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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22nd November 1988 to 25th November 1988
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- The testing using the guinea pig maximisation test protocol was completed on 25 November 1988. The LLNA 429 was not formally adopted by the OECD until 22 July 2010.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
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
- Specific details on test material used for the study:
- Composition:
99.2% L-654,969, 0.2% lovastatin ammonium salt, 0.2% triol
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: A. Smith, Warlingham, Surrey, England
Animals were acclimatised to laboratory conditions. The rabbits were housed in metal cages with perforated floors. Each animal was identified by a numbered aluminium tag placed through the edge of one ear.
Temperature: 19oC
Humidity: 30-70%
Light sequence: 12 hour light / 12 hour dark
Food: SDS Standard Rabbit Diet
Water: ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Test substance was applied under a gauze pad moistened with 0.5ml distilled water
- Controls:
- no
- Amount / concentration applied:
- 0.5g moistened with 0.5ml water
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 days
- Number of animals:
- 3
- Details on study design:
- 0.5g of the test item moistened with 0.5ml water was applied to a gauze patch (2.5cm). The treated patch was occluded with elastic adhesive dressing. Patches were removed after 4 hours. The residual test item was gently wiped off with water.
The skin sites were examined 1, 2, 3 and 4 days after removal of patches for signs of skin reaction and symptoms. Dermal reactions for erythema /eschar or oedema of test sites of each animal were scored and recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single, semi-occlusive application of L-654,969 to intact rabbit skin for four hours elicited no dermal irritation.
The test substance does not require labelling with risk phrase R38 "Irritating to skin". - Executive summary:
The study was performed to assess the acute dermal irritation/corrosion of L-654 969 in New Zealand rabbits. The method was designed to be in accordance with OECD Guidelines 'Acute Dermal Irritation/Corrosion' (404).
Three male rabbits were used for the study. A quantity of 0.5g of the test item was applied to the skin of each animal for an exposure period of 4 hours. Dermal reactions (erythema/eschar and oedema) of test sites were scored at approximately 1, 2, 3 and 4 days after patch removal.
No abnormal signs or symptoms were observed in any animal throuhout the course of the test. The scores of erythema/eschar and oedema for all animals at 1, 2, 3 and 4 days were all 0 after patch removal.
A single, semi-occlusive application of L-654,969 to intact rabbit skin for four hours elicited no dermal irritation. The test substance does not require labelling with risk phrase R38 "Irritating to skin".
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