Registration Dossier
Registration Dossier
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EC number: 218-524-5 | CAS number: 2172-33-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 21 May, 1979 to 11 June, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The procedure used is described in the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone
- EC Number:
- 218-524-5
- EC Name:
- 6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone
- Cas Number:
- 2172-33-0
- Molecular formula:
- C42H18N2O6
- IUPAC Name:
- 6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- Test material: FAT 46014/E
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 3 kgs
- Housing: The animals were housed individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period : Prior to treatment they were adapted to our laboratories for a minimum of 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right eye remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 g - Duration of treatment / exposure:
- few second
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.
SCORING SYSTEM:
Degree of eye irritation
0-10: minimal
11-25: slight
26-55: moderate
56-84: marked
above 84: extreme
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- None
- Other effects:
- None
Any other information on results incl. tables
The irritation index in this experiment was established to be 0 for the cornea, 0 for the iris and 0 for the conjunctiva.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 46014/E was found to cause no irritation when applied to the rabbit eye mucosa.
- Executive summary:
The eye irritation potential of FAT 46014/E was evaluated in a study conducted according to the procedure described in the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. 0.1 g of FAT 46014/E was placed into the conjunctival sac of the left eye of each of 3 male and 3 female rabbits, after gently pulling away the lower lid from the eyeball. The lids were then held together for few seconds in order to prevent loss of the test material. The right eye remained untreated and served as a control. The ocular reactions were evaluated 1, 2, 3, 4 and 7 days after the instillation of FAT 46014/E. The irritation index in this experiment was established to be 0 for the cornea, 0 for the iris and 0 for the conjunctiva, as no irritation was observed at any of the observations. Hence, FAT 46014/E was found to cause no irritation when applied to the rabbit eye mucosa.
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