Registration Dossier
Registration Dossier
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EC number: 827-162-2 | CAS number: 2218502-12-4
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The toxicokinetics of the substance CAS 2218502-12-4 / EC 827-162-2 has been assessed based on the physicochemical properties and available toxicological data and following the ECHA Guidance R.7c from June 2017 (version 3.0).
As a result of the assessment, it has been found that the substance could be absorbed from the gastro-intestinal tract. The respiratory deposition and is assessed to be low and the dermal absorption could occur.
Distribution in the body is expected to take place, mainly based upon the water solubility.
Limited data were available for estimation of metabolism of this substance. Based on the chemical structure it is known that the existing double bonds -C=C- or –N=N- might react with strong acids (pH << 4) to give new structures. Reductive cleavage of the azo bond is considered to be a necessary metabolic reaction for these substances to exert their toxicity, as it releases some free aromatic amines that are further converted to reactive electrophilic intermediates through metabolic activation. There are references that these dyes are reduced following oral administration and the released aromatic amines are absorbed into systemic circulation(1). Bioabsorption of the relatively smaller aromatic amine metabolites is expected to dominate over absorption of the intact parent dye.
From the biodegradability testing it was concluded that the test item is not readily biodegradable. However, bioaccumulation is not expected, based on the log Kow and the calculated BCF value(2).
Based on the physicochemical properties of the substance one route of excretion (urine) was assessed as possible. Based on observations from a study conducted on an analogue substance, faeces and urine could be assessed too as route of excretion. (3)
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
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