Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

As a worst case, absorption of zinc 3,5-bis(α-methylbenzyl)salicylate in humans via the oral and inhalation routes is assumed to be 100%. Absorption by the dermal route is assumed to be 10% based on the substance having a molecular weight > 500.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
10
Absorption rate - inhalation (%):
100

Additional information

Toxicokinetic parameters such as uptake, distribution, metabolism and excretion form the essential toxicological profile of a substance. An approximate indication of the toxicokinetic pattern can be gained from the results of basic toxicity testing. The assessment of the toxicokinetic properties of zinc 3,5-bis(α-methylbenzyl)salicylate detailed below is based on the results obtained for the physical/chemistry and toxicological endpoints.

In the acute oral toxicity study and the repeated dose toxicity studies with the test substance, signs of toxicity were observed indicating that the substance is absorbed by this route. As a worst case, absorption via the oral route is assumed to be 100%. The molecular weight (754 to 757) of the test substance is > 500. Consequently, absorption via the dermal route is assumed to be 10%. Signs of systemic toxicity were observed in the oral toxicity studies with the substance therefore it is likely that the substance will also be absorbed if it is inhaled, however, the likelihood that inhalable atmospheres may be generated is low. As a worst case, absorption via the inhalation route is assumed to be 100%.

 

The substance is considered to be lipophilic (based on log Kow >0) therefore it is likely to distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues. Zinc 3,5-bis(α-methylbenzyl)salicylate contains zinc and zinc is distributed to all tissues and tissue fluids in humans.

 

The organic component of the test substance is likely to undergo metabolism in the liver and other organs with the resultant metabolites eliminated by the kidneys in the urine. Bioaccumulation of the test substance is not expected based on its low log Kow value, water solubility and predicted metabolism.