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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-699-4 | CAS number: 68-96-2
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Additional information
- the overall negative genotoxicity (in vitro and in vivo)
- its low gestagenic potency
- only slight findings at the high dose (1000 mg/kg; slight effects on kidney) in the combined repeated dose and reproductive toxicity study in rats
Due to the overall conclusion of a negative genotoxic potential for Hydroxyprogesterone a potential for a genotoxic carcinogenicity is not expected. However, it should be kept in mind that sex steroids might stimulate the growth of hormone-dependent tissues and tumors. Regarding TRGS 905 (version 12.03.20202 and the justification for Steroid Hormones, version Sept 1999) OHPA is classified as gestagen (group 7) with carcinogenicity Cat. 2 (CLP), but Hydroxyprogesterone is not listed in the regulation, due to the low pharmacological activity
No studies with exogenous Hydroxyprogesterone were conducted to assess the carcinogenicity potential. Observational studies suggesting some degree of association between higher serum 17-hydroxyprogesterone in pregnancy and a woman’s future risk of ovarian cancer exhibit several limitations e.g. only a single time-point of measurement and largely varying lag times in follow-up. Consequently, it was concluded that more data are needed to determine sufficiently whether certain blood hormone levels measured in pregnancy are predictive of future cancer risk (Iqbal, 2019).
Therefore, due to
no indication for a carcinogenic potential of Hydroxyprogesterone can be concluded.
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.
