Registration Dossier

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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:
20 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.01 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:
0.02 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Studies on short-term toxicity in freshwater from each of the three trophic levels (on fish, aquatic invertebrate and aquatic plants) were available, which showed no toxicity of Direct Red 23 (DR23) to aquatic organisms at the limit concentrations tested; also the test in microorganisms confirms that DR23 is not toxic.

 

DR23 is unlikely to be present in the marine environment based on CSR and risk management measures, therefore the here derived PNEC marine aquatic, based on freshwater data, should be considered to be hypothetical.

 

Long-term toxicity was not tested because direct and indirect exposure is unlikely due to the risk management measures that will be applied at industrial level. The risk management measures to avoid any release of the substance directly in the environment are discussed in detail within the exposure scenario; furthermore DR23 has a low potential for bioaccumulation and aquatic toxicity is unlikely to occur as indicated by the short-term aquatic testing results.

Therefore, long-term toxicity testing is not necessary, because the chemical safety assessment according to Annex I does not indicate the need to investigate further the effects on aquatic organisms.

 

In all cases considered, no L(E)C50 was determined below limit concentrations, because no mortality, nor signs of toxicity, were noted at the limit concentrations tested; thus the higher than (>) L(E)C50 values determined were set as the L(E)C50 for PNEC derivation.

 

No data on terrestrial toxicity were available and no terrestrial testing was performed, because direct and indirect exposure of the soil compartment is unlikely. Based on CSR and risk management measures reported there is no soil exposure, thus no specific test is necessary.

 

Although toxicity is unlikely, PNEC values for aquatic toxicity and for terrestrial organisms have been anyway calculated for completeness sake.

On the contrary, the PNEC for secondary poisoning was not calculated, because DR23 is not expected to be bioaccumulable based on a Pow value of 0.0019.

Also the PNEC for air was not calculated because no hazard for the atmosphere compartment was identified, based on exposure considerations as well as the chemical and physical characteristics of DR23.

 

Conclusion on classification

Direct Red 23 (DR23) does not meet the criteria to be considered as hazardous to the environment, thus, in accordance with CLP regulation (EC1272/2008), DR23 is not classified as toxic to the environment.