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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

Classification of N,N-dimethylanilinefor effects in the environment

Several major guideline – estimation values (Klimisch 2) are available for N,N-dimethylaniline, which indicates substantial toxic effect on all the three key trophic levels (fish, invertebrates and algae) when exposed to the substance, N,N-dimethylaniline 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 = 2.3 mg/L.

 

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

N,N-dimethylanilineis non persistent and does not satisfy the criteria for classification as persistent (P). 

 

Potential to accumulate 

Predicted and measured log Kow values for N,N-dimethylaniline are less than 4 (Log Kow = 1.171). The potential for N,N-dimethylaniline 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 calculated BCF of N,N-dimethylaniline is 16 dimensionless and below the threshold of 2000. 

 

N,N-dimethylanilinedoes not satisfy the criterion for classification as bioaccumulative (B).

 

The toxicity values of fish, invertebrates and algae 33 mg/L, 2.3 mg/L are 14 mg/L, respectively. All the values of the 3 trophic levels fulfill the criteria for classification in the category of 10-100 mg/L and 1 – 10 mg/L and so the substance will qualify for classification as per the CLP regulation in the criteria of chronic category 2.

N,N-dimethylanilinedoes satisfy the environmental effects criterion for classification as toxic (T).

 

N,N-dimethylanilineis therefore not a P & B (or vPvB) substance, but will qualify for T. But based on Annex XIII of REACH regulation the chemical is not PBT in nature.