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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, 69592 L'Arbresle, France (SPF breed)
- Age at study initiation: 14 to 15 weeks (male); 12 -14 weeks (females)
- Weight at study initiation (animal#73 male/#74 female/#75 female at the first day of treatment): 2747/2856/2839 g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test item/per animal was moistened with approximately 0.5 mL of purified water
The pH of the test item was measured before study initiation date. A formulation of a 1 % (w/w) suspension was prepared. The pH value was found to be 7.12. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 (1 male, 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 4 cm x 4 cm
- Type of wrap if used: surgical gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD 404 appr. 1, 24, 48 and 72 hours as well as 7, 10 and 14 days after removal of the test item.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of animals #73, 74, 75 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility inapplicable since no signs of irritation (edema) at any time
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of animals #73, 74, 75 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Reversibility inapplicable since no signs of irritation (erythema) at any time
- Remarks on result:
- other: not assessable after 1 h due to staining produced by the test item
- Irritant / corrosive response data:
- Overall the observations continued for 14 days due to staining present on the skin, not because of positive dermal reactions.
- Other effects:
- Signs such as erythema could not be evaluated in all animals 1 hour after treatment due to presence of staining produced ba the test item at the application site. Where evaluation was possible, the test item did not cause any skin reactions at the application site of any animal at any of the observation times.
The test item caused a marked orange staing at the test site of all animals 1 hour after treatment and slight orange staining persisted throughout the whole study.
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- The test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
- Conclusions:
- Test material is not irritating to skin under these test conditions. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
- Executive summary:
Test material was subject to an acute dermal irritation/corrosion test in 3 New Zealand White rabbits (one male, two females) according to OECD TG 404. No skin reactions occurred during the 4 h exposure to 500 mg of test item (moistened with 0.5 mL purified water) as well as during the following 14 days observation period.
The mean score for oedema and erythema grades was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal separately. The mean score for oedema and erythema was 0 for all three animals. The application of the test item to the skin resulted in slight to marked orange staining produced by the test item of the treated skin in all animals at the 1- hour reading and persisted in all animals up to test day 14, the end of the observation period. Marked orange staining produced by the test item prevented the observation of any possible erythema in all animals at the 1-hour reading. From the 24 -hour reading the assessment of erythema was possible in all animals and no erythema was observed at any time. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
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