Registration Dossier

Ecotoxicological information

Ecotoxicological Summary

Currently viewing:

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
97.9 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.5 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
9.79 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
50 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
44.9 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:
32.2 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Classification is triggered based on available data, according to REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

Conclusion on classification

Classification of sulisobenzone for effects in the environment

In determining the classification appropriate to sulisobenzone, it is necessary to consider all available evidence concerning its persistence, potential to accumulate and predicted or observed environmental fate and behaviour that may present a long-term and/or delayed danger to the structure and/or functioning of aquatic ecosystems. These points are considered below.

 

Persistence

Reliable studies are available to demonstrate that sulisobenzone is non persistent in the aquatic and soil environment. However, it is persistent in sediment compartment considering iys half life. However, there is minimal diffusion in the sediment compartment. Thus, it can be inferred that sulisobenzone is non persistent in nature.

 

Sulisobenzone is therefore classified as a not persistent chemical. 

 

Potential to accumulate

Predicted and measured log Kow values for sulisobenzone is less than 4 (Log Kow = 0.313). The potential for sulisobenzone to bioaccumulate in the tissues of organisms that inhabit aquatic or terrestrial matrices is negligible as the BCF factor for the substance is less than 2000.  

 

The calculated BCF of sulisobenzone is 3.2 dimensionless and below the threshold of 2000. 

 

Thus, Sulisobenzone does not satisfy the criterion for classification as bioaccumulative (B).

Toxicity

The toxicity values of fish, invertebrates and algae are LC50 = 15.33 mg/L, LC50 = 50 mg/L and EC 50 >200 mg/L, respectively. Thus, based upon these values, it is considered that sulisobenzone shall exhibit aquatic toxicity to fish and daphnia and thus the chemical will qualify for aquatic toxicity level in category 3. But the long term study effect (NOEC) values are greater than 0.01 mg/L as thus as per the Annex XIII of the REACH regulation the chemical shall not be considered to be toxic

So, sulisobenzone does not satisfy the environmental effects criterion for classification as aquatic toxic chemical (T).

 

Thus it can be inferred that sulisobenzone is not a PBT chemical.