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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-370-5 | CAS number: 58-22-0
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Adequacy of study:
- supporting study
Data source
Reference
- Reference Type:
- publication
- Title:
- European Public Assessment Report:Scientific Discussion Regarding Intrinsia (testosterone transdermal system)
- Author:
- EMA
- Year:
- 2 006
Materials and methods
Results and discussion
Applicant's summary and conclusion
- Executive summary:
• Reproduction Toxicity: Extensive data are available on the reproductive and developmental effects of testosterone. Testosterone is a potent androgenic hormone and its effects on developing foetuses are pronounced and thus, developing foetuses should not be exposed to testosterone. Across multiple species, masculinisation of the foetus anatomically and increases in aggressive behaviour, are the end results of exposure to testosterone during neonatal development. A NOEL of 0.1 mg testosterone propionate per rat, administered subcutaneously is reported in the literature. Assuming a rat weight of 300 g, this is a dose of 333 μg/kg/day. For comparison the daily dose of testosterone from the patch is 300 μg. Thus a 50 kg woman would be exposed to 6 μg/kg/day, over 50 fold less than the NOEL in rats. No topical reproductive studies are reported in the literature.
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.
