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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

It is well known from the literature that highly lipid - soluble chemicals given orally are initially distributed by the lymphatic system following gastric absorption yielding a slow diffusion across the membranes. The rate of entry into tissues is limited by the physico-chemical properties of the molecules.

The substance is a low melting point solid with the following physico-chemical characteristics:

·      it is practically water insoluble

·      it is lipophilic

·       log Pow >>6

No adverse effects were observed upon subacute oral toxicity in rats. In comparison, a substance of slightly lower alkyl chain length (C8 versus C12) caused slight reversible effects on liver:

The 3-month toxicity study in rats and dogs revealed the liver as possible target organ in the high dose animals ( 100 and 1000 mg/kg bw in rats and 1000 mg/kg bw in dogs). The slight to moderate biliary cell proliferation may indicate the need for increased bile production and elimination via the bile. Biliary cell proliferation in general reverses slowly, so its occurance at the end of the recovery period is not indicative of bioaccumulation or enterohepatic circulation.

The substance contains functional groups that are known to undergo xenobiotic metabolism. Overall, no bioaccumulation hazard is expected.