Registration Dossier
Registration Dossier
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EC number: 233-520-3 | CAS number: 10213-78-2
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.161 µg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.107 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.016 µg/L
- Assessment factor:
- 1
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 3.5 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 1.692 mg/kg sediment dw
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.169 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:
- 5 mg/kg soil dw
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 7.77 mg/kg food
- Assessment factor:
- 90
Additional information
All endpoints are based on measured data applying assessment factors.
The PNECaquatic is calculated using the assessment factor proposed by the TGD. As long-term NOECs from species representing three trophic levels are available (algae, daphnia and fish (read-across to highly similar substance PFAEO-C (CAS 25307-17-9) an assessment factor of 10 may be used.
Conclusion on classification
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 toand suspended matter a factor of 10 should be applied to the L(E)C50to correct for the lower ecotoxicity observed.
Table Available algae, daphnia and fish test results (Klimisch 1, 2 and 4)
Primary fatty amines ethoxylates | CAS number | 96 h Fish LC50 (µg/L) | 72 h algae ERC50(µg/L) | 72 h algae ERC10/ NOEC (µg/L) | 48 h daphnia EC50 (µg/L) | 21 d daphnia EC50 (µg/L) | 21 d daphnia EC10/ NOEC (µg/L) | EC50corr(µg/L) (corrected for Classification with Factor 10) |
EC10corr(µg/L) (corrected for Classification with Factor 10)
|
2,2'-(C16-18 (evennumbered) alkyl imino) diethanol | 1218787-30-4 |
| 40 | 34.5 |
| 566 | 320 | 40 | 3.45 |
Figures given in bold are based on read across; figures given in italic and underlined are performed in reconstituted lab water and these are therefore not corrected.
Biodegradability
The primary fatty amine ethoxylates are readily biodegradable
Bioaccumulation potential
No measured BCF fish is available for the primary fatty amine ethoxylates. Standard OECD 305 tests are technically very complicated with these strongly sorbing easily biodegradable substances. Three valid measured log Kow values are however available as presented in the table below.
primary fatty amines ethoxylates | CAS number | Measured Log Kow |
2,2'-(C12-18 evennumbered alkyl imino) diethanol | 71786-60-2 | 0.7 |
2,2'-(C16-18 (evennumbered) alkyl imino) diethanol | 1218787-30-4 | 3.6 |
2,2’(octadec-9-enylimino)-bisethanol | 25307-17-9 | 3.4 |
The highest log Kow is observed for 2,2'-(C16-18 (evennumbered) alkyl imino) diethanol (CAS no 1218787-30-4). For this product has also the lowest CMC of 3.5 mg/L was observed. The measured log Kow value of 3.6 indicates a moderate bioaccumulation potential for narcotic substances. For polar narcotics like the primary fatty amine ethoxylates however there is only limited information on the relationship between log Kow and BCF. The observed rapid biotransformation of the C12 to C18 alkyldiethanol amines demonstrates that it will be very unlikely that these substances will accumulate in fish. This was confirmed by the calculated BCF values which were all below the CLP threshold value of 500 L/kg.
With a log Kow of 3.6 the BCFBAF model predicts a BCF of 110 L/kg wwt without metabolism and 14.7 L/kg wwt with metabolism.
Classification according(Classification, Labeling & Packaging Directive 1272/2008/EC)
As all acute ecotoxicity values (corrected and uncorrected) as given in the first table are below 1 mg/L the substances should be classified as acute aquatic hazard category 1. Primary fatty amine ethoxylates are all ‘readily biodegradable’ and have a measured log Kow < 4. Based on long-term studies a classification for chronic aquatic toxicity is warranted according to 2nd ATP to CLP. This leads to the following environmental classification accordingfor n-Primary alkyl amines ethoxylates
Acute (short-term) aquatic hazard category 1
M factor 10
Chronic aquatic hazard category 1
M factor 10
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