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EC number: 222-908-8 | CAS number: 3658-77-3
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 October to 04 November 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Non GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- purity of test item not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-hydroxy-2,5-dimethylfuran-2(3H)-one
- EC Number:
- 222-908-8
- EC Name:
- 4-hydroxy-2,5-dimethylfuran-2(3H)-one
- Cas Number:
- 3658-77-3
- Molecular formula:
- C6H8O3
- IUPAC Name:
- 4-hydroxy-2,5-dimethylfuran-3(2H)-one
- Test material form:
- liquid
- Details on test material:
- Physical state: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Company of Calco, Italy.
- Age at receipt: 40 days
- Weight at reeipt: Males: 100-125 g; Females: 75-100 g
- Fasting period before study: Animals were fasted 16 h before the administration of test item.
- Housing: Animals were housed in stainless steel wire grill cages suspended over automatically flushed racks.
- Diet: Pellet-form feed, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature: 22-24 °C
- Humidity: 60 ± 20 %
- Air changes: 15 air changes per hour
- Photoperiod: Subdued natural lighting
IN-LIFE DATES: 18 October to 04 November 1983
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100, 200, 250, 310, 350 and 390 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION
Estimated amounts of the test item were weighed for each dosage and dissolved in a calculated volume of corn oil (Commercial brand: CARAPELLI) so that the concentration of the dosing solution was kept constant for all dosage levels and the amount received by each animal did not exceed 10 mlLkg bw. - Doses:
- Preliminary study: 2000, 3000 and 5000 mg/kg bw
Main study: 1000, 2000, 2500, 3100, 3500 and 3900 mg/kg bw - No. of animals per sex per dose:
- Preliminary study: 1 animal/sex/dose
Main study: 5 animals/sex/dose - Control animals:
- yes
- Remarks:
- corn oil
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Following administration, the animals were observed for mortality and toxic effects twice during the first day and once daily thereafter for 14 days.
- Frequency of weighing: The body weight of the animals was recorded on the day before the final trial, the day of the final trial and on days 1, 2, 4, and 14 after administration.
- Necropsy of survivors performed: Yes; all animals dying during the observation and those killed on day 14 were subjected to gross pathology to detect possible lesions. - Statistics:
- Data was evaluated according to the method of Litchfield and Wilcoxon (1949).
Results and discussion
- Preliminary study:
- Mortality was observed in 1/2, 2/2 and 2/2 animals at 2000, 3000 and 5000 mg/kg bw, respectively.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 320 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 95% confidence limits: 2010 - 2660 mg/kg bw
- Mortality:
- Death occurred within two days after administration in 0, 3, 5, 8, 10 and 10 animals (the mortality percentage was 0, 30, 50, 80, 100 and 100) at 1000, 2000, 2500, 3100, 3500 and 3900 mg/kg bw, respectively.
- Clinical signs:
- other: - All animals displayed listlessness during the initial 24 h after treatment. In those at the higher doses, this lasted up to 48 h. - Some animals also manifested chromodacryorrhea. - For the remaining observation period, no untoward signs were noted amon
- Gross pathology:
- All animals that died during the experiment were found to have gastro-intestinal and pulmonary hemorrhaging and in some cases both were observed.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions, the oral LD50 for test item is 2320 mg/kg bw (95% confidence limits: 2010 - 2660 mg/kg bw) in rats therefore the substance should not be classified according to the Regulation (EC) No. 1272/2008 (CLP). Based on the mortality observed, it should be classified in Category 5 according to the GHS criteria.
- Executive summary:
In an acute oral toxicity study performed similarly to OECD Guideline 401, CD rats (5/sex/dose) were given a single oral (gavage) dose of test item in corn oil at 0, 1000, 2000, 2500, 3100, 3500 and 3900 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. The dose levels selected on the basis of results of preliminary study (2000, 3000 and 5000 mg/kg bw; 1/sex/dose).
All animals displayed listlessness during the initial 24 h after treatment. In those at the higher doses, this lasted up to 48 h. Some animals also manifested chromodacryorrhea. For the remaining observation period, no untoward signs were noted among the survivors. Death occurred within two days after administration in 0, 3, 5, 8, 10 and 10 animals (the mortality percentage was 0, 30, 50, 80, 100 and 100) at 1000, 2000, 2500, 3100, 3500 and 3900 mg/kg bw, respectively. Only a slight body weight loss was observed among the animals at higher dosages (2500 and 3100 mg/kg bw). All animals that died during the experiment were found to have gastro-intestinal and pulmonary hemorrhaging and in some cases both were observed.
The combined LD50: 2320 mg/kg bw (95% confidence limits: 2010 - 2660 mg/kg bw).
Under the test conditions, the oral LD50 for test item is 2320 mg/kg bw (95% confidence limits: 2010 - 2660 mg/kg bw) in rats therefore the substance should not be classified according to the Regulation (EC) No. 1272/2008 (CLP). Based on the mortality observed, it should be classified in Category 5 according to the GHS criteria.
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