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The substance has low acute toxicity following oral and dermal exposures (LD50 > 2000 mg/kg bw), is not irritating to the skin and eyes and has no skin sensitisation potential. On this basis no acute DNELs either for systemic or local effects are required.
Low toxicity is confirmed also following repeated oral exposure, as the NOAELs obtained for systemic toxicity and for reproductive and developmental toxicity as well (OECD 407 and OECD 421 fully compliant studies, respectively) were greater than the limit dose of 1000 mg/kg bw/day.
The substance does not possess any genotoxic potential, as results obtained for all in-vitro end points (i.e. gene mutation in bacterial cells, clastogenicity in mammalian cells and gene mutation in mammalian cells) were all negative.
As the substance is not genotoxic and does not pose any risk for reproductive or developmental toxicity, the NOAEL of 1000 mg/kg bw/day obtained in both the 28-d oral gavage study and the OECD 421 oral gavage study has been chosen as the starting point for DNELs setting. Consideration of rate of absorption for each route of exposure can be found under the toxicokinetic assessment.
Appropriate assessment factors were applied, according to the guidance.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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