Registration Dossier

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
basic toxicokinetics in vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Description of key information

Based on the data generated forC.I. Direct Blue 279, it can be concluded that the log Kow is low (<-4.3.) and the water solubility is high (55-60%). The molecular weight is 1031 Da (as free acid). These physico-chemical data are indicative for low absorption. As blue discoloration of some organs was observed after oral application and the substance is a skin sensitizer, come absorption via the oral and dermal route cannot be excluded (set at default 10%). The substance has a very low vapour pressure and during use it is not expected that aerosols will be formed. Therefore inhalation exposure is not expected.

The substance is an azo dye, but no cleavage of the azo bonds by reductases in the bacteria in the intestines and/or by liver reductases is expected, mainly because of sulfonation of the colorant.

The substance is very water soluble, uptake is limited and it is expected that the substance is easily cleared,

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
10
Absorption rate - dermal (%):
10
Absorption rate - inhalation (%):
0

Additional information

see attached document