Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.244 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
2.444 mg/L

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
3 105.01 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
3 105.01 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:
1 438.92 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Classification is not 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 5-nitrosalicylic acid for effects in the environment

In determining the classification appropriate to 5-nitrosalicylic acid, 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 5-nitrosalicylic acid is not persistent in the aquatic and soil environment. Moreover, its persistent characteristics were observed in the sediment compartment and hence it has been concluded that 5-nitrosalicylic acid is not persistent in nature.  

 

Thus, 5-nitrosalicylic acid is classified as a non persistent (P) chemical. 

 

Potential to accumulate

The estimated log Kow values for 5-nitrosalicylic acid is less than 4 (Log Kow = 1.1576). The potential for 5-nitrosalicylic acid 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 1000.  

 

The estimated BCF of 5-nitrosalicylic acid is highest 3.2 dimensionless and below the threshold of 2000. 

 

Thus, 5-nitrosalicylic acid does not satisfy the criterion for classification as bioaccumulative (B).

 

The toxicity values of fish, invertebrates and algae are LC50 = 228.214 mg/L, EC50 = 244.4349 mg/L and NOEC = 5.3331 mg/L, respectively. These values suggest classification for aquatic toxicity will not be applicable for all of the tropic levels and the same is based on the above mentioned estimation studies.

 

So,5-nitrosalicylic acid does not satisfy the environmental effects criterion for classification as toxic (T).

 

Thus it can be inferred that sodium 5-nitrosalicylic acid is a non PBT (including vPvB) substance.