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Registration Dossier
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EC number: 219-169-9 | CAS number: 2379-81-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- March 29, 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The substance has been tested according to a procedure similar to accpeted guideline but the content of the active ingredient in the test substance is very low.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S..A.. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification
- Version / remarks:
- 1965
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-6,9-diyl)bis(benzamide)
- EC Number:
- 219-169-9
- EC Name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-6,9-diyl)bis(benzamide)
- Cas Number:
- 2379-81-9
- Molecular formula:
- C42H23N3O6
- IUPAC Name:
- N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-6,9-diyl)bis(benzamide)
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Porton strain
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.44 to 2.96 kg
- Housing: rabbits were caged singly in an experimental room
- Diet (e.g. ad libitum): commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 50 - 70 %
- Photoperiod (hrs dark / hrs light): 10 hours daily from 08.00 - 18.00 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- day 1, 2, 3, 4 and 7
- Number of animals or in vitro replicates:
- 3 per sex per dose
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 200 ml of warm water
- Time after start of exposure: after 30 sec of exposure
SCORING SYSTEM: according to the guideline
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not eye irritant
- Executive summary:
Method
The procedure used was the test for eye irritants described in the " Hazardous Substances Regulations" under the U.S..A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.
The test was performed on 3 male and 3 female rabbits. 0.1 ml was inserted into the conjunctival sac of the left eye of 6 rabbits and
the lids were gently held open for one second. The right eye remained untreated and served as a control.
Results
No signs of irritation were observed in none of the animals therefore the substance resulted not irritant to the eye, under this test conditions.
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