Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

There were no study available in which the toxicokinetic properties of DGEBADA were investigated. However, as per REACH guidance document R7.C (2014), information on absorption, distribution, metabolism and excretion may be deduced from the physicochemical properties and QSAR prediction.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
1
Absorption rate - inhalation (%):
100

Additional information

DGEBADA is a UVCB type of substance having a molecular weight of ~484,6 g/mol (range 430-822). It is a liquid with a tested water solubility between 82 and 484 mg/L. Volatility was determined  to be very low (1.10^-4 Pa) and has a limited lipophilic character (log Kow in the range of 1.6 to 3.8). The structure shows hydrolysable elements but no ionic elements. Hydrolysis studies concluded that the product is stable in acidic medium and hydrolysis is increasing with pH at 25°C.

The expected toxicokinetic behaviour is derived from the physical-chemical properties following the guide given in the REACH guidance document 7c :

Oral absorption: Based on the water solubility the substance is supposed to be soluble in GI fluid. It can then be expected that the substance can be at least partially absorbed in the gastrointestinal system, due to its moderate molecular weight. Systemic effects were observed at the doses equal or higher than 100 mg/kg/d in the oral 90 -day study, confirming the oral absorption of DGEBADA. The worst-case value of 100% is considered for the oral absorption.

Inhalation absorption: It can be assumed that the DGEBADA will be effectively removed in the upper respiratory tract due to its hydrophilicity, solubility and limited vapour pressure. Nevertheless absorption is still possible via upper mucosa but is limited by the inhaled amount which is assumed to be low due to the very low vapour pressure. The worst-case value of 100% is considered for the inhalation absorption.

Dermal absorption: No experimental data is available on dermal absorption of BADGEDA. Some bioavailability of the test material via the dermal route is confirmed by the positive sensitisation studies indicating that some transfer through the first epidermal layer should take place. However a very low absorption is predicted with QSAR (IH Skin Perm): below than 1%. The value of 1% is considered for the dermal absorption.

Distribution: The physical-chemical information (molecular weight, lipophilicity and water solubility) indicates that DGEBA diacrylate could be distributed to many tissues. This is confirmed in the oral 90-day repeated toxicity study..

Accumulative potential: Based on the physico-chemical information (log P=Kow, structure not containing ionisable elements and water solubility), it is concluded that the potential for bioaccumulation is low.

Metabolism: No data is available.

Excretion: Based on the physical-chemical information (average molecular weight of ~484.4 g/mol and water solubility), main excretion of DGEBADA via urines can be expected.