Registration Dossier
Registration Dossier
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EC number: 260-982-3 | CAS number: 57843-53-5
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Based on the results obtained after single oral administration of [14C]-N,N,N',N'-tetrakis(2-hydroxyethyl)adipamide to male and female rats at two dose levels as well as after repeated oral administration of unlabelled PRIMID followed by [14C]-PRIMID XL-552 at the low dose level to male and female rats, the following can be concluded: Excretion occurred in all groups rapidly, mainly via faeces. Within 48 hours, the radioactivity was almost completely excreted. At 96 hours after the administration, radioactive residues in organs/tissues were very low. Concerning pharmacokinetic parameters, no differences between male/female rats, low/high dose as well as single/repeated administration were found. The major amount of the radioactivity in the faeces could be extracted by using acetonitrile/purified water (8+2, v/v). In faeces up to 6 radioactive fractions (F1-F6) were detected. F2 was identical to the parent item. Fractions F1, F3-F6 were unknown metabolite fractions. In urine at least 4 radioactive fractions (U1-U4) were detected. U1 was identical to the parent item. Fractions U2-U4 were unknown metabolite fractions.
No significant difference between N,N,N',N'-tetrakis(2-hydroxyethyl)adipamide (PRIMID XL-552) and N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide is expected and the results found can be assumed being valid also for the target substance.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
Additional information
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