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Toxicological information

Endpoint summary

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Description of key information

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Assessment of the toxicokinetic behavior

 

No studies are available investigating the toxicokinetic properties of the test substance.

The test substance is a liquid consisting of a monoester and a diester compound with a molecular weight of 370 (diester) and 238 (monoester). The water solubility is 0.0251 g/L (di-substituted component) and 6.93 g/L (mono-substituted component), the log Pow is 0.572 (monoester) and 3.01 (diester).

Absorption

Based on the physico-chemical properties (water solubility, molecular size, Log Pow) and in consideration of Lipinski’s rule of Five, the test article is expected to be absorbed during gastrointestinal passage. Absorption through the skin is also anticipated. This is in line with the results obtained in a guinea pig maximization study (Safepharm, 2002). Here, the test substance caused sensitization upon skin contact demonstrating penetration through the dermal barrier. No inhalation toxicity data are available but physico-chemical properties indicate that inhalative exposure might only be possible through aerosol aspiration.

 

Metabolism and Excretion

Upon oral administration, the test item might be subject to cleavage to some extent in the gastro-intestinal tract. A proportion might also be absorbed unchanged and is subject to hepatic metabolic degradation. The test article is readily biodegradable and subject to hydrolysis. It is not bioaccumulating as shown experimentally. Hydrolysis reactions of the esters may generate carboxylic acids and/or alcohols followed by glucuronidation of the hydroxyl-groups. Subsequently, the test item and/or its metabolites will be excreted effectively. The primary elimination pathway might be the urinary excretion of parent compound and the metabolites. In the available genotoxicity studies no indications were found for the generation of toxic metabolites by enzymatic reactions. Furthermore, by-products are identified and qualified in the various experiments performed.