Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.3 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.1 µg/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:
7.97 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.8 mg/kg sediment dw
Assessment factor:
1
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:
5 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
6.67 mg/kg food
Assessment factor:
300

Additional information

Tetramine di-C16 -18 is poorly soluble in water and will be positively charged under environmental conditions. It will due to these properties sorb strongly to soil, sediment, sludge and other negatively charged surfaces. The exposure of aquatic organisms during the ecotoxicity testing in synthetic growth media was therefore checked at the beginning and end of the exposure period and corrected for the observed decrease. Only in the algae study in relation to the strongly adsorbing nature of the test substance the measured initial concentrations were used for the dose response as described by the OECD 201 test guideline under point 40.

Conclusion on classification

·        The short term fish test (Noack, 2016) with Tetramine di-C16 -18 gave a LC50 of >0.272 mg/L (Threshold test).

·        The short term daphnia test (Kean, 2016) with Tetramine di-C16-18 gave an EC50 of 0.244 mg/L.

·        The algae test (Kean, 2016) with Tetramine di-C16-18 gave an ErC50 of 0.23 mg/L.

The lowest short term toxicity observed is within the range: 0.1 < L(E)C501

This leads to an acute 1 classification and an M-factor of 1

 

For the long term environmental classification of Tetramine di-C16 -18 no read across from other substances is considered necessary as there are two long term study endpoints for Tetramine di-C16 -18 available and fish are based on the acute data and similar to primary alkyl amines, diamines, quaternary ammonium compound etc. expected to be less sensitive to tetramine di-C16 -18 when compared to daphnia and algae.

The two long term studies available with tetramine di-C16 -18

·        The algae test (Kean, 2016) with tetramine di-C16 -18 gave an ErC10 of 0.05 mg/L.

·        The long term daphnia test (Kean, 2016) with tetramine di-C16 -18 gave an EC10 (reproduction) of 0.148 mg/L. The 21d NOEC for adult mortality is 0.204 mg/L. 

The lowest long term toxicity value is within the range: 0.01 < EC100.1

This leads to a chronic 1 classification and an M-factor of 1 because the substance is not rapidly biodegradable (NRD)