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: 931-257-5 | CAS number: -
The test substance, Fluidized Bed Combustion (FBC) Fly Ash, was tested for subchronic toxicity using the Method B.26 Sub-Chronic Oral Toxicity Test: Repeated Dose 90-day Oral Toxicity Study in Rodents, Council Regulation (EC) No. 440/2008, Published in O.J. L142, 2008. This sub-chronic oral toxicity test method is a replicate of the OECD Test Guideline No. 408: Repeated Dose 90-day Oral Toxicity Study in Rodents, Adopted 21st September 1998.
Wistar rats of SPF quality were used for testing. The test substance was administered in olive oil by stomach tube; oral application of rats was made daily. The study includes four main groups and two satellite groups of animals. Each main group consisted of 10 males and 10 females; each satellite group consisted of 5 males and 5 females. Main groups contained 3 treated groups (doses 50, 200, 800 mg/kg of body weight /day) and one control group (vehicle only). The satellite groups contained one control group (vehicle only) and one treated group (800 mg/kg/day). The administration period lasted 90 days. After that animals of main groups were sacrificed and satellite animals were observed for the next 28 days without treatment.
The dose levels for the main study - 50, 200, 800 mg/kg/day were chosen on the basis of results of Fluidized Bed Combustion (FBC) Fly Ash - Repeated Dose 90-day Oral Toxicity Study – Dose–range finding experiment .
During the 90-day study clinical observation and health status control were performed daily. The body weight, food consumption were measured weekly and the detailed clinical observation was carried out in the same time interval. Water consumption was measured twice a week. Ophthalmologic examination was done at the beginning and at the end of the study. Before the end of study the functional observation was accomplished. The study was finished by urinalysis, haematological and biochemical analysis, and gross necropsy of animals. The selected organs for weighing and histopathological examination were removed.
The oral administration of Fluidized Bed Combustion (FBC) Fly Ash to rats by gavage for period of 90 consecutive days at the dose levels 50, 200, 800 mg/kg/day did not cause any mortality. No negative treatment-related effects were detected during body weight, food consumption, food conversion and water consumption control, health condition control, functional observation, ophtalmological examination and biometry of organs.
Clinical status of animals after application, urinalysis parameters and microscopical structure of organs were not seriously affected by treatment of the test substance at the dose level 50 mg/kg/day.
Clinical status of animals after application were unaffected by treatment of the test substance at the dose level 200 mg/kg/day.
Haematological parameters (increase of haematocrit in males) and blood biochemical parameters (increase of albumin in males), some urinalysis parameters (slight decrease of pH in females), macroscopical structure of liver (change of colour in males) and microscopical structure of liver (fatty change - sporadically in males) in animals at the dose level 50 mg/kg/day were influenced by administration of the test substance.
Haematological parameters (increased haemoglobin in males, decreased of MCV in females) and blood biochemical parameters (increased albumin in both sexes), urinalysis parameters (decrease of pH in females, presence of leucocytes in males), macroscopical structure of stomach (congestion or susp. mucosal haemorrhages - slightly in males) and liver (change of colour and marked structure in both sexes) and microscopical structure of liver (fatty change - slightly in males) in animals at the dose level 200 mg/kg/day were influenced by administration of the test substance.
Clinical status of animals after application (slightly in males and sporadically in females), haematological parameters (HCT, MCV in males, haemoglobin, total and differential leucocyte count, platelet count in females) and blood biochemical parameters (total protein in both sexes, sodium ions in females), urinalysis parameters (decrease of pH in females, increase of volume in males, presence of leucocytes in both sexes), biometry of organs (decrease of relative weight of kidney), macroscopical structure of stomach (congestion or susp. mucosal haemorrhages - slightly in males) and liver (change of colour and marked structure in males and females) and microscopical structure of liver (fatty change, esp. in males) in animals at the dose level 800 mg/kg/day were influenced by administration of the test substance.
The test substance administration had not effect on food consumption, food conversion, water consumption, mortality, health condition, parameters of functional and ophtalmological examination of animals. Body weight and accompanied biometry of organs was not negatively influenced by the test substance treatment.
The test substance, Fluidized Bed Combustion (FBC) Fly Ash, after 90-day oral application caused significant changes of haematological (haematocrit, haemoglobin, MCV, total leucocyte count, monocytes portion) and biochemical parameters (albumin, sodium) at all dose levels. But exceeding of reference interval was recorded only in females at the end of observation period (MCV, haemoglobin, total leucocyte count and platelet count).
The urinalysis demonstrated effect of the test substance on properties of urine (pH, presence of leucocytes).
The test substance had influence on microscopical structure of liver (focal fatty changes).
The highest incidence of statistically significant differences was recorded at the highest dose level (sometimes with delayed character) while most of changes which were found out at the middle and the lowest dose level had only mild intensity without adverse alteration of animal organism.
The value of NOAEL (No Observed Adverse Effect Level) for MALES and FEMALES was established as 200 mg/kg/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