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Description of key information

A paper-based toxicokinetic assessment has been conducted for this substance (see IUCLID section 13 as attachment). Available studies were reviewed by a qualified toxicologist. The assessment of the likely toxicokinetic behaviour of the test item was provided to the extent that can be derived from the relevant available information at the time of the assessment. The available information suggests that the test item is not readily bioavailable via the oral, dermal or inhalation routes. This is supported by the physico-chemical and toxicological properties of the test item. If any absorption occurs, the test item would most likely be distributed systemically in the serum. Urinary excretion is considered to be the significant route for the test item.

The absorption, distribution, metabolism and excretion of FAT 40868/A TE has been predicted based on the following information:

FAT 40868/A TE being highly water soluble would in all probability be absorbed via the gastrointestinal tract subsequently entering the circulatory system in the blood. It is also possible some absorption could take place through the skin. However, the risk of uptake via the inhalation route was considered to be low as the test material was not volatile.

The available evidence including single and 90 Day Repeated Oral (Gavage) Toxicity Studies together with a repeated dose reproductive screening oral gavage study indicated the test item and/or its predicted metabolites to have only low toxic potential when absorbed or distributed through the gastro-intestinal tract and serum.

Excretion of FAT 40868/A TE and any of its predicted metabolites is expected to be from urine and faeces with the latter likely to be a result of unabsorbed material.

The studies conducted for FAT 40868/A TE provided evidence to indicate absorption will primarily take place in the gastrointestinal tract following oral ingestion with some absorption potentially also taking place via the skin; once absorbed, the test substance would primarily be distributed in the serum. There was no evidence to indicate test item or metabolite influenced hepatic metabolism. Excretion of the test substance and/or its metabolites would be predominantly via the urine and faeces.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential
Absorption rate - oral (%):
10
Absorption rate - dermal (%):
10
Absorption rate - inhalation (%):
10

Additional information

The available information suggests that absorption of the test item through the skin, gastro-intestinal tract or via inhalation is unlikely or very limited (a worst case of 10% for all routes is assumed). If absorbed, the test item may be distributed in the serum. Elimination in urine may be the significant route of excretion for any material that is absorbed and accumulation in tissue is not expected due to the negative logPow and the high water solubility.