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Diss Factsheets
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EC number: 483-980-6 | CAS number: -
- 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:
- study completion date: 02 MAY 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is performed according to OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Vegeflux soy
- Substance type: UVCB
- Physical state: viscous liquid
- Stability under test conditions: data not available
- Storage condition of test material: at room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal House, SGS Life Sciences Services
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 210 - 244 g
- Fasting period before study: data not available
- Housing: animals were housed group wise (3 animals per cage) in standard polypropylene cages with stainless steel top grill
- Diet: rat pellet feed (Amrut brand), ad libitum
- Water: potable water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19.9 - 22.5 °C
- Humidity: 60 - 69%
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): data not available
IN-LIFE DATES: from 14 March 2008 to 5 April 2008
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 2% DMSO in distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: data not available
- Amount of vehicle (if gavage): 10 mL / kg bw
- Justification for choice of vehicle: data not available
CLASS METHOD
- Rationale for the selection of the starting dose: data not available - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> general health and mortality: animals were observed daily for mortality and morbidity. Clinical signs were recorded at 30 minutes and then at 1h interval till 4h on the day of dosing and daily thereafter for a period of 14 days
> body weight: body weight of each animal was recorded prior to dosing and at weekly interval thereafter
- Necropsy of survivors performed: yes - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality
- Mortality:
- No mortality was observed in any of the animals treated with the test item
- Clinical signs:
- All the animals treated with the test item were found normal throughout the 14 day observation period
- Body weight:
- No marked changes were observed in the body weight gain of animals treated with the test item
- Gross pathology:
- The lesions observed were found in the study matched with the historical gross pathology data. Hence the lesions observed can not be related to the test item
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of Vegeflux Soy is > 2000 mg/kg bw by oral intake
- Executive summary:
In an acute oral toxicity study (Venkatasubramani R, 2008), groups of 8-12 weeks old Wistar rats (2 x 3 females per group) were given a single oral dose of Vegeflux Soy in 2% DMSO at doses of 300 and 2000 mg/kg bw and observed for 14 days. The test was performed according to OECD test guideline 423 and GLP.
Oral LD50 Females > 2000 mg/kg bw
No mortality, clinical signs, body weight changes or gross pathology changes were observed during the observation period.
Vegeflux Soy is of low toxicity based on the LD50 in females by gavage. Vegeflux soy is not classified as dangerous according to EU criteria, by oral intake.
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.
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