Registration Dossier
Registration Dossier
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EC number: 229-904-5 | CAS number: 6829-22-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 14H-benz[4,5]isoquino[2,1-a]perimidin-14-one
- EC Number:
- 229-904-5
- EC Name:
- 14H-benz[4,5]isoquino[2,1-a]perimidin-14-one
- Cas Number:
- 6829-22-7
- Molecular formula:
- C22H12N2O
- IUPAC Name:
- 14H-benz[4,5]isoquino[2,1-a]perimidin-14-one
- Test material form:
- other: red granulate
- Details on test material:
- Content: at least 97 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5 months
- Weight at study initiation: 2.8-3 kg
- Housing: singly
- Diet ad libitum
- Water ad libitum
- Acclimation period: at leats 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Photoperiod (hrs dark / hrs 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye served as control
- Amount / concentration applied:
- 100 mg/animal
- Duration of treatment / exposure:
- once
- Observation period (in vivo):
- Up to 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- A dose of 100 mg Macrolex Rot E2G was administered into th conjunctival sac of the right eye of each of 3 male rabbits after gently pulling the lower lid away fron the eyeball. The lid was thengently held together for about one second in order to prevent losss of test material.The left eye which remains untreated seved as a control.. the eyes were examined phthalmoscopically with a slit lamp prior to the administration and also 1,24, 48 and 72 hours after administration. Eyes were evaluated for cornea opacity, iris and conjunctival changes Scoring was done according to Draize.
24 hours after administration the eyes were treated additionally with fluorescein and examined
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: before dosing, and 1, 24, 48 and 72 hours afterwards
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects were observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: before and 1, 24, 48, 72 hours post application
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: no effects were observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: before and 1, 24, 48, 72 hours post application
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: no effects were observed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: before and 1, 24, 48, 72 hours post application
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no effects were observed
- Irritant / corrosive response data:
- No irritational effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Cornea, iris, conjunctiva and chemosis score = 0 at any time point (before dosing, and 1, 24, 48 and 72 hours afterwards).
- Executive summary:
According to OECD 405 and GLP each of 3 male rabbits received instillations of 100 mg test substance into the conjunctival sac of the right eye; the respective left eye remained untreated and seved as control. The eyes of the animals were observed 1, 24, 48 and 72 hours post application. Additionally, 24 hours post application the eyes were treated with fluorescein and examined. The scoring was done according to Draize. In none of the animals the eyes were affected by treatment. Therefore the test substance was evaluated to be non-irritating to the eyes of rabbits.
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