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EC number: 695-757-2 | CAS number: 897381-19-0
- 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:
- 6/6/2013-6/12/2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted at a GLP accredited laboratory
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Oxirane, 2-ethyl-, homopolymer, ether with 1,2-ethanediol (2:1)
- IUPAC Name:
- Oxirane, 2-ethyl-, homopolymer, ether with 1,2-ethanediol (2:1)
- Reference substance name:
- 1-[2-(2-hydroxybutoxy)ethoxy]butan-2-ol
- EC Number:
- 695-757-2
- Cas Number:
- 897381-19-0
- Molecular formula:
- UVCB
- IUPAC Name:
- 1-[2-(2-hydroxybutoxy)ethoxy]butan-2-ol
- Test material form:
- other: liquid
- Details on test material:
- Clear light yellow liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- 170-217 grams body weight range rats.
Lighting: 12 h light/ 12 h dark
Room temp: 17-23
Relative Humiditiy: 22 to 84 %
Food: Animals were fasted overnight prior to dose administration. Food was returned to the animals 30 mins after dosing.
Water: Water was available ad libitum.
Acclimation: A min of 5 days prior to dosing
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test article was adminsterednon D1 to each rat as a single dose via oral gavage. Animals were fasted overnight prior to dose adminstration. Each animal received its designated dose based on fasted bw. Dose volume was 2 mL/kg and was based on the relative density of 1.0 g/mL as per the MSDS.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 female rats with 170-217 grams body weight range.
- Details on study design:
- Initally one rat was dosed at 2000 mg/kg. No mortality was observed, and in accordance with the guideline the study continued with the dosing of another 4 females at 2000 mg/kg. Mortality checks were made at least once daily. Clinical observations were recorded prior to dosing, as well as at 30 mins, 4 h post dose, and daily thereafter through D15. BW were recorded on the day of dosing, and on D8 and D15.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- For the dose of 2000 mg/kg, no mortality was observed in any of the animals.
- Clinical signs:
- other: Animal 3381 exhibited clinical signs of abnormal gait and stance piloerection, decreased activity, and decreased body tone at 30 minutes post dose.Clinical signs of prostration and labored respiration were observed in this animal at 4 hours post dose. Ani
- Gross pathology:
- Terminal necropsy revealed no visible lesions in the any of the animals receiving test article at 2000 mg/kg.
Any other information on results incl. tables
No biologically significant effect was seen on body weights on Days 8 or 15. No mortality was observed in the initial animal (3381) dosed during the limit study at 2000 mg/kg. Animal 3381 exhibited clinical signs of abnormal gait and stance piloerection, decreased activity, and decreased body tone at 30 minutes post dose. Clinical signs of prostration and labored respiration were observed in this animal at 4 hours post dose. Animal 3381 appeared normal from Days 2-15. Terminal necropsy of animal 3381 revealed no visible lesions.
No mortality was observed when the additional four animals (3382-3385) were added to the study at 2000 mg/kg. Animal 3382 exhibited clinical signs of prostration and labored breathing 30 minutes post dose and at 4 hours post dose exhibited abnormal gait and stance decreased body tones piloerection, decreased activity.
Animal 3383 exhibited clinical signs of abnormal gait and stance, decreased body tone, decreased activity and piloerection 30 minutes post dose and at 4 hours post dose.
Animals 3384 and 3385 exhibited clinical signs of abnormal gait and stance, decreased body tone and piloerection 30 minutes post dose and at 4 hours post dose. Animals 3382-3385 appeared normal from Days 2-15. Terminal necropsy of the animals revealed no visible lesions.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Based on the results of this study, the oral LD50 for PD 206 in rats was estimated to be greater than 2000 mg/kg and hence PD 206 is not classified based upon the EU CLP and DSD.
- Executive summary:
The purpose of this study was to assess the toxicity of the test article following a single oral dose to the rat. Initially one female Sprague Dawley rat was dosed at 2000 mg/kg. No mortality was observed at 2000 mg/kg and in accordance with the guideline the study continued with the dosing of another four females at 2000 mg/kg. Mortality checks were made at least once daily. Clinical observations were recorded prior to dosing, as well as at 30 minutes. 4 hours post-dose, and daily thereafter through Day 15. Body weights were recorded on the day of dosing (Day 1), and on Days 8 and 15. All rats were euthanized by C02 asphyxiation and necropsied on Day 15.
For the dose of 2000 mg/kg, no mortality was observed in any of the animals. Based on the results of this study, the oral LD50 for PD 206 in rats was estimated to be greater than 2000 mg / kg.
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