Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
17.4 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
174 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
1.74 µg/L
Assessment factor:
10 000
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:
124 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
12.4 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:
16.5 µg/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 Blue 168, therefore the aquatic toxicity assessment and classification are 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 (Brachydanio rerio) the effect level LC50 after 96 hours of exposure was recorded at 117.7 mg/l

- for short-term toxicity to aquatic invertebrates (Daphnia magna) the EC50 after 48 hours of exposure resulted to be 64.9 mg/l

- for toxicity to aquatic algae and cyanobacteria (Desmodesmus subspicatus) the ErC50 (72h) resulted to be greater than 17.4 mg/l

- for toxicity to microorganisms the EC0 at 3 hours of exposure was stated at 100 mg/l; the EC50 resulted greater than 100 mg/l

 

The outcomes from the short-term tests performed on the three trophic levels suggest that algae is the most sensitive species.

In order to derive the PNEC water (both freshwater and marine water), the short-term effect level of the most sensitive species has been chosen. The PNEC for STP has been derived taking into account the EC0 value resulted from the respiration inhibition test on microorganisms.

Conclusion on classification

Adequate chronic toxicity data are not available; Direct Black 168 is very water soluble, not readily biodegradable and has a negative log kow.

No L(E)C50 value was recorded at concentration equal/lower than 1 mg/l, thus the classification criteria for acute (short-term) aquatic hazard (category 1) of the CLP Regulation (EC) No 1272/2008 are not met.

On the basis of the short-term toxicity data on the three trophic levels (details above), effects were recorded in the range of 10 - 100 mg/l; therefore, the substance can be classified as hazard to the aquatic environment in category 3 (H412), according to the CLP Regulation (EC) No 1272/2008.