Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.002 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:
0.004 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1.1 mg/kg food
Assessment factor:
90

Additional information

Conclusion on classification

Tridecylamine, branched and linear (CAS 86089 -17 -0) is a mixture of alkylamines of C13 isomers (99.8 -100%). For this fraction1-tridecanamine (CAS 2869-34-3) was selected as representative C13 substance. This isomer is a linear molecular with the largest chain length within the mixture. As toxicity increases with the chain length toxicity data can be regarded as a worst-case approach. The assessment of ecotoxicology is predominantly focused on this molecule.

Official classification regarding environmental hazards

Aquatic compartment

In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.1, the substance is not officially classified.

In accordance with Regulation (EC) 1272/2008 Annex VI Table 3.2, the substance is not officially classified.

 

Self-classification

Aquatic compartment

Acute (short-term) aquatic hazard

Following CLP, the substance is to be classified as acutely hazardous to the aquatic environment (Category Acute 1).

 

Rationale:

The substance is to be classified as acutely hazardous to the aquatic environment, since all the lowest acute effect value of the three trophic levels is <= 1 mg/L (E(r)C50 = 0.015 mg/L; ((48-h) daphnia: read-across to CAS 2869-34-0, Pedersen et al., 1998; algae: (76-h) BASF AG, 1988-1989; Rep no.: 2/1034/(2)/88(89)).

 

Long-term aquatic hazard

Following CLP, the substance is to be classified as chronically hazardous to the aquatic environment (Category Chronic 1).

 

Rationale:

Chronic data are available only for algae. Therefore, classification is based on the available chronic and acute toxicity data.

- Chronic toxicity data: The substance is not rapidly degradable and the ErC10 is <= 0.1 mg/L (algae, ErC10 = 0.0032 mg/L). According to the criteria outlined in Table 4.1.0(b) (i) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) the substance is to be classified as chronically hazardous to the aquatic environment (Category Chronic 1).

- Acute toxicity data: Fish and aquatic invertebrates are the trophic levels which are not covered by chronic data. Therefore, classification is based on the respective acute effect data. The lowest EC50 was determined for aquatic invertebrates (EC50 = 0.015 mg/L), the substance is not rapidly degradable and the log Pow is > 4. According to the criteria outlined in Table 4.1.0(b) (iii) (Commission Regulation (EU) No 286/2011 amending Regulation (EC) No 1272/2008) the substance is to be classified as chronically hazardous to the aquatic environment (Category Chronic 1).

- Conclusion: The substance is to be classified as chronically hazardous to the aquatic environment.

 

Based on Table 4.1.3, the lowest acute toxicity value (E(r)C50 = 0.015 mg/L) is within the range of 0.01 to 0.1 mg/L; therefore, the M-factor is 10 for acute toxicity. The lowest chronic value (EC10 = 0.0032 mg/L) is within the range of 0.001 and 0.01 mg/L; therefore, the M-factor is 10 for chronic toxicity as well.