Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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).