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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
- 4 instead of 3 animals
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Oestr-5(10)-ene-3,17-dione
EC Number:
223-564-1
EC Name:
Oestr-5(10)-ene-3,17-dione
Cas Number:
3962-66-1
Molecular formula:
C18H24O2
IUPAC Name:
(3aS,3bR,9bS,11aS)-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,6H,7H,8H,9H,9bH,10H,11H,11aH-cyclopenta[a]phenanthrene-1,7-dione

Test animals / tissue source

Species:
rabbit
Strain:
other: Kbl:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.93 - 3.18 kg (male), 2.80 - 2.85 kg (female)
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.7 - 22.8
- Humidity (%): 45 - 63 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye, which remained untreated, served as control.
Amount / concentration applied:
0.1 mL (corresponded to 39-41.8 mg substance)
Duration of treatment / exposure:
test substance remained in the eye (eye was not rinsed)
Observation period (in vivo):
4 days
Number of animals or in vitro replicates:
2 males and 2 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
reddening
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
swelling
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The single application of 0.1 mL ZK 67026 into the conjunctival sac of the right eye led to predominantly slight reactions observed within 2 hours after application. The data reveal that conjunctiva was only transiently affected. However, cornea and iris were not affected. Moreover, all animals were without findings 2 hours after application.

Applicant's summary and conclusion

Interpretation of results:
other: very slight transient irritation
Remarks:
in opinion of study director
Executive summary:

In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight transient irritation (only 0.5 to 1 hours after application).

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