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: 911-490-9 | CAS number: -
Analytical verification of dose formulations:
Formulations at the entire range were found to be stable when stored at room temperature under normal laboratory light conditions for at least 6 hours (maxmum relative difference -2.3%).
The concentrations analysed in the test item formulations were in agreement with target concentrations (i.e. mean accuracies between 94% and 105%).
A small response at the retention time of the test substance was observed in the chromatograms of the control group formulation. Maximum contribution to the other samples was 0.055% based on peak area.
The formulations of the mid and the high dose group were analyse to be homogeneous (i.e. maximum coefficient of variation 1.2%).
In a sub-acute repeated dose study performed according to OECD guideline and GLP principles, rats were treated with 100, 300 or 1000 mg/kg bw Accelerator (PT 25E or PT 25E/2). Due to mortality in the highest dose group on day 1 (2/5 males and 3/5 females), the highest dose was lowered to 600 mg/kg bw and the animals were replaced. One male and one female died shortly after the first dose of 600 mg/kg bw. At macroscopic examination these animals showed foci in the thymus and/or lungs and thickened thymus. No further mortality occurred. Clinical signs were noted during the study period at 600 mg/kg (lethargy, clonic spasms, tremors, flat and/or hunched posture, quick breathing, rales, laboured and/or shallow respiration, piloerection, salivation and/or chromodacryorrhoea). During the first week the body weight gain was slightly lower but recovered from week 2 onwards. No changes were noted in food consumption, or functional behaviour were noted compared to control animals. At the highest dose level of 600 mg/kg higher liver weights and thyroid gland weights were noted in males and females, coinciding with changes in total bilirubin and cholesterol levels. Liver weights were also increased in females at 300 mg/kg. In females ALAT-values, total bilirubin, and cholesterol were elevated in all groups and increased in a dose-dependent way (significant at 600 mg/kg bw).
Microscopic examination revealed in some females diffuse hyperplasia of the urothelium of the urinary bladder (2/5 females at 600 mg/kg). Based on the low grade and the absence of additional histopathologic findings, this was considered to be a non-adverse treatment-related effect. Based on the effects on liver at 300 mg/kg with dose-related changes in biochemical parameters (ALAT, cholesterol, total bilirubin and bile acids), a No Observed Adverse Effect Level (NOAEL) for Accelerator (PT 25E or PT 25E/2) of 100 mg/kg was established.
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