Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.008 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.017 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.003 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:
10 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Degradation (only key data needed for classification)

Biodegradation: readily biodegradable; 63-79% (CO2 evolution) after 28 d (OECD 301B)

Bioaccumulation (only key data needed for classification)

Bioaccumulation is expected to be low.

LogKow: -0.4 (EU Method A.8)

Aquatic acute toxicity (for each species only one key data used for classification)

For fish: 96 h, LC50 (Brachydanio rerio): 14.8 (test material) / L (4.44 mg act. ingr. /L)

For aquatic invertebrates: 48 h, EC50 (Daphnia magna): 7.76 act. ingr. mg/L

For algae/aquatic plant: 72 h, ErC50 (Pseudokirchneriella subcapitata):  1.7 mg act. ingr./L

Aquatic chronic toxicity (for each species only one key information)

For fish:                                              no data available on the substance itself.

For aquatic invertebrates:          21 d NOEC of 2.99 mg/L (100% substance), Daphnia magna

For algae/aquatic plant:              72 h, NOErC (Pseudokirchneriella subcapitata): 0.38 mg/L

Classification assigned according to DSD

Based on the data above, Betaines, C12-14 (even numbered)-alkyldimethyl, EC No. 931-700-2 is considered to be rapidly degradable and has low potential for bioaccumulation (log Kow < 3). The acute aquatic toxicity L(E)C50 is > 1mg/L for all three trophic levels. Hence, the substance does not need to be classified according to the Directive 67/548/EEC.

Classification assigned according to GLP

Betaines, C12-14 (even numbered)-alkyldimethyl, EC No. 931-700-2 is considered to be rapidly degradable. Valid chronic toxicity data are available to alga; the lowest NOEC is 0.38 mg/L (for Pseudokirchnerella subcapitata).Therefore, Betaines, C12-14 (even numbered)-alkyldimethyl needs to be classified and labelled as long-term aquatic hazard Chronic Cat. 3 according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).