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EC number: 433-480-9 | CAS number: 623-53-0
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 March - 19 March 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted in accordance with Japanese MAFF "Good Laboratory Practice Standards for Toxicological Studies" {59 NohSan No. 3850 August 10 1984) and Safepharm Standard Operating Procedures. The method was designed to comply with requirements of the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF), Testing Guidelines for Toxicology Studies, 59 NohSan No. 4200, January 28 1985.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF), Testing Guidelines for Toxicology Studies, 59 NohSan No. 4200, January 28 1985.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 433-480-9
- EC Name:
- -
- Cas Number:
- 623-53-0
- Molecular formula:
- C4H8O3
- IUPAC Name:
- ethyl methyl carbonate
- Details on test material:
- Sponsor's identification: ETHYL METHYL CARBONATE
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.68 - 3.16 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22 °C
- Humidity (%): 44-56%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml unchanged test material
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1 hour and 24, 48 and 72 hours following treatment
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- In order to minimise pain on instillation of the test material, one drop of local anaesthetic "Ophthaine", 0.5% proxymetacaine hydrochloride, E.R. Squibb & Sons Limited, Hounslow, Middlesex, U.K.) was instilled into both eyes of these animals I - 2 minutes before treatment.
SCORING SYSTEM:
A modified version of the system described by Kay J.H. and Calandra J.C., J. Soc. Cosmet. Chem., 1962 13 281-289 was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test material. In addition, the number of rabbits showing a positive effect was recorded.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
- light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 4.8
- Max. score:
- 13
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No corneal effects were noted during the study. Iridial inflammation was noted in one treated eye one hour after treat¬ment. No other iridial effectswere noted. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Minimal conjunctival redness persisted in one treated eye at the 24-hour observation. Treated eyes appeared normal 24 to 48 hours after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material, ETHYL METHYL CARBONATE, produced a maximum group mean score of 4.8 to the rabbit eye according to a modified Kay and Calandra classification system. In addition, positive effects were noted in 1/6 rabbits. based on these data, ETHYL METHYL CARBONATE does not need to be classified according to EU Directive 67/548/EC amended and repealed by EU Regulation No. 1272/2008 and CLP.
- Executive summary:
Purpose
The purpose of this primary eye irritation assay was to provide information on possible health hazards in case of acute eye contact with a test material and serve as a a rational basis for risk assessment to the eye irritating potential of the test item in man.
Study Design
The method was designed to comply with requirements of the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF), Testing Guidelines for Toxicology Studies, 59 NohSan No. 4200, January 28 1985.Results
No corneal effects were noted during the study. Iridial inflammation was noted in one treated eye one hour after treatment. No other iridial effectswere noted. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment.The test material produced a maximum group mean score of 4.8. Minimal conjunctival redness persisted in one treated eye at the 24-hour observation. Treated eyes appeared normal 24 to 48 hours after treatment.
Conclusion
The test material, ETHYL METHYL CARBONATE, produced a maximum group mean score of 4.8 to the rabbit eye according to a modified Kay and Calandra classification system. In addition, positive effects were noted in 1/6 rabbits. based on these data, ETHYL METHYL CARBONATE does not need to be classified according to EU Directive 67/548/EC amended and repealed by EU Regulation No. 1272/2008 and CLP.
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