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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

It is considered likely that if ingested, there will be some abiotic activity with dissociation and hydrolysis processes.  The theoretical products of this activity, including 6[(p-tosyl)amino] hexanoic acid are likely to be absorbed and transported in the blood.  There is no indication of accumulation and metabolic action is likely.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion of the registered substance. However, an assessment of the toxicokinetics behaviour of the constituents of the Reaction mass of 2-aminoethanol and 6-[(p-tosyl)amino]hexanoic acid, compound with 2-aminoethanol (1:1) - namely 6-[(p-tosyl)amino]hexanoic acid, 2-aminoethanol, and water - has been performed in conjunction with an assessment of the available toxicological data.

2-aminoethanol and its products are expected to be absorbed if ingested and readily metabolised with NH3 and acetyl-CoA as its final metabolites, but there is little evidence regarding the 6-[(p-tosyl)amino]hexanoic acid. It is considered that adsorption of the dissociation and acid-hydrolysis products of the 6-[(p-tosyl)amino]hexanoic acid will occur, and a non-quantitative assay performed on the substance did demonstrate a peak in blood concentrations at 3 hours, indicating that a significant amount of the acid is therefore absorbed; this is supported by unchanged substance being identified in urine after an oral ingestion. This presence in blood indicates that the substance is likely to be distributed in the body, but there is no effects reported that could highlight specific target organs. Metabolism of the 6-[(p-tosyl)amino]hexanoic acid is expected, as the cytotoxicity was reduced in presence of metabolic activation during the bacterial gene mutation assay. This metabolism and the peak in blood suggest that the substance will not accumulate. 6-[(p-tosyl)amino]hexanoic acid was identified in urine after an oral ingestion, but the amount of unchanged product and metabolites was not calculated.

It should also be noted that no evidence of hydrolysis was identified in a hydrolysis study on a structurally similar substance to the registered substance. The read-across substance consists of the same acid and sulphonamide bond as the registered substance, differing only in the presence of triethanolamine in place of monoethanolamine. The sulphonamide bond is the only hydrolysable bond in both substances. Extremes of pH and temperature are needed to induce hydrolysis. Although the pH of the stomach is around 2 -4 based on the presence of acid the required temperature is not present therefore hydrolysis is not expected to occur following ingestion of the registered substance.

It is therefore not considered appropriate to perform further animal studies on this substance.