Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Based on in vivo eye and skin irritation studies the substance is not considered to be irritating to the eye or the skin
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- 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
- Specific details on test material used for the study:
- Composition:
99.2% L-654,969, 0.2% lovastatin ammonium salt, 0.2% triol - 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 - 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. - 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)
- 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".
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29th November 1988 to 13th December 1988
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- 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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 45mg
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 1 hour, 1, 2, 3, 4 and 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Eye Examination before Testing
The eyes of each animal were examined to ensure that there was no pre-exisitng corneal damage or conjunctival inflammation.
Administration Method
0.45mg of test item was placed into the everted lid of one eye of each animal. after gently pulling the lower lid away from the eyeball. The lids were gently held together for approximately one second in order to prevent loss of the material. The other eye remained untreated and served as a control.
Observation
Examination of the eye was made 1 hour after administration of the test item. All treated eyes were examined at approximately 1, 2, 3, 4, and 7 days after administration. - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: other: Max. duration: 7 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: other: Max. duration: 3 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: other: Max. duration: 4 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A corneal opacity was observed in one animal 3 and 4 days after instillation only. A diffuse crimson-red colouration of the conjunctivae was observed in two animals. Mild conjunctival reactions were observed in the remaining animal.
All eyes had returned to normal by day 7. The substance does not require labelling with risk phrase R36 "Irritating to eyes". - Executive summary:
The study was performed to assess the acute eye irritation/corrosion of L654 969 in New Zealand rabbits. The method was designed to be in accordance with the OECD Guidelines 'Acute Eye Irritation/Corrosion' (405).
Three male rabbits were used for the study. Each animal was administered 0.45mg of the test item in one eye. The untreated eye served as the control. The rabbits were observed and recorded for initial reaction after 1 hour, then 1, 2, 3, 4, and 7 days after administration. Ocular lesions were scored for treated eyes.
A corneal opacity was observed in one animal 3 and 4 days after instillation only. A diffuse crimson-red colouration of the conjunctivae was observed in two animals. Mild conjunctival reactions were observed in the remaining animal.
All eyes had returned to normal by day 7.Based on the above results in New Zealand rabbits, installation of L654 969 into the rabbit eye elicted a positive response in two or the three animals according to OECD test criteria. The substance does not require labelling with risk phrase R36 "Irritating to eyes".
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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.
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.