3'H-Cycloprop[15,16]androsta-6,15-dien-17-one, 15,16-dihydro-3,5-dihydroxy-, (3.beta.,5.beta.,15.alpha.,16.alpha.)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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:

Reference substance 001

Cas Number:

82543-15-5

Test material form:

solid

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 and eye was not rinsed

Observation period (in vivo):

72 hours

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:

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

Remarks:

reddening

Basis:

mean

Time point:

24/48/72 h

Score:

0.08

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Remarks:

swelling

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

The treatment did not result in any effect on body weight.

Any other information on results incl. tables

Results of the study

		Irritant Effects (Score)
Animal		24 h	48 h	72 h	Mean scores
1 (male)	Corneal Opacity	0	0	0	0.0
	Iris (redness, swelling, reaction of pupillary reflex etc.)	0	0	0	0.0
	Conjunctivae (reddening)	1	0	0	0.3
	Conjunctivae (swelling)	0	0	0	0.0
2 (male)	Corneal Opacity	0	0	0	0.0
	Iris (redness, swelling, reaction of pupillary reflex etc.)	0	0	0	0.0
	Conjunctivae (reddening)	0	0	0	0.0
	Conjunctivae (swelling)	0	0	0	0.0
3 (female)	Corneal Opacity	0	0	0	0.0
	Iris (redness, swelling, reaction of pupillary reflex etc.)	0	0	0	0.0
	Conjunctivae (reddening)	0	0	0	0.0
	Conjunctivae (swelling)	0	0	0	0.0
4 (female)	Corneal Opacity	0	0	0	0.0
	Iris (redness, swelling, reaction of pupillary reflex etc.)	0	0	0	0.0
	Conjunctivae (reddening)	0	0	0	0.0
	Conjunctivae (swelling)	0	0	0	0.0

A slight reddening of the conjunctivae were seen in all animals and a slight swelling of the conjunctivae in three out of four animals on administration day.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritant to eye.

Executive summary:

The single administration of Endiol into the right eye of male and female rabbits with a volume of 0.1 ml/eye (corresponding to 59.1 -71.0 mg) results in a slight reddening of the conjunctivae in all animals and a slight swelling of the conjunctivae in three out of four animals on administration day. On day 2 (24 h after administration) only slight conjunctival reddening was seen in one out of four animals and from day 3 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, iris and conjuntival swelling and 0.08 for conjunctival reddening. Therefore, according to EU classification criteria the test substance is not eye irritating.

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