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EC number: 700-515-7 | CAS number: 1236007-63-8
- 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
Biodegradation in water: screening tests
Administrative data
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 301 E (Ready biodegradability: Modified OECD Screening Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.4-B (Determination of the "Ready" Biodegradability - Modified OECD Screening Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): "ISOMALTULOSE SOLUTION"
- Molecular formula (if other than submission substance):Not applicable.
- Charge No.: 03160483
- Appearance: Yellowish viscous syrup.
- Purity test date: referring to dry weight (HPLC): 33.8 % isomaltulose, 8.0 % dextrose, 12.5 % fructose, 2.8 % isomaltose, 34.7 % trehalulose, 0.5 % saccharose, 7.64 % Dp3+ (higher carbohydrates)
- Solubility: In water: Unlimited
- pH: 4.7 - 7.0 (1:1)
- Density: 1.2 g/cm3 (20 °C)
- Boiling point: > 100 °C
- Conditions of storage: Room temperature.
- Stability at conditions of storage: No data available
- Expiry date: No data available.
Study design
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Details on inoculum:
- - Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): effluent from a sewate treatment plant, A-2451 Au am Leithagebirge
- Storage conditions: The effluent was aerated by means of filtered compressed air for about 45 minutes before being used for the study
- Preparation of inoculum for exposure: The number of cells of the effluent was determined. Each flask was inoculated with 0.5 mL sewage effluent with approximately 1 600 000 cells per mL.
- Pretreatment: None.
- Initial cell/biomass concentration: approx. 800 000 cells per vessel - Duration of test (contact time):
- 28 d
Initial test substance concentration
- Initial conc.:
- 20 mg/L
- Based on:
- DOC
Parameter followed for biodegradation estimation
- Parameter followed for biodegradation estimation:
- DOC removal
- Details on study design:
- TEST CONDITIONS
- Composition of medium: Mineral medium as described in the guidelines
- Additional substrate: None.
- Solubilising agent (type and concentration if used): Not used
- Test temperature: 20.2 to 22.7 °C
- pH: Day 0: 7.4 - 7.5, Day 28: 7.4 - 7.6
- pH adjusted: No.
- Aeration of dilution water: No.
- Suspended solids concentration: Not applicable
- Continuous darkness: Yes.
TEST SYSTEM
- Culturing apparatus: 2L conical flask reaction vessel filled with 1 000 mL test medium.
- Number of culture flasks/concentration: 2 negative control flasks, 2 test substance flask, 1 positive control, 1 toxicity control, 1 abiotic steril control, 1 adsorption control
- Method used to create aerobic conditions: the opening of the vessels was covered with aluminium foil in such a way that the exchang of air was guaranteed.
- Measuring equipment: Measurements were performed with a carbon analyser (TOC-Analysator multi N/C 2000, Analytik Jena).
SAMPLING
- Sampling frequency: Day 0, 2, 4, 7, 10, 14, 18, 22, 25, and 28. Abiotic steril control and adsorption control were determined only on day 28.
- Sampling method: DOC concentrations were determined from the supernatants.
- Sample storage before analysis: Samples were analysed on the same day.
CONTROL AND BLANK SYSTEM
- Inoculum blank: Yes
- Abiotic sterile control: Yes.
- Toxicity control: Yes.
- Other: Adsorption control
STATISTICAL METHODS: no.
Reference substance
- Reference substance:
- benzoic acid, sodium salt
Results and discussion
% Degradation
- Parameter:
- % degradation (DOC removal)
- Value:
- 96.2
- Sampling time:
- 28 d
- Details on results:
- The test substance was 96.2% degraded during the test. The 10-day window started onday 1 and 70% degradation was exceeded at Day 4. The test is therefore valid.
BOD5 / COD results
- Results with reference substance:
- The plateau of biodegradation was reached on Day 4 and the degradation of sodium benzoate exceeded the pass level of 70 % within 14 days.
Any other information on results incl. tables
The test is considered valid if the difference of extremes of replicate values of the removal of the test substance at the plateau, at the end of the test or at the 10-d window, as appropriate, is less than 20 % and if the percentage degradation of the reference compound has reached the pass levels by day 14. These criteria were fulfilled.
Percent biodegradation
|
test substance |
positive control |
toxicity control |
||
Day |
A13 |
A14 |
mean |
PK5 |
TK16 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
43.41 |
42.62 |
43.01 |
87.34 |
49.79 |
4 |
86.16 |
79.72 |
82.94 |
92.87 |
55.52 |
7 |
80.81 |
80.45 |
80.63 |
91.26 |
84.72 |
10 |
83.13 |
83.27 |
83.20 |
95.07 |
83.33 |
14 |
93.07 |
90.69 |
91.88 |
95.94 |
93.79 |
18 |
93.43 |
91.74 |
92.59 |
95.60 |
93.53 |
22 |
95.97 |
94.85 |
95.41 |
97.66 |
94.13 |
25 |
92.54 |
91.31 |
91.92 |
93.69 |
92.58 |
28 |
96.37 |
95.93 |
96.15 |
97.93 |
95.30 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- The isomaltulose solution can be classified as readily biodegradable, with 96.2% biodegradability achieved by day 28.
- Executive summary:
This study examined the potential of the test substance to biodegrade. Sodium benzoate was used as the reference substance. Oxygen measurements were taken at 7, 14, 21, and 28 days. The test substance was 96.2% degraded at the end of 28 days. Results with the reference substance were valid. The test substance is readily biodegradable.
Aim and methods
The ready biodegradability of "ISOMALTULOSE SOLUTION" was determined by the measurement of DOC (dissolved organic carbon) at frequent intervals over a 28 d period. The method used was that described in Part C.4-B of the Regulation (EC) 440/2008 and in the OECD Guideline 301 E.
Results
· The reference substance sodium benzoate was degraded by 95.9 % within 14 days.
· Degradation in the toxicity control, which contained sodium benzoate and the test substance, was not indicative of an inhibition of the microbial activity by the test substance.
· The test substance"ISOMALTULOSE SOLUTION"with a nominal starting concentration of 20 mg DOC/L was degraded by 96.2 % after 28 days of incubation at a mean temperature of 21.6 °C. The "10-d window" as defined by the guidelines started at approximately Day 1. 70 % degradation was exceeded at about Day 4.
Classification
According to the Guidelines a substance giving a result greater than 70 % loss of DOC in a 10-d window within 28 days is regarded as "readily biodegradable". According to the results of this study,"ISOMALTULOSE SOLUTION" can therefore be classified as readily biodegradable.
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