Registration Dossier
Registration Dossier
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EC number: 404-520-2 | CAS number: 139893-43-9 SIMVASTATIN AMMONIUM SALT
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Adequacy of study:
- other information
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Internal method in accordance with standard operating procedures - Chromosomal aberrations in Mouse Bone Marrow
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ammonium 7-(2,6-dimethyl-8-(2,2-dimethylbutyryloxy)-1,2,6,7,8,8a-hexahydro-1-naphthyl)-3,5-dihydroxyheptanoate
- EC Number:
- 404-520-2
- EC Name:
- Ammonium 7-(2,6-dimethyl-8-(2,2-dimethylbutyryloxy)-1,2,6,7,8,8a-hexahydro-1-naphthyl)-3,5-dihydroxyheptanoate
- Cas Number:
- 139893-43-9
- Molecular formula:
- C25 H43 O6 N
- IUPAC Name:
- ammonium 7-{8-[(2,2-dimethylbutanoyl)oxy]-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl}-3,5-dihydroxyheptanoate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous methylcellulose
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 667 mg/kg bw/day (nominal)
- Dose / conc.:
- 5 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Dose level Number per group
(mg/kg)
0 12
500 8
1667 8
5000 10 - Control animals:
- yes, concurrent no treatment
Results and discussion
- Details on results:
- There were no deaths. Ptosis and decreased activity were observed in 2 animals from the 6-hour 5000mg/kg group, 1 animal from the 24-hour 5000 mg/kg group and 2 animals from the 6-hour 1667 mg/kg group.
Mitotic index: No effect of test compound on mitotic index at any dose level and at any time interval.
Any other information on results incl. tables
Negative
Applicant's summary and conclusion
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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