Registration Dossier
Registration Dossier
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EC number: 223-564-1 | CAS number: 3962-66-1
Eye irritation
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:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 February 1987
- Deviations:
- yes
- Remarks:
- - 4 instead of 3 animals
- GLP compliance:
- yes
Test material
- 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
- Reference substance name:
- 5(10)-Estrene-3,17-dione
- IUPAC Name:
- 5(10)-Estrene-3,17-dione
- Reference substance name:
- Delta-5-Norandrostendion
- IUPAC Name:
- Delta-5-Norandrostendion
- Test material form:
- not specified
- Details on test material:
- Purity not specified
Constituent 1
Constituent 2
Constituent 3
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:
- chemosis score
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Chemosis refers to reddening of the eye lids and nictating membranes, only reddening of the conjunctivae was measured.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1 to #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1 to #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal: #1 to #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal: #1 to #4
- Time point:
- 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:
- GHS criteria not met
- Remarks:
- only slight irritation of the conjuntivae which were fully reversible within 2h after application
- Conclusions:
- In a local tolerance test on the rabbit eye similar 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).
- Executive summary:
In a primary eye irritation study similar to OECD TG 405, 0.1 mL corresponding to 39-41.8 mg of Delta-5-Norandrostendion was instilled into the conjunctival sac of the right eye of young adult female and male Kbl:New Zealand White rabbits (2/sex) and the animals were observed for 4 days. The eyes were not washed. Irritation was scored by the method described in the guideline.
A single application of the test substance into the conjunctival sac provoked on the whole slight irritation which lasted up to 2 h after application. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameters cornea, iris and conjunctival swelling and reddening. In this study, the test item is not an eye irritant.
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