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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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- -1984 followed; reliability scoring based on 2004 guideline
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 1500 mg/L (nominal)
- Sampling method: During the exposure, the concentrations of test substance were measured at renewal of the test solutions (at the beginning of exposure and before renewal of test solutions at 24 hours). Test solution was taken to vial and analyzed by high performance liquid chromatography (HPLC).
- Sample storage conditions before analysis: Not reported - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test substance was added directly to dilution water.
- Controls: The control solution contained only the dilution water.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): No, solubility in dilution water of the test substance is >1500 mg/L (visual observation, measured by M.S.I.). - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: Not reported
- Source: National Institute for Environmental Studies, Japan
- Age at study initiation (mean and range, SD): Female, juvenile (less than 24 hours)
- Weight at study initiation (mean and range, SD): Not reported
- Length at study initiation (length definition, mean, range and SD): Not reported
- Method of breeding: acyclic parthenogenesis
- Feeding during test: None
ACCLIMATION
- Acclimation period: Culturing period: February 16, 2005 to March 9, 2005
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: Feed: Chlorella vulgaris (culture of alga was centrifuged to separate cells and supernatant was replaced with dilution water); Feeding amount: 0.2 mg C (organic carbon)/daphnid/day
- Feeding frequency: Daily
- Health during acclimation (any mortality observed): None
Mortality of parental daphnids during 2 weeks before test: 0%
Presence of ephippia and males: None - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- None
- Hardness:
- 240 mg/L (CaCO3)
- Test temperature:
- 20±1°C
- pH:
- 8.0 to 8.4 (pH adjustment of test solutions was not done)
- Dissolved oxygen:
- Over 60% of the saturation value (8.6 to 8.8 mg/L)
- Salinity:
- freshwater
- Nominal and measured concentrations:
- Nominal: 1500 mg/L; Geometric mean measured: 1450 mg/L (test material); 1020 mg/L (active ingredient)
- Details on test conditions:
- TEST SYSTEM
- Test vessel
- Type (delete if not applicable): Closed; Surface was covered with Teflon sheet.
- Material, size, headspace, fill volume: 100 mL glass beaker (vessel was covered with plate); filled with 100 mL of test medium.
- No. of organisms per vessel: 5 daphnids
- No. of vessels per concentration (replicates): 4
- No. of vessels per vehicle control (replicates): 4
- Biomass loading rate: 5 daphnids/100 mL
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (Elendt M4) recommended by OECD Guidelines for Testing Chemicals No. 211 "Daphnia magna Reproduction Test" (1998) was used for dilution water.
CaCl2 2H2O: 293.8 mg/L
MgSO4 7H2O: 123.3 mg/L
KCl: 5.80 mg/L
NaHCO3: 64.8 mg/L
Na2SiO3 9H2O: 10.0 mg/L
NaNO3: 0.274 mg/L
KH2PO4: 0.143 mg/L
K2HPO4: 0.184 mg/L
H3BO3: 2859.5 µg/L
MnCl2 4H2O: 360.5 µg/L
LiCl: 306.0 µg/L
RbCl: 71.0 µg/L
SrCl2 6H2O: 152.0 µg/L
NaBr: 16.0 µg/L
Na2MoO4 2H2O: 63.0 µg/L
CuCl2 2H2O: 16.8 µg/L
ZnCl2: 13.0 µg/L
CoCl2 6H2O: 10.0 µg/L
KI: 3.25 µg/L
Na2SeO3: 2.19 µg/L
NH4VO3: 0.575 µg/L
Na2EDTA 2H2O: 2500 µg/L
FeSO4 7H2O: 995.5 µg/L
Thiamine hydrochloride: 75.0 µg/L
Cyanocobalamine (B12): 1.00 µg/L
Biotine: 0.750 µg/L
- Total organic carbon: Not reported
- Particulate matter: Not reported
- Metals: Not reported
- Pesticides: Not reported
- Chlorine: Not reported
- Alkalinity: Not reported
- Ca/mg ratio: Not reported
- Conductivity: Not reported
- Culture medium different from test medium: Not reported
OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16 hours light/ 8 hours dark
- Light intensity: 800 lux or less
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): The daphnids were observed at 24 and 48 hours after the start of exposure, and number of immobile daphnids was recorded.
TEST CONCENTRATIONS
- Range finding study: Yes
- Test concentrations: 15.0, 150, 1500 mg/L (nominal)
- Results used to determine the conditions for the definitive study: A range-finding test (2 vessels/concentration, 10 daphnids/concentration) was conducted before the definitive test. Immobility was 0% at 24 hours and 48 hours in all concentrations. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 24 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 1 450 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 1 020 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 450 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 020 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 1 450 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 1 020 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 450 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 1 020 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: Not reported
- Observations on body length and weight: Not reported
- Other biological observations: Not reported
- Mortality of control: 0 of 20
- Other adverse effects control: Not reported
- Abnormal responses: Not reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None, solution was clear colourless. - Results with reference substance (positive control):
- Acute immobilization test of a reference substance has been conducted every 6 months since June 1998. 48-hour median effect concentration (EC50) was as follows: average ±standard deviation: 0.75 ± 0.15 mg/L, n=14; minimum value - maximum value = 0.57 to 1.02 mg/L
- Reported statistics and error estimates:
- The LC50 value and its 95% confidence limits could not be determined by statistical method because the mortality at the maximum concentration level was less than 50%.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity to Daphnia magna of Maltitol was determined as 48h-LC0 ≥ 1020 mg/L (active ingredient, measured geometric mean). So maltitol shows no adverse effect to Daphnia magna and it is not classified for its aquatic toxicity according to CLP criteria.
- Executive summary:
The acute toxicity of maltitol to Daphnia magna was determined according to the OECD guideline 202 and in compliance with GLP.
20 daphnids distributed in four flasks were exposed to the test item Maltitol at the nominal concentration of 1500 mg/l in a semi-static test. During the exposure, the concentrations of the test substance were measured at a renewal set of the test solutions (at the beginning of exposure and before renewal of test solutions at 24 hours) by high performance liquid chromatography (HPLC). The geometric mean measured concentration was 1500 mg/L (test substance) and 1020 mg/L (active ingredient).
No mortality was observed during the exposure. The acute toxicity to Daphnia magna of Maltitol was determined as 48h-LC0 ≥ 1020 mg/L (active ingredient, measured geometric mean). So maltitol shows no adverse effect to Daphnids and it is not classified for its aquatic toxicity according to CLP criteria.
The Daphnia magna acute toxicity study is classified as acceptable, and satisfies the guideline requirements of OECD 202.
Reference
Description of key information
The acute toxicity to Daphnia magna of Maltitol was determined as 48h-LC0 ≥ 1020 mg/L (active ingredient, measured geometric mean). So maltitol shows no adverse effect to Daphnia magna and it is not classified for its aquatic toxicity according to CLP criteria.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 1 020 mg/L
Additional information
The acute toxicity of maltitol to Daphnia magna was determined according to the OECD guideline 202 and in compliance with GLP.
20 daphnids distributed in four flasks were exposed to the test item Maltitol at the nominal concentration of 1500 mg/l in a semi-static test. During the exposure, the concentrations of the test substance were measured at a renewal set of the test solutions (at the beginning of exposure and before renewal of test solutions at 24 hours) by high performance liquid chromatography (HPLC). The geometric mean measured concentration was 1500 mg/L (test substance) and 1020 mg/L (active ingredient).
No mortality was observed during the exposure. The acute toxicity to Daphnia magna of Maltitol was determined as 48h-LC0 ≥ 1020 mg/L (active ingredient, measured geometric mean). So maltitol shows no adverse effect to Daphnids and it is not classified for its aquatic toxicity according to CLP criteria.
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