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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
Description of key information
The LD50 for Oral toxicity is greater than 2000mg/kg, the substance does meet the GHS classification criteria
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2nd December 1988 to 20th January 198
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Composition:
99.2% L-654,969, 0.2% lovastatin ammonium salt, 0.2% triol - Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were sourced from Charles River France, weight range 138 - 155g and 4 - 6 weeks old. The animals were acclimatised to the laboratory conditions for 15 days prior to the test. The rats were allocated to cages within the treatment groups in Building R14 Room 6. They were housed in groups of up to 5 rats of the same sex in metal cages. Each animal was identified by cage number and ear punching.
Temperature: 20-22oC
Humidity: 66%
Light sequence: 12 hour light / 12 hour dark
Food: Standard Rodent diet (Labsure LAD 1)
Water: ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- 20 ml/kg
- Doses:
- 1260, 2000, 2500, 3200 mg/kg
- No. of animals per sex per dose:
- 5 x males, 5 x females
- Control animals:
- not specified
- Details on study design:
- Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (6 hours), On subsequent days the animals were observed once in the morning and once at the end of the experimental day. Clinical signs were recorded at each observation.
Animals surviving treatment were observed for 5 and 14 days after dosing. Time of death, clinical observations and body weights were recorded. All animals were subject to gross necroscopy. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 400 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 2 100 - <= 2 700
- Remarks on result:
- other: Slope of the mortality curve: 13.8
- Mortality:
- Male: 1260 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Male: 2500 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 3200 mg/kg bw; Number of animals: 5; Number of deaths: 5
Female: 1260 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 2500 mg/kg bw; Number of animals: 5; Number of deaths: 5
Female: 3200 mg/kg bw; Number of animals: 5; Number of deaths: 5 - Clinical signs:
- other: Signs of toxicity related to dose levels: Deaths occurred from within 2 hours of dosing until day 10. Pilo-erection was observed in all animals within 10 minutes of dosing, accompanied by: hunched posture, increased salivation, pallor of the extremities,
- Gross pathology:
- Congested blood vessels of the stomach were observed postmortem in one female dosed at 2.0g/kg, two females dosed at 2.5 g/kg and two males and one female dosed at 3.2 g/kg. Autoposy of rats that died revealed no macroscopic abnormalities.
Terminal autopsy findings were normal. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- It is notable that deaths in this test occurred over a prolonged period and that the clinical symtoms persisted, indicating that the substance has a rather prolonged toxic action in the rat. However, since the LD50 is greater than 2000mg/kg, the substance does not require labelling with risk phrase R22 "Harmful if swallowed".
- Executive summary:
Objective
The study was performed to assess the acute oral toxicity of the test substance following a single oral dose. The method met OECD Guidelines for the Testing of Chemicals - Acute Oral Toxicity (401).Method
A preliminary test was carried out to establish a dosing regime for the main study. Groups of two male and 2 female rats were dosed at 1000 and 2500 mg/kg. Based on the results, further groups of 5 male and 5 female rats were dosed at 1260, 2000, 2500 and 3200 mg/kg. Clinical observations and body weights were monitored during the study. All animals were subject to gross necroscopy.There were deaths amongst male rats dosed at 2000 and 3200 mg /kg and amongst females dosed at 2000mg /kg and above. Deaths occured from within 2 hours of dosing until Day 10.
Conclusions: Since the LD50 is greater than 2000mg/kg, the substance does not require labelling with risk phrase R22 "Harmful if swallowed".
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Specific details on test material used for the study:
- Composition:
99.2% L-654,969, 0.2% lovastatin ammonium salt, 0.2% triol
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28th November 1988 to 12th December 1988
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Composition:
99.2% L-654,969, 0.2% lovastatin ammonium salt, 0.2% triol - Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were sourced from Charles River France, weight range 220 - 250g and 7 - 10 weeks old. The animals were acclimatised to the laboratory conditions for 11 days prior to the test. The rats were allocated to cages within the treatment groups in Building R14 Room 6. They were housed individually in metal cages. Each animal was identified by cage number and ear punching.
Temperature: 20-22oC
Humidity: 66%
Light sequence: 12 hour light / 12 hour dark
Food: Standard Rodent diet (Labsure LAD 1)
Water: ad libitum - Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- 24 hours
- Doses:
- Test substance prepared at a concentration of 50%w/v in distilled water and administered at a vol of 4.0 ml/kg.
One dose - No. of animals per sex per dose:
- 5 x male, 5 x female
- Details on study design:
- One day prior to treatment, hair was removed from the dorso-lumbar region with clippers, Th test substance was applied by spreading it evenly over the prepared skin. The treated area was covered by gauze, held in place with an impermeable dressing encircled firmly around the trunk.
At the end of the 24 hour exposure period, the dressings were carefully removed and the treated skin decontaminated by washing with warm water and blotted dry with absorbent paper.
Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (6 hours), On subsequent days the animals were observed once in the morning and once at the end of the experimental day. Clinical signs were recorded at each observation.
The treated areas of skin examined daily for signs of dermal irritation for 4 days after dosing. Body weights were recorded. All animals were subject to gross necroscopy. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: There were no deaths or signs of systemic reaction to treatment.
- Gross pathology:
- Effects on organs:
Terminal autopsy findings were normal. - Other findings:
- Signs of toxicity (local):
Sites of application showed no irritation reactions or other dermal changes. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- As the LD50 was greater than 2000mg/kg bodyweight, the test substance does not require labelling with Risk Phrase R21 "Harmful in contact with skin".
- Executive summary:
Objective
The study was performed to assess the acute dermal toxicity of the test substance following a single dose. The method met OECD Guidelines for the Testing of Chemicals - Acute Dermal Toxicity (402).Method
A groups of 10 rats (five male and five female) were dosed at 2000 mg/kg. Clinical observations and body weights were monitored during the study. All animals were subject to gross necroscopy.There were no deaths amongst male or female rats dosed at 2000 mg /kg.
Conclusions: Since the LD50 is greater than 2000mg/kg bw, the substance does not require labelling with risk phrase R21 "Harmful in contact with skin".
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 1
Additional information
Justification for classification or non-classification
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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