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EC number: 211-949-7 | CAS number: 719-59-5
- 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 vitro
- Remarks:
- h-CLAT
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 442E
- Deviations:
- yes
- Principles of method if other than guideline:
- In vitro Human Cell Line Activation Test (h-CLAT) is performed to assess the dendritic cell activation potential (third key event of a skin sensitization AOP)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of dendritic cells
Test material
- Reference substance name:
- 2-amino-5-chlorobenzophenone
- EC Number:
- 211-949-7
- EC Name:
- 2-amino-5-chlorobenzophenone
- Cas Number:
- 719-59-5
- Molecular formula:
- C13H10ClNO
- IUPAC Name:
- (2-amino-5-chlorophenyl)(phenyl)methanone
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Details on the study design:
- The following concentrations of the test item were tested in the main experiments (h-CLAT): 10, 12, 15, 17, 21, 25, 30 and 36 μg/mL
Medium control : Culture medium
Positive control : 2,4-dinitrochlorobenzene (DNCB)
Test system : THP-1 cells (Human monocytic leukemia cell line)
Solvant conrol : Dimethyl sulfoxide (DMSO)
Results and discussion
- Positive control results:
- In the DMSO control, RFI values compared to the medium control of both CD54 and CD86 did not exceed the positive criteria (CD54 ≥ 200% and CD86 ≥ 150%). The RFI values of the positive controls (DNCB) for CD54 and CD86 exceeded the positive criteria (CD54 ≥ 200% and CD86 ≥ 150%) and the cell viability was >50%.
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Max concentration - Mean of 2 runs
- Parameter:
- other: RFI (%) - CD86 antibody
- Value:
- 241.75
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: Max concentration - Mean of 2 runs
- Parameter:
- other: RFI (%) - CD54 antibody
- Value:
- 151.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The test item with a log Pow of 3.16 ± 0.05 was tested in 2 independent runs. The RFI of CD86 was equal or greater than 150% in at least one concentration of the first run and the RFI of CD86 and CD54 was equal or greater than 150% and 200%, respectively, in at least one concentration of the second run. Therefore the h-CLAT prediction is considered positive for the tested test item in this h-CLAT.
did not exceed the positive criteria (CD54 ≥ 200% and CD86 ≥ 150%). The RFI values of the positive controls (DNCB) for CD54 and CD86 exceeded the positive criteria (CD54 ≥ 200% and CD86 ≥ 150%) and the cell viability was >50%. For details see Annex 1 and 2.
This human cell line activation test can be used as part of a testing battery (including e.g. DPRA (Direct Peptide Reactivity Assay), ARE-Nrf2 luciferase test method) based on the OECD adverse outcome pathway for the assessment of the skin sensitisation potential of chemicals.
Applicant's summary and conclusion
- Interpretation of results:
- other: This human cell line activation test can be used as part of a testing battery
- Conclusions:
- This in vitro Human Cell Line Activation Test (h-CLAT) was performed to assess the dendritic cell activation potential (third key event of a skin sensitization AOP) of D4223 accodring to OECD 442E guideline. The test item D4223 with a log Pow of 4.1 activated THP-1 cells under the test conditions of this study. Therefore the test item is considered positive for the third key event of the skin sensitisation Adverse Outcome Pathway (AOP).
- Executive summary:
This in vitro Human Cell Line Activation Test (h-CLAT) was performed to assess the dendritic cell activation potential (third key event of a skin sensitization AOP) of D4223 accodring to OECD 442E guideline. The test item D4223 with a log Pow of 4.1 activated THP-1 cells under the test conditions of this study. Therefore the test item is considered positive for the third key event of the skin sensitisation Adverse Outcome Pathway (AOP).
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