Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Oral: evidence presented by the acute oral toxicity study indicates that the substance is absorbed following administration in arachis oil with systemic effects noted in the lungs, liver and kidney following exposure to 2000 mg/kg. No toxicologically significant effects were noted following exposure of rats in a subacute study at a maximum concentration of 100mg/kg bw/day, indicative of a low potential for bioaccumulation. Additionally, no toxicologically significant effects were observed on reproductive or developmental parameters in the exposed animals.
The water solubility, partition coefficient and molecular mass all indicate that this substance will be bioavailable via the oral route.
Inhalation: The particle size distribution indicates that there is limited potential for exposure by this route.
Dermal absorption: Results from in vivo irritation and dermal toxicity studies, in addition to the physical parameters of molecular weight and log Pow, indicate that the substance can penetrate the stratum corneum and is systemically available from dermal exposure.
Metabolism: There is no evidence from the 28 day study to indicate that the substance is undergoing extensive hepatic metabolism (lack of adaptive hepatic hypertrophy). No specific metabolism studies have been undertaken however the reduction of genotoxic activity of the substance by S9 fraction in the in vitro genotoxicity and mutagenicity assays conducted would indicate that hepatic metabolism of the substance is likely.
Excretion: There is limited evidence from the oral toxicity studies conducted ( dark kidneys in acute studies and non-significant increases in creatinine in repeat dose studies) that the substance may interact with the kidneys.

Key value for chemical safety assessment

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

Additional information

Based upon the results of acute toxicity testing and the physical properties of the substance, it can be predicted that absorption and distribution can be expected by the oral and dermal routes. Default absorption rates of 100% are assigned to these routes based upon the relevant physical properties of molecular weight, log Kow and water solubility. Uptake is unlikely by the inhalation route, given the particle size distribution of the substance and a default absorption rate of 0% is assigned.

There is little to no evidence of the metabolic or excretion profile of the substance however the lack of systemic effects observed in the repeat dose study is indicative of a metabolic/excretion pathway.