Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 272-211-8 | CAS number: 68783-88-0 Complex combination obtained by steam distillation of soybean oil followed by condensation of the steam. Contains fatty acids, sterols, aldehydes and ketones.
- 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
Short-term toxicity to fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From Mar. 24, 2010 to Apr. 17, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to standard guidelines in compliance with GLP.
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Series on testing and assessment No. 23: Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 'Soybean oil, deodorizer distillates'
- IUPAC Name:
- 'Soybean oil, deodorizer distillates'
- Reference substance name:
- Soybean oil, deodorizer distillate
- EC Number:
- 272-211-8
- EC Name:
- Soybean oil, deodorizer distillate
- Cas Number:
- 68783-88-0
- Molecular formula:
- No generic molecular formula is available
- IUPAC Name:
- Not available for UVCB
- Details on test material:
- - Name of test material (as cited in study report): 'Soybean oil, deodorizer distillates' (CAS N°68783-88-0, EINECS N° 272-211-8)
- Substance type: Fatty acids and unsaponifiable matter of vegetable origin
- Physical state: Liquid pasty, brown
- Storage condition of test material: In original container, at room temperature (15 - 25°C), in the dark
- Purity test date: October 27, 2009
- Expiration date of the lot/batch: April 27, 2010
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not applicable
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Appropriate amounts of the stock solution were diluted with pure water to get TC standard solutions in the range from 1 to 50 mg Carbon/L and IC standard solutions in the range of 1 to 25 mg Carbon/L.
Analysis of the Test Item Concentrations:
- Sampling: Duplicate samples from the freshly prepared test medium of the only test concentrations and the control were taken at the start of the test. For the determination of the stability of the test material under the test conditions, respectively the maintenance of the test item concentrations during the test period, samples were taken in duplicate out of all test media and the control at the end of the test (96 h).
- Analysis: The concentrations of the test item were analysed in the duplicate test media samples from the only test concentration and both sampling times (0 and 96 h). From the control samples only one of the duplicate samples was analysed from each of both sampling times.
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
1,000 mg of the test item were added directly to 10,000 mL test water and carefully stirred for about 24 hours at room temperature in the dark to dissolve as much as possible. After cessation of mixing and a following period of settling to allow phase separation, the aqueous phase, i.e. the water accommodated fraction, was drawn off carefully and used as the test medium.
Test organisms
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow Trout
- Source: Forellenzuchtbetrieb Fraunhofer Institut Molekularbiologie und Angewandte Oekologie, Auf dem Aberg 1, 57392 Schmallenberg, Germany.
- Age at study initiation (mean and range, SD): Juveniles
- Length at study initiation (length definition, mean, range and SD): 4.83 ± 0.36 cm
- Weight at study initiation (mean and range, SD): 0.90 ± 0.25 g
- Method of breeding:
- Feeding during test: No
ACCLIMATION
- Acclimation period: 12 d
- Acclimation conditions (same as test or not): Same
- Feeding frequency: Three times/wk or daily until 24 h before the test was started
- Health during acclimation (any mortality observed): No
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- None
Test conditions
- Hardness:
- 2.5 mmol/L (= 250 mg/L) as CaCO3
- Test temperature:
- 14 - 15 °C
- pH:
- 7.9- to 8.1
- Dissolved oxygen:
- 91- 100% of the air saturation value
- Salinity:
- No data
- Nominal and measured concentrations:
- Nominal: 0, 100 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria
- Type (delete if not applicable): Closed
- Material, size, headspace, fill volume: 12 L glass aquaria with 8 L test medium
- Aeration: Yes (slightly aerated during the test)
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water
- Alkalinity: 0.8 mmol/L
- Ca/mg ratio: 4:1 (based on molarity)
- Conductivity: < 10 µScm-1
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod: 16 h light : 8 h dark; 30 min dawn/dusk period
- Light intensity: 590 - 1160 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The test fish were observed after approximately 2, 24, 48, 72 and 96 h test duration for sublethal effects and mortality.
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: water accommodated fraction
- Basis for effect:
- other: mortality and sublethal effects
- Duration:
- 96 h
- Dose descriptor:
- LOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: water accommodated fraction
- Basis for effect:
- other: mortality and sublethal effects
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: water accommodated fraction
- Basis for effect:
- other: mortality and sublethal effects
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: water accommodated fraction
- Basis for effect:
- other: mortality and sublethal effects
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: water accommodated fraction
- Basis for effect:
- other: mortality and sublethal effects
- Details on results:
- - Behavioural abnormalities: No
- Mortality of control: No
- Other adverse effects control: No sublethal effects during the exposure time
- Abnormal responses: No
- Effect concentrations exceeding solubility of substance in test medium: There were no remarkable observations - Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- No data
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Determination of the Test Item
Based on the results of TOC measurements the concentration of the test item was determined using a calibration curve.
Calibration Range
1 to 50 mg Carbon/L in pure water in the case of TC-calibration and
1 to 25 mg Carbon/L in pure water in the case of IC-calibration
Linearity of Response
Correlation of peak area of different standard solutions with their corresponding concentrations, using a linear regression
Regression Coefficient
At least 0.9987 in the case of TC
at least 0.9955 in the case of ICTypical Calibration Curve
y =4.1577 * x - 1.0347in the case of TC
y =3.5631 * x – 1.1193in the case of IC
Limit of Detection
LODTC:2.252mg Carbon/L;
LODIC:1.911 mg Carbon/LLimit of Quantification
5 mg Carbon/L
119 % (n = 4, RSD 9 %)Mean Recovery in the Fortified Samples
111 % (n = 4, RSD 2 %)
Mean recovery in the test samples
Since the test item is not well water soluble, all results were below LOQ
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the test conditions, the 96 h LC50 of the test substancewas > 100 mg/L (nominal). The96 h NOECwas 100 mg/L (nominal).
- Executive summary:
A study was conducted to evaluate the acute toxicity of 'soybean oil, deodorizer distillates' to freshwater rainbow trout (Oncorhynchus mykiss) in a static test (OECD Guideline 203 and EU method C.1).
Rainbow trout were exposed to water accommodated fraction of the nominal test concentrations of 0 and 100 mg/L for 96 h. Mortality and signs of toxicity were followed throughout the study. Analytical verification of the test concentrations were conducted at the concentrations of the test material in the test medium. The samples collected at start and after 96 h were analysed via the TOC-method.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.