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: 931-597-4
CAS number: -
significant differences in health status, the studied parameters or the
reproductive performance between experimental and control animals were
order to find out appropriate means to utilize electrofilter ash dumping
areas, pastures and hay production areas for sheep were experimentally
cultivated and effects on sheep health and breeding studied. Ash
deposits were spread out in dumping areas in the depth of 2-4 meters
followed by several months of watering and compression to stabilize the
ground. The second phase included conveying, spreading, compression and
preparation of earth deposit at the depth of 0.5 meters, seeding of
grass and corresponding one year maintenance to make the pasture
suitable for grazing and production of hay for winter nutrition.
Experimental and control groups of 10 older ewes and 10 one year old
ewes grazed on the pasture cultivated with electrofilter ash or ordinary
pastures in the surrounding area, respectively. Health condition, body
weight, hematology, clinical chemistry and reproductive performance were
monitored during the study. Animals from each group were slaughtered
after one or two years and hematological, clinical chemistry, gross
pathological, histopathological and analytical chemistry analyses were
carried out. No significant differences in health status, the studied
parameters or the reproductive performance between experimental and
control animals were found.
2: Chemical analysis on coal combustion fly ash (Scholven)
1 sample analysed
3: Individual observations
Age, body weight and
pregnancy status at initiation of exposure
(in kg at similar stages of pregnancy, measured in 1950, 1951, 1952 and 1953)
(kg /d; mean values)
No clinical signs of toxicological
relevance were observed.
No disturbances of conception and parturition.
657, 697, 720, 744
No clinical signs of toxicological relevance were observed.
No disturbances of conception and parturition up to the 3rdbirth in 1953. During the 4th pregnancy an infection with Brucella abortus occured, followed by a preterm delivery in the 8thmonth of pregnancy.
535, n.d., 590, 682
5 years, 585 kg,
No disturbances of conception and parturition up to the 2ndbirth in April, 1953. In November 1953 an abortion occured after a Brucella infection.
n.d., n.d., 554, 709
4.75 years, 625 kg,
Observed clinical signs (uterus catarrh, bronchial catarrh) couldn´t be associated with fly ash administration, as the milk production was highest during fly ash administration
Mastitis due to a Streptococcus infection occured early after experimental start. Infection with Brucella abortus during post exposure period.
625, n.d., 695, 691
4.5 years, 645 kg,
No disturbances of conception and parturition up to the 3rdbirth in 1953. During the 4thpregnancy an infection with Brucella abortus occured, followed by an abortion in the 8thmonth of pregnancy.
645, 636, 686, n.d.
5 years, 710 kg,
No clinical signs of toxicological relevance were observed. The occuring mastitis could not be associated with fly ash administration.
No disturbances of conception and parturition up to the 3rdbirth. During the 4thpregnancy the animal was euthanised after an accident with fracturing of the lumbar vertebrae.
710, 727, n.d., 812
5.5 years, 627 kg,
Abortion in February 1951 without evidence of bacterial infection. No disturbances of conception and parturition were observed for the following 3 pregnancies.
627, 683, 685, n.d.
5.75 years, 670 kg,
No disturbances of conception and parturition up to the 3rdbirth.During the 4thpregnancy the animal was euthanised.
670, 719, 732, n.d.
No clinical signs of toxico logical relevance were observed.
No disturbances of conception and parturition during all 4 pregnancies and deliveries.
682, 765, 784, 809
of pregnancies / number of natural matings
n:o 3 was incorporated to the experiment in March 1952 as a replacement
for another animal, which was euthanised due to diseases of the lung and
intestine. This was not considered treatment-related, as this animal
belonged to the control group.
4:Individual macroscopic and microscopic pathological findings
Histological findingsain kidney, liver, stomach, lymph nodes and intestine samples
infectious diseases: Liver Trematodes, Tuberculosis;
changes in claws, considered normal under the given circumstances
no histopathological changes
infectious diseases: Liver Trematodes, Tuberculosis, Brucella abortus;
liver: high glycogen deposition and fatty changes; kidney: glomerulonephritis, brownish pigmentation in tubular epithelial cells, mild nephrosis; lymph nodes: pigmentation
infectious diseases: Liver Trematodes, Brucella abortus;
changes in uterus and vagina considered to be a consequence of Brucella infection
infectious diseases: Tuberculosis, Streptococcus, Brucella abortus
kidney: glomerulonephritis, pigmentation of tubular epithelial cells; liver: fatty changes, centrilobular glycogen deposits
petechial changes of the gall bladder mucosa, notconsidered toxicologically relevant;
infectious diseases: Tuberculosis;
fracture of the lumbar vertebra;
necropsy findings of this animal were omitted, as the animal suffered for 6 weeks from the downer cow syndrome due to the lumbar vertebra fracture.
kidneys: lymphocytic interstitial infiltration; liver: mild perivascular lymphocytic infiltration;
infectious diseases: Liver Trematodes;
mild erythemab´in the pyloric mucosa of the abomasum, the amounts of sand in the gastro-oesophageal mucosa was considered normal and there were no defects, bleeding or necrosis in the mucosa of the gastro-oesophageal tract
no histopathological changes with the exception of a single focal fatty change in liver
the amounts of sand in the gastro-oesophageal mucosa was considered normal, and there were no irritation of gastro-oesophageal mucosae
the amounts of sand in the gastro-oesophageal mucosa was considered normal;
mild erythema in the abomasal mucosa, and there were no defects, bleeding or necrosis in the mucosa of the gastro-oesophageal tract
kidney: chronic glomerulonephritis, focal chronic interstitial nephritis, protein deposition in tubular epithelial cells;
liver: hydropic degeneration with cell lysis, mild centrilobular fatty change and glycogen deposits; lymph nodes: pigmentation
findings detected in animals 2, 4 and 9 (groups 1, 2 and 3,
respectively) were considered to be of no toxicological relevance,
because no dose-response relationship was found.
mild erythemas in some gastrooesophageal tracts were considered to be of
no toxicological relevance, as this finding were also observed in 25 out
of 30 animals analysed at the butchery of Hannover, Germany.
Groups of 3
milking cows were exposed daily to coal fly ash mixed with fodder at 0,
300 or 1500-1800 g/day (equivalent with about 0, 430 or 2100-2600 mg/kg
bw/day) for 3 years in a non-GLP study. (After 2 years the control group
and the low dose group were switched.) Observations included clinical
signs, body weight, milk production, reproduction and parturition,
chemical analyses of milk, excreta and tissues as well as macroscopic
pathology and histopathology. Male reproduction parameters and litters
were not examined. No treatment-related effects were observed. A
NOAEL of about 2100 mg/kg bw/day was identified. Chemical analyses
suggested low oral bioavailability of As, Mn, Pb, Fe, Cu, Zn and Co
from coal fly ash.
A published reproductive study in sheep maintained on pastures treated with electrofilter ash did not indicate toxic effects on ewes, effects on fertility, or effects on body weight development or viability of the offspring.Similarly, no effects on fertility or birth were found in milking cows after oral exposure to coal fly ash at doses up to about 2100 mg/kg bw/day for 2 years (Herrmann, 1955).
Short description of key information: No effects observedJustification for selection of Effect on fertility via oral route: The study were selected, because they addresses the reproductive effects after chronic high dose exposure to coal fly ash and provide additional information onreproductive toxicity of ash.
No effects observed.
No animal was found dead during the study.
No clinical signs, test item-related effects on body weight or food consumption parameters, were observed in the study.
No test item related macroscopic findings were present at necropsy in any of the animals in the study.
There was no statistically significant difference in foetal death in any test item treated groups compared to the control. The mean number of corpora lutea was comparable with the control in all test item treated groups. No significant differences were noted in preimplantation loss or number of implantations of the test item treated groups when compared to the control.
The early and the late embryonic loss values of the test item treated groups, and the number of dead foetuses were comparable with control. There was no statistically significant difference in the postimplantation loss or total intrauterine mortality between the test item treated and control groups.
No toxicologically relevant adverse effect of the test item was observed on the foetal parameters, including mean foetal weight and in the sex distribution in the Top dose group. There was significant difference in the number of foetuses with retarded body weight for males in the Top dose group compared to the Control group.
Placentas were normal for all observed animals.
There was no test item related effect on the external development of foetuses in the study.
Mixed Ash, when administered daily by oral gavage to pregnant Hannover Wistar rats from gestation days GD6 to GD19 at 1000 mg/kg bw/day induced no maternal systemic toxicity and no effect on body weight or growth in a GLP-compliant OECD 414 Prenatal Developmental Toxicity test. No effect on the embryotoxicity and foetotoxicity was observed (number of foetuses with retarded body weight and malformations) in the study based on overall development. No mortality occurred during the study.
All test item formulations were within the range of 98-108% of nominal concentration and were found to be homogenous. No test item was detected in the vehicle control samples.
In the higher dose group, some symptoms were present. Noisy respiration was observed in 1 out of 20 and 1 out of 24 animals in the Mid and High dose group. The finding appeared from Day 12 until Day 19, the symptom occurred for a maximum of eight days.
Piloerection was present in 1 out of 24 animals in the High group. The finding appeared from Day 12 until Day 19, the symptom occurred for a maximum of eight days. Red discharge around right eye was observed in 1 out of 24 animals.
No test item related body weight effects were observed in any of the dose groups. No changes in the food consumption in any of the dose groups was observed during the treatment period. No test item related macroscopic and microscopic findings were present at necropsy in the surviving animals.
There were no statistically significant changes in the concentration of the T3, T4 and TSH level between the Control and the Dose groups. There were no statistical differences in the organ weights between the control and the Dose groups. There were no statistically significant differences in the intra-uterine parameters in the test item treated animals when compared to the controls. There was no toxicologically significant difference in the foetal weights of either sex of foetuses, sex distribution or on anogenital distance between the control and treatment groups. There were no adverse test item related effects on external, visceral or skeletal development of foetuses in the study.
Foetal malformations observed in the study were all considered to be incidental. They showed no dose dependency and thus were not regarded as a test item related effect.
The following no-observed-adverse-effect (NOAEL) levels were derived:
NOAELmaternal toxicity: 1000 mg/kg bw/day
Based on no maternal systemic effects at 1000 mg/kg bw/day.
NOAELembryotoxicity: 1000 mg/kg bw/day
Based on the lack of any test-item related intra-uterine effect in any treatment group.
NOAELfoetotoxicity: 1000 mg/kg bw/day
Based on no effect on runts at 1000 mg/kg bw/day.
NOAELteratogenecity: 1000 mg/kg bw/day
Based on the lack of treatment related malformations in any dose group.
Prenatal Developmental toxicity study (OECD 414):
In conclusion, Mixed Ash, when administered daily by oral gavage to pregnant Hannover Wistar rats from gestation days GD6 to GD19 at 1000 mg/kg bw/dayinduced no maternal systemic toxicity and no effect on body weight or growth. Noeffect on the embryotoxicity and foetotoxicity was observed (number of foetuseswith retarded body weight and malformations) in the study based on overalldevelopment.The following no-observed-adverse-effect (NOAEL) levels were derived:NOAELmaternal toxicity: 1000 mg/kg bw/dayBased on no maternal systemic effects at 1000 mg/kg bw/day.NOAELembryotoxicity: 1000 mg/kg bw/dayBased on the lack of any test-item related intra-uterine effect in any treatment group.NOAELfoetotoxicity: 1000 mg/kg bw/dayBased on no effect on runts at 1000 mg/kg bw/day.NOAELteratogenecity: 1000 mg/kg bw/dayBased on the lack of treatment related malformations in any dose group.
The information available is conclusive for classification. No classification is required based on.
(1) No reproductive or developmental effects observed in OECD 414 Prenatal developmental toxicity Test at doses up to 1000 mg/kg bw/day (2) Low systemic toxicological activity and no effects on reproductive organs reported in repeated dose toxicity studies or in the literature.
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.
Do not show this message again