Registration Dossier
Registration Dossier
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EC number: 254-754-2 | CAS number: 40027-38-1
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.276 µg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 2.76 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.028 µg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
- PNEC marine water (intermittent releases):
- 0.276 µg/L
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 0.251 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 8.6 mg/kg sediment dw
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.86 mg/kg sediment dw
- Assessment factor:
- 100
- 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:
- 100
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
Due to the complex structure of the substance evaluated N-(Oleyl alkyl)- 1,3 -propanediamine mono-oleates (UVCB) and low water solubility, the WSF approach was used for ecotoxicity testing.
Per definition of the WSF, all terms related to concentration levels have to be given as loading levels because partly dissolved compounds and mixtures cannot be related to concentrations. Therefore, the EL10/50/100-values given were based on the nominal loading levels.The PNECaquatic is calculated using these loading levels applying the assessment factor as proposed by the REACH guidance.
In contrast to previous studies with similar substances the aquatic ecotoxicity studies with N-(Oleyl alkyl)-1,3 -propanediamine mono-oleates were not performed in natural river water which makes is far more complicated to evaluate the results.
Only three short term test results for species representing three trophic levels are available and therefore an assessment factor of 1000 needs to be applied to the lowest EL50 of 0.276 mg/L (algae).
Ecotoxicity testing with cationic surfactants is complicated as these substances tend to sorb to negatively charged surfaces like glassware organic and suspended matter. The reproducibility of these tests is in general poor. When cationic surfactants enter the environment they will be immediately sorbed to the suspended matter and DOC present in the environment. The toxicity will due to this sorption be mitigated. The degree of this mitigation is however poorly predicted with the currently available exposure models (e. g. EUSES) as they only predict sorption based on hydrophobic interaction with organic matter where the main sorption of these substances will be due to ionic interaction.
Conclusion on classification
For classification purposes Ecotoxicity, Biodegradability and Bioconcentration have to be considered.
Ecotoxicity
Three acute aquatic ecotoxicity test results are available where for algae the lowest ErL50 is observed of 0.276 mg/L. For algae an ErL10 of 0.232 mg/L is observed this long term endpoint is considered unsufficient for long term classification.
Biodegradability
The substance is for 52% degraded on day 28 and 64% degraded on day 60 as demonstrated with an enhanced Closed bottle test according to OECD TG 301 D.
Bioaccumulation potential
The substance has a low calculated bioaccumulation potential.
Conclusion classification according to CLP Regulation 1272/2008
Based on the results of the acute aquatic toxicity (values < 1 mg/L) the substance is classified with Category Acute 1 (M-factor 1).
Sufficient reliable chronic toxicity data are not available and therefore the acute data is used for the chronic classification.
Based on the results of the acute aquaci toxicity (0.1< values <1) the substance is classified with Category Chronic 2 (M-factor 1)
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