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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 616-212-7 | CAS number: 75330-75-5
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no OECD method used
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other: not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- (1S,3R,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-methylbutanoate
- EC Number:
- 616-212-7
- Cas Number:
- 75330-75-5
- Molecular formula:
- C24-H36-O5
- IUPAC Name:
- (1S,3R,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl}-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-methylbutanoate
Constituent 1
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Spontaneous testicular degeneration
(e.g., testicular atrophy, decreased spermatogenesis, spermatocytic degeneration
and giant cell formation) was observed in dogs treated with 20 mg/kg/day for one
year, however this effect was poorly reproducible and not dose-dependent (AHFS,
2004; PDR, 2005). It is not clear if fertility was altered in dogs. No effects on
fertility were observed in rats (details not specified).
We suggest classifying lovastatin as Reproductive toxiciy cat 2 , H361: Suspected ofdamaging fertility or the unborn child
Applicant's summary and conclusion
- Conclusions:
- Spontaneous testicular degeneration
(e.g., testicular atrophy, decreased spermatogenesis, spermatocytic degeneration
and giant cell formation) was observed in dogs treated with 20 mg/kg/day for one
year, however this effect was poorly reproducible and not dose-dependent (AHFS,
2004; PDR, 2005). It is not clear if fertility was altered in dogs. No effects on
fertility were observed in rats (details not specified). - Executive summary:
Spontaneous testicular degeneration
(e.g., testicular atrophy, decreased spermatogenesis, spermatocytic degeneration
and giant cell formation) was observed in dogs treated with 20 mg/kg/day for one
year, however this effect was poorly reproducible and not dose-dependent (AHFS,
2004; PDR, 2005). It is not clear if fertility was altered in dogs. No effects on
fertility were observed in rats (details not specified).
We suggest classifying lovastatin as Reproductive toxiciy cat 2 , H361: Suspected ofdamaging fertility or the unborn child
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.
