Registration Dossier
Registration Dossier
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EC number: 293-615-0 | CAS number: 91081-13-9
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
No specific ADME or potential metabolites studies are available and assessment is based on the physio-chemical data and toxicity studies available at the time of review.
Physico-chemical data demonstrate that the test item is sparingly soluble in water, highly lipophilic (partition coefficient: Log10 Pow > 10.0) and has a low vapour pressure (0.0345 Pa at 25 °C). These data suggest that absorption of the substance via the GI tract and epidermis are likely to be significant. However, inhalation exposure is unlikely to be either an issue or a major route of exposure and therefore of limited concern regarding systemic exposure. Data indicate that the substance may have the potential to be widely distributed in the body although potential for bioaccumulation is limited. The nature of the UVCB substance makes prediction of its potential metabolic pathways, metabolites and excretion products difficult to ascertain.
The substance is of very low toxicity both acutely (oral or dermal) and after repeat oral dosing. The physico-chemical data suggest there is significant potential for both absorption and systemic exposure; the dosing vehicles, used in the in vivo acute and repeat dose studies, were such that absorption should not have been impeded. It is likely that both significant local and systemic exposure were achieved in the toxicity studies considered. Thus, exposure to the parent substance, and subsequent metabolism and metabolites (e.g. no in vitro genotoxicity was seen presence of metabolic activation), was without obvious adverse toxicological consequences. The exception to this being the data from the LLNA which demonstrated that the substance is a skin sensitiser (at 10% or 25% w/w). Clearly, in the LLNA, both local and dermal absorption and subsequent exposure were demonstrated sufficient to elicit a lymphocytic response.
It is highly likely that the substance undergoes extensive metabolism in the liver and that the metabolites do not cause obvious adverse acute or sub-chronic toxicological symptoms.Excretion is expected via the faeces and urine.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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