Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
100 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
100 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.037 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:
0.015 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Adequate chronic toxicity data are not available for Direct Red 253, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data available on the substance and on analogue Similar Substance 01.

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 greater than 1000 mg/l

- for short-term toxicity to aquatic invertebrates the EC50 (48h) resulted to be greater than 100 mg/l

- for toxicity to aquatic algae and cyanobacteria the EC50 (72 h) has been identified as higher than 100 mg/l

- for toxicity to microorganisms the no inhibition was recorded at dose of 100 mg/l

The substance resulted to be non harmful/toxic for none of the tested organisms, thus the limit value of 100 mg/l has been chosen for the PNEC freshwater water (both freshwater and marine water) derivation.

Conclusion on classification

Adequate chronic toxicity data are not available; Direct Red 253 is very water soluble, not readily biodegradable and has a negative log kow.

On the basis of the short-term toxicity data on the three trophic levels (details above), Direct Red 253 does not meet the criteria to be classified as hazard to the aquatic environment, according to the CLP Regulation (EC 1272/2008).