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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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- 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 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- 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 a renewal set of the test solutions (at the beginning of exposure and before renewal of test solutions at 24 hours). Test solutions were collected into each vial from each vessel 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: The test substance was added directly to the dilution water such that the final concentration was 1500 mg/L.
- Controls: The control solution contained only the dilution water.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Solubility in dilution water of the test substance is >1500 mg/L (visual observation, measured by M.S.I.). - Test organisms (species):
- Oryzias latipes
- Details on test organisms:
- TEST ORGANISM
- Common name: Medaka
- Source: Tsunashima Fishing Co. (5-18-1 Tsunashima-nishi, Kouhoku-ku, Yokohama, Kanagawa)
- Age at study initiation (mean and range, SD): Less than a year after hatching
- Length at study initiation (length definition, mean, range and SD): 1.96 cm (1.81 to 2.28 cm), n=10
- Weight at study initiation (mean and range, SD): 0.048 g (0.031 to 0.087 g), n=10
- Method of breeding: Not reported
- Feeding during test: None
ACCLIMATION
- Acclimation period: March 17, 2005 to April 11, 2005
- Acclimation conditions (same as test or not): Same as test, except flow-through procedure
- Type and amount of food: TetraMin (TetraWerke), 2% of the body weight/day (until 24 hours before exposure)
- Feeding frequency: Daily
- Health during acclimation (any mortality observed): Mortality of fish during the week before exposure: <5%. The test fish used were in good health and free from any apparent malformation. During the acclimation period, fish were kept without medicine in the aquarium. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- None
- Hardness:
- 30 to 100 mg/L (CaCO3)
- Test temperature:
- 23.6 to 23.9°C
- pH:
- 7.6 to 7.9
- Dissolved oxygen:
- 7.4 to 8.3 mg/L
- Salinity:
- Freshwater
- Nominal and measured concentrations:
- Nominal = 1500 mg/L; geometric mean measured = 1500 mg/L (test substance); 1050 mg/L (active ingredient)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 5.0 L glass vessel; Aerated
- No. of organisms per vessel: 10 fish/vessel
- No. of vessels per concentration (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: ≤1.0 g fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated water (tap water supplied by Yokohama City Water Service was dechlorinated with activated charcoal and then aerated) was used for the study. The water temperature was controlled at 24 ± 2°C. Water quality of the dilution water has been checked on the 35 parameters twice a year. Values of hardness and pH usually are 30 to 100 mg/L (CaCo3) and 6.5 to 8.5, respectively. At the use of this water, residual chlorine was not detected. This water was, therefore, suitable for the test water.
Cadmium: <0.01 mg/L
Cyanide: Not detected
Lead: <0.1 mg/L
Chromium: <0.05 mg/L
Arsenic: <0.05 mg/L
Mercury: <0.0005 mg/L
Copper: <0.005 mg/L
Zinc: <0.1 mg/L
Aluminum: <0.1 mg/L
Tin: <1.0 mg/L
Manganese: <1.0 mg/L
Iron: <1.0 mg/L
Nickel: <0.1 mg/L
Selenium: <0.001 mg/L
- Chlorine: <0.02 mg/L (reported as free chlorine)
- Alkalinity: 44 mg/L
- Ca/mg ratio: 3.3
- Conductivity: 155 µS/cm
- Intervals of water quality measurement: Twice a year
OTHER TEST CONDITIONS
- Adjustment of pH: Not adjusted
- Photoperiod: 16 hours light/ 8 hours dark
- Light intensity: 1000 lux or less
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): The appearance, temperature, dissolved oxygen concentration, and pH of each test solution were observed or measured once a day (before and after renewal). Number of dead fish, toxicological symptoms and abnormalities were recorded at 24, 48, 72, and 96 hours after the start of exposure.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test
- Range finding study: Yes
- Test concentrations: 14.3, 143, and 1430 mg/L (nominal)
- Results used to determine the conditions for the definitive study: No mortalities and no toxicological symptoms were observed after the test period of 96 hours. - Reference substance (positive control):
- yes
- Remarks:
- Copper sulfate
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 1 500 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 1 050 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 500 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 1 050 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: In all concentration levels, no abnormal symptom was observed during exposure.
- Mortality of control: None
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None. There was no significant matter that may have affected the reliability of the test results. - Results with reference substance (positive control):
- 96 hour median lethal concentration (LC50) of reference substance = 0.88 mg/L (95% confidence limits: 0.63 to 1.2 mg/L). This value is consistent with the background data (n=28, since 1995): average ± standard deviation=0.90±0.28 mg/L; Minimum value-maximum value=0.44 to 1.5 mg/L.
- Reported statistics and error estimates:
- Concentration of the test substance to calculate median lethal concentration (LC50) was the average of measured concentration (geometric mean).
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 fish of Maltitol was determined as 96h-LC0 ≥ 1050 mg/L (active ingredient, measured geometric mean). So maltitol shows no adverse effect to fish and it is not classified for its aquatic toxicity according to CLP criteria.
- Executive summary:
The acute toxicity of maltitol to fish was determined according to the OECD guideline 203 and in compliance with GLP.
10 fish, Oryzias latipes, 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 1050 mg/L (active ingredient).
No mortality and and no abnormal symptom were observed during the exposure.
The acute toxicity to fish of Maltitol was determined as 96h-LC0 ≥ 1050 mg/L (active ingredient, measured geometric mean). So maltitol shows no adverse effect to fish and it is not classified for its aquatic toxicity according to CLP criteria.
The fish acute toxicity study is classified as acceptable, and satisfies the guideline requirements of OECD 203.
Reference
Description of key information
The acute toxicity to fish of Maltitol was determined as 96h-LC0 ≥ 1050 mg/L (active ingredient, measured geometric mean). So maltitol shows no adverse effect to fish and it is not classified for its aquatic toxicity according to CLP criteria.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 1 050 mg/L
Additional information
The acute toxicity of maltitol to fish was determined according to the OECD guideline 203 and in compliance with GLP.
10 fish, Oryzias latipes, 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 1050 mg/L (active ingredient).
No mortality and and no abnormal symptom were observed during the exposure.
The acute toxicity to fish of Maltitol was determined as 96h-LC0 ≥ 1050 mg/L (active ingredient, measured geometric mean). So maltitol shows no adverse effect to fish and it is not classified for its aquatic toxicity according to CLP criteria.
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