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EC number: 209-567-0 | CAS number: 585-88-6
- 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
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 February 2018 to 09 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- version 2014
- Deviations:
- yes
- Remarks:
- the temperature during the agitation at 30°C of the test item was not registered. This deviation was not considered to have affected the quality or the interpretation of the results obtained.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- Version 1995
- Deviations:
- yes
- Remarks:
- the temperature during the agitation at 30°C of the test item was not registered. This deviation was not considered to have affected the quality or the interpretation of the results obtained.
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Identification : MALTITOL
CAS No. : 585-88-6
EC No. : 209-567-0
Batch ELEL7
Appearance White powder - Key result
- Water solubility:
- 738 g/L
- Conc. based on:
- act. ingr. (dissolved fraction)
- Loading of aqueous phase:
- 2 000 g/L
- Incubation duration:
- >= 24 - <= 72 h
- Temp.:
- 20 °C
- pH:
- 6.7
- Details on results:
- Calibration curve : R = 0.9987
A = 0.996 x C + 0.626 - Conclusions:
- The water solubility of the maltitol is 738 g/L at 20°C and pH 6.7.
- Executive summary:
The water solubility of maltitol was determinated according to the EU method A.6 and OECD 105 and in compliance with the GLP.
The shake flask method was used and in a preliminary test based on visual observations the solubility was found between 200 and 1000 g/L.
In the main study a suspension of 2000gr/L was prepared in 6 glass vessels. The flasks were sealed and subjected to magnetical stirring into a water bath at about 30 °C.
Two solutions were removed after 24 h, 48 h and 72 hours of stirring. After a minimum of 24 hours at 20.0 °C ± 2.0 °C, an aliquot was centrifuged at 7000 rpm for 10 minutes, filtered on 0.45 μm filter 1000 times with water and then diluted again 1000 times with water before analysis by ionic chromatography using amperometric detection. The analysis method was demonstrated to satisfy the SANCO/3030/99 rev.4 regarding the specificity, linearity, accuracy and prcision (Report 18 -918023 -004).
The water solubility of maltitol at 20°C and pH 6.7 is equal to 738 ± 20 g/L ( relative standard deviation 2.71%).
The water solubility study is classified as acceptable, and satisfies the guideline requirements of the EU method A.6 and OECD 105.
Reference
|
Reference of test solutions |
Peak area (area units) |
Mean peak area (area units) |
Conc. (mg/L) |
Dilution factor |
Final conc. in maltitol (mg/L) |
Final conc. in maltitol (g/L) |
|
|
|
A |
B |
Df |
Cf |
Cf1 |
After 24h |
18-078 1Bdil |
1.3932 |
1.3861 |
0.763 |
1000000 |
763350 |
763.4 |
18-078 1Bdil |
1.3790 |
||||||
18-078 1Cdil |
1.3807 |
1.3810 |
0.758 |
1000000 |
758179 |
758.2 |
|
18-078 1Cdil |
1.3812 |
||||||
After 48h |
18-078 1Ddil |
1.3660 |
1.3544 |
0.731 |
1000000 |
731468 |
731.5 |
18-078 1Ddil |
1.3427 |
||||||
18-078 1Edil |
1.3265 |
1.3331 |
0.710 |
1000000 |
710080 |
710.1 |
|
18-078 1Edil |
1.3396 |
||||||
After 72h |
18-078 1Fdil |
1.3429 |
1.3504 |
0.727 |
1000000 |
727452 |
727.5 |
18-078 1Fdil |
1.3578 |
||||||
18-078 1Gdil |
1.3561 |
1.3575 |
0.735 |
1000000 |
734581 |
734.6 |
|
18-078 1Gdil |
1.3588 |
||||||
|
|
|
|
|
|
Mean |
738 |
|
|
|
|
|
|
SD |
20 |
|
|
|
|
|
|
RSD (%) |
2.71 |
Description of key information
The water solubility of the maltitol is 738 g/L at 20°C and pH 6.7.
Key value for chemical safety assessment
- Water solubility:
- 738 g/L
- at the temperature of:
- 20 °C
Additional information
The water solubility of maltitol was determinated according to the EU method A.6 and OECD 105 and in compliance with the GLP.
The shake flask method was used and in a preliminary test based on visual observations the solubility was found between 200 and 1000 g/L. In the main study a suspension of 2000gr/L was prepared in 6 glass vessels. The flasks were sealed and subjected to magnetical stirring into a water bath at about 30 °C. Two solutions were removed after 24 h, 48 h and 72 hours of stirring. After a minimum of 24 hours at 20.0 °C ± 2.0 °C, an aliquot was centrifuged at 7000 rpm for 10 minutes, filtered on 0.45 μm filter 1000 times with water and then diluted again 1000 times with water before analysis by ionic chromatography using amperometric detection. The analysis method was demonstrated to satisfy the SANCO/3030/99 rev.4, regarding the specificity, linearity, accuracy and prcision (Report 18 -918023 -004).
The water solubility of maltitol at 20°C and pH 6.7 is equal to 738 ± 20 g/L (relative standard deviation 2.71%).
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