Registration Dossier
Registration Dossier
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EC number: 701-008-3 | CAS number: -
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
No toxicokinetic studies have been conducted on Santicizer 278, however read-across information available for the structurally related, high molecular weight phthalates DIDP (European Chemicals Bureau, 2003a) and DINP (European Chemicals Bureau, 2003b) provides useful supporting information. Metabolism proceeds via the corresponding monoester and its oxidation products, with excretion occurring primarily via urine and (to a lesser extent) faeces. Both are recovered mainly from the gastrointestinal tract, liver and kidney following oral administration whereas liver, muscle and adipose tissue contain most of the retained dose after dermal exposure. However results of repeated dosing studies with DINP demonstrated no bioaccumulation. Uptake from the gastrointestinal tract appears a saturable process, with the proportion absorbed decreasing with increasing dose (e. g. 56%, 46% and 17% absorbed, respectively, following oral administration of 0.1, 11.2 or 1000 mg/kg bwt DIDP mg/kg; 49% and 39%, respectively, absorbed of an oral dose of 50 or 500 mg/kg bw DINP). Dermal absorption of both phthalates is quite low (uptake of less than 4% of the applied dose over 7 days) with bioavailability of around 75% following inhalation exposure. For the purposes of risk characterisation of Santicizer 278, 50% absorption from the gut, 75% absorption after inhalation exposures and 5% uptake by skin will be assumed.
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