1,4:3,6-dianhydro-2,5-bis-O-(diphenoxyphosphoryl)-D-glucitol

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with analytical concentration control

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4:3,6-dianhydro-2,5-bis-O-(diphenoxyphosphoryl)-D-glucitol

EC Number:

935-211-5

Cas Number:

1305113-15-8

Molecular formula:

C30H28O10P2

IUPAC Name:

1,4:3,6-dianhydro-2,5-bis-O-(diphenoxyphosphoryl)-D-glucitol

Details on test material:

- Name of test material (as cited in study report): Isosorbid-O,O'-bis(diphenylphosphorsäureester)
- Physical state: solid
- Analytical purity: 97.9 Mol-%
- Storage condition of test material: ambient

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Sampling method: Sampling for concentration control was done within 30 min before insertion of the test organisms (0 h) and after approx. 48 hours and 96 hours from all test vessels. The samples were taken from the middle of the test vessel using a glass pipette and deposited into glass ampoules, which were rinsed with test solution before they were filled. Sample volume approx. 10 mL.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
The test substance is poorly soluble in water. Therefore the test solution was prepared using a saturation column in order to achieve a saturated solution of the test substance. The saturation column was prepared by weighing approx. 1.6 g of test substance into a weighing boat and dissolving his mass in approx. 200 mL dichloromethane. The solvent solution was then poured over the pre-cleaned glass wool (approx. 20 g) in a stainless steel pan and the solvent was completely evaporated leaving the test substance adhered to the glass wool. The loaded glass wool was rolled and packed into a glass column (50 cm long with 2.8 cm internal diameter) fitted with a plug of clean glass wool to keep particulate matter in the column. Silicon stoppers fitted with short glass tubes were attached to the ends of the column, which was then connected to a peristaltic pump (Watson Marlow GMBH, Germany, 500 series) via a short length flexible tubing (Watson Marlow GmbH, Germany, Marprene). The packed column was rinsed with dilution water (column flow rate < 1 L/h) for about one day and the rinse water discarded. The test was carried out in a flow-throug system. The outflow of the column was introduced into the 100% test vessels.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: Zierfischzüchterei Friedrich, 33739 Bielefeld, Germany
- Age at study initiation: juvenile
- Length at study initiation: 3.0 ± 0.5 cm
- Weight at study initiation: < 3.0 g
- Feeding during test: none

ACCLIMATION
- Acclimation period: at least 14 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Commercial fish diet, ("Tetramin", Tetra-Werke, Melle, Germany), daily ad libitum, and additionally live juvenile brine shrimp (Artemia nauplii) generally on workdays.
- Medical treatment: none
- Mortality during the last week before start of exposure: < 5%

Study design

Test type:

flow-through

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

100 CaCO3 mg/L

Test temperature:

23 °C

pH:

7.9 - 8.0

Dissolved oxygen:

8.0 - 8.3 mg/L

Nominal and measured concentrations:

Nominal: 0.3 mg/L (and control)
Measured at 0 h: 0.151 mg/L
Measured at 48 h: 0.156 mg/L
Measured at 96 h: 0.1645 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: stainless steel aquaria
- Fill volume: 9 L
- Aeration: none
- Type of flow-through: peristaltic pump
- Renewal rate of test solution (flow rate): at least 2.25 L/h and test vessel, resulting in at least 6 volume exchanges per day
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: max. 1 g fish /L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: charcoal-filtered tap water from the municipal water works of the city of Frankenthal mixed with deionised water
- The tap water used is regularly assayed for chemical contaminants by municipal authorities and BASF SE s well as for presence of microbes by a contract laboratory. On the basis of the analytical findigs, the water was found to be suitable. The German Drinking Water Regulation served as guideline for maximum tolerable contaminant concentrations.
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH, temperature and dissolved oxygen daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light, 8 h dark
- Light intensity: ca. 20 - 850 Lux, 400 - 750 nm

EFFECT PARAMETERS MEASURED
Each test vessel was visually checked for mortality and clinical observations (such as abnormal behavior, signs of intoxication and visible morphological alterations) within one hour after start of exposure and after approx. 6, 24, 48, 72 and 96 hours.

TEST CONCENTRATIONS
- Reason for the selection of the test concentrations: In a preliminary test using zebrafish, a nominal concentration of 100 mg/L caused no mortality or signs of toxicity after 96 hours. Since the substance is known to be poorly soluble in water, only a saturated solution was tested.

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

> 0.157 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: saturated solution

Details on results:

- A saturated solution was tested. No effects were observed within the range of solubility.