Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

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 not PBT (including vPvB) substance.