Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 692-722-3 | CAS number: 835621-07-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Toxicity to reproduction: other studies
Additional information
A potential of BAY 73-4506 to adversely affect male and female reproduction has to be considered based on morphological changes in the testes, ovaries and the uterus seen after repeated dosing in rats and dogs. In the absence of specific measurements of hormone profiles, the biological significance of the changes in frequency of vulva and mammary complex swelling in the 12-month dog study is uncertain. A potential for effects of BAY 73-4506 on intrauterine development is expected based on the pharmacological mode of action (in particular, influence on neovascularization), and was confirmed in rabbits. Findings in tissue distribution studies in rats performed with BAY 73-4506 indicate a risk to breast-fed children during lactation. In these studies mammary glands showed an approx. 2-fold higher exposure than the maternal blood, suggesting secretion of drug or labeled metabolites with the milk.
Since neither repeated dose toxicity data nor reproductive toxicity data are available for BAY 73-4506 HCl, and based on the observed adverse effects after repeated oral administration of BAY 73-4506 the above mentioned data were used for the classification of BAY 73-4506 HCl. Due to the high structure similarity of the two compounds an identical toxicity profile of BAY 73-4506 and BAY 73-4506 HCl is to be expected. BAY 73-4506 is approved as an oral anticancer drug under the tradename Stivarga®.
Justification for classification or non-classification
Based on the classification of BAY 73-4506 a self classification of BAY 73-4506 HCl according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP) is recommended as follows:
DSD: R61, Repr. Cat. 2 (May cause harm to the unborn child) and R62, Repr. Cat. 3 (Possible risk of impaired fertility)
GHS: Repr. 1B (H360Df: May damage the unborn child, suspected of damaging fertility)
DSD: R64 (May cause harm to breast-fed babies)
GHS: Additional category for effects on or via lactation (H362: May cause harm to breast-fed children)
Additional information
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.
