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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Classification of N,N-dimethyl-p-toluidine for effects in the environment

Several major guideline – estimation values (Klimisch 2) are available for N,N-dimethyl-p-toluidine, which indicates substantial toxic effect on invertebrates and algae when exposed to the substance, N,N-dimethyl-p-toluidine at concentrations up to its limit of solubility in the respective test media. Among the values lower values which lead to the classification of the substance the value which have been considered for further calculation (invertebrate) is EC50 = 13.7 mg/L.

 

In determining the classification appropriate to N,N-dimethyl-p-toluidine, 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 N,N-dimethyl-p-toluidine is persistent in nature and so is considered to be non biodegradable in the environment. In other words N,N-dimethyl-p-toluidine may therefore be expected to degrade slowly. Thus it can be inferred that N,N-dimethyl-p-toluidine is persistent in nature. 

 

 

N,N-dimethyl-p-toluidine is persistent (P). 

 

 

Potential to accumulate

Predicted and measured log Kow values for N,N-dimethyl-p-toluidine are less than 4 (Log Kow = 1.729). thus, the potential for N,N-dimethyl-p-toluidine to bioaccumulate in the tissues of organisms that inhabit aquatic or terrestrial matrices is considerable though the BCF factor for the substance is less than 1000.  

 

N,N-dimethyl-p-toluidinedoes not satisfy the criterion for classification as bioaccumulative (B).

 

 

The toxicity values (EC 50) of fish, invertebrates and algae 41.5 mg/L, 13.7 mg/L are 15.481 mg/L, respectively. The values of all the 3 trophic levels (fish, invertebrate and algae) fall in the criteria for classification (CLP regulation) and so will qualify for classification as per the CLP regulation in the criteria of category 3 due to non biodegradable criteria as well.

 

N,N-dimethyl-p-toluidinesatisfies the environmental effects criterion for classification as toxic (T).

 

 

N,N-dimethyl-p-toluidineis therefore will not be B substance, but will qualify as P and T. But as per Annex XIII of the REACH regulation the chemical will not quality as PBT