Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The substance has a low potential for absorption via oral, dermal and respiratory routes.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

According to the Annex VIII of the REACH Regulation (EC 1907/2006), the assessment of the toxicokinetics behaviour of the substance should be done to the extent that can be derived from the relevant available information.

Based on the physicochemical properties of the substance (mainly physical state and particle size, chemical structure and functional groups, molecular weight, water solubility, octanol/water partition coefficient), the potential of absorption is expected to be low. In particular, hydrophilicity and water solubility of the substance are expected to limit its potential for accumulation and to control its distribution and excretion.

Once entered the body, enzymatic reactions typically degrade the molecule, leading to metabolites with higher solubility that are more rapidly excreted.

Azo bonds within the molecule are susceptible to metabolic transformations, leading to bond cleavage by a reductive process. Sulfonation of azo molecules increase stability and decrease toxicity of the molecule itself and of its metabolites by enhancing urinary excretion. Azo compound or its metabolites may also undergo microsomal oxidation, N-acetylation or O-esterification.

Available toxicological studies by oral route, i.e. acute toxicity, repeated dose toxicity and reproductive toxicity, did not evidenced systemic effects, thus suggesting poor absorption and/or low toxicity of the substance and its metabolites. Similarly, in available studies by dermal route, i.e. acute toxicity, skin irritation and skin sensitisation, no systemic effects were seen, thus indicating low absorption rate.