Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
3.37 µg/L
Assessment factor:
10

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.071 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:
0.123 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

According to Directive 67/548 EC and the results mentioned hereafter, Dodecane-12-lactam, manufacturing of, by-products from, distillation residues is classified R52/53.

 

* Short term Toxicity to Fish: LC50-96h > 100 mg/L

Based on the results of this study, Dodecane-12-lactam, manufacturing of, by-products from, distillation residues would not be classified as toxic to fish in accordance with the Directive 67/548/EC.

 

* Short term toxicity to aquatic invertebrates: EC50-48h = 33.67 mg/L

Based on the results of this study, Dodecane-12-lactam, manufacturing of, by-products from, distillation residues is classified as harmful for aquatic invertebrates in accordance with the Directive 67/548/EC.

 

* Toxicity to aquatic algae: EC50-72h > 100 mg/L

Based on the results of this study, Dodecane-12-lactam, manufacturing of, by-products from, distillation residues would not be classified as toxic to algae in accordance with the Directive 67/548/EC.

 

* Toxicity to aquatic micro-organisms: EC50-3h > 100 mg/L

Based on the results of this study, Dodecane-12-lactam, manufacturing of, by-products from, distillation residues shows low toxicity to activated sludge.

 

* Dodecane-12-lactam, manufacturing of, by-products from, distillation residues is not readily biodegradable

 

According to GHS regulation, these results are conclusive and so show that Dodecane-12-lactam, manufacturing of, by-products from, distillation residuesis classified in the acute category III (Harmful to aquatic life) and chronic category III (Harmful to aquatic life with long lasting effects).

 

According to CLP, Dodecane-12-lactam, manufacturing of, by-products from, distillation residues is classified in the chronic category III (Harmful to aquatic life with long lasting effects).

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