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EC number: 241-922-5 | CAS number: 18015-76-4
- 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
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.03 µg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.305 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.003 µg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 0.16 µg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.193 µg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.019 µg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 0.021 µg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 4.67 mg/kg food
- Assessment factor:
- 30
Additional information
The primary source of Malachite Green (MG) environmental pollution is represented by industrial waste water and it is very hazardous to the aquatic environment. It has been evaluated that MG is toxic to several aquatic species belonging to different trophic levels like fishes, invertebrates, algae and microorganisms; MG may also have acute, sub-chronic and chronic effects with organ damage or systemic damage.
No data on terrestrial toxicity were available and no terrestrial testing was performed, because direct and indirect exposure of the soil compartment is unlikely.
The available chronic toxicity data have been judged as not adequate, therefore the aquatic toxicity assessment is based mainly on the short-term toxicity data available.
The key values chosen for Chemical Safety Assessment concerning the aquatic compartment are the following:
- for the short-term toxicity to fish the LC50 (96h) resulted to be 0.0305 mg/l
- for short-term toxicity to aquatic invertebrates the EC50 (48h) resulted to be greater than 0.079 mg/l
- for toxicity to aquatic algae and cyanobacteria the EC50 (72 h) is 3.6 mg/l
- for toxicity to microorganisms the EC50 (3h) was determined to be 16 mg/l
The outcomes of the tests performed on the three trophic levels suggest that fish is the most impacted species.
In order to derive the PNEC water (both freshwater and marine water), the short-term effect level of the most sensitive species was chosen. Thus, the EC50 related to the fish has been selected.
Based on the available literature data, a bioaccumulative potential for Malachite Green and its transformation products/metabolites cannot be excluded, thus the PNECoral for secondary poisoning has been estimated; data from mammalian carcinogenicity test have been used (NOAEL (2y): 7 mg/kg bw/day on rats).
Conclusion on classification
The available chronic toxicity data have been judged as not adequate, therefore the aquatic toxicity assessment and classification accoding to the CLP Regulation (EC 1272/2008) are based mainly on the short-term toxicity data available.
MG and its transformation products are regarded as possible bioaccumulative and the substance it is not considered as rapidly degradable.
The available data concerning the short-term toxicity to fish, invertebrates and to amphibia showed that Malachite Green causes toxic effects at concentrations below 1 mg/l (0.0305 mg at 96h, 0.079 mg/l at 48h and 0.068 mg/l at 96 h, respectively), thus the following classification according to CLP Regulation (EC 1272/2008) is proposed:
- very toxic to aquatic life (Aquatic Acute 1, H400), M factor 10
- very toxic to aquatic lifewith long lasting effects (Aquatic Chronic 1, H410), M factor 10
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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