Registration Dossier
Registration Dossier
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EC number: 268-776-5 | CAS number: 68140-14-7
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 25.49 µg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 2.94 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 2.54 µg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 5.57 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 99.4 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 9.94 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:
- 9.44 mg/kg soil dw
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 2 mg/kg food
- Assessment factor:
- 300
Additional information
Based on structural and chemical considerations and taking into account the results of bridging study data, and a review of the available Rosin data, read-across from DTO_DETA to data on AAI_DETA is considered to be feasible in order to meet the REACH Annex VII-VIII data requirements for endpoints for which studies are not available.
Based on a direct acute aquatic toxicological comparison, AAI_DETA is considerably more toxic than Rosin and therefore the more conservative component from the ecotoxicity perspective (based on acute data). For each compartment above the worst case PNEC based on AAI_DETA is presented.
PNECs were derived for freshwater, marine water, intermittent releases, the STP, soil, and secondary poisoning using the available endpoints. PNEC values for sediment were derived by the equilibrium partitioning method (EPM). No PNECs were calculated for air as they were deemed unnecessary on the basis that no hazard to air is expected.
The PNECs are as follows:
PNECfreshwater= 25.4 µg/L
PNECmarine water= 2.54 µg/L
PNECintermittent= 2.94 µg/L
PNECSTP= 5.57 mg/L
PNECsediment (freshwater)= 99.4 mg/kg sediment dw
PNECsediment (marine)= 9.94 mg/kg sediment dw
PNECair= Not calculated
PNECsoil= 9.44 mg/kg soil dw
PNECsecondary poisoning= 2 mg/kg food
Conclusion on classification
Comparison of the ecotoxicological profiles of AAI_DETA and rosin show that the AAI_DETA dataset is worst case with regards to biodegradability and aquatic toxicity, with the dataset for rosin showing a much lower toxicity profile. Data for AAI_DETA indicate that the amine, amide and imidazoline components of DTO_DETA will confer acute and chronic aquatic toxicity; CLP classification of DTO_DETA for acute toxicity (Acute category 1; M factor acute 10) and chronic toxicity (Chronic category 1; M factor chronic 1) is therefore proposed.
Biodegradability
For amidoamines/imidazolines no ready biodegradability results have been obtained.
Ecotoxicity
Due to intrinsic properties of amine containing cationic surfactants river water ecotoxicity tests deliver more reproducible test results with limited uncertainty. As river water has a mitigating effect on ecotoxicity due to sorption of the amines to suspended matter a factor of 10 should be applied to the L(E)C50 to correct for the lower ecotoxicity observed. Algae are in general the most sensitive species but because for most of the amidoamines/imidazolines only the 21 d EC50 for daphnia is available this endpoint serves as basis for the acute classification of the amidoamines/imidazolines as a worst-case.
Table1: Available algae, daphnia and fish test results for the amidoamines/imidazoline.
| Amidoamines/ imidazolines | CAS number | 96h Fish LC50 (µg/L) | 72h algae EC50 (µg/L) | 72h algae (EC10/NOEC (µg/L) | 48h daphnia EC50 (µg/L) | 21d daphnia EC50 (µg/L) | 21d daphnia EC10/NOEC (µg/L) | EC50corr (µg/L) (corrected for Classification with Factor 10) | EC10corr (µg/L) (corrected for Classification with Factor 10) |
| AAI-DETA (Fatty acids, C18 unsat, reaction products with diethylenetriamine) | 1226892-43-8 | 190 | 505 | 343 | 180 | 270 | 50.5 | 27 |
This leads to the following environmental classification:
Acute aquatic hazard H400: Very toxic to aquatic life
M factor acute 10
Chronic (long-term) aquatic hazard Chronic Category 1 H410: Very toxic to aquatic life with long term effects
M factor chronic 1
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