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EC number: 605-076-4 | CAS number: 156928-09-5
- 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:
- 2007-02-21 to 2007-03-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- : certificate issued by Swiss GLP Monitoring Authorities
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-ol
- EC Number:
- 605-076-4
- Cas Number:
- 156928-09-5
- Molecular formula:
- C6H10O3
- IUPAC Name:
- (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-ol
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study reports): T002675, TIC876
- Physical state: liquid
- Appearance: colorless to yellowish liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Name of test material (as cited in study report): T002675 (TIC876)
- Physical state: liquid, colorless to yellowish
- Analytical purity: 97.76%
- Lot/batch No.: 603T-1
- Expiration date of the lot/batch: 2007-12-19
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (range of 20 +/- 5 °C), light protected
- Stability under test conditions: unknown in PEG 300, is excluded from teh statement of compliance
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The dose formulations were made shortly before each dosing occasion using a magnetic stirrer as homogenizer. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
Test animals
- Species:
- rat
- Strain:
- other: HanRcc: Wist (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd., Laboratory Animal Services CH-4414 Füllinsdorf / Switzerland
- Age when treated: 11 weeks
- Weight at study initiation (day 1): 178.1-191.7 g
- Fasting period before study: approximately 18 to 19 hours, access to water was permitted. Food was provided again approximately 2 hours after dosing.
- Housing: in groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 89/06, ad libitum
- Water (e.g. ad libitum): community tap water from Füllinsdorf, ad libitum
- Acclimation period: 2007-02-21 to 2007-02-27 (females, 2000 mg/kg); 2007-02-23 to 2007-03-05 (females, 300 mg/kg); 2007-03-07 to 2007-03-13 (females, 300 mg/kg)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12, music during light period
IN-LIFE DATES: From: 2007-02-28 To: 2007-03-03 (females, 2000 mg/kg); 2007-03-06 To: 2007-03-20 (females, 300 mg/kg); 2007-03-14 To: 2007-03-28 (females, 300 mg/kg)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 or 0.03 g/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.
- Lot/batch no. (if required): 130022563006152
MAXIMUM DOSE VOLUME APPLIED:
- 10 mL/kg bw - Doses:
- 2000 mg/kg bw or 300 mg/kg bw
- No. of animals per sex per dose:
- 3 females/ group,
2 groups at 300 mg/kg bw (6 total)
1 group at 2000 mg/kg bw (3 total) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded; all animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15; mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15;
- Body weights were recorded on day 1 (prior to administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Remarks on result:
- other: no data on confidence level
- Mortality:
- All the animals treated with 2000 mg/kg died spontaneously 2 or 3 days after treatment. No deaths occurred in the animals treated with 300 mg/kg during the study.
- Clinical signs:
- other: The animals treated with 2000 mg/kg all showed a slight to moderate ruffled fur and a slight to moderate sedation from the 30-minute reading until their respective deaths. The animals also had closed eyes between 30 minutes after treatment and the 3-hour
- Gross pathology:
- One animal from the 2000 mg/kg treatment group which died spontaneously showed a distended stomach, and the jejunum and ileum were empty. No other macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the test substance after single oral administration to female rats, observed over a period of 14 days was greater than 300 mg/kg bw and less than 2000 mg/kg bw.
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