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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug. 08, 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 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted April 24, 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal 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
- Expiration date of the lot/batch: unlimited at room temperature
- Analytical purity: 99.9%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- A 1077 INRA (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: 8 - 9 months
- Weight at study initiation: 3.02 kg - 4.16 kg
- Housing: Individually in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: 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%
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: Feb. 01, 2005 (Arrival of the animals) To: Aug. 15, 2005 (Day of last observation)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: minimally moistened with a suitable amount of doubly-distilled water
- Controls:
- other: untreated skin of the same animals served as control
- Amount / concentration applied:
- TEST MATERIAL:
- Amount(s) applied (volume or weight with unit): The solid test substance was minimally moistened with a suitable amount of doubly-distilled water to guarantee skin contact immediately before test substance application (corresponding to a dose of 0.5 g of unchanged test substance). Because of the natural moisture of the skin doubly-distilled water was used for moistening, so that the test was carried out under conditions as physiological as possible. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 3 (2 males, 1 female animal)
- Details on study design:
- TEST SITE
- Area of exposure: flank
- Type of wrap if used: The test substance was covered with a test patch (2.5 x 2.5 cm) Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull stretch (adhesive fleece), Beiersdorf AG
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with LutroI and Lutrol / water (1: 1).
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Scaling at the end of the observation period (7 days)
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- Slight or moderate erythema was observed in the animals during the course of the study.
The application area was slight black discolored in two animals during the observation period. Scaling was noticed in one animal at study termination, only.
The cutaneous reactions, with the exception of scaling, were reversible in all animals within 7 days after removal of the patch at latest.
The average score (24 to 72 hours) for irritation was calculated to be 1.2 for erythema and 0.0 for edema.
Any other information on results incl. tables
Exposition: | 4 h (semiocclusive) | |||
Animal | Reading | Erythema | Edema | Comments |
1 | 0 h | 1 | 0 | |
2 | 0 h | 2 | 0 | Application area slight black discolored |
3 | 0 h | 2 | 0 | Application area slight black discolored |
1 | 1 h | 2 | 0 | |
2 | 1 h | 2 | 0 | Application area slight black discolored |
3 | 1 h | 2 | 0 | Application area slight black discolored |
1 | 24 h | 1 | 0 | |
2 | 24 h | 2 | 0 | Application area slight black discolored |
3 | 24 h | 2 | 0 | Application area slight black discolored |
1 | 48 h | 1 | 0 | |
2 | 48 h | 2 | 0 | Application area slight black discolored |
3 | 48 h | 1 | 0 | Application area slight black discolored |
1 | 72 h | 0 | 0 | Study discontinued because the animal was free of findings |
2 | 72 h | 2 | 0 | Application area slight black discolored |
3 | 72 h | 0 | 0 | Study discontinued because the animal was free of findings |
2 | 7 days | 0 | 0 | Scaling |
mean (animal 1) | 24 - 72 h | 0.7 | 0 | |
mean (animal 2) | 24 - 72 h | 2 | 0 | |
mean (animal 3) | 24 - 72 h | 1 | 0 | |
mean (animal 1-3) | 24 - 72 h | 1.2 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the described cutaneous reactions as well as the average score for irritation, the test substance shows a slight skin irritation potential below the regulatory threshold under the test conditions chosen.
- Executive summary:
The test article's potential to cause acute dermal irritation or corrosion was assessed by a GLP-compliant study according to OECD guideline 404. An amount of 0.5 g of the test substance was applied topically for 4 hours to the intact skin of three White New Zealand rabbits, using a patch of 2.5 cm x 2.5 cm, covered with semiocclusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and on day 7. Slight or moderate erythema was observed in the animals during the course of the study. The application area was slight black discolored in two animals during the observation period. Scaling was noticed in one animal at study termination, only. The cutaneous reactions, with the exception of scaling, were reversible in all animals within 7 days after removal of the patch at latest. The average score (24 to 72 hours) for irritation was calculated to be 1.2 for erythema and 0.0 for edema. Therefore, under the test conditions chosen, the test article is considered to be non irritating according to GHS and EU regulations.
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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