1H-Isoindole-1,3(2H)-dione, 2-[[(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-({(5S)-2-Oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1H-isoindole-1,3(2H)-dione

EC Number:

610-201-0

Cas Number:

446292-08-6

Molecular formula:

C22 H19 N3 O6

IUPAC Name:

2-({(5S)-2-Oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)-1H-isoindole-1,3(2H)-dione

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Concentrations: Concentration of 7.98 mg/L was measured at 24 and 48 h only.
Sample storage conditions before analysis: Routinely, the sample were analysed immediately. Only in exceptional cases, there were stored overnight deep frozen and protect from light.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: To accelerate the solution procedure a five fold amount of the water solubility of the test item according to information given in the safety data sheet (11.5 mg/L / 57.5 mg/L) was weighed into water. To produce the only test concentration 57.4 mg (on Feb. 13, 2006) and 57.6 mg (on Feb. 14, 2006) of the test item were added to 1 L of dilution water, treated for 1 hour in an ultrasonic bath and then stirred for 24 hours on a magnetic stirrer. Finally undissolved pmticles of the test item were removed by filtration using folded filters of pore size 7-12 µm.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Age at study initiation (mean and range, SD): < 24 h
- Method of breeding: A population of parthenogenetic females of synchronized age structure is maintained since more than 15 years in the test facility under constant temperature conditions (20 +/- 1 °C) at a 16:8 hour light-dark photoperiod (illumination: < 1000 lux). The culture water (so-called 'M4 medium') is partly renewed once a week. The Daphnia are exclusively fed with unicellular green algae (Desmodesmus subspicatus) 'ad libitum'. Mortalities of parent Daphnia during the culture period are recorded daily in a semi­ quantitative way. The neonates are separated from their parent Daphnia by filtration prior to the acute test.
- Source: Bundesgesundheitsamt, Berlin, Germany
- Feeding during test: none

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 d

Test conditions

Hardness:

15.3 °dH (= 273.11 mg/L CaCO3).

Test temperature:

18 - 22 °C

pH:

8.0 - 8.2

Dissolved oxygen:

8.3 - 8.5 mg O2/L (95-97%)

Nominal and measured concentrations:

Nominal: control, 7.98 mg/L
Measured: See "Any other information on results incl. tables"

Details on test conditions:

Test system:
-Test vessels: 50 mL glass beakers holding 10 neonates in 20 mL of test medium
-1 test concentration plus 1control
-10 neonates per vessel, 2 replicates per concentration/control
-no feeding during the exposure period semi-static system
-mean ± 1 °C (in the temperature range 18-22 °C)
-Photoperiod: 16 h light: 8 h dark
-Aeration: none
-Medium renewal: daily
-Criteria of effects: The criterion of adverse effects used in this study was the item-induced alteration of the normal mobility behaviour and the loss of locomotory actions of the neonates, observed at 24 and 48 hours

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 3.315 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

The results are expressed in terms of geometric mean measured concentrations. Recovery rates ranged from 76.5 -93.7% of nominal values in the freshly prepared media, and from 18.3 -22.8% of nominal values in the media after 24 hours of exposure, respectively.

Any other information on results incl. tables

Table 1: Measured concentrations

Nominal concentration (mg/L)	Mean measured concentration (mg/L)
	0 h	24 h (old)	24 h (fresh)	48 h
Control	< 0.053	< 0.053	< 0.053	< 0.053
7.98 mg/L	6.104	1.817	7.474	1.458

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

(The immobilisation in the controls must not exceed 10% by the end of the test. The dissolved oxygen concentration should remain above 3 mg/L throughout the exposure period)

Conclusions:

EC50 (48 h) > 3.315 mg/L (geometric mean measured)

Executive summary:

In order to test the acute toxicity to invertebrates of the substance, Daphnia magna was exposed to the test solution of one nominal concentration of the test substance (7.98 mg/L) and a blank control solution for a period of 24 and 48 h under semi-static conditions. Mobility and visible abnormalities were recorded at 24 and 48 h.This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute Daphnia study. Oxaphthalimid does not show any toxic effects on the mobility of Daphnia resulting in an EC50 (48 h) > 3.315 mg/L (geometric mean measured).

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