Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

Based on the results after single oral administration of (C)-Lunamer 552 to male and female rats at two dose levels as well as after repeated oral administration of unlabelled test substance followed by (C)-Lunamer 552 at the low dose level to male and female rats, the conclusion are:

Excretion occured 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 difference 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 radioative 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.