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Diss Factsheets
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EC number: 222-012-7 | CAS number: 3317-67-7
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Deviations:
- yes
- Remarks:
- The dilution strategy was different from the study plan. Given the slight solubility of the test item, the stock solution dilution was prepared 4X in treatment medium-4% DMSO instead of 100X. This has no impact on the study result
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- As Tier 1 approach and in order to avoid animal testing, no LLNA has been performed. Skin sensitisation has been assessed using appropriate in vitro assay.
- Details on the study design:
- 125 µl of the cell suspension at 8.104 cells/ml (i.e. 104 cells per well) were distributed in three white plates for the induction measurement and two transparent plates to assess the cytotoxicity. The seeded plates were incubated 24 hours ± 1 hour at 37°C, 5% CO2.
In the 5 seeded plates, the medium was aspirated and replaced with 150 µl of treatment medium. Then the 4 X plate was replicated 5 times: 50 µl from the 4 X plate were placed in each of the three white plates and in the two transparent plates. The plates (1 X) were covered with an adhesive plastic foil to prevent evaporation and incubated for 48 hours ± 1 hour (37°C, 5% CO2).
After 48 hours, the medium was aspirated and each well was gently washed once with 200 µl of PBS. Then 100 µl of luciferase substrate (luciferine + ATP + lysing agent) were then added in each well. The plates were incubated at least 15 minutes at room temperature to ensure cells lysis.
The plates were placed in the luminometer then the luciferase activity was measured with an integration time of 2 seconds.
After 48 hours, the medium was aspirated and each well was gently washed once with 200 µl of PBS. Then, 225 µl of staining solution diluted at 0.6 mg/ml in treatment medium (from the 5mg/ml stock solution) were distributed in each well. The plates were covered with an adhesive plastic foil and incubated for 4 hours ± 30 minutes (37°C, 5% CO2).
After this contact time, the staining solution was eliminated and the cells were treated with 200 µl of 10% SDS one night in the dark (37°C, 5% CO2). After a 10 minutes homogenization, the absorbances were measured at 540 nm to assess cell viability
Cinnamaldehyde represents the positive control and culture medium represents the negatice control - Positive control results:
- Positive control : Cinnamaldehyde
Geometric mean EC1.5 = 16.62
Mean Imax = 3.44 - Run / experiment:
- other: Assay 1
- Parameter:
- other: Imax
- Remarks:
- Mean value
- Value:
- 2.54
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Run / experiment:
- other: Assay 1
- Parameter:
- other: Linear EC1.5 µM
- Remarks:
- Geometric mean value
- Value:
- 160.98
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Run / experiment:
- other: Assay 1
- Parameter:
- other: EC1.5 Lin/Log (µM)
- Remarks:
- Geometric mean value
- Value:
- 153.86
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: Assay 2
- Parameter:
- other: Imax
- Value:
- 1.5
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Other effects / acceptance of results:
- For the 4 higher concentrations (from 2000 µM to 250 µM), the culture wells were stained by the test item.
The viability curves obtained are biphasic. From 0.98 µM to 125 µM, viability is decreasing, related to the concentrations and from 250 µM to 2000 µM viability is increasing. This is probably due to the blue staining of the well by the test item. The complementary assay on keratinocytes without gene insersion showed a viability curve with the same shape what seems to confirm the crossed reaction. IC70 was therefore calculated in the downward part of the curve.
In both repetitions, Imax are higher than 1.5 and the EC1.5 are lower than 1000 µM. The complementary assay did not showed any induction what indicates that inductions in the main test are not due to the crossed reaction. However at the EC1.5 concentration we can consider that the measured viability is overestimated. Taking into account the calculated IC70, at the EC1.5 concentration, viability should be lower than 70%. - Interpretation of results:
- other: Based on a part of integrated approach, these results support a non-classification.
- Conclusions:
- Based on OECD 442D GLP compliant study, results are considered scientifically valid to be used as part of an integrated approach to support a non classification.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Skin sensitisation
Based on OECD 442D GLP study, Cobalt Phthalocyanine did not show evidence of sensitising effect. However, theses results have to be considered as part of an integrated approach. It can be noted that OECD 442C assay is not applicable to metal compounds and results of assay OECD 442E depends of log Kow according the Guidance on information Requirements and chemical safety assessment - Chapter R.7a - Version 6.0 - 2017. Based on data of IUCLID (section 4.7), log Kow cannot be determined due to the low solubility of test item in water and octanol. Therefore, only OECD 442D test has been performed.
Besides, from data on 29H,31H-phthlalocyanine (EC number: 209 -378 -3, CAS number: 574 -93 -6) on ECHA website, no skin sensitisation properties is identified. For cobalt, a harmonised classification for skin sensitization has been established (refer to Annex VI of CLP Regulation) but due to the high molecular weight (571.47 g/mol) of test item and spatial conformation (cobalt is enclosed), no cobalt interaction is expected for this endpoint. Furthermore, according to C&L notifications from ECHA website, 47/49 notifications do not propose classification for skin sensitisation.
To conclude, in a weight of evidence approach and in order to avoid unnecessary testing on animals, considering all the elements listed above, it can be concluded that Cobalt Phthalocyanine does not have skin sensitising potential.
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