Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 695-748-3
CAS number: 65286-55-7
An NOAEL of 25 mg/kg bw/day was established in the 90-day repeated dose toxicity study (oral route, OECD 408; Chase, 2022).
This dose descriptor starting point was therefore used to derive a DNEL long-term, systemic effects via the inhalation route. After route-to-route extrapolation from oral to inhalation, the modified dose descriptor starting point NOAEC is 61.71 mg/m³ = 25 mg/kg/day x 1/0.38 m³/kg/day x 0.67 x 1 x (7d/5d). The oral dose for rats was converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m³/kg for 8 hours exposure for workers). For workers, the resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor is derived from the inhaled volumes in 8 hours under respective conditions (6.7 m³ for base level, 10 m³ for light activity). A correction factor of 7/5 for the difference in exposure duration and frequency was added (7 days/week dosing in the animal study, 5 days/ week exposure of the workers). No additional correction factor is required as the bioavailability after both oral and inhalatory exposure is considered to be 100%.
No long-term dermal toxicity study is available for the test substance. However, data from an oral 90-day repeated dose toxicity study (OECD 408; Chase, 2022) could be used after extrapolation to the dermal route. The NOAEL established at 25 mg/kg bw/day was therefore used to derive a DNEL long-term, systemic effects via the dermal route.
For route-to-route extrapolation (oral to dermal), a correction factor of 2 should be applied as part of the overall assessment factor, as it is assumed that bioavailability after oral exposure is 100% and after dermal exposure 50%. A correction factor of 7/5 is applied to correct for difference in exposure duration and frequency (7days/ week for the animal study, 5 days/week for the workers) The modified NOAEL was 70mg/kg bw/d ( 25 mg/kg bw/d * 2 * (7d/5d).
No effect threshold levels were derived for the general population, as
no consumer use is expected.
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.
På den här webbplatsen används kakor. Syftet är att optimera din upplevelse av den.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again