Registration Dossier
Registration Dossier
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EC number: 423-070-8 | CAS number: 58890-25-8
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
A toxicokinetic assessment was performed based on the available data of the substance. No bioaccumulation potential is to be expected.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
The acute oral and dermal toxicity of the substance is low (LD50 > 2000 mg/kg in both cases). Therefore, an extensive toxicokinetic assessment is considered of limited value. Below, an assessment of the anticipated toxicokinetic behaviour of the substance is given.
Dissolution of a compound is required for absorbtion from
the gastro-intestinal tract into the blood. Based on the
physico-chemical properties of the substance, the initial
dissolution is expected to be low. In the presence of
gastric acid and/or bile salts, the solubility of the
substance may be somewhat increased in the gastro-intestinal
fluids. However, it is unlikely that the compound will be
absorbed to a high extent from the gastro-intestinal tract.
Although the substance shows a very low solubility in water,
some dissolution may occur at low pH because of protonation
of the oxygen atom. The O-protonated amide will be greatly
stabilised by resonance.
In the gastro-intestinal tract, especially the colon,
dissolved substance may already be partly metabolised by amidases.
After absorption, the substance will be extensively
distributed throughout the body, especially fatty tisues. In
case the substance is absorbed, it will be extensively
metabolised by amidases, but also hydroxylation of the
phenyl rings may occur. The formed hydroxy-metabolites will
then probably be conjugated and excreted via urine or bile.
Although theoretically aniline could be one of the
metabolites, based on the toxicity studies, there are no
indications that this compound is formed after ingestion or
dermal application of the substance.
Since it is generally accepted that substances with log Pow
ranging from 0.1 to 6 penetrate the skin easily, it is to be
expected that the substance will be readily absorbed through
the skin. This assumption is supported by the findings
during the acute dermal toxicity study.
Based on the expected kinetic behaviour in the body, as
described above, the substance will not accumulate in the
body after prolonged exposure.
The anticipated kinetic behaviour is supported by the acute
oral and dermal toxicity data.
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