4-O-α-D-glucopyranosyl-D-glucitol

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

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.

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.