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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
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"): MEC
Description: clear colourless liquid
Batch number: 00925
Date received: 11.27.2000
Storage conditions: stored at room temperature in the dark until 01.16.2001, thereafter 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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Twenty-one male albino Dunkin Hartley guinea pigs were supplied by David Hall Limited, Burton-on-Trent, Staffordshire, UK.
animal weight at start of study: 300 - 328 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- Test material selected for the intradermal induction stage of the main study was 1 % (v/v) in arachis oil; undiluted test material was selected for the main study topical induction; concentrations of the test material selected for the main study topical challenge were 50 % and 25 % (v/v) in arachis oil.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Test material selected for the intradermal induction stage of the main study was 1 % (v/v) in arachis oil; undiluted test material was selected for the main study topical induction; concentrations of the test material selected for the main study topical challenge were 50 % and 25 % (v/v) in arachis oil.
- No. of animals per dose:
- 2 for intradermal injections (0.1 mL/injection site)
2 for Topical Induction
2 for Topical challenge
15 for main study (10 test animals, 5 control animals)
Results and discussion
In vivo (non-LLNA)
Results
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % to 50 % (v/v) test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: test group. Dose level: 25 % to 50 % (v/v) test material. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Skin reactions noted at the challenge sites of the test group animals will be attributed to skin sensitisation, providing that the reactions of equal severity are not seen at the corresponding challenge sites of the control group animals. If skin reactions are seen at the challenge sites of the control group animals, these will be due ro skin irritation, and therefore only skin reactions of greater severity in the test group animals will be attributed to skin sensitisation.
Intradermal induction: Discrete or patchy to moderate and confluent erythema was noted at the induction sites of the test group animals with discrete or patchy erythema noted at the induction sites of control group animals.
Topical induction: Discrete or patchy to moderate and confluent erythema was noted at the induction sites of test and control group animals one hour after dressing removal with discrete or patchy erythema persisting 24 hours after patch removal. Bleeding from the intradermal injection sites was also noted in test and control group animals after dressing removal.
Topical Challenge: 50 % v/v in Arachis Oil BP, no skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 -hour observations. 25 % v/v in Arachis Oil BP, no skin reactions were noted at the challenge sites of the test control group animals at the 24 or 48 -hour observations.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: as stated in study report
- Conclusions:
- The test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin under the conditions of the test. The test material did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commissions Directive 93/21/EEC. No classification according to the classification criteria in REGULATION (EC) No 1272/2008, Chapter 3.4. Respiratory or skin sensitisation (table 3.4.2).
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