Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 221-264-5 | CAS number: 3049-71-6
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- only a 50% aqueous substance preparation was tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- A 50% aqueous preparation of the substance has been applied on the back and ear of rabbits for 20 hours, observations were reported after 24, 48, 72h and 8 days.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
- EC Number:
- 221-264-5
- EC Name:
- 2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone
- Cas Number:
- 3049-71-6
- Molecular formula:
- C48H26N6O4
- IUPAC Name:
- 2,9-bis[4-(phenyldiazenyl)phenyl]isoquino[4',5',6':6,5,10]anthra[2,1,9-def]isoquinoline-1,3,8,10(2H,9H)-tetrone
- Details on test material:
- Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Average weight at study initiation: 2.9 kg
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 50% aqueous preparation
- Observation period:
- 8 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back of the animals. The skin on the left side of the exposure are was abraded, the right side remained intact.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact and damaged skin
- Basis:
- mean
- Time point:
- 24 h
- Remarks on result:
- other: could not be scored due to coloration of the skin from the pigment
- Irritation parameter:
- erythema score
- Remarks:
- intact and damaged skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- other: 48 h time point not evaluated
- Irritation parameter:
- erythema score
- Remarks:
- intact and damaged skin
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- other: could not be scored due to coloration of the skin from the pigment
- Irritation parameter:
- erythema score
- Remarks:
- intact and damaged skin
- Basis:
- mean
- Time point:
- other: 8 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- other: 48h time point not evaluated
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- damaged skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Remarks:
- damaged skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- other: 48h time point not evaluated
- Irritation parameter:
- edema score
- Remarks:
- damaged skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test item was found to have no irritation potential, however the erythema reactions could not be scored due to coloring effects of the test substance. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Foi. Cosm. Tox. 13, 355, 1975). Mild edema reactions (score = 1) were reported in all animals at the 24 hours observation time point, abraded skin only. This effect reverted back to normal after 72 hours. On the eighth day the staining effect had cleared; all animals were free of any irritation signs. The test item was found to cause no irritation when applied to intact rabbit skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to have no irritation potential.
- Executive summary:
The test substance was applied to the skin of rabbits as a 50% aqueous preparation (amount applied not specified) in an irritation study, comparable to OECD guideline 404 (using 6 animals) and observed for 8 days. Application caused no edema to intact skin, but forming of edema (mean score of 1) was observed at the damaged skin after 24 hours which was fully reversible within 72 hours. Determination of erythema was not possible at 24 and 72 hours, due to substance induced coloration of the skin. At day 8 no erythema was observed. The test article was judged to be not irritating to the skin.
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