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EC number: 279-967-8 | CAS number: 82461-14-1
- 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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- No guideline available in the report as the test has been performed prior to the OECD guideline. However it conforms to the OECD 401 guideline.
- Principles of method if other than guideline:
- No guideline available in the report as the test has been performed prior to the OECD guideline. However it conforms to the OECD 401 guideline.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- rel-(2R,4R)-2,4-dimethyl-4-phenyltetrahydrofuran
- Cas Number:
- 99343-90-5
- Molecular formula:
- C12H16O
- IUPAC Name:
- rel-(2R,4R)-2,4-dimethyl-4-phenyltetrahydrofuran
- Reference substance name:
- rel-(2S,4R)-2,4-dimethyl-4-phenyltetrahydrofuran
- Cas Number:
- 99343-91-6
- Molecular formula:
- C12H16O
- IUPAC Name:
- rel-(2S,4R)-2,4-dimethyl-4-phenyltetrahydrofuran
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Name: Rhubafuran
Received on September 9, 1980
Stored in refrigerator until use
Appearance: Light-yellow liquid with a pungent odour
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Cpb:WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS (Cpb:WU; Wistar random)
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands.
- Age at study initiation: young adult
- Weight at study initiation: 92 to 168g for males and 94 to 170g for females.
- Fasting period before study: overnight before dosing
- Housing: in stainless-steel cages with grid-bottom and front
- Diet (e.g. ad libitum): Stock diet.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 °C +/- 1°C, well-ventilated
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Remarks:
- Concentration in vehicle: 50 % (v/v)
- Doses:
- 2381, 2877, 3422, 4117 and 4960 mg test material/kg bw diluted in a solution of propylene glycol (50% v/v).
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- After treatment, the rats received stock diet and tap water ad libitum. They were observed for signs of intoxication during a 14-day period after which autopsies were carried out on the survivors.
The LD50 was calculated according to the method of Weil (Biometrics 8 (1952), 249-263).
Each dose was expressed in milliliter per kg in the study.
Considering the relative density of the substance (0.992 g/cm3), the dose level was converted in miligramme per kg.
Results and discussion
- Preliminary study:
- The dose selection was performed based on a previous study (TNO, 1981b, Tentative determination of the acute oral toxicity of Rhubafurane in rats).
The undiluted test material was administered by gavage to ten males and ten females in one single dose of 4960 mg test material/kg bw.
Out of 10 males and 10 females, 7 males and 7 females succumbed within a 6 hours to 5 days period after treatment. The LD50 is determined to be lower than 4960 mg test material/kg bw.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 980 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Death occurred between 6 hours and 5 days after treatment.
See the table of results below. - Clinical signs:
- other: Within a few hours after dosing the rats showed sedation and signs of ataxia. Later on encrustations around eyes and nostrils, signs of emaciation and coma were frequently observed. Survivors recovered gradually and looked quite healthy again at the end o
- Gross pathology:
- Macroscopic examination of the survivors at autopsy did not reveal any treatment-related gross alterations.
Any other information on results incl. tables
Table 7.2.1/01. Dose applied and mortality results
Dose | Mortality | ||
Test material | Number | % | |
(mg/kg) | males | females | |
2381 | 0/5 | 0/5 | 0 |
2877 | 1/5 | 1/5 | 20 |
3422 | 1/5 | 2/5 | 30 |
4117 | 2/5 | 4/5 | 60 |
4960 | 4/5 | 3/5 | 70 |
The LD50 of the test substance to male/female Wistar rats was found to be 3980 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions of this study, the oral LD50 of the test substance to male/female Wistar rats was estimated to be equal to 3980 mg/kg bw.
Therefore, the test material is classified Category 5 (H303: May be harmful if swallowed) according to the GHS, as the LD50 value is comprised between 2000 and 5000 mg/kg bw, and is not classified according to the Regulation (EC) No. 1272/2008 (CLP). - Executive summary:
In an acute oral toxicity study equivalent to the OECD test guideline No. 401, five males and five females Wistar (Cpb:WU) rats per dose were given the following dose level as a solution in propylene glycol (50% v/v): 2381, 2877, 3422, 4117 and 4960 mg test material/kg bw.
Mortality and clinical signs were monitored during the study, and all surviving animals were subjected to gross necropsy after a 14-day observation period.
Death occurred between 6 hours and 5 days after treatment. Within a few hours after dosing the rats showed sedation and signs of ataxia. Later on encrustations around eyes and nostrils, signs of emaciation and coma were frequently observed. Survivors recovered gradually and looked quite healthy again at the end of the observation period. Macroscopic examination of the survivors at autopsy did not reveal any treatment-related gross alterations.
Oral LD50 Males/Females = 3980 mg/kg bw (4.02 mL/kg bw)
The LD50 of the test substance to male/female Wistar rats was found to be 4.02 ml/kg bw, with a 95% confidence limits between 3.34 to 4.85.
Considering the relative density of the substance, the oral LD50 of the test substance to male/female Wistar rats was estimated to be equal to 3980 mg/kg bw.Therefore, the test material is classified Category 5 (H303: May be harmful if swallowed) according to the GHS, as the LD50 value is comprised between 2000 and 5000 mg/kg bw, and is not classified according to the Regulation (EC) No. 1272/2008 (CLP).
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