4,4'-dioxo-4,4'-dioxydibutyric acid

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998

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:

1984

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

1992

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all test concentrations and the control
- Sample storage conditions before analysis: In pre-experiments significant losses of test article were determined in deep-frozen test medium samples. Therefore, all samples were analyzed immediately after sampling without prior storage.

Vehicle:

yes

Remarks:

Reconstituted test water

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
The test medium of the highest test concentration of nominal 100 mg/L was prepared by dissolving 482 mg test article in 3 liters test water by intense stirring and short ultrasonic treatment. The amount of test article required was adjusted based on its purity (62.2%).

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Waterflea
- Clone: Straus
- Source: University of Sheffield/UK in 1992
- Age of animals: 6 - 24 h (not first brood progeny)
- Feeding during test: no

ACCLIMATION
not necessary, breed under test conditions

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

21 - 22 °C

pH:

7.5 - 8.1

Dissolved oxygen:

8.2 - 8.4 mg/L

Nominal and measured concentrations:

Nominal concentrations: 4.6, 10, 22, 46 and 100 mg/L
Measured concentrations: 3.6, 7.4, 17.6, 40 and 94 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: n100 mL glass beaker
- Material, fill volume: glass, 50 mL
- Aeration: untill oxygen saturation was reached before test, no aeration during test
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST WATER PARAMETERS
- Preparation of dilution water: analytical grade salts were added to purified water to obtain the following nominal concentrations:
CaCI2 x 2H20: 2.0 mmol/L (= 294.0 mg/L)
MgS04 x 7H20: 0.5 mmol/L (= 123.0 mg/L)
NaHC03: 0.75 mmol/L (= 65.0 mg/L)
KCI: 0.075 mmol/L (= 5.8 mg/L)
Water Hardness Alkalinity: 2.5 mmol/L (= 250.0 mg/l) as CaC03 0.8 mmol/L
Ratio of Ca : Mg = 4 :1 (based on molarity)
Na : K =10:1 (based on molarity)

OTHER TEST CONDITIONS
- Adjustment of pH: yes, for the nominal concentrations of 22, 46 and 100 mg/L adjustment with 0.1M (NaOH) to values between 8.0 and 8.1
- Photoperiod: 16-hour light to 8-hour darkness
- Light intensity: 200 - 1200 Lux

EFFECT PARAMETERS MEASURED
Immobility of daphnids tested after 24 and 48h, pH and Oxygen after 0 and 48 h

RANGE-FINDING STUDY
- Test concentrations: not available
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

not specified

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

13 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95 %CI: 11 - 14 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

7.4 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

40 mg/L

Nominal / measured:

meas. (geom. mean)

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
- Effect concentrations exceeding solubility of substance in test medium: no

Reported statistics and error estimates:

The 24-hour and 48-hour EC50 and the 95% confidence limits were calculated by Moving average interpolation. The NOEC, ECO and EC100 were determined directly from the raw data.

Validity criteria fulfilled:

yes

Conclusions:

According to OECD 202 the test item showed a EC50 of 13 mg/L.

Executive summary:

The acute toxicity of the test substance was evaluated with Daphnia magna STRAUS using a 48-hour static test according to OECD guideline No. 202 and EU method C.2. A preliminary test preceded the definitive test. Five concentrations of the test substance were used together with a control at: 4.6, 10, 22, 46 and 100 mg/L. Twenty daphnids (in two replicates of ten) were exposed to each concentration for 48 hours and immobilization was recorded at 0, 24 and 48 hours. Initial concentrations of the test item measured in the definitive test solutions were 69% till 82 % of the corresponding nominal values. Therefore, the reported biological results are related to the total mean measured test article concentrations: 3.6, 7.4, 17.6, 40 and 94 mg/L. Under the experimental conditions, the 48-hour EC50 of the test substance in a static test system is 13 mg/L (95% CI: 11 - 14 mg/L) for Daphnia magna.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to section 13 for "Read-Across justification".

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

13 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95 % CI: 11 - 14 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

7.4 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

40 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Description of key information

According to OECD 202 the source item 5-[(4-carboxybutanoyl)peroxy]-5-oxopentanoic acid showed an EC50 of 13 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

13 mg/L

Additional information

The endpoint short-term toxicity to aquatic invertebrates was covered with read-across approach to the source substance 5-[(4-carboxybutanoyl)peroxy]-5-oxopentanoic acid, GAP (CAS 10195-54-7, EC 600-254-8).

The acute toxicity of the source substance was evaluated with Daphnia magna STRAUS using a 48-hour static test according to OECD guideline No. 202 and EU method C.2. A preliminary test preceded the definitive test. Five concentrations of the test substance were used together with a control at: 4.6, 10, 22, 46 and 100 mg/L. Twenty daphnids (in two replicates of ten) were exposed to each concentration for 48 hours and immobilization was recorded at 0, 24 and 48 hours. Initial concentrations of the test item measured in the definitive test solutions were 69 % till 82 % of the corresponding nominal values. Therefore, the reported biological results are related to the total mean measured test article concentrations: 3.6, 7.4, 17.6, 40 and 94 mg/L. Under the experimental conditions, the 48-hour EC50 of the test substance in a static test system is 13 mg/L (95 % CI: 11 - 14 mg/L) for Daphnia magna.