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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Malachite Green (MG) has confirmed the very hazardous to the aquatic environment indicated on the classification of EC Regulation 1272/2008. To have control of environmental risk, it is necessary that all importers, manufacturers and users of the substance, in order to limit leakage into the environment, draw up a series of security measures and operational conditions.

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