Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.026 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
3.76 mg/kg sediment dw
Assessment factor:
50
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.376 mg/kg sediment dw
Assessment factor:
500
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
10 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

The ECHA Committee for Risk Assessment decided on the Harmonized Classification & labeling according 2ndATP of CLP Regulation (2011/286/EU) and DSD (67/548/EEC) for the five Primary alkyl amines of the Category Approach (ECHA, 2011). This CLH is also adopted for the Dodecyl amine and C12-14(even numbered) alkyl amines being part of the extended Category approach.

The rationale for the Harmonized Classification and Labeling is given in the Annex 1 Background documents of the Committee for Risk Assessment (RAC):

-    For Amines, tallow alkyl see ECHA/RAC/CLH-O-0000002199-69-01/A1 (DocLinkhttp://echa.europa.eu/documents/10162/13626/rac_annex1_bd_amines_tallow_alkyl+5_en.pdf)

-    For Amines, coco alkyl see ECHA/RAC/CLH-O-0000002195-77-01/A1 (DocLinkhttp://echa.europa.eu/documents/10162/13626/rac_annex1_bd_amines_coco_alkyl+5_en.pdf)

-    For Amnes, hydrogenated tallow alkyl see ECHA/RAC/CLH-O-0000002198-71-01/F (DocLinkhttp://echa.europa.eu/documents/10162/1e7eed4f-1662-43c3-b62c-ec60cce7431b)

-    For Octadecylamine see ECHA/RAC/CLH-O-0000002196-75-01/F

-    (DocLinkhttp://echa.europa.eu/documents/10162/e7e2c472-0902-4ee2-a7a2-f2803204cab7)

-    For (Z)-octadec-9-enylamine see ECHA/RAC/CLH-O-0000002197-73-01/F (DocLinkhttp://echa.europa.eu/documents/10162/bd40638b-9be4-46a4-a074-cab59a04758e)

 

Harmonized Classification according 2ndATP of CLP (2011/286/EU)

Acute (short-term) aquatic hazard

The lowest reliable short-term aquatic toxicity result for this category is a 48-h EC50 of 0.011 mg/L forDaphnia magna based on nominal concentrations for (Z)-octadec-9-enylamine (due to the lack of recovery rates it is expected the real EC50 to be lower). Therefore,Primary alkyl amines of the (extended) Category Approach are classifiable as Aquatic Acute 1 (H400). Since this toxicity value is in the range 0.01- 0.1 mg/L, the M-factor (Acute) applied would be 10.

 

Chronic (long-term) aquatic hazard

Two different approaches are included, both justifying the same result:

Two long-term results are available (for invertebrates and algae), both of which give NOECs of

0.01 mg/l or lower. Therefore, the substance is classifiable as Aquatic Chronic 1 (H410) based on toxicity information. The rapid degradability of the substance affects the M-factor, but since it is unclear how much lower the true NOECs might be (the behaviour of the substance and

experimental designs mean that the true exposure concentrations are unknown) it not considered

relevant to set an M-factor based on these data. As fully reliable chronic toxicity data are not available for any of the three trophic levels, the surrogate approach can be applied, based on acute effects and fate properties. The lowest acute L(E)C50s for all three trophic groups are in the range 0.01 - 0.1 mg/l, and the realistic worst case BCF is > 500 for fish, based on the study for hexadecylamine as representative substance (and the estimated log Kow > 4). Consequently,Primary alkyl amines of the (extended) Category Approachfulfil the criteria for classification as Aquatic Chronic 1 (H410). The M-factor (chronic) is 10, according to the surrogate approach, based on the acute toxicity data.

 

Classification according to the DSD criteria

The classification as N; R50/53 (Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment) is adequate, because although the amines in question are readily biodegradable, they have BCFs for fish above 100, and a 48-h EC50 of 0.011 mg/L forDaphnia magna.The following specific concentration limits should be applied:

 

Classification Concentration

N; R50/53 C2.5%

N; R51/53 0.25%C < 2.5%

R52/53 0.025%C < 0.25%

Where C is the concentration of the amine.