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EC number: 224-597-4 | CAS number: 4424-06-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
- Remarks:
- According to OECD TG 405 and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to the Swiss Ordinance relating to GLP [RS 813.016.5]
Test material
- Reference substance name:
- Bisbenzimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione
- EC Number:
- 224-597-4
- EC Name:
- Bisbenzimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione
- Cas Number:
- 4424-06-0
- Molecular formula:
- C26H12N4O2
- IUPAC Name:
- bisbenzimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione
- Test material form:
- solid: nanoform
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kisslegg, Germany (SPF breed)
- Age at study initiation: 11 to 12 weeks (male and females)
- Weight at study initiation (animal#77 male/#78 female/#79 female at the first day of treatment): 2264/2654/2511 g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowles.
- Diet: pelleted standard Provimi Kliba 3418 rabbit maintenance diet; ad libitum
- Water: community tap water; ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70 %
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye remained untreated and served as control respectively
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
The pH of a 1 % (w/w) suspension was measured in RCC study No A13195 and was found to be 7.12. - Duration of treatment / exposure:
- single instillation (not rinsed after instillation)
- Observation period (in vivo):
- 1, 24, 48, 72 h and 7 d after instillation
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
- Details on study design:
- Application of the substance to the conjunctival sac of the left eye of each animal, the right eye served as control respectively
- Instillation: 100 mg of the undiluted substance
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed after instillation
SCORING SYSTEM: according to OECD TG 405. Additionally, ocular discharge, reddening of sclerae and staining of conjunctivae, sclerae and cornea by the test item was assessed.
TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic -lamp
The eyes are examined and the grade of ocular reaction is recorded at 1, 7, 24, 48, 72 h and 7 d.
The mean scores were calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 77, 78, 79 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility inapplicable since no signs of irritation (cornea) at any time
- Irritation parameter:
- iris score
- Basis:
- animal: # 77, 78, 79 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Reversibility inapplicable since no signs of irritation (iris) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 77
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: initial signs of irritation (conjunctiva) were fully reversible within 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 78
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 79
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 77, 78, 79 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: initial signs of irritation (chemosis) were fully reversible within 24 h
- Irritant / corrosive response data:
- No corrosion of the cornea was observed at any of the reading times.
- Other effects:
- After one hour there were still remnants in the eye or the conjunctival sac in all three animals. Slight discharge was observed in all animals at the 1 h readings. Orange staining was noted 1 h up to 48 h.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The test item has not to be classified for eye irritation according to Regulation (EC) No 1272/2008.
- Conclusions:
- All (initial) signs of irritation noted were fully reversible within 72 h. According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions.
- Executive summary:
The test material was subject to a primary eye irritation/corrosion test in 3 New Zealand White rabbits according to OECD 405. No corneal or iridial effects were observed. Conjunctival redness was observed in all animals at one hour after instillation of the test item (scores (redness): 1-1-2) and persisted up to the 48 hour examination in one of these animals. Slight to moderate reddening of the sclerae was present in all animals at the 1 hour reading. Slight ocular discharge was noted at the same time in all animals. As no abnormal findings were observed in the treated eye of any animal 72 hours after treatment or later and the mean values of the observed eye responses fall well below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.
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