjunctivae and the outer eye lids were observed in all animals. All animals were without findings after 48 hours.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating to the eye.

Executive summary:

A single administration of 6 -Chlor-Chlormethyldien (ZK 10882) into the right eye of four female rabbits with a volume of 0.1 ml/eye (corresponding to 71.5 -76.5 mg) results in slight to moderate transient reddening and swelling of the conjunctivae and the outer eye lids in all animals on administration day. Afterwards slight to moderate conjunctival reddening (in all animals) and slight swelling (in two animals) were seen up to 24 hours after application . All animals were without findings 48 hours after application.

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, iris, 0.17 for conjuntival swelling and 0.42 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.