Dibenzoyl-L-tartaric acid monohydrate

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:

25/02/2003 - 27/03/2003

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)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)

Deviations:

no

Qualifier:

according to guideline

Guideline:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

Version / remarks:

1989

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 (control), 12.5, 25, 50 and 100 mg/L
- Sampling method: At the begin (after 0 h) and at the end of the exposition (after48 h) samples from vessels without daphnids were analysed.
- Sample storage conditions before analysis: none (analysed immediately)

Vehicle:

no

Remarks:

M4 medium

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was stirred in M4 medium for about 30 minutes at 20 ± 2 ºC.
- Differential loading: The concentration of the stock solution was 100 mg/I (net weight : 50.1 mg / 500 ml).
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: daphnia magna
- Strain/clone: STRAUS 1820
- Source: bred in the Laboratory Experimental Toxicology and Ecology of BASF AG, originally from Institut National de Recherche Chimiche Apliquée, France (1978).
- Age of parental stock (mean and range, SD): 2-4 weeks
- Feeding during test: no

ACCLIMATION
- Acclimation period: no (culturing conditions same as test).

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

2.20 - 3.20 mmol/l

Test temperature:

20 ± 2ºC

pH:

7.5 - 8.5

Dissolved oxygen:

> 3 mg/L

Conductivity:

550 - 650 μS/cm

Nominal and measured concentrations:

Nominal concentrations: 0 (control), 12.5, 25, 50 and 100 mg/L test item (factor 2).
Measured concentrations were 99.2 - 101% of nominal at the start and at the end of the study.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass test tubes with flat bottom (20 ml).
- Material, size, headspace, fill volume: glass, 20 ml, 10ml, 10 ml.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 0.5 animals/ml

TEST MEDIUM / WATER PARAMETERS (M4 medium)
- Source/preparation of dilution water: synthetic freshwater
- Composition according to ISO 10706. After preparation the M4 medium is aerated for approximately 24 h until saturation with oxygen is reached.
- pH: 8.2
- Alkalinity: 0.87 mmol/I
- Ca/mg ratio: about 4:1
- Conductivity: 596 μS/cm
- Hardness: 2.42 mmol/l

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light / 8h dark
- Light intensity: Artificial light, type warm white (OSRAM L58 W31), about 1- 8 μE/(m2•s) at a wave length of 400 - 750 nm

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Visual determination of swimming ability after 0, 24 and 48 h

VEHICLE CONTROL PERFORMED: yes

RANGE-FINDING STUDY
- Test concentrations: The test concentrations were determined in a range finding test (non GLP). No further details specified.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: no
- Observations on body length and weight: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no.

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50: 1.37 mg/l

Table 1. Number of mobile Daphnids in the different test conditions.

Conc. (mg/l)	Parallel 1 (h)			Parallel 2 (h)			Parallel 3 (h)			Parallel 4 (h)			Total (h)
	0	24	48	0	24	48	0	24	48	0	24	48	24	48
Control	5	5	5	5	5	5	5	5	5	5	5	5	20	20
12.5	5	5	5	5	5	5	5	5	5	5	5	5	20	20
25	5	5	5	5	5	5	5	5	5	5	5	4	20	19
50	5	5	5	5	5	5	5	5	5	5	5	5	20	20
100	5	5	5	5	5	5	5	5	5	5	5	5	20	20

 

Table 2. Minimum and maximum values of the chemical and physical parameters of the test solutions during the test period.

Parameter	Min	Max
pH value	6.7	8.2
Oxygen content (mg/L)	8.4	9.1
Temperature (ºC)*	19.6	20.1

*measured in a separate vessel.

Table 3. pH and O2 values in the test solutions after 0 and 48h.

Conc. (mg/l)	pH value		O2 value (mg/L)
	0 h	48 h	0 h	48 h
Control	8.2	8.1	9.1	8.9
12.5	8.2	8.1	9.1	8.8
25	8.1	8.1	8.9	8.9
50	7.7	8.1	8.9	8.5
100	6.7	7.9	8.8	8.4

 

Validity criteria fulfilled:

yes

Remarks:

in the control the immobilization was ≤ 10%, and no daphnids were captured in a surface film; O2 concentration was > 3 mg/I in all tested replicates; 24h-EC50 of the control substance (non-GLP) was 1,37 mg/I (last control 13/02/03, project 02/0106/50/13).

Conclusions:

The 48h-EC50 of the test item in Daphnia magna was found to be higher tan 100 mg/L, based on mobility.

Executive summary:

An acute immobilisation test on Daphnia magna was performed in accordance with OECD Guideline 202 / EU method C.2, under GLP. Based on the results of a preliminary range-finding test, the main test was carried out using concentrations of 0 (control), 12.5, 25, 50 and 100 mg/L test item in a static system. Test concentrations were analytically determined by HPLC at the beginning and at the end of the test and did not deviate more than 20%. Twenty animals, divided into four groups of five animals each were exposed to the test item or the control for 48 h (glass test tubes). The results of the last performed positive control (potassium dichromate) were used to ensure the quality of the results. All validity criteria were met. The 48h-EC50 of the test item in Daphnia magna was determined to be higher than 100 mg/L, based on mobility.

Description of key information

Key study. Method according to OECD 202 / EU C.2, GLP study. The 48h-EC50 of the test item in Daphnia magna is higher than 100 mg/L, based on mobility.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L