Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

The uptake of the test substance via dermal route is very unlikely and since the substance is not classified for acute dermal, inhalation, and oral toxicity. 
The available information suggests that absorption of the test substance will primarily take place in the gastrointestinal tract following oral ingestion. Some absorption may also take place via damaged skin. Once absorbed, the substance would be distributed in the serum and in all likelihood excreted via the urine and faeces.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The absorption, distribution, metabolism and excretion of FAT 40061/F TE have been predicted based on the following information:

FAT 40061/F TE absorption was indicated via the gastro-intestinal tract following oral gavage administration.

FAT 40061/F TE no absorption was indicated via intact skin or ocular routes of exposure. However, available data confirmed the test item was a sensitizer to Guinea pig skin and also indicated to potentially cause respiratory sensitisation.

FAT 40061/F TE no uptake via inhalation is anticipated on the basis that the inhalable fraction was shown from the Particle size test to be ~99% at <100 μm indicating almost all inhaled particles will be cleared in the oral/nasal region and subsequently swallowed with the mucus.

FAT 40061/F TE based on the available evidence including single oral dose and repeated oral dose reproductive screening studies that the test item and/or its predicted metabolites to have limited toxic potential whether absorbed through the skin or gastro-intestinal tract.

Excretion of FAT 40061/F TE and any of its predicted metabolites is expected to be from urine and faeces.