Registration Dossier
Registration Dossier
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EC number: 269-125-8 | CAS number: 68187-80-4
Endpoint summary
Administrative data
Description of key information
Additional information
This chemical safety assessment and chemical safety report characterizes the hazards and risks associated with the use of HE Rape Oil, reaction product with diethanolamine, a diethanolamine derived fatty acid alkanolamide (“DEA-FAA”) in which fatty acids are bound to diethanolamine (DEA) by an amide bond. The alkyl chain length typically ranges between 18 carbon atoms.
Grouping hypothesis and justification of read-across adopted
As adequate data is not available on HE Rape Oil, reaction product with diethanolamine, supplement safety data from structurally similar fatty acid alkanolamides have been used to read-across based on grouping of substances (category approach) and from supporting substance (structural analogue or surrogate) using data from the following diethanolamine (DEA) derived FAA substances:
1. Amides, C18 (unsatd.), N,N-bis(hydroxyethyl)
2. Amides, C8-18(even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl)
3. Amides, C12-18(even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl)
4. Amides, C12, N,N-bis(2-hydroxyethyl)
5. Amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl)
The grouping hypothesis and therefore the read-across approaches adopted are based on the following characteristics of DEA derived FAA substance:
- DEA derived FAA substances all share common functional group (group (i.e., fatty acid alkanol amide) and constituents, with only variable carbon range numbers, i.e., the basic structure and functional groups are the same.
- DEA derived FAA substances all have common constituents, i.e., incremental and constant change across the category relating to the physical-chemical properties (e.g., melting/boiling point; Kow; Koc; water solubility; environmental distribution characteristics).
The use of data from the “DEA-FAA” category is justified due to structural similarities as indicated by a common functional group (i.e., fatty acid alkanolamide) and comparable fate properties: DEA-FAA are all readily biodegradable (see Chapter 4 of the CSR) and expected to degrade by the same pathways involving omega- and beta oxidation finally leading to complete mineralization.
The structural similarity of “DEA-FAA” results in similar physico-chemical properties such as water solubility and octanol-water partition coefficient as well as similar expected biodegradation pathways.
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