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EC number: 608-659-1 | CAS number: 31692-85-0
- 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:
- 04 - 25 Oct 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adopted 2002
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[(oxolan-2-yl)methoxy]ethan-1-ol
- EC Number:
- 608-659-1
- Cas Number:
- 31692-85-0
- Molecular formula:
- C5H10O2[C2H4O]n, n = 0, 1, 2, 3, 4, ... (data given for max n of 4)
- IUPAC Name:
- 2-[(oxolan-2-yl)methoxy]ethan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: step 1: 156 - 169 g; step 2: 164 - 178 g
- Fasting period before study: animals were fasted 16 - 19 h prior to administration
- Housing: group-caged in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water, sulphur acidified to a pH value of approx. 2.8, ad libitum (analysis were performed)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: no information provided in the test report
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no information provided in the test report - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females per step (2 steps)
- Control animals:
- no
- Remarks:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of dosing animals were observed for general clinical signs, morbidity and mortality at least once during the first 30 min and with more attention during the first 4 h, then once daily. Body weights were determined on Day 1 prior to dosing, on Day 8 and Day 15.
- Necropsy of survivors performed: yes - Statistics:
- Mean values and standard deviations were calculated for body weights.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Slightly reduced spontaneous activity, moderate piloerection, hunched posture, slow movements, slight ataxia and prone position were observed in all 6 animals during the first 2 days, but vanished afterwards.
- Gross pathology:
- No abnormal morphological findings were observed in any animal.
Any other information on results incl. tables
Table 1: Absolute body weights and body weight gain
Step | Animal No. | Starting dose (mg/kg bw) | Body weight (g) | Body weight gain in comparison to Day 1 (%) | ||
Day 1 | Day 8 | Day 15 | ||||
1 | 1 | 2000 | 168 | 184 | 199 | 18 |
2 | 156 | 185 | 192 | 23 | ||
3 | 169 | 197 | 207 | 22 | ||
2 | 4 | 173 | 191 | 196 | 13 | |
5 | 164 | 181 | 196 | 20 | ||
6 | 178 | 206 | 220 | 24 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- An acute oral toxicity study according to OECD Guideline 423 in rats was performed with the test substance and resulted in a LD50 greater than 2000 mg/kg bw. Thus the test substance does not meet the classification criteria according to Regulation (EC) 1272/2008, and its data are therefore conclusive but not sufficient for classification.
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