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EC number: 287-836-1 | CAS number: 85586-34-1
- 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:
- December 20th, 2013 to January 24th, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was carried according to OECD guideline 420. A minor deviation (one animal was not observed on day 8) was reported and it is not deemed to affect the scientific validity of the study.
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 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- One animal was not examined on day 8 however since no clinical signs were reported prior and after day 8, this deviation is not deemed to affect the scientific validity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- yes
- Remarks:
- One animal was not examined on day 8 however since no clinical signs were reported prior and after day 8, this deviation is not deemed to affect the scientific validity of the study
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Soybean oil, epoxidized, ether with ethylene glycol
- EC Number:
- 287-836-1
- EC Name:
- Soybean oil, epoxidized, ether with ethylene glycol
- Cas Number:
- 85586-34-1
- Molecular formula:
- UVCB-not applicable
- IUPAC Name:
- Soybean oil, epoxidized, ether with ethylene glycol
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report):Soybean, epoxydised, ether with ethylene glycol
- Physical state: Viscous liquid
- Lot/batch No.: 39595
- Stability under test conditions: The test material is expected to be stable for the duration of the test.
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd.
- Age at study initiation: 8-12 weeks of age
- Weight at study initiation: 168-201 g
- Fasting period before study: Overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing
- Housing: Groups of up to 4 animals in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Food (2014C Teklad Global Rodent diet) ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness
IN-LIFE DATES: From: December 20th, 2012 To: January 24th, 2013
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Remarks:
- Arachis oil BP was used because the test item did not dissolve in water.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL
- Justification for choice of vehicle: The test substance did not dissolve/suspend in water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data regarding toxicity, one animal was administered 300 mg/kg of test substance. In the absense of toxicity at the 300 mg/kg dose level, an additional animal was treated at 2000 mg/kg. Since no toxicity was reported at 2000 mg/kg, 4 additional animals were treated at a dose level of 2000 mg/kg, - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 300 mg/kg: 1 animal
2000 mg/kg: 5 animals - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: clinical observations were made at 30 minutes, 1, 2 and 4 hours after dosing and once daily therafter until study termination. Morbidity and mortality were checked twice daily. Body weights were recorded on the day of administration and on days 7 and 14.
- Necropsy of survivors performed: yes, necropsy was performed at the end of the 14-day observation period.
- Other examinations performed: At necropsy, external examination and opening of the abdominal and thoracic cavities were carried out. The appearance of any macroscopic abnormalities was recorded and no tissues were retained. - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- No mortality was reported at 300 mg/kg bw in one animal. No mortality was recorded in animals treated with a dose level of 2000 mg/kg bw.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality at the Limit Dose
- Mortality:
- There was no mortality at 300 and 2000 mg/kg bw.
- Clinical signs:
- other: No signs of toxicity were reported during the course of the study.
- Gross pathology:
- No abnormalities were reported at necrospy
- Other findings:
- Not applicable
Any other information on results incl. tables
No additional results or findings were reported.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the acute oral median lethal dose (LD50) for female rats is greater than 2000 mg/kg bw.
- Executive summary:
This study was conducted to determine the acute oral toxicity of soybean, epoxydised, ether with ethylene glycol when administered by gavage to female Wistar rats at the limit dose level 2000 mg/kg bw. The test substance was administered as a solution in arachis oil. In the absence of toxicity data, a preliminary test was performed at 300 mg/kg bw and 2000 mg/kg bw. No effect was reported at these dose levels and 4 additional animals were treated at 2000 mg/kg bw. The animals were fasted overnight prior to dosing. The rats were observed for 14 days following administration. No mortalities were observed; no abnormal clinical findings were reported and all animals gained weight throughout the course of the study. Gross pathology performed at the end of the 14-day observation period did not show abnormal findings. Based on these results under the conditions of this study, the acute oral LD50 was found to exceed 2000 mg/kg bw.
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