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7,17,28,38-tetraazatridecacyclo[24.16.2.2²,⁵.1⁸,¹².1²⁹,³³.0³,²².0⁴,¹⁹.0⁶,¹⁷.0²³,⁴³.0²⁷,³⁸.0⁴⁰,⁴⁴.0¹⁶,⁴⁶.0³⁷,⁴⁵]octatetraconta-1(42),2(48),3,5(47),6,8,10,12(46),13,15,19,21,23,25,27,29(45),30,32,34,36,40,43-docosaene-18,39-dione; 7,17,28,38-tetraazatridecacyclo[24.16.2.2²,⁵.1⁸,¹².1²⁹,³³.0³,²².0⁴,¹⁹.0⁶,¹⁷.0²³,⁴³.0²⁸,³⁹.0⁴⁰,⁴⁴.0¹⁶,⁴⁶.0³⁷,⁴⁵]octatetraconta-1(42),2(48),3,5(47),6,8,10,12(46),13,15,19,21,23,25,29,31,33,35,37(45),38,40,43-docosaene-18,27-dione
EC number: 475-310-6 | CAS number: -
- 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
- Study period:
- Aug. 23, 2005 - Sep. 14, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
- Reference Type:
- other: Amendment
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted April 24, 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: nanoform, no surface treatment
- Details on test material:
- - State of aggregation: solid, powder
- Particle size distribution (TEM): 29.1 nm (D50)
- Mass median aerodynamic diameter (MMAD): not specified
- Geometric standard deviation (GSD): not specified
- Shape of particles: plate
- Surface area of particles: 89 m²/g
- Crystal structure: crystalline
- Coating: no
- Surface properties: not applicable
- Density: 1566 kg/m³ at 20°C
- Moisture content: refer to IUCLID chapter 1
- Residual solvent: refer to IUCLID chapter 1
- Activation: not applicable
- Stabilisation: not applicable
Constituent 1
- Specific details on test material used for the study:
- - Physical state: Powder / black
- Storage condition of test material: Room temperature
- Analytical purity: 99.9%
- Expiration date of the lot/batch: unlimited at room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- A 1077 INRA (SPF)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: 2 - 3 months
- Weight at study initiation: 2.23 kg - 2.34 kg
- Housing: Individually in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): Fully air-conditioned rooms with a central air-conditioning system
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: Aug. 17, 2005 (arrival of the animals) To: Sep. 01, 2005 (Day of last observation)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (about 16 mg of the comminuted test substance) - Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 9 days
- Number of animals or in vitro replicates:
- 3 animals (2 males, 1 female animal)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): About 1 hour after application of the solid test substance the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 1 h
SCORING SYSTEM: according to OECD 405
TOOL USED TO ASSESS SCORE: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)
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:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Two animals showed injected scleral vessels in a circumscribed area (reversible within 24 - 48 h)
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- Slight to moderate conjunctival redness, slight conjunctival chemosis and slight discharge were observed in the animals up to 24 hours after application.
Two animals showed injected scleral vessels in a circumscribed area.
The ocular reactions were reversible in all animals within 48 hours after application.
The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis and 0.3 for conjunctival redness.
Any other information on results incl. tables
Cornea | Iris | Conjunctiva | ||||||
Animal | Reading | Opacity | Area involved | Redness | Chemosis | Discharge | Additional findings | |
1 | 1 hr | 0 | 0 | 0 | 2 | 1 | 1 | |
2 | 1 hr | 0 | 0 | 0 | 1 | 0 | 0 | Scleral vesseis injected, circumscribed area |
3 | 1 hr | 0 | 0 | 0 | 2 | 0 | 0 | Scleral vesseis injected, circumscribed area |
1 | 24 hrs | 0 | 0 | 0 | 1 | 0 | 0 | |
2 | 24 hrs | 0 | 0 | 0 | 1 | 0 | 0 | Scleral vesseis injected, circumscribed area |
3 | 24 hrs | 0 | 0 | 0 | 1 | 0 | 0 | |
1 | 48 hrs | 0 | 0 | 0 | 0 | 0 | 0 | |
2 | 48 hrs | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | 48 hrs | 0 | 0 | 0 | 0 | 0 | 0 | |
1 | 72 hrs | 0 | 0 | 0 | 0 | 0 | 0 | |
2 | 72 hrs | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | 72 hrs | 0 | 0 | 0 | 0 | 0 | 0 | |
mean animal 1 | 24 - 72 hrs | 0 | 0 | 0.3 | 0 | |||
mean animal 2 | 24 - 72 hrs | 0 | 0 | 0.3 | 0 | |||
mean animal 3 | 24 - 72 hrs | 0 | 0 | 0.3 | 0 | |||
mean 1 - 3 | 24/48/72 h | 0.0 | 0.0 | 0.3 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, the test article does not show an eye irritation potential under the test conditions chosen.
- Executive summary:
The test article's potential to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL bulk volume (about 16 mg) of the test substance to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). The study was performed according to OECD test guideline 405 and in compliance with GLP. About 1 hour after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Slight to moderate conjunctival redness, slight conjunctival chemosis and slight discharge were observed in the animals up to 24 hours after application. Two animals showed injected scleral vessels in a circumscribed area. The ocular reactions were reversible in all animals within 48 hours after application. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris and chemosis and 0.3 for conjunctival redness. In conclusion, considering the described ocular reactions as well as the average score for irritation, the test article is considered to be not irritating under the test conditions chosen.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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