Registration Dossier
Registration Dossier
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EC number: 276-974-8 | CAS number: 72901-31-6
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- no hazard identified
Marine water
- Hazard assessment conclusion:
- no hazard identified
STP
- Hazard assessment conclusion:
- no hazard identified
Sediment (freshwater)
- Hazard assessment conclusion:
- no hazard identified
Sediment (marine water)
- Hazard assessment conclusion:
- no hazard identified
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
Justification for analogue approach of substances and read-across
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests", which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, whereby substances may be considered as an analogue substances provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity, the substances listed below are structural similar related secondary fatty amides. In particular, for each specific endpoint the source substance(s) structurally closest to the target substance is chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across.
A detailed justification for analogue approach of chemicals and read-across is provided in the technical dossier (see IUCLID Section 13).
Read-across from (Z)-N-Octadec-9-enylhexadecan-1-amide (oleyl palmitamide, CAS No. 16260-09-6) to 9-Octadecenamide, N-(9Z)-9-octadecen-1-yl-, (9Z) (oleyl oleamide, CAS No. 72901-31-6).
The target substance and the source substance are amides of unsaturated or saturated fatty acids, respectively. The target substance, oleyl oleamide, and the source substance, oleyl palmitamide, are secondary N-alkyl alkylamides produced from a coupling reaction between an appropriate fatty acid and a fatty amine (March, 1992). It should be noted that the original raw materials used for manufacture of the fatty amines are also similar (or the same) fatty acids. For the following endpoints, data from the related substance (oleyl palmitamide) will be used as read-across:
Short term toxicity data for invertebrates and algae are available for (Z)-N-Octadec-9-enylhexadecan-1-amide (CAS No. 16260-09-6). The test substance is highly insoluble in water and no effects were observed to aquatic algae and daphnia in the range of water solubility of(Z)-N-Octadec-9-enylhexadecan-1-amide (CAS No. 16260-09-6). As no hazard was identified and no toxicity observed at the saturation level, no PNEC derivation and risk characterisation for the environment is perfomred in accordance with the ECHA guidance on information requirements and chemical safety assessment Part B.8 scope of the exposure assessment, verison 2.1, 2011.
Conclusion on classification
Parameter |
Oleyl oleamide (CAS No. 72901-31-6) |
Oleyl palmitamide (CAS No. 16260-09-6) |
Partition coefficient (log Kow) |
15.08 (QSAR) |
14.31 (QSAR) |
Water solubility (mg/L) |
5.9E-11 (QSAR) |
3.92E-10 (QSAR) |
Biodegradability |
Not readily biodegradable (53%, OECD 301B) |
Not readily biodegradable (42% OECD, 301 D) |
Bioaccumulation |
Low bioaccumulation potential (BCF = 3.16 L/kg wet-wt, QSAR) |
Low bioaccumulation potential (BCF = 0.89 L/kg wet-wt, QSAR) |
Fish acute toxicity 96h LC50 (mg/L) |
No toxicity up to the limit of water solubility (7.04E-8 mg/L, QSAR) |
RA from stearyl stearamide: > 1000 mg/L. No toxicity up to the limit of water solubility. |
Daphnia acute toxicity 48h EC50 (mg/L) |
No toxicity up to the limit of water solubility (1.87E-10 mg/L, QSAR) |
No toxicity up to the limit of water solubility |
Algae acute toxicity 72h EC50/NOEC (mg/L) |
No toxicity up to the limit of water solubility (3.75E-8 mg/L, QSAR |
No toxicity up to the limit of water solubility |
Long-term toxicity to fish |
N/A |
N/A |
Long-term toxicity to aquatic invertebrates |
N/A |
N/A |
Long-term toxicity to algae |
N/A |
N/A |
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