Pregna-5,7-diene-3,20-dione, cyclic 3,20-bis(1,2-ethanediyl acetal), (9.beta.,10.alpha.)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15-Jan-1992 to 11-Mar-1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Performed in accordance with OECD guideline and GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD guideline 405

Deviations:

yes

Remarks:

Due to a malfunction of a thermohygrograph the temperature and the relative humidity in the animal room were not recorded on two days. This deviation was not considered to have affected the integrity of the study performed.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(9R,10S,13S)-10,13-dimethyl-17-(2-methyl-1,3-dioxolan-2-yl)spiro[1,2,4,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,2'-1,3-dioxolane]

EC Number:

611-207-6

Cas Number:

5488-51-7

Molecular formula:

C25H36O4

IUPAC Name:

(9R,10S,13S)-10,13-dimethyl-17-(2-methyl-1,3-dioxolan-2-yl)spiro[1,2,4,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,2'-1,3-dioxolane]

Test material form:

solid: crystalline

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test animals
SPF-derived male New Zealand White rabbits (2.5-3.0 kg) were obtained from Harlan Olac, Zeist, The Netherlands. The animals were inspected for signs of illness at the beginning of the acclimatization period. No abnormalities were detected.

Animal care
Three rabbits were individually housed in stainless steel wire cages KK 102. Sawdust, woodchips, or other extraneous material that might produce eye irritation were excluded. The rabbits received 80 g food (a standard laboratory diet LKK-20, Hope Farms, Woerden, The Netherlands) per day during the acclimatization period of 12 days. During the experiment the animals had free access to food and water.

Animals were housed in room no. 301, CDA Ill with the following animal room conditions:

Temperature 18-20°c;
Relative humidity 60-74%;
Artificial light from 7 a.m. till 7 p.m.;
Radio-sound on 12 hours per day;
Ventilation approximately 16 air changes per hour.

Test system

Vehicle:

not specified

Controls:

other: The other eye, remaining untreated, served as a control.

Amount / concentration applied:

A quantity of 0 .1 g of Retroketal was placed in the conjunctiva! sac of the left eye by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was placed.

Duration of treatment / exposure:

Readings of reactions were made in all three rabbits at 1, 24, 48 and 72 hours after treatment.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 males

Details on study design:

After the acclimatization period, both eyes of each rabbit were examined with the aid of a slit­lamp. Only those rabbits without eye defects or signs of irritation were used. A quantity of 0 .1 g of Retroketal was placed in the conjunctiva! sac of the left eye by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was placed. The lids were then gently held together for one second and the rabbit was released. The other eye, remaining untreated, served as a control.

Readings of reactions were made in all three rabbits at 1, 24, 48 and 72 hours after treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Very slight iritis and swelling of the conjunctiva was observed in one animal at 1 hour after application of the test material. No significant eye irritation in three rabbits was observed. The test material is therefore classified as not irritant to the eye according to EEC labelling regulations. No symbol and no risk phrase are required.