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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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EC number: 700-442-0 | CAS number: 73573-88-3
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: QSAR
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no OECD test method was used
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
Data source
Reference
- Reference Type:
- other: literature review
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- other: not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- 75330-75-5
- EC Number:
- 616-212-7
- Cas Number:
- 75330-75-5
- IUPAC Name:
- 75330-75-5
- Details on test material:
- Lovastatin
Constituent 1
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Repeated dose toxicity
Here, reference is made to human data from clinical use in the treatment of hypercholesterinemia (see Summary of Product Characteristics/SPC for lovastatin, "New class warnings for statins", and review article "Lovastatin for hypercholesterinemia").
Myositis/Rhabdomyolysis (reversible/irreversible):
Lovastatin occasionally causes myopathymanifested as muscle pain, tenderness or weakness with creatine kinase above 10 fold the upper limit of normal. Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred.
Hepatopathia (reversible)
Histologically verified inflammation and increase of transaminases have been observed in some patients.
Impairment of sexual function
Induction of Diabetes Mellitus
So you may consider classifying mevastatin for target organ toxicity (Cat. 1, toxicity on the muscoskeletal system).
Repeated dose toxicity
Rhabdomyolysis was observed in rare cases in patients treated with mevastatin or lovastatin.
Consider classification as repeated dose Cat. 1/2, hazard statements H372: Causes damage to organs through prolonged or repeated exposure/H373: May cause damage to organs through prolonged or repeated exposure.
IST FDA v3b Maximum Recommended Daily Dose 0.00504 mmol, Confidence 0.163
Applicant's summary and conclusion
- Conclusions:
- Repeated dose toxicity
Here, reference is made to human data from clinical use in the treatment of hypercholesterinemia (see Summary of Product Characteristics/SPC for lovastatin, "New class warnings for statins", and review article "Lovastatin for hypercholesterinemia").
Myositis/Rhabdomyolysis (reversible/irreversible):
Lovastatin occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase above 10 fold the upper limit of normal. Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred.
Hepatopathia (reversible)
Histologically verified inflammation and increase of transaminases have been observed in some patients.
Impairment of sexual function
Induction of Diabetes Mellitus
So you may consider classifying mevastatin for target organ toxicity (Cat. 1, toxicity on the muscoskeletal system).
Repeated dose toxicity
Rhabdomyolysis was observed in rare cases in patients treated with mevastatin or lovastatin.
Consider classification as repeated dose Cat. 2, hazard statements H373: May cause damage to organs through prolonged or repeated exposure.
IST FDA v3b Maximum Recommended Daily Dose 0.00504 mmol, Confidence 0.163 - Executive summary:
Repeated dose toxicity
Rhabdomyolysis was observed in rare cases in patients treated with mevastatin or lovastatin.
Consider classification as repeated dose Cat.2, hazard statements H373: May cause damage to organs through prolonged or repeated exposure.
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.
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