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EC number: 608-245-0 | CAS number: 28770-01-6
- 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:
- from 2008-01-10 to 2008-01-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2-[2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol
- EC Number:
- 608-245-0
- Cas Number:
- 28770-01-6
- Molecular formula:
- C8H17NO2
- IUPAC Name:
- 2-[2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethan-1-ol
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Sex: females, nulliparous and non-pregnant
- Age at study initiation: eight to twelve weeks
- Weight variation at study initiation: ± 20 % of the initial/mean bodyweight of any previously dosed animal(s)
- Fasting period before and during study: overnight immediately before dosing and for approximately three to four hours after dosing
- Housing: in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 (06:00 to 18:00) / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL for 300 mg/kg bw dose level
- Amount of vehicle: 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: For the purpose of the 300 mg/kg bw dose level the test material was freshly prepared, as required, as a solution in distilled water. For the purpose of the 2000 mg/kg bw dose level the test material was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level. - Doses:
- 300 mg/ kg bw (initial study)
300 mg/ kg bw and 2000 mg/ kg bw (main study) - No. of animals per sex per dose:
- 5 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were recorded 30 min and 1, 2, and 4 hours after dosing and then daily for up to fourteen days. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14 or at death.
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- Dose level: 300 mg/kg bw (Initial animal)
- Mortality: There was no death.
- Clinical Observations: No signs of systemic toxicity were noted during the observation period.
- Bodyweight: The animal showed expected gains in bodyweight over the observation period.
- Necropsy: No abnormalities were noted at necropsy.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two animals were found dead three days after dosing and another animal was found dead four days after dosing in the high dose group.
- Clinical signs:
- other: In the high dose group signs of systemic toxicity noted during the observation period were hunched posture, ataxia, pilo-erection, prostration, decreased respiratory rate, laboured respiration and occasional body tremors.
- Body weight:
- lower than 10% body weight loss
- Remarks:
- The surviving animals in the high dose group showed expected gains in bodyweight over the observation period.
- Gross pathology:
- Abnormalities noted at necropsy of the animals that died during the observation period were abnormally red lungs, dark liver, dark kidneys and slight haemorrhage of the gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be in the range of 300 - 2000 mg/kg bodyweight.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the OECD Guidelines for Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose Method" (2001) and Method B1 bis "Acute Toxicity (Oral)" of Commission Directive 2004/73/EC.
Following a sighting test at dose levels of 300 mg/kg bw and 2000 mg/kg bw, a further two groups of four fasted females were given a single oral dose of undiluted test material or the test material as a solution in distilled water, at dose levels of 300 mg/kg or 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Three animals treated at a dose level of 2000 mg/kg bw were found dead three or four days after dosing. There were no signs of systemic toxicity noted in animals treated at a dose level of 300 mg/kg bw. Hunched posture, ataxia, prostration, decreased respiratory rate, laboured respiration, pilo-erection and occasional body tremors were noted in animals treated at a dose level of 2000 mg/kg bw. Surviving animals showed expected gains in bodyweight. Abnormally red lungs, dark liver, dark kidneys and slight haemorrhage of the gastric mucosa were noted at necropsy of animals that died during the observation period. No abnormalities were noted at necropsy of animals that were killed at the end of the observation period. The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be in the range of 300 - 2000 mg/kg bw.
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