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: 216-343-6 | CAS number: 1562-00-1
Tabelle 5: Mean severity of Findings
Number of animals examined
Mixed Cell Infiltration
Single Cell Necrosis
Focal Hepatic Hyperplasia
Bile Duct Hyperplasia
Oral administration of Sodium 2-hydroxyethanesulphonate to Wistar rats at doses of 50, 200 and 1000 mg/kg/day for 91/92 days resulted in no deaths, no clinical signs during daily or weekly observations, no clinical signs during the functional observational battery, no test item-related differences in the mean fore-or hindlimb grip strength or mean locomotor activity, no toxicologically relevant ophthalmoscopic changes, no differences in the mean food consumption, no changes in hematology parameters at 200 mg/kg/day or at 50 mg/kg/day, and no changes in urinalysis parameters at 50 mg/kg/day.
Although statistically significant differences were noted in the mean hindlimb grip strength values of males treated with 1000 mg/kg/day, these were considered to be secondary effects to the lower body weights.
Test item-related findings were generally restricted to slightly lower mean absolute and relative body weights in males treated with 1000 mg/kg/day, changes in the hematology parameters of the rats treated with 1000 mg/kg/day (reduced mean corpuscular hemoglobin concentration values, elevated mean absolute and relative reticulocyte counts, and a ‘left-shift’ in the reticulocyte maturity indices indicative of increased reticulocyte turnover, reduced hemoglobin distribution width in females only), the clinical biochemistry parameters at 1000 mg/kg/day (reduced glucose levels, elevated total bilirubin levels, elevated cholesterol and phospholipid levels, elevated aspartate or alanine aminotransferase activities at 1000 mg/kg/day) including electrolytes (elevated sodium levels at 50, 200 or 1000 mg/kg/day, reduced potassium levels at 50, 200 or 1000 mg/kg/day, increased calcium levels at 1000 mg/kg/day, increased phosphorus in females at 1000 mg/kg/day, increased chloride levels in males at 200 mg/kg/day), increased spleen weights in rats at 1000 mg/kg/day, macroscopical changes in the liver (a higher incidence of tan foci reported in the liver of males and females treated with 1000 mg/kg/day) after the treatment period only, microscopical changes in the liver (presence of degeneration, necrosis (focal or of single hepatocytes), bile ducts hyperplasia, focal hepatocytic hyperplasia, peribiliary fibrosis and an increased incidence and severity of mixed inflammatory cells infiltration in the parenchyma) and spleen (increased hemopoiesis) with complete post-recovery reversibility.
Based on the results of this study, the no-observed-adverse-effect-level (NOAEL) for the test item, Sodium 2-hydroxyethanesulphonate, was considered to be 200 mg/kg body weight/day.
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.
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.
Close Do not show this message again