Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
2 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.99 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.2 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
3.6 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:
29.1 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNECaquatic is calculated using the assessment factor approach proposed by the TGD. Since long-term NOECs from species representing two trophic levels are available (algae and daphnia) an assessment factor of 50 may be used. No effects due to exposure to 1-methylpiperazine were observed in the short-term but also in the long-term toxicity tests. The lowest observed NOEC/EC10 were used to derive the PNECaquatic.

No tests were performed with sediment organisms or terrestrial organisms. The PNEC for these compartments was derived using the equilibrium partitioning method and available sorption data. This approach is considered to be justified based on recent publications.

Conclusion on classification

Classification according to GHS

Acute (short-term) aquatic hazard

Acute toxicity data for fish, crustacea and algae are > 99 mg/L. Therefore the substance needs no classification with Catagory Acute 1.

Long-term aquatic hazard

Acute toxicity data are available for fish, crustacea and algae and all E(L)C50 values are > 99 mg/L. Reliable long-term toxicity data are available for crustacea and algae and with chronic NOEC/EC10 values > 99.9 mg/L. Further chronic fish testing has been waived to avoid unnecessary animal testing as in the acute fish study no effects were observed upto 995 mg a.i./L (pH adjusted). In addition the bioaccumulation potential of the substance is very low given the log Kow of -0.57 and the low observed BCF of a structurally strongly related substance. Based on the available information it can be concluded that chronic toxicity is > 99.9 mg a.i./L and therefore the substance does not meet the criteria for classification with Categories Chronic 1, 2 or 3.

Safety net classification

The safety net classification does not apply. The substance is not persistent and considering the low bioaccumulation potential. In addition all long-term NOEC/EC10 values are > 99.9 mg a.i./L. Therefore the substance needs no classification as Chronic Category 4.

Conclusion classification according to GHS

Based on the results from the acute aquatic toxicity (values > 99 mg/L) and chronic aquatic toxicity (> 99.9 mg/L) and since the substance has a low bioaccumulation potential and is not considered to be persistent, the substance needs no classification as hazardous to the environment according to the CLP Regulation 1272/2008.

Classification according to 67/548/EEC (DSD)

Acute aquatic toxicity is > 99 mg a.i./L and is not considered to be persistent. Long-term aquatic toxicity is > 99.9 mg a.i./L and the substance has a low bioaccumulation potential. Therefore the escape clause applies and the substance needs no classification as hazardous for the environment according to Directive 67/548/EEC.