Registration Dossier
Registration Dossier
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EC number: 939-682-8 | CAS number: -
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.013 mg/L
- Assessment factor:
- 10
- 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:
- 100
- 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:
- 0.42 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.042 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:
- 1.23 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
Alkyldimethyl betaines EC 931-700-2 is used as main source substance in the analogue approach used to fill in the data gaps for environmental fate and ecotoxicity endpoints of the registered substance, considering its close structural similarity with the latter. Long-term toxicity studies have been performed with the above cited source substance with Daphnia magna and chronic toxicity data on aquatic algae are available. Chronic toxicity data on or fish are not available. Actual PNECs are thus estimated using chronic toxicity data from a structurally related cocoamidopropyl betaines for which chronic toxicity data are available for all trophic levels. An analysis of acute toxicity data available for alkyldimethyl betaines and cocoamidopropyl betaines (see below) shows that both betaines exhibit toxicity effects to aquatic organisms in a similar range: 1 mg/L < E(L)C50 < 10 mg/L. A read-across from chronic toxicity data available for cocoamidopropyl betaines was considered as a reasonable and relevant approach to derive PNECS for the registered substance, representing a worst case scenario.
The data for cocamidopropyl betaine:
Acute fish: 96h-LC50 = 1.11 mg/L
Acute Daphnia: 48h-EC50 = 1.9 mg/L
Acute/chronic algae: 72h-EC50 = 2.4 mg/L; 72h-NOEC = 0.6 mg/L
Chronic fish: 0.135 mg/L
Chronic Daphnia: 0.3 mg/L (geometric mean)
The data for the alkyl dimethyl betaines:
Acute fish: 96h-LC50 = 4.44 mg a.i./L
Acute Daphnia: 48h-EC50 = 5.3 mg a.i./L
Acute/chronic algae: 72h-EC50 = 1.7 mg a.i./L; 72h-NOEC = 0.38 mg a.i./L
Chronic Daphnia: 21d-NOEC = 2.99 mg a.i./L
Conclusion on classification
Biodegradation in water: readily biodegradable (OECD 301B)
Bioaccumulation: no potential to bioaccumulate; log Kow: = 2.73 at 23 °C (OECD 107)
Water solubility: > 470 g/L at 20 ºC (EU Method A.6)
Acute toxicity:
- For fish: 96 h LC50 (Danio rerio) = 4.44 mg a.i./L (nominal, OECD 203)
- For invertebrates: 48 h EC50 (Daphnia magna, immobilization) = 5.3 mg a.i./L (nominal, OECD 202)
- For algae: 72 h ErC50 (Pseudokirchneriella subspicata) = 1.7 mg a.i./L (measured, OECD 201)
Chronic toxicity:
- For algae: 72h NOErC (Pseudokirchenriella subspicata) = 0.38 mg a.i./L (measured, OECD 201)
- For invertebrates: 21d NOEC (Daphnia magna) = 2.99 mg a.i./L (nominal, OECD 211)
Classification justification according to CLP
Based on the data above, the substance is considered to be rapidly degradable and has a low potential for bioaccumulation. The acute aquatic toxicity L(E)C50 are above 1 mg/L for fish, invertebrates and algae. Valid chronic toxicity data are available for algae, the NOEC is 0.38 mg/L, and Daphnia (NOEC = 2.99 mg/L), and thus in the range of > 0.1 to < 1 mg/L for the lower value. The test substance needs to be classified and labeled as environmental hazard Chronic Cat. 3 according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 487/2013 (4th ATP).
M-factor for acute aquatic toxicity: not need to be assigned
M-factor for chronic aquatic toxicity: not need to be assigned
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