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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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: official guideline method, GLP with certificate, good documentation, identity of substance clear but no details on its purity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- 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:
- Test material as stated in study report ("Sponsor's identification"): EMC
Description: Clear colourless liquid
Batch number: 009141
Date received: 11.27.2000
Storage conditions: Room temperature, in the dark until 01.16.2001, thereafter stored at approximately 4 °C in the dark.
Remark of the author of this IUCLID dossier concerning the substance identity:
Every page of the copy of the study report contains an annotation referring to the data sharing agreement in place between the licensee that uses this study report and the data owner. In this data sharing agreement the identity of the chemical substance is specified with "Ethyl Methyl Carbonate - EC No. 433-480-9, CAS Nr. 623-53-0".
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley Crl:CD (registered trademark) (SD) IGS BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Sprague-Dawley Crl:CD(R) (SD) IGS BR strain rats were supplied by Charles River (UK) Ltd, Margate, Kent.
Animal age before study: approximately eight to twelve weeks
Animal weight: 200 - 350 g (one female rat below weight range with 186 g)
Females, specification: nulliparous, non-pregnant
Acclimatisation: minimum 5 d
Animal identification: individually numbered by ear punching and a number written on a colour-coded cage card
Husbandry: groups of five, sex-separated, solid-floor polypropylene cages with stainless steel lids floored with softwood flakes (Datesand Ltd., Cheshire, UK), enriched with wooden chew blocks (B & K Universal Ltd, Grimston, Hull, UK) and cardboard "fun tunnels" (Datesand Ltd., Cheshire, UK). Diet, drinking water, bedding and chew blocks routinely analysed and considered free of any contaminants that could affect the study results. Drinking water and food ad libitum except during exposure period (food: Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK). Temperature 21 +/- 2 °C, relative humidity 55 +/- 15 % (occasional deviations of rel. humidity at beginning of study), air exchange rate minimum 15 times/h, light-darkness times 12h/12h (electric lighting); except during actual exposure to the test substance these conditions were maintained throughout the study.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Details on inhalation exposure:
- Test material was vaporised by injecting it directly into the air supply to the exposure chamber (30 L). The material was contained in a glass syringe located on an infusion pump thus providing a constant supply of test material into the air stream. Immediately after the injection site, the air supply was ducted, via suitable tubing and a conical flask, through a water bath, maintained at approximately 60 °C, to ensure complete vaporisation.
Concentration equilibration prior to beginning of exposures. Homogeneity of the test substance in the chamber was assumed as for chambers of the same design this has been validated (reference to publication).
The rats were held in a restraining tube and only the nose was exposed to the test atmosphere. The oxygen concentration in test atmosphere was at least 19 %, the temperature 21-22°C and the relative humidity 47-55 %. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 20.0 mg/L (target); 20.8 mg/L (nominal); 17.6 mg/L (mean achieved, determined by analytical verification via GC) with standard deviation of 0.42. Concentrations were measured ca. every 1 h during the exposure period.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- A group of ten rats (five males, five females) was exposed to an atmosphere of the test material for a period of four hours. A target concentration of 20.0 mg/L was used for exposure.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 17.6 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: SD 0.42
- Mortality:
- no mortality at a mean achieved atmospheric concentration of 17.6 mg/L of test material.
- Clinical signs:
- other: During exposure, increased respiratory rate and wet fur were noted in all animals and there was an isolated instance of laboured respiration. On removal from the chamber, animals showed increased respiratory rate, hunched posture, pilo-erection and wet fu
- Body weight:
- Normal bodyweight development was noted during the study (measured prior to treatment on day of exposure, on days 7 and 14).
Any other information on results incl. tables
No macroscopic abnormalities were detected at necroscopy.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- No deaths occured in a group of ten rats exposed to a mean achieved atmosphere concentration of 17.6 mg/L. The acute inhalation median lethal concentration (LC50) of MEC, in the Sprague-Dawley Crl:CD(R) (SD) IGS BR strain rat, was therefore greater than 17.6 mg/L.
In REGULATION (EC) No 1272/2008 (16 Dec 2008), 3.1.2. Criteria for classification of substances as acutely toxic, the lowest acute toxicity hazard category falls in the range of LC50 = 10-20 mg/L. As no mortalities occurred at 17.6 mg/L and the substance did not lead to other major signs of toxicity the substance is regarded as not to be classified in any acute toxicity hazard category.
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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