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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 908-300-1 | 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:
- 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- short chain Fructo-Oligosaccharides
- EC Number:
- 908-300-1
- Molecular formula:
- C6H11O5(C6H10O5)nOH
- IUPAC Name:
- short chain Fructo-Oligosaccharides
- Test material form:
- solid: particulate/powder
- Details on test material:
- CAS no. 308066-66-2
Composition (on dry basis):
- FOS 95.46%
a) 1-Kestose (GF2): 40.23%
b) Nystose (GF3): 47.15%
c) 1F-Fructofuranosylnystose (GF4) :8.08%
- Other sugars 4.50%
a) Glycerol: 1.40%
b) Fructose: 0.36%
c) Arabitol: 0.36%
d) Glucose: 0.63%
e) Sucrose: 1.75%
- Physical appearance: Fine white powder
- Moisture content (as per COA): 2.26%
- Heavy metals (Pb, As, Hg, and Cd) Below detection limits (Pb— 0.03 ppm, As—0.05 ppm, Hg— 0.01 ppm, and Cd—0.01 ppm)
- Microbial analysis Standard plate count: <10 cfu/g
Yeast count: <10 cfu/g
Mould count: <10 cfu/g
Enterobacteriaceae: 10 MPN/g
E.coli: Absent/10 g
Salmonella sp: Absent/100 g
Shigella sp: Absent/10g
- pH 5.48
Constituent 1
- Specific details on test material used for the study:
- FOS (FOSSENCE TM) used for the experiments was provided by Tata Chemicals Limited (Tamilnadu, India) and stored at ambient conditions (>15°C to <25°C).
- CAS no. 308066-66-2
- Composition (on dry basis)
- FOS: 95.46%
a) 1-Kestose (GF2): 40.23%
b) Nystose (GF3):47.15%
c) 1F-Fructofuranosylnystose (GF4): 8.08%
- Other sugars 4.50%
a) Glycerol: 1.40%
b) Fructose: 0.36%
c) Arabitol: 0.36%
d) Glucose: 0.63%
e) Sucrose: 1.75%
- Physical appearance Fine white powder
- Moisture content (as per CoA): 2.26%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The test item was mixed in Milli-Q water and administered as a single oral dose at the dose levels of 2000, 5000, and 9000 mg/kg
5 Wistar rats of each sex were randomly assigned to 4 groups (control, 2000, 5000, and 9000 mg/kg).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Milli-Q water.
- Details on oral exposure:
- The highest dose of 9000 mg/kg was considered as maximum feasible dose from oral administration perspective considering high viscosity factor and dose volume.
The dose volume employed was 15 mL/kg body weight. - Doses:
- 2000, 5000, and 9000 mg/kg
- No. of animals per sex per dose:
- n= 5 rats/sex/group
- Control animals:
- yes
- Remarks:
- Milli-Q water was administered to control group rats.
- Details on study design:
- The rats were observed for clinical signs or mortality, and body weights and feed consumption were measured. All the rats were euthanized under isoflurane anesthesia on day 15, and gross pathological examinations were performed.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 9 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Oral gavage administration of test item i did not reveal any mortality at 2000, 5000, and 9000 mg/kg body weight.
- Clinical signs:
- other: other: other: Oral gavage administration of test item i did not reveal any clinical signs at 2000, 5000, and 9000 mg/kg body weight.
- Gross pathology:
- Necropsy at the end of study (day 15 post-dose) did not reveal any gross pathological abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, Wistar rats did not reveal any clinical signs, mortality, on body weight, and feed consumption at any dose level. No gross pathological abnormalities were also observed after necropsy. The MTD and the LD50 were > 9000 mg/kg bw (Highest dose tested).
- Executive summary:
The objective of this study was to evaluate the toxicity of FOS product FOSSENCETM following a single oral administration in rats according to methods similar to OECD 420 guidelines. The study was GLP compliant.
The FOSSENCETM was mixed in Milli-Q water and administered as a single oral dose at the dose levels of 2000, 5000, and 9000 mg/kg (n=5 rats/sex/group). The highest dose of 9000 mg/kg was considered as maximum feasible dose from oral administration perspective considering high viscosity factor and dose volume.
Under the test conditions, Wistar rats did not reveal any clinical signs, mortality, on body weight, and feed consumption at any dose level. No gross pathological abnormalities were also observed after necropsy. The MTD (Maximum Tolerable Dose) and the LD50 were > 9000 mg/kg bw (Highest dose tested).
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.