Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.018 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:
0.028 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met.

Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint”.

Classification related key information

Readily biodegradable: 74 - 82% in 28 days (OECD 301B); read across

Acute aquatic toxicity:

-             Fish: LC50 (96 h) = 13 mg/L (nominal); read across

-            Aquatic invertebrates: EC50 (48 h) > 100 mg/L (nominal)

-            Algae: ErC50 (72 h) >91 mg/L (measured, geom. mean)

Chronic aquatic toxicity: 

-            Aquatic algae: NOErC (72 h): 7 mg/L (measured, geom. mean)

Conclusion on classification

Reaction mass of bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate and [2-[2-(2-butoxyethoxy)ethoxy]ethyl](3,6,9,12-tetraoxahexadecyl)adipate (EC 943-330-9) is readily biodegradable. The acute aquatic toxicity L(E)C50 values are > 1 mg/L for fish, aquatic invertebrates and algae. Furthermore the chronic effect concentration is above the trigger value of 1 mg/L (NOErC (72 h): 7 mg/L). Thus, the substance does not need to be classified and labelled according to to the consolidated version of Regulation (EC) No. 1272/2008 (CLP) considering all further amendments.