Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

For the registration substance no specific metabolism or kinetic study is available. All information for a toxicokinetic assessment is taken from study results performed with the test substance.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
10
Absorption rate - inhalation (%):
100

Additional information

Results from oral toxicity studies in rats up to 28 days indicated that there is systemic availability of the substance or metabolites at a high oral dosage. Direct evidence in the form of plasma data is not available.

Observation of red discoloration of feces and yellow-brown to red-brown discoloration of the urine after repeated oral administration indirectly shows a certain distribution of the substance in the body and its excretion. Direct evidence in form of analytical data is not available. The estimated low log POW indicates a low potential for accumulation in fatty tissues.

No evidence of dermal bioavailability is given, although adsorption of the dyestuff was noted in the acute dermal toxicity study, i.e. red discoloration at the application area persisting until 5 -6 days, indicating a low tendency for absorption on skin. The substance is not a skin sensitizer as examined in an LLNA test. Thus bioavailability via the dermal route cannot be confirmed by the available data.

The substance has a very low vapour pressure and evaporation into air is not likely to happen but inhalation of dust may be happen when using the registration ware which is especially generated as solid. However, the registration substance is only manufactured and marketed as aqueous solution at a maximum of 20% (w/w). The solid form of the registration substance is generated solely for registration purposes. The mass median diameter (MMD) of the solid test substance indicates that 50 % (by mass) of particles are smaller than 3.7 µm. Therefore, a potential for respiration of the substance is given for the registration ware.