4,4'-oxydiphthalic anhydride

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019-10-30 to 2019-01-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Remarks:

TOC measurements

Details on sampling:

- Concentrations: control and 100 mg/L
- Sampling method: sampling from test solutions without fish in intervals of 24h
- Sample storage conditions before analysis: refrigerated until transfer to analytical lab

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The test item has a low water solubility and is hydrologically unstable, therefore a degraded solution of the test item was prepared before application based on OECD Series on Testing and Assessment No. 23.
- Method: The necessary amounts of test item for preparing the stock solutions were weighed and transferred to separate Schott bottles for each test item loading rate. These bottles were filled with 1.5 L of test medium and these solutions were stirred at room temperature in the dark for 24 hours. Afterwards the undissolved test item was allowed to sediment and/or float for a period of one and a half hours. The solutions were withdrawn from the middle of the vessel using a Teflon tube. Transfer of undissolved test item was avoided. For each test concentration, a separate solution was prepared to achieve the corresponding nominal concentration.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Strain: Danio rerio Hamilton (Cypriniformes: Cyprinidae)
- Source: University of Heidelberg Germany
- Length at study initiation: between 1 and 3 cm
- Food during culturing: commercial fish flake food and protein-enriched pellet food once per day

ACCLIMATION
- Acclimation period: none

FEEDING DURING TEST
- Food type: None

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

10° dH

Test temperature:

25

pH:

7.3

Dissolved oxygen:

85%

Conductivity:

426 µS/cm

Nominal and measured concentrations:

0 and 100 mg/L
Meausured as TOC: 28 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 2L glass vessels
- Type : open
- Material, size, headspace, fill volume: 1.5L
- Aeration: No
- No. of organisms per vessel: 7 for control and 100 mg/L
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted test water

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Interval: 0, 4, 24, 48, 72 and 96h
- observations: movement, loss of equilibrium, swimming behaviour, respiratory function, pigmentation and all other observed events

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable - limit test

- Range finding study: At the same time of the limit test a range finding study was conducted with test concentrations 1 and 10 mg/L
No mortality was observed at these concentrations.

Reference substance (positive control):

yes

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

28 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

other: TOC

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

> 28 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

other: TOC

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: None
- Observations on body length and weight: no difference in body length and weight between control and 100 mg/L test solution
- Other biological observations: none
- Mortality of control: no mortality in control
- Other adverse effects control: no adverse effects in control
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Precipitation was observed in the 100 mg/L test solution.

Results with reference substance (positive control):

not reported

Sublethal observations / clinical signs:

Determination of test item concentrations by TOC measurement:

Test item nominal (mg/L)	TOC content nominal (mg/L)	Sampling	TOC found		Geometric mean (%)	Actual test item conc. (mg/L)
			[mg/L]	% of nominal
Control	0	0 h fresh	1.26	-	-	-
		96 h aged	0.91	-
100	51.3	0 h fresh	15.7	28	28	28
		96 h aged	16	29

Validity criteria fulfilled:

yes

Conclusions:

The toxicity of ODPA to fish (Danio rerio) was assessed in a 96h study according to OECD 203. The test material was found to be not toxic up to concentration 100 mg/L (nominal). No mortality or other signs of toxicity were observed.

Executive summary:

The toxicity of ODPA to fish (Danio rerio) was assessed in a study according to OECD 203. Fish were exposed for 96h to a concentration having 100 mg/L nominal test concentration. Since the substance is not hydrolytically stable, test solutions were prepared by weighing the nominal test amount, and stirring the solution for 24h in the dark. Test were then performed with the resulting aged solution. A TOC measurement was performed and 28 mg/L test material appeared to be dissolved in the resulting solution. This test concentration was maintained throughout the study.

No signs of toxicity or mortality has been observed in the control or the test solutoin (100 mg/L). As a result, the effect levels of ODPA on fish are: NOEC = 100 mg/L (nominal) = 28 mg/L (TOC measurement) and EC50 > 100 mg/L (nominal) or > 28 mg/L (TOC measurement).

Description of key information

There is one study available in which the toxicity of ODPA to fish (Danio rerio) was assessed. This is in a study conducted in 2018 -2019 according to OECD 203. Fish were exposed for 96h to a concentration having 100 mg/L nominal test concentration. Since the substance is not hydrolytically stable, test solutions were prepared by weighing the nominal test amount, and stirring the solution for 24h in the dark. Test were then performed with the resulting aged solution. A TOC measurement was performed and 28 mg/L test material appeared to be dissolved in the resulting solution. This test concentration was maintained throughout the study.

No signs of toxicity or mortality has been observed in the control or the test solutoin (100 mg/L). As a result, the effect levels of ODPA on fish are: NOEC = 100 mg/L (nominal) = 28 mg/L (TOC measurement) and EC50 > 100 mg/L (nominal) or > 28 mg/L (TOC measurement).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

28 mg/L