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Administrative data

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Description of key information

The absence of specific toxicokinetic data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion.  

Key value for chemical safety assessment

Additional information

Toxicokinetic assessment

The data provided suggested no significant clinical signs. No useful evidence relating to toxicity was obtained from the data provided for the acids.

Absorption

There was no evidence of systemic effects reported in the data provided on the acute oral or dermal toxicity studies, but blood parameter changes observed in the repeat dose oral toxicity study would suggest that absorption does take place orally.

Distribution

System effects were observed in the subacute oral toxicity study with changes in blood chemistry and minor findings in the liver and kidneys. It is therefore possible to conclude that the substance, or the metabolites, are transported.

Metabolism

The triethanolamine will readily metabolise, with the nitrogen and carbon being utilised. There is no evidence of metabolic activity in animals, but work on phenylsulphonamides suggests metabolic pathways will exist in cells.

Excretion

There is no evidence from testing performed that there is subsequent excretion of the absorbed substance or any metabolites formed.

Conclusion

The absence of specific toxicokinetic data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion. It is not considered appropriate to perform further animal studies on this substance.