Registration Dossier

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):
1 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
200 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:
PNEC oral
PNEC value:
4.17 mg/kg food
Assessment factor:
300

Additional information

Adequate chronic toxicity data are not available for Direct Blue 199, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data available on both Direct Blue 199 and Direct Blue 199, sodium salt. The usage of information on a different salification form, which has the same main component and with a different counter ion, can be considered as suitable and appropriated because the difference is expected to not influence the ecotoxicological properties. The impurity profile does not impact on the read across proposed. Details on the approach followed are included in the document attached to the IUCLID section 13.

 

The key values chosen for Chemical Safety Assessment concerning the aquatic compartment are the following:

- the substance resulted to be not harmful/toxici for short-term toxicity to fish, thus the LC50 (96 h) can be considered tio be higher than 100 mg/l

- for short-term toxicity to aquatic invertebrates the EC50 (48 h) 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 1000 mg/l

- for toxicity to microorganisms the no inhibition was recorded at dose of 2000 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 water (both freshwater and marine water) derivation.

Conclusion on classification

Adequate chronic toxicity data are not available; the substance 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, the substance does not meet the criteria to be classified as hazard to the aquatic environment, according to the CLP Regulation (EC 1272/2008).