Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.005 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.007 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
0.4 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
6.33 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.633 mg/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:
10 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Black 400 is highly insoluble in water with toxic effects to aquatic organisms that are greater than its solubility in water indicating that the substance would not be hazardous to aquatic organisms.

Conclusion on classification

Under REACH, Black 400 is not classified for environmental effects as all chronic studies return NOEC's greater than the water solubility, with no biological effects. PNECs are based on the following data:

Aquatic organisms:

LC50 fish 1 mg/l

EC50 daphnia 0.69 mg/l

EC50 algae 0.76 mg/l

Daphnia chronic 1 EC50 48 hr and NOEC 21d >=0.83 mg/l

Daphnia chronic 2 EC50 48hr >0.63 mg/l and NOEC 21d >0.63 mg/kg

Daphnia chronic 3 EC50 48 hr >=0.53 mg/l NOEC 21d 0.012 mg/l (discounted due to physical effect of ingestion)

Conclusion: most sensitive species is Daphnia, therefore value carried through for PNEC calculation is EC50 48 hr >0.53 mg/l.

Microorganisms:

Inhibition of microbial activity: EC50 (3h) > 4 mg/l

Terrestrial organisms:

Acute earthworm toxicity EC50 >1000 mg/kg

Although no toxic effects are seen in the database of information, a harmonised classification exists for environmental hazard for this substance of Chronic Category 3. Therefore an exposure estimation will be undertaken and the values obtained compared to PNECs based on the limit value (with application of the appropriate assessment factor).