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EC number: 233-251-1 | CAS number: 10101-50-5
The test substance,Potassium permanganatewastested for prenatal developmental toxicity using the EUMethod B.31, Prenatal Developmental Toxicity Study, Council Regulation (EC) No. 440/2008, Published in O.J. L142, 2008.
Wistar rat females of SPF quality were used for testing. After acclimatization the females were mated with males. The test substance was then administered to pregnant females - daily from the 5thto the 19thday of pregnancy. Thestudyincluded four groups of females – 3 treated groups and 1 control group (vehicle only).The test substance was administered dissolved in water by stomach tube and the concentrations of solutions at all dose levels were adjusted to ensure the administered volume of 1 mL per 100 g of body weight.
The dose levels for study – 20, 100 and 500 mg/kg/day were chosen on the basis of results of Study No. 15/06/7: Potassium permanganate – Repeated Dose (28 days) Toxicity (Oral); VUOS-CETA Report No. 0680, 2006 and Study No. 15/06/15: Potassium permanganate – One-Generation Reproduction Toxicity Test; VUOS-CETA Report No. 08142, 2008.
The health condition, clinical status after application, body weight and food consumption of maternal animals were monitored during developmental toxicity study. On the 20thday of pregnancy the maternal animals were killed, the uterine contents were examined and the foetuses were evaluated for soft tissue and skeletal changes.
At the dose level of 20 mg/kg/day the weight increments, mortality, health condition, clinical status after application, macroscopical structure of organsof pregnant females, values of reproduction parameters (number of live and dead foetuses, intra uterine death early), development of foetuses (foetal weight, evaluation of external and visceral affections)were unaffected by treatment of the test substance.
At the dose level of 100 mg/kg/day the mortalityof pregnant females and development of foetuses (evaluation of external and visceral affections)were unaffected by treatment of the test substance.
At the dose level of 500 mg/kg/day the mortality,values of some reproduction parameters (number of dead foetuses, intra uterine death early) of pregnant femalesand foetal development judged according to the external and visceral observationwere unaffected by treatment of the test substance.
The following effects could be attributed to the administration of the test substance:
At the dose level of 20 mg/kg/day food consumption (decrease) anduterus biometry (decrease of relative weight of uterus) was very slightly influenced by administration of the test substance. Effect of the test substance on the weight of foetuses (slightly decrease) and the increased incidence of delayed ossification of vertebrae (skeletal variations) was recorded.
At the dose level of 100 mg/kg/day body weight increment (slight decease at the end of application), food consumption (decrease), health condition, clinical status after application (sporadic occurrence of clinical symptoms of toxicity), biometry of uterus (decrease of relative weight of uterus), macroscopical structure of organsofmaternal animals were influenced by administration of the test substance. Some of reproduction parameters (intra uterine death earlyand late, decreased number of live foetuses), weight of foetuses (decrease) and increased incidence of skeletal variation (delayed ossification of vertebrae) were also affected.
At the dose level 500 mg/kg/day body weight increment (significantly decreased), food consumption (markedly decreased), health condition, clinical status after application (occurrence of clinical symptoms of toxicity), biometry of uterus (decrease of relative weight) and macroscopical structure of organs of maternal animals (findings in digestive system) were influenced by administration of the test substance. Important effect on reproduction parameters (high incidence of aborted females, hight incidence of resorptions and accompanying high postimplantation losses), number of live foetuses (slight decrease of number), weight of male and female foetuses (significantly decrease in female foetuses) and increased incidence of skeletal variation (delayed ossification of vertebrae) were also recorded.
Administration of the test substance Potassium permanganateaffectedgrowth,clinical status and macroscopic structure of organs in treated maternal animals. These effects were significantly manifested in the results of health condition controls and clinical observations (cachexia, anemia, cough or hoarse breath, secretion from nostrils and eyes, piloerrection, apathy). During maternal animalnecropsies the pathologic changesin stomach and uterus and slightly lower relative weight of pregnant uterus were found. Above mentioned changes were recorded markedly at the highest dose level and sporadically at the middle dose. Important effect represented by the significantly decreased maternal weight was detected at the highest dose level.
In individual foetuses examination the effect to the weight of foetuses was found especially at the highest dose level. Increased number of aborted females and related negative changes of reproduction parameters (postimplantation losses) was also recorded in treated groups with higher incidence at highest and middle dose levels. The increased incidence of some of skeletal variations was found out in foetuses of all treated groups and could be attributed to an adverse effect of treatment.
Developmental effect of the test substance together with toxicity to the maternal animals was detected at the highest and middle dose levels. At the lowest dose level 20 mg/kg/day developmental effect(the decreased weight of foetuses, the increased incidence of delayed ossification of vertebrae)occurred in the absence of toxicity to the maternal animals.
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