Registration Dossier

Ecotoxicological information

Ecotoxicological Summary

Currently viewing:

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
48.245 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:
20.365 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

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 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-toluidine satisfies 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