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EC number: 209-566-5 | CAS number: 585-86-4
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
- Reference Type:
- other: Published secondary source
- Title:
- Lactitol
- Author:
- WHO/FAO
- Year:
- 1 983
- Bibliographic source:
- WHO/FAO: Expert Committee on Food Additives Summary of Toxicological Data of Certain Food Additives Series 18 (http://www.inchem.org/documents/jecfa/jecmono/v18je10.htm)
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 301 A (Ready Biodegradability: DOC Die Away Test)
- Deviations:
- yes
- Remarks:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method C.5 (Degradation: Biochemical Oxygen Demand)
- Version / remarks:
- carried out according to Dutch standard method (NEN3235-5.4)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method C.6 (Degradation: Chemical Oxygen Demand)
- Version / remarks:
- carried out according to Dutch standard method (NEN3235-5.3)
- Deviations:
- not specified
- Principles of method if other than guideline:
- A die-away test (modified OECD-screening test), chemical- (COD) and biochemical oxygen demand (BOD) determinations were carried out to determine the biodegradability of Lactitol. In the die-away test, biodegradation was based on dissolved organic carbon analysis (DOC). The modified OECD-screening test was also carried out, because normally COD and BOD findings underestimate biodegradation of carbohydrates.
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-O-β-D-galactopyranosyl-D-glucitol
- EC Number:
- 209-566-5
- EC Name:
- 4-O-β-D-galactopyranosyl-D-glucitol
- Cas Number:
- 585-86-4
- Molecular formula:
- C12H24O11
- IUPAC Name:
- 4-O-beta-D-galactopyranosyl-D-glucitol
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Test substance name: lactitoldihydrate
- Source and lot/batch number of test material: CCA; tests described in this report were carried out with a sample of the homogenized lot sent to CIVO-TNO.
Study design
- Oxygen conditions:
- anaerobic
- Inoculum or test system:
- sewage, domestic, adapted
- Details on inoculum:
- Settled effluent from a sewage purification plant receiving only domestic sewage was used as the inoculum.
- Duration of test (contact time):
- 2 d
- Details on study design:
- Medium, inoculum, and test or control substance were added to 300 mL Erlenmeyer flasks (in duplicate). The flasks were incubated on a rotary shaker at 23±1°C. Samples for analysis were taken at the start of the test and after 2, 5, 7, 9, 12, 14, and 16 days. Suspended solids were removed by centrifuging the samples for 10 minutes at 500000 x g in stainless steel tubes. The dissolved organ carbon content of the samples was determined using a Beckmann Total Organic Carbon Analyser.
The degradation (%) was calculated according to the following formula:
% biodegradation = [ (co - ct) ÷ co ] x 100
where :
co is the DOC content at the start of the experiment.
ct is the DOC content at time t.
Results and discussion
% Degradationopen allclose all
- Parameter:
- % degradation (DOC removal)
- Value:
- 0
- Sampling time:
- 0 d
- Parameter:
- % degradation (DOC removal)
- Value:
- 94
- Sampling time:
- 2 d
- Parameter:
- % degradation (DOC removal)
- Value:
- 84
- Sampling time:
- 5 d
- Parameter:
- % degradation (DOC removal)
- Value:
- 88
- Sampling time:
- 7 d
- Parameter:
- % degradation (DOC removal)
- Value:
- 84
- Sampling time:
- 9 d
- Parameter:
- % degradation (DOC removal)
- Value:
- 71
- Sampling time:
- 12 d
- Parameter:
- % degradation (DOC removal)
- Value:
- 93
- Sampling time:
- 14 d
- Details on results:
- The somewhat irregular results of the lactitol degradation are most probably due to the death of the biomass formed during degradation and the subsequent release of soluble organic matter. This can, in turn, be metabolized by other micro-organisms finally leading to exhaustion of the system. The same sort of irregularities occur in the inoculum blank. The inoculum blank was neglected in the calculation of the biodegradation.
As expected, the test substance appeared to be non-toxic at the concentration tested; this is demonstrated by the identical results for the biodegradation of the test substance/acetate mixture and acetate alone. The results of the BOD and COD determinations and of the degradability test seem to be in contradiction. After five days only just over 50% of the amount of oxygen theoretically needed to oxidize the test substance had been used up completely, although the test substance was ultimately degraded (based on DOC) in this period. Compounds like the test substance are used for a substantial part during degradation for growth of micro-organisms (synthesis of cell materials) and for this reason oxygen consumption is less than expected although degradation is complete. The substance must therefore be considered readily biodegradable.
BOD5 / COD results
BOD5 / CODopen allclose all
- Key result
- Parameter:
- COD
- Value:
- 955 mg O2/g test mat.
- Key result
- Parameter:
- BOD5
- Value:
- 550 mg O2/g test mat.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Interpretation of results:
- readily biodegradable
- Conclusions:
- A die-away test (modified OECD-screening test), chemical- (COD) and biochemical oxygen demand (BOD) determinations were carried out to determine the biodegradability of Lactitol. The values for COD and BOD5 were 955 and 550 mg/g Lactitol respectively. In the die-away test, biodegradation based on dissolved organic carbon analysis (DOC) was complete in two days. For this reason, Lactitol is considered readily biodegradable.
- Executive summary:
A die-away test (modified OECD-screening test), chemical- (COD) and biochemical oxygen demand (BOD) determinations were carried out to determine the biodegradability of Lactitol. In the die-away test, biodegradation was based on dissolved organic carbon analysis (DOC). The modified OECD-screening test was also carried out, because normally COD and BOD findings underestimate biodegradation of carbohydrates. The values for COD and BOD5 were 955 and 550 mg/g lactitol respectively. In the die-away test, biodegradation based on dissolved organic carbon analysis (DOC) was complete in two days. For this reason, lactitol is considered readily biodegradable.
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