4-O-α-D-glucopyranosyl-D-glucitol

Short-term toxicity to fish

Link to relevant study record(s)

Reference

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.

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.

Categories Display