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: 233-791-8 | CAS number: 10361-44-1
No further studies are available.
In order to evaluate the potential effects of bismuth trinitrate on fertility, a 90 day repeated dose toxicity study with additional evaluations of reproductive effects was performed on Bismuth trinitrate.
Maternal findings: No maternal toxicity was observed in the 100, 300 and 1000 mg/kg groups.
Developmental findings: No developmental toxicity was observed in the 100, 300 and 1000 mg/kg groups.
In conclusion, based on the results in this prenatal developmental toxicity study the maternal and developmental No Observed Adverse Effect Level (NOAEL) for Bismuth trinitrate was established as being at least 1000 mg/kg
Figures and tables are attached below under 'Attached background material'.
Eighty-eight mated female Wistar Han rats were assigned to four dose groups. The test item was administered once daily by oral gavage from Days 6 to 20 post-coitum at doses of 100, 300 and 1000 mg/kg (Groups 2, 3 and 4 respectively). The rats of the control group received the vehicle, propylene glycol, alone. Females were checked daily for the presence of clinical signs. Food consumption and body weight were determined at periodic intervals. Formulations prepared on one day during treatment were analyzed for accuracy and homogeneity.
All animals surviving to Day 21 post-coitum were subjected to an examination post-mortem and external, thoracic and abdominal macroscopic findings were recorded. A laparohysterectomy was performed on each surviving female of the groups. The uteri, placentae and ovaries were examined, and the numbers of fetuses, early and late resorptions, total implantations and corpora lutea were recorded. Gravid uterine weights were recorded, and corrected body weights (changes) were calculated. The fetuses were weighed, sexed and examined for external, visceral and skeletal malformations and developmental variations. All live fetuses were euthanized. One half of the fetuses were decapitated and the heads were fixed in Bouin’s fixative; these fetuses were dissected and examined for visceral anomalies. The other one-half of the fetuses were processed and stained with Alizarin Red S for skeletal examinations.
Accuracy and homogeneity of formulations were demonstrated by analyses.
No maternal toxicity was observedin the 100, 300 and 1000 mg/kg groups.
No developmental toxicity was observedin the 100, 300 and 1000 mg/kg groups.
Based on the results in this prenatal developmental toxicity study the maternal and developmental No Observed Adverse Effect Level (NOAEL) for Bismuth trinitrate was established as being at least 1000 mg/kg.
In a study published as an abstract only, it was concluded that no adverse effects of read-across substance, bismuth citrate, upon pre- or post-implantation loss, numbers of viable foetuses or foetal development were apparent in either AHA rats or Dutch rabbits. Rat post-natal development was also unaffected. It is not possible to assess the reliability of this study as it is only available as an abstract.
In order to evaluate the potential effects of bismuth trinitrate on prenatal development, a prenatal developmental toxicity study (OECD Guideline 414) is proposed using read-across substance, bismuth subnitrate.
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