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

Endpoint summary

Description of key information

Skin irritation in vivo (Rabbit-NZW, GLP, comparable to OECD TG 404): not irritant

Eye irritation in vivo (Rabbit-NZW, GLP, equivalent to OECD TG 405): not irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Vehicle:

physiological saline

Controls:

no

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2 males/ 2 females

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results of the study:

Test compound ZK 5690		Animal number and sex
Location (finding)	Time-point after end of exposure	266M	270M		295F	299F
Reddening and scab formation	30 -60 min	0	0		0	0
	24 hours	0	0		0	0
	48 hours	0	0		0	0
	72 hours	0	0		0	0
Individual mean values:		0	0		0	0
Mean value of all animals:							0
Swellings	30 -60 min	0	0		0	0
	24 hours	0	0		0	0
	48 hours	0	0		0	0
	72 hours	0	0		0	0
Individual mean values		0	0		0	0
Mean values of all animals							0

Interpretation of results:

GHS criteria not met

Conclusions:

the test item revealed no skin irritating properties

Executive summary:

ZK 5.690 was tolerated without any compound-related findings on the intact skin of the rabbit after single application. The irritation index according to Draize (see table 2) was 0, indicating no local irritation of ZK 5.690.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987-02-24

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

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

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.41

Max. score:

4

Reversibility:

fully reversible within: 9 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.41

Max. score:

4

Reversibility:

fully reversible within: 4 days

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

 

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the study results a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.