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EC number: 221-254-0 | CAS number: 3047-32-3
- 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:
- 16th April 1998 to 6th May 1998.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 3-ethyloxetane-3-methanol
- EC Number:
- 221-254-0
- EC Name:
- 3-ethyloxetane-3-methanol
- Cas Number:
- 3047-32-3
- Molecular formula:
- C6H12O2
- IUPAC Name:
- (3-ethyloxetan-3-yl)methanol
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TMP oxetane
-CAS No 3047-32-3
- Physical state: Colourless liquid.
- Analytical purity: No information provided.
- Lot/batch No.: JNS 980121 F 1-3
- Expiration date of the lot/batch: No information provided.
- Storage condition of test material: Stored in a refrigerator at 2 - 8°C in the dark.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Møllegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved.
- Age at study initiation: 6 - 7weeks
- Weight at study initiation: 147 - 172g
- Fasting period before study: Fasted overnight prior to dosing.
- Housing: HOused in groups of 2 or 3 in transparent polycarbonate cages (Macrolon type II) with a floor area of 810cm2. Males and females were grouped separately.
- Diet (e.g. ad libitum): A pelleted complete rodent diet (Altromin 1314) ad libitum.
- Water (e.g. ad libitum): Free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.
IN-LIFE DATES: From: To: Not documented.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Sterile water.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000mg/kg body weight.
- Amount of vehicle (if gavage): No information provided.
- Justification for choice of vehicle: No information provided.
- Lot/batch no. (if required): No information provided.
- Purity: No information provided.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight.
DOSAGE PREPARATION (if unusual): No information provided.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No information provided. - Doses:
- Test animals were administered a single dose.
- No. of animals per sex per dose:
- 5 animals per sex per dose.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight was measured on days 1, 8 and 15. Each rat was observed for clinical signs at 1, 3 and 6 hours after administration and daily thereafter for 14 consecutive days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: No additional observations recorded. - Statistics:
- No information provided.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities recorded.
- Clinical signs:
- other: Seven animals showed mild signs of toxicity, including ataxia, piloerection and subdued behaviour from 1 - 3 hours after dosing: piloerection in 7 animals, piloerection and ataxia in 5 animals and subdued behaviour in 2 animals. During the rest of the ob
- Gross pathology:
- No abnormalities were recorded.
- Other findings:
- No additional findings recorded.
Any other information on results incl. tables
Body Weight: Group Mean:
Dose (mg/kg bw) |
Sex |
Day 1 |
Day 2 |
Day 3 |
||||||
Mean |
SD |
N |
Mean |
SD |
N |
Mean |
SD |
N |
||
2000 |
Male |
163.5 |
8.05 |
5 |
219.2 |
13.79 |
5 |
254.6 |
15.5 |
5 |
2000 |
Female |
153.4 |
5.39 |
5 |
176.9 |
7.29 |
5 |
183.8 |
7.40 |
5 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, the oral LD50 in rats was found to be above 2000mg TMP oxetane/kg body weight.
- Executive summary:
The acute oral toxicity in rats was determined in accordance with OECD Guideline 420 and EEC Guideline B.1.bis "Acute Toxicity (Oral). The study was carried out with one group consisting of five male and five female rats given a dose of 2000 mg TMP oxetane/kg body weight. All animals survived the treatment. Seven animals showed mild signs of toxicity, including ataxia, piloerection and subdued behaviour from 1 - 3 hours after dosing: piloerection in 7 animals, piloerection and ataxia in 5 animals and subdued behaviour in 2 animals. During the rest of the observation period, no signs of toxicity were observed. The rats had a normal body weight gain during the study period.
Under the experimental conditions of this study, the oral LD50in rats was found to be above 2000mg TMP oxetane/kg body weight.
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