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Administrative data

Link to relevant study record(s)

Description of key information

Review of toxicokinetic data as required by Annex VIII of REACH. The available test data do not permit extensive conclusions concerning absorption, metabolism or excretion to be conclusively drawn. Acute toxicity (via the oral route) and repeated oral administration results, no mortality was observed although treatment related systemic effects were reported.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

Repeated oral administration of the test substance (in an OECD 421 study) to rats provided paternal NOAEL of 250 mg/kg/day. The clinical signs evident at the top dose indicated that some absorption and distribution of the test substance can be expected. At 62.5 and 250 mg/kg/day, no adverse effects were noted and it is possible that bioelimination through normal metabolic and excretory pathways allows some removal of the test substance, with the potential for these pathways to be overwhelmed at the top dose.

The substance was determined to be a skin sensitiser based on the results of 3 in chemico/in vitro skin sensitisation assays (weight-of-evidence assessment), indicating that the test substance potentially has the ability to pass through the dermal layers of the skin or produce systemic effects; it was noted that loss of fur was evident in the oral reproductive screening test.

Based on the relatively low Log Kow values (<4.5) and low aqueous solubility of the test substance, bioaccumulation of the test substance is expected to be low.

No in vivo mutagenicity/clastogenicity data are available. It was observed in an in vitro chromosome aberration assay that the test substance was clastogenic to human lymphocytes with the possible indication that test substance is absorbed and not excreted without any toxicological effects.