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Registration Dossier
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EC number: 219-034-4 | CAS number: 2322-77-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 February 1987
- Deviations:
- yes
- Remarks:
- 4 animals (2M, 2F)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Gona-2,5(10)-dien-17-one, 13-ethyl-3-methoxy
- IUPAC Name:
- Gona-2,5(10)-dien-17-one, 13-ethyl-3-methoxy
- Reference substance name:
- 13-β-ethyl-3-methoxygona-2,5(10)-dien-17-one
- EC Number:
- 219-034-4
- EC Name:
- 13-β-ethyl-3-methoxygona-2,5(10)-dien-17-one
- Cas Number:
- 2322-77-2
- Molecular formula:
- C20 H28 O2
- IUPAC Name:
- 3-Methoxy-18-methyl-2,5(10)-estradien-17-on
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Schriever
- Weight at study initiation: 3.1 kg (males), 2.9-3.1 kg (females)
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 25 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23°C
- Humidity (%): 56-60%
- 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
- Duration of treatment / exposure:
- test substance remained in the eye (eye was not rinsed)
- Observation period (in vivo):
- before application, 0.5; 1 and 2 hours thereafter and then every 24 hours until day 8 of the test
- Number of animals or in vitro replicates:
- 2 females, 2 males
- Details on study design:
- 0.1 mL corresponded to 63-64 mg substance.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: No washing
SCORING SYSTEM: Evaluation of the local tolerance on the conjunctiva of the rabbit after a single application was performed according to the score system recommended for the EU.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- Chemosis refers to reddening of the eye lids and nictating membranes, only reddening of the conjunctivae was measured.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- Chemosis refers to reddening of the eye lids and nictating membranes, only reddening of the conjunctivae was measured.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- Chemosis refers to reddening of the eye lids and nictating membranes, only reddening of the conjunctivae was measured.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- other: not applicable
- Remarks on result:
- not measured/tested
- Remarks:
- 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 #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
Table 1: Results of the study
Irritant effects (score) | |||||
Animal no. (sex) | Irritation parameter | 24 h | 48 h | 72 h | Mean scores |
1 (M) | Cornea | 0 | 0 | 0 | 0.0 |
Iris | 0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) | 0 | 0 | 0 | 0.0 | |
Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
2 (M) | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
3 (F) | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 2 | 1 | 1 | 1.33 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
| 4 (F) | Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 1 | 1 | 1 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0 | |
The control eyes were without findings.
A single application of 0.1 ml of the test item into the conjunctival sac of the rabbit eye led to slight to moderate secretion, reddening and swelling of the outer eyelids and eyelid closure mainly on days 1-2. Additionally, reddening and swelling of the conjunctivae were observed which were slight to moderate up to day 2, while slight conjunctival reddening and/or vascular injection were observed up to day 7. One animal was without findings on day 2, while the other animals were without findings on days 7 or 8.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- 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 on the whole slight irritation which lasted up to day 7. 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. With regard to conjunctival reddening 2/4 animals showed a mean score of 1 and 1.33 .
- Executive summary:
In a primary eye irritation study similar to OECD TG 405, 0.1 mL corresponding to 63-64 mg of D-ET-Dienon was instilled into the conjunctival sac of the right eye of young adult female and male New Zealand White rabbits (2/sex) and the animals were observed for 8 daysThe 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 day 7. 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. With regard to conjunctival reddening 2/4 animals showed a mean score of 1 and 1.33. In this study, the test item is not an eye irritant.
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