Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Following a conservative approach, 10% absorption via oral, dermal and inhalative route are assumed, although true absorption is expected an order of magnitude lower. Potential for bioaccumulation is not expected.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
10
Absorption rate - dermal (%):
10
Absorption rate - inhalation (%):
10

Additional information

Aradur 450 BD is expected to have very limited absorption into body via oral and dermal route (anticipated <1%). Inhalation exposure is not a foreseeable route due to the physico-chemical properties (i.e., low vapor pressure, high molecular weight, not highly soluble in water, highly viscous liquid). Based on the poor absorption, it can be expected that Aradur 450 BD has very low bioavailability, and systemic distribution is hardly relevant. Therefore, Aradur 450 BD is expected to be almost completely excreted unchanged in the faeces and urine, and will not bioaccumulate in the body. Any uptake portion is estimated to be excreted in the form of glucuronide conjugate.