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EC number: 203-419-9 | CAS number: 106-65-0
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 25,2010 to March 16,2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Dimethyl succinate
- EC Number:
- 203-419-9
- EC Name:
- Dimethyl succinate
- Cas Number:
- 106-65-0
- Molecular formula:
- C6H10O4
- IUPAC Name:
- dimethyl succinate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot No.of test material: T14B208335
- Production date: 30 Nov 2008
- Expiration date of the lot/batch: 31 December 2010
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy S.r.l., 33049 San Pietro al Natisone (UD), Italy
- Age at study initiation: 6 to 8 weeks old
- Weight at study initiation: 176 to 200 grams
- Housing: Polycarbonate cages measuring 42.5x26.6x18 cm with stainless steel mesh lid and floor.
- No. of animals/cage: Individually caged (both during acclimatisation and study)
- Cage tray control: Daily inspected and changed as necessary (at least 3 times/week)
- Diet:4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy) , ad libitum throughout the study
- Water :drinking water supplied to each cage via a water bottle , ad libitum.
- Acclimation period: At least 5 days
- Veterinary health check: After arrival
- Choise of species:The Sprague Dawley SD rat was used, being the species and strain of choice because it is accepted by many regulatory authorities and there is ample experience and background data on this species and strain.
- Choice of the route: The route of administration is a potential route of exposure during manufacturing, handling or use of the substance.
- Room lighting: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
- Air changes : Approximately 15 to 25 air changes per hour
- Temperature range:22°C ± 2°C
- Relative humidity range: 55% ± 15%
Actual conditions were monitored, recorded and the records retained. No relevant deviations occurred.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Exposure time :24 hours
Washing procedure:After exposure, the adhesive bandage and gauze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water. - Duration of exposure:
- 24 hours
- Doses:
- single dose at level of 2000/mg/kg bw
- No. of animals per sex per dose:
- 5 animals /sex/dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Allocation (Day-1), Days 1, 8 and 15
- Necropsy of survivors performed: yes
- Clinical signs: controlled on the Day of dosing (on dosing, approximately 1, 2 and 4 hours after dosing). Daily thereafter (14 days).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred and no clinical signs were observed in male or female animals during the observation period.
- Clinical signs:
- other: No clinical signs were observed in male or female animals during the observation period.
- Gross pathology:
- No abnormalities were found at necropsy examination performed on all animals at termination of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No mortality occurred following dosing and no signs of toxicity were observed.
These results indicate that the test item, Dimethyl Succinate (DMS), has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg. - Executive summary:
Acute dermal toxicity has been investigated according to OECD/EU test methods. No mortality occurred and no clinical signs were observed at a limit dose level of 2000 mg/kg, demonstrating the LD50 to be in excess of this value .
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