17-acetoxy-1β,2β-methanopegna-4,6-diene-3,20-dione

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June - July 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987-02-24

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

17-acetoxy-1β,2β-methanopegna-4,6-diene-3,20-dione

EC Number:

427-820-5

EC Name:

17-acetoxy-1β,2β-methanopegna-4,6-diene-3,20-dione

Cas Number:

2701-50-0

Molecular formula:

C24H30O4

IUPAC Name:

(1S,2S,3R,5S,11R,12S,15R,16S)-15-acetyl-2,16-dimethyl-6-oxopentacyclo[9.7.0.0²,⁸.0³,⁵.0¹²,¹⁶]octadeca-7,9-dien-15-yl acetate

Test material form:

solid: bulk

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Controls:

other: left eye served as control

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

test substance remained in the eye, eye was not rinsed

Observation period (in vivo):

11 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:

0.41

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.41

Max. score:

4

Reversibility:

fully reversible within: 4 days

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/ animal
429 (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
432 (M)	Cornea	0	0	0
	Iris	0	0	0			0.0
	Conjunctivae (reddening)	1	0	0			0.33
	Conjunctivae (swelling)	2	1	0			1.0
401 (F)	Cornea	0	0	0			0.0
	Iris	0	0	0			0.0
	Conjunctivae (reddening)	0	0	0			0.0
	Conjunctivae (swelling)	0	0	0			0.0
422 (F)	Cornea	0	0	0			0.0
	Iris	0	0	0			0.0
	Conjunctivae (reddening)	1	1	0			1.0
	Conjunctivae (swelling)	3	1	1			1.66

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

not eye irritating
The single application of 100 mg ZK 5.690 into the right eye of rabbits led to irritation which is on the whole judged as slight to moderate. Similar reactions might be expected after inadvertent contact of the human eye with the substance. Since the rabbit eye reacts more sensitively than the human eye due to anatomical and physiological differences, no severe intolerance reactions need to be expected after inadvertent contact of the human eye with ZK 5.690. According to the EU criteria for general classification and labelling requirements for dangerous substances and preparations, however, ZK 5.690 need not be labelled as an eye irritant.

Executive summary:

The local tolerance of ZK 5.690 after a single application of 100 mg of the substance into the conjunctival sac of the right eye was tested in 4 New Zealand White rabbits (2M, 2F).
The respective left eye remained untreated and served as contral. Observations were performed before application, 0.5, 1 and 2 hours thereafter and then once daily until day 11 of the test.
On the day of application, slight to moderate irritation [reddening and swelling of eyelids, conjunctivae and membrana nictitans, and vascular injection of conjunctivae, sclera (only in two animals) .and membrana nictitans] was found in 3 of 4 animals. In one animal (422F) severe swelling of the conjunctiva and moderat~ to severe swelling of the membrana nictitans were observed on the application day, which subsided graduallyon days 2-4.
The animals were without symptoms from day 2 (no. 401 F) or 3 (432M, 429M) onwards.
Animal 422F showed only vascular injection of the membrana nictitans fram day 5 onwards and was without findings from day 9 onwards.
The calculation of mean values of the findings according to the system of evaluation recommended for the EU (Draize) revealed 0 for the parameters cornea and iris and 0.41 for conjunctival reddening and swelling.