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Key value for chemical safety assessment

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Since no toxicokinetic studies are available for ethylviolet acetate the following assessment is based on the available physicochemical properties and results from other toxicological studies:

The substance is a solid, green violet homogeneous mass with a partition coefficient (log Kow) of 2.374 at 25 °C. Based on this rather low partition coefficient the test substance is unlikely to bioaccumulate with the repeated intermittent exposure patterns normally encountered. The substance has a very low vapour pressure (0.0000026 hPa at 20 °C and 0.0000053 hPa at 25 °C).

Acute oral toxicity studies in rats provide evidence for systemic availability of ethylviolet acetate by the oral route (based on the observed colored organs and tissues, clinical symptoms and the LD50 of 410 mg/kg bw).

The positive result of a local lymph node assay in mice with application of the test substance to the intact skin suggests that dermal uptake of the test substance might occur to a certain extent.

The severe signs of toxicity observed in a 28-day repeated dose toxicity study by oral application (gavage) in rats indicate systemic availability of ethylviolet acetate by this exposure route. Furthermore, in this study a blue discoloration was observed macroscopically in carcass, organs and gastrointestinal contents indicative for distribution of ethylviolet acetate to these organs and tissues. Supportingly, in a prenatal developmental toxicity study in rats by oral application (gavage) blue or dark discolorations were found in a number of organs/tissues at necropsy. These discolorations mirror the systemic availability of the test substance or its metabolites.

The results from several in vitro genotoxicity studies with and without metabolic activation indicate that no reactive metabolite was formed after the addition of rat liver S9 mix.