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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 404-520-2 | CAS number: 139893-43-9 SIMVASTATIN AMMONIUM SALT
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- This test represents the results of two independent studies. 20th June 1985 to 24th June 1985 24th May 1989 to 1st June 1989
- Reliability:
- 1 (reliable without restriction)
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Internal method in accordance with standard operating procedures (see comments).
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
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
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Salmonella typhimurium TA1535, TA97a, TA98 and TA100 E.Coli: WP2, EP2 urvA,
WP2 urvA pKm101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 30 ... 3000 μg/plate
Concentration range in the main test (without metabolic activation): 30 ... 3000 μg/plate - Vehicle / solvent:
- Solvent: Ethanol
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: Hydrazine sulfate
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 3000 μg/plate
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: Salmonella typhimurium TA1535, TA97a, TA98 and TA100 E.Coli: WP2, EP2 urvA, WP2 urvA pKm101
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: Salmonella typhimurium TA1535, TA97a, TA98 and TA100 E.Coli: WP2, EP2 urvA, WP2 urvA pKm101
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
No evidence of mutagenic potential of L-654,969 was observed either in the presence or absence of metabolic activation. - Remarks on result:
- other: Test system: main test (migrated)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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.
