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EC number: 209-052-0 | CAS number: 553-86-6
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-08-11 to 2004-10-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (3H)-benzofuran-2-one
- EC Number:
- 209-052-0
- EC Name:
- (3H)-benzofuran-2-one
- Cas Number:
- 553-86-6
- Molecular formula:
- C8H6O2
- IUPAC Name:
- 2,3-dihydro-1-benzofuran-2-one
- Details on test material:
- - Name of test material (as cited in study report): 2-Coumaranone
- Physical state: solid
- Analytical purity: 99.9 %
- Lot/batch No.: 01V1264/38
- Expiration date of the lot/batch: 2005-06-21
- Storage condition of test material: At room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- In the main study, three groups of five experimental animals were epidermally exposed to a 5%, 25% and 50% concentration. Based on the results, two additional groups of animals were treated similarly with test substance concentrations of 0.25 and 1 %.
- No. of animals per dose:
- 5
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- 1. 0% (vehicle control) / DPM: 241 / SI: 1.0
2. 5% test substance / DPM: 235 / SI: 1.0
3. 10% test substance / DPM: 766 / SI: 3.2
4. 25% test substance / DPM: 1708 / SI: 7.1
EC3: 9.5%
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 2.8
- Test group / Remarks:
- Test concentration: 0.25
- Parameter:
- SI
- Value:
- 7.8
- Test group / Remarks:
- Test concentration: 1.0
- Parameter:
- SI
- Value:
- 19
- Test group / Remarks:
- Test concentration: 5.0
- Parameter:
- SI
- Value:
- 42
- Test group / Remarks:
- Test concentration: 25.0
- Parameter:
- SI
- Value:
- 24.9
- Test group / Remarks:
- Test concentration: 50.0
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Test concentrations: 0.0 / 0.25 / 1.0 / 5.0 / 25.0 / 50.0 DPM: 244 or 268 / 743 / 2092 / 4637 / 10256 / 6077
- Parameter:
- EC3
- Value:
- 0.3
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on these results 2-Coumaranone should be considered to be a skin sensitiser.
- Executive summary:
The study was carried out based on the guidelines described in: OECD, Section 4, Health Effects, No.429 (2002).
Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, three groups of five experimental animals were epidermally exposed to a 5%, 25% and 50% concentration respectively on three consecutive days. Five vehicle control animals were similarly treated, but with vehicle alone (N.N-dimethylformamide). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised. After precipitating the DNA of the lymph node cells, radioactivity measurements were done. Based on the results, two additional groups of animals were treated similarly with test substance concentrations of 0.25 and 1 %. Five vehicle control animals were treated with vehicle alone (N.N-dimethylformamide).
All nodes of the control groups and the majority of nodes of the 0.25 and 1% groups were considered normal in size. The largest nodes were found in the higher dose groups. No other macroscopic abnormalities of the nodes were noted. Mean DPM/animal values for the experimental groups treated with test substance concentrations 5, 25 and 50% were 4637, 10256 and 6077 respectively. The mean DPM/animal value for the vehicle control group was 244. In order to achieve more information regarding the Sl=3 value, additional groups of animals were with a 0.25 and 1% test substance concentration respectively and mean DPM/animal values of 743 and 2092 were calculated. A mean DPM/animal value of 268 was calculated for the vehicle control group. The SI values calculated for the substance concentrations 0.25, 1, 5, 25 and 50% were 2.8, 7.8, 19.0, 42.0 and 24.9 respectively. These data showed a dose-response and an EC3 value of 0.3% was calculated using linear interpolation.
Based on these results 2-Coumaranone should be considered to be a skin sensitiser.
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