Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

The substance is a monoconstituent with >98-100% (w/w) purity. The substance was evaluated according to latest Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7c: Endpoint specific guidance; Version 2.0 November 2014).

The substance is liquid with a molecular weight between 150.2196g/mol, moderate water solubility of 1.46 g/L and log Pow = 3 at ambient conditions. The vapour pressure is low, i.e. 2.98 Pa = 2.24 x 10E-2mm Hg. Assessment of the molecular, physicochemical and toxicological properties leads to following conclusions:

-         Oral/GI absorption:

Based upon the molecular structure and weight, moderate water solubility and high log Pow, and toxicological signs after oral dosing, oral absorption is most likely. From a conservative viewpoint, 100% oral absorption is considered.

-         Respiratory absorption:

Based upon the low vapor pressure, evaporation and inhalation of the substance is unlikely. Deposition in the airways is therefore assumed to be absent and absorption by inhalation is considered to be negligible. From a conservative viewpoint, 30% inhalation absorption is considered.

-         Dermal absorption:

Most of the physicochemical and toxicological parameters are in favour of dermal absorption. Dermal absorption is considered to be likely and comparable to oral absorption (100%). This is supported by an estimated dermally absorbed dose (DAD) of 6.2 mg/kg bw/day by means of Episuite Dermwin, which is considered substantial compared to DNELs.

For the assessment of distribution, metabolism and excretion physicochemical and toxicological properties are also taken into account, and following conclusions were deduced:

-         Distribution:

Based upon the low molecular weight, high Log P and moderate water solubility, as well as target organs (liver and CNS), distribution is very likely. 

-         Metabolism & accumulation potential

For the various tissues mentioned, there is no direct indication of bioaccumulation potential.

-        Excretion:

Excretion via the urine, breast milk and saliva/sweat are likely because of the ionisable structure, small molecular weight and moderate water solubility. Excretion via the air, bile, hair/nails and exfoliation are less likely.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
100
Absorption rate - inhalation (%):
30

Additional information

More detailed information is given in the Basic Toxicokinetics assessment attached.