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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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Guinea Pig
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26th January 1988 to 20th February 1988
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The testing using the guinea pig maximisation test protocol was completed on 20 February 1988. The LLNA 429 was not formally adopted by the OECD until 22 July 2010.
- Specific details on test material used for the study:
- Composition:
98.7% L-654,969, 0.6% lovastatin ammonium salt, 0.2% triol. - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Guinea pigs were sourced from D. Hall, New Church, Staffordshire, England, weight range 386 - 482g. The animals were acclimatised to laboratory conditions. The guinea pigs were housed in suspended cages with wire mesh floors in Building R17 Room 5. Each animal was identified by ear tattoo.
Temperature: 21oC
Humidity: 30 - 70%
Light sequence: 12 hour light / 12 hour dark
Food: Vitamin C enriched Guinea Pig diet FD1 (Special Services Ltd)
Water: ad libitum - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Freund's Complete Adjuvant for intradermal
- Remarks:
- Water for epicutaneous
- Concentration / amount:
- Intradermal injection: 0.25% w/w;
topical application, 20% w/w, in distilled water. - Day(s)/duration:
- Intradermal: 7 days Epicutaneous: 48 hours
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 0.2ml
- Day(s)/duration:
- 3
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- Animals were randomly assigned to two groups (control and treated). There were 10 animals in the control group and 20 animals in the treated group.
Induction phase
An area of dorsal skin on the scapular region of the guinea pigs was clipped free of hair prior to each induction (approximately 4cm x 6cm). Three pairs of intradermal injections were made simultaneously into this area:
1) Freund's Complete Adjuvant diluted with an equal amount of water for irrigation
2) Test article 0.25% w/w in water for irrigation
3) Test article 0.25% w/w in 50:50 mixture Freund's Complete Adjuvant with water irrigation.
One week after injections, the area was clipped free of hair. A patch of Whatman No. 3 paper (2cm x 4cm) was saturated with test item (20% w/w in distilled water). The patch was placed on the skin and covered with a length of impermeable plastic adhesive tape. This was firmly secured by elastic adhesive bandage and left in place for 48 hours. Control animals were treated similarly to test animals with the exception that the test article was omitted.
Challenge phase
The left flanks of the guinea pigs were clipped free of hair. A patch of Whatman No. 3 paper (2cm x 2cm) was saturated with 0.2ml test item (10% w/w in distilled water). The patch was placed on the skin and covered with a length of impermeable plastic adhesive tape. This was firmly secured by elastic adhesive bandage and left in place for 24 hours.
Observations
Observations were made 24, 48, and 72 hours after the patch was removed.
Erythema and oedma scores were recorded.
Animals were weighed at the start and at conclusion of the study. - Challenge controls:
- 10 animals
- Positive control substance(s):
- no
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.25% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse effect observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.25 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse effect observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.25% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse effect observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Freud's Treated controls
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.1 ml Freud's complete adjuvant and water 50:50
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article did not produce evidence of delayed contact hypersensitivity. L654, 969 does not require labelling with the risk phrase R43 'may cause skin sensitisation by skin contact' as described in the EEC Directive 67/548/EEC Part II (D)
- Executive summary:
The study was designed to determine the potential for L-654,969, to elicit a skin sensitisation reaction. The method was designed to be meet OECD Guideline 406 (Skin sensitisation).
Thirty animals were used in the study, which included one control group (10 animals) and one treated group (20 animals). In the induction phase, three pairs of intradermal injections were made simultaneously
1) Freund's Complete Adjuvant diluted with an equal amount of water for irrigation
2) Test article 0.25% w/w in water for irrigation
3) Test article 0.25% w/w in 50:50 mixture Freund's Complete Adjuvant with water irrigation.
In the challenge phase, 0.2ml test item (10% w/w in distilled water) was applied to the left flank of each animal in the control and treated group. 24, 48 and 72 hours after patch removal in the challenge group, the skin reactions were observed and scored. Individual animal body weights were recorded at the start and conclusion of the study.Mortality: There were no deaths or moribund during the test.
The test article did not produce evidence of delayed contact hypersensitivity.
L654, 969 does not require labelling or classification was per EC 1272/2008
Reference
Maximum concentration not causing irritating effects in preliminary test: 10 %
Signs of irritation during induction: Not recorded
Evidence of sensitisation of each challenge concentration: 0/20
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No effects were seen in a OECD 406 Guinea Pig Maximisation study
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