4,4'-biphthalic dianhydride

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:

31-03-2016 to 20-12-2016

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:

2004

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

2008

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

All concentration levels and the control were analytically verified via LC-MS/MS at the start (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours). At the start of the exposure intervals (0 and 24 hours), sampling was carried out from the newly prepared test concentrations. At the end of the exposure intervals (24 and 48 hours), samples were taken directly from the test vessels.

Vehicle:

no

Details on test solutions:

The test item is known to degrade quickly (half-life < 1 hour) by hydrolysis. Therefore, the hydrolysis product was tested as recommended in OECD Guidance Document No. 23 (2000). For this purpose, a saturated solution with a nominal concentration of 100 mg/L of the test item was prepared with dilution water one day prior to the start of each exposure interval (at -24 and 0 hours). The test item was mixed with the dilution water by constant stirring with a magnetic stirrer at approximately 1100 rpm for 24 hours at room temperature to ensure complete hydrolysis of the test item. Thereafter, undissolved particles were removed by membrane filtration (membrane filter 0.45 µm, RC, MACHEREY-NAGEL). During filtration the filter was always kept covered. The filtrate, i.e. the saturated solution, was used as the highest concentration in the test and as a stock solution for the preparation of further concentration levels.

Test organisms (species):

Daphnia magna

Details on test organisms:

Less than 24 hours old daphnids from a healthy stock were used for the study. Juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period of max. 24 hours preceding the exposure were used for the test. No first brood progeny was used for the test. Acclimatization was not necessary, because the dilution water was equivalent to the culture medium.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

Water Quality Parameters of the Dilution Water at the Start of the Exposure Intervals (0 and 24 hours)
Dilution water Temperature [°C]
dated:
0 hours: 2016-04-27 20.2
24 hours: 2016-04-28 20.2

pH:

pH values at the start of the Exposure Intervals (0 and 24 hours)
Geometric mean 0 hours 24 hours
measured concentration pH-value pH-value
of the test item
[mg/L]
28.1 7.54 7.94
15.6 8.11 8.08
7.59 8.75 8.18
4.48 8.89 8.20
2.15 8.79 8.16
Control 7.92 7.62

pH values at the End of the Exposure Interval (24 hours)

Geometric mean pH values
measured concentration measured in all replicates
of the test item
[mg/L]
28.1 7.59 7.56 7.49 7.45
15.6 7.65 7.63 7.62 7.61
7.59 7.68 7.68 7.64 7.66
4.48 7.69 7.70 7.67 7.69
2.15 7.68 7.70 7.69 7.68
Control 7.62 7.65 7.65 7.66

pH values at the End of the Exposure Interval (48 hours)

Geometric mean pH values
measured concentration measured in all replicates
of the test item
[mg/L]
28.1 7.77 7.76 7.75 7.75
15.6 7.76 7.76 7.76 7.75
7.59 7.71 7.73 7.72 7.75
4.48 7.67 7.70 7.71 7.71
2.15 7.59 7.62 7.63 7.65
Control 7.23 7.37 7.47 7.53

Dissolved oxygen:

Water Quality Parameters at the Start of the Exposure Intervals (0 and 24 hours)
Geometric mean Dissolved O2 concentration [mg/L]
measured concentration 0 hours 24 hours
of the test item
[mg/L]
28.1 8.10 8.02
15.6 8.23 8.15
7.59 8.34 8.26
4.48 9.08 8.43
2.15 9.33 9.02
Control 8.48 8.26


Water Quality Parameters at the End of the Exposure Interval (24 hours)

Geometric mean Dissolved O2 concentration [mg/L]
measured concentration measured in all replicates
of the test item
[mg/L]
28.1 8.31 8.18 8.20 8.34
15.6 8.10 8.31 8.33 8.31
7.59 8.10 8.27 8.16 8.12
4.48 8.30 8.23 8.32 8.21
2.15 8.25 8.34 8.30 8.19
Control 8.22 8.23 8.13 8.15


Water Quality Parameters at the End of the Exposure Interval (48 hours)

Geometric mean Dissolved O2 concentration [mg/L]
measured concentration measured in all replicates
of the test item
[mg/L]
28.1 8.40 8.50 8.54 8.41
15.6 8.26 8.23 8.49 8.46
7.59 8.46 8.38 8.22 8.36
4.48 8.39 8.35 8.20 8.22
2.15 8.20 8.37 8.39 8.44
Control 8.09 8.17 8.20 8.19

Nominal and measured concentrations:

5 concentration levels of the test item in a geometric series with a separation factor of 2, prepared by dilution of the saturated solution with dilution water, were tested as follows: 6.25 - 12.5 - 25.0 - 50.0 - 100% of the saturated solution. The concentration rates mentioned above correspond to the geometric mean measured concentrations of: 2.15 - 4.48 - 7.59 - 15.6 - 28.1 mg/L.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 28.1 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

EC50-Value (with 95% confidents limits) of the Reference Item Potassium dichromate based on nominal concentrations [mg/L], (0 - 24 hours)

Current Study Valid Range
EC50 1.95 mg/L 0.6 - 2.4 mg/L, acc. to AQS P 9/2 (02/2000)
95% confidence limits 1.14 - 3.30 mg/L 0.6 - 2.1 mg/L, acc. to OECD 202 (2004)

Measured Concentrations of the Test Item during the Definitive Test

Sampling date	2016-04-27 Start of the  exposure interval 0 hours	2016-04-28 End of the  exposure interval 24 hours		2016-04-28 Start of the  exposure interval 24 hours	2016-04-29 End of the  exposure interval 48 hours
Start of analysis	2016-04-27	2016-04-28		2016-04-28	2016-04-29
Dilution level of the saturated solution [%]							Geometric mean measured test item concentration [mg/L]
	Meas. conc. [mg/L]	Meas. conc. [mg/L]	%	Meas. conc. [mg/L]	Meas. conc. [mg/L]	%
100*	30.1	38.9	129	25.0	21.2	85	28.1
50.0	16.3	22.0	135	13.8	12.0	87	15.6
25.0	8.29	11.0	132	6.25	5.85	94	7.59
12.5	5.21	5.79	111	3.66	3.64	99	4.48
6.25	2.48	2.69	108	1.78	1.79	101	2.15
Control	< LOQ	< LOQ		< LOQ	< LOQ

Validity criteria fulfilled:

yes

Conclusions:

In this study, no biological effects occurred in the saturated solution with a geometric mean measured concentration of 28.1 mg/L. Thus, the test item is not toxic up to the limit of water solubility.
The validity criteria of the test guidelines were fulfilled.

Executive summary:

In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item were determined according to OECD 202 (2004), which is equivalent to the Council Regulation (EC) No.440/2008 Method C.2 (2008). The study was conducted under semi-static conditions over a period of 48 hours with a saturated solution (prepared with a nominal concentration of 100 mg/L of the test item and further four dilution levels in a geometric series with a separation factor of 2 (nominal concentrations of 6.25 to 100% of the saturated solution).

Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration level and the control. The concentrations of the test item were analytically verified via LC-MS/MS at the start of the exposure intervals (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours) in all tested concentration levels and the control.

The measured concentrations of the saturated solution were 30.1 mg/L at 0 hours and 25.0 mg/L at 24 hours. The measured concentrations of the test item at the start of the exposure intervals (0 and 24 hours) reflect the dilution factor of 2. At the end of the exposure intervals (24 and 48 hours), the measured concentrations were within the range of 85 to 135% of the initially measured concentrations.The effect values are based on the geometric mean measured concentrations of the test item. The calculated geometric mean measured concentrations were as follows: 2.15 - 4.48 - 7.59 - 15.6 - 28.1 mg/L.

In this study, no biological effects occurred in the saturated solution with a geometric mean measured concentration of 28.1 mg/L. Thus, the test item is not toxic up to the limit of water solubility.

The validity criteria of the test guidelines were fulfilled.

Description of key information

In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item were determined according to OECD 202 (2004), which is equivalent to the Council Regulation (EC) No.440/2008 Method C.2 (2008). The study was conducted under semi-static conditions over a period of 48 hours with a saturated solution (prepared with a nominal concentration of 100 mg/L of the test item and further four dilution levels in a geometric series with a separation factor of 2 (nominal concentrations of 6.25 to 100% of the saturated solution).

Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration level and the control. The concentrations of the test item were analytically verified via LC-MS/MS at the start of the exposure intervals (0 and 24 hours) and at the end of the exposure intervals (24 and 48 hours) in all tested concentration levels and the control.

The measured concentrations of the saturated solution were 30.1 mg/L at 0 hours and 25.0 mg/L at 24 hours. The measured concentrations of the test item at the start of the exposure intervals (0 and 24 hours) reflect the dilution factor of 2. At the end of the exposure intervals (24 and 48 hours), the measured concentrations were within the range of 85 to 135% of the initially measured concentrations.The effect values are based on the geometric mean measured concentrations of the test item. The calculated geometric mean measured concentrations were as follows: 2.15 - 4.48 - 7.59 - 15.6 - 28.1 mg/L.

In this study, no biological effects occurred in the saturated solution with a geometric mean measured concentration of 28.1 mg/L. Thus, the test item is not toxic up to the limit of water solubility.

The validity criteria of the test guidelines were fulfilled.

In this study, no biological effects occurred in the saturated solution with a geometric mean measured concentration of 28.1 mg/L. Thus, the test item is not toxic up to the limit of water solubility.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

28.1 mg/L