Registration Dossier
Registration Dossier
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EC number: 806-795-8 | CAS number: 909419-73-4
Carcinogenicity
Administrative data
Description of key information
The results of two-year mouse and rat carcinogenicity studies were taken to the Carcinogenicity Assessment Committee - Executive Committee (CAC-EC) on April 28, 1998. The report of that meeting is not yet available. It was agreed that both studies were adequate and that there were dose-related increases in female mice in pituitary gland adenomas and carcinomas and mammary gland adenocarcinomas. The doses at which these tumors occurred were equal to or greater than the maximum recommended human dose of 200 mg/day on a surface area basis. A no-effect dose was not established. There was no increase in tumors in male mice or either sex of rat. Tumors of the mammary and pituitary glands (and also of the endocrine pancreas, not increased in these studies with ziprasidone) have been increased in studies with other drugs of this class and are thought to be mediated by chronic exposure to elevated prolactin levels in rodents. The relevance to humans is unknown.
Overall, available data are inconclusive for the classification of the substance.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
The relevance to humans is unknown.
Justification for classification or non-classification
Tumors of the mammary and pituitary glands (and also of the endocrine pancreas, not increased in these studies with ziprasidone) have been increased in studies with other drugs of this class and are thought to be mediated by chronic exposure to elevated prolactin levels in rodents. The relevance to humans is unknown.
Overall, available data are inconclusive for the classification of the substance.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.
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