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EC number: 404-520-2 | CAS number: 139893-43-9 SIMVASTATIN AMMONIUM SALT
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The substance was negative with metabolic activation and negative without metabolic activation in a In Vitro Ames study
Link to relevant study records
- 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)
- 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
- 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
- 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
- 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)
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
There was no evidence for induction of chromosome aberrations in MK-0733 under the conditions of a In Vivo ChromAb test
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 6th January 1986 to 27th June 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Internal method in accordance with standard operating procedures
- GLP compliance:
- yes
- Type of assay:
- mammalian bone marrow chromosome aberration test
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Mice were sourced from Charles River Breeding Farms, weight range 14 - 27.1 The mice were housed 4-12 per cage. Each animal was identified by a metal ear tag.
Food: Purina Certified Rodent Chow
Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- Aqueous Methylcellulose
- Duration of treatment / exposure:
- 6, 24 and 48 hours
- Frequency of treatment:
- once
- Dose / conc.:
- 5 000 mg/kg bw/day
- Dose / conc.:
- 1 667 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Positive control(s):
- Mitomycin C
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- Bone marrow was harvested in pre-warmed Hank's Balanced Salt Solution. Bone marrow cells were treated with a hypotonic solution of potassium chloride in water and is fixed in freshly prepared absolute methanol : glacial acetic acid (3:1).
Fixed cells were dropped onto clean wet slides and allowed to dry. All slides were stained with Giemsa and coverslips applied. - Evaluation criteria:
- For each mouse the following quantities were calculated:
% mitotic cells
Total aberrant cells
% aberrant cells
Total aberrants
frequency of aberrant/cell - Statistics:
- Adjusted trend P-value
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- There was no evidence for induction of chromosome aberrations in MK-0733 under the conditions of this test
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
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