Bis(2-ethylhexyl) succinate

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

not specified

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Stock solution: 1 g/L test material + 1 g/L vehicle, the calculated test concentrations of 0.19, 0.39, 0.77 mg/L contained 2.0 mg/L vehicle (nominal)
- Chemical name of vehicle: 1 g/L MARLOWET R 40

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: clone 5
- Source: own breeding
- Feeding during test
- Food type: green algae
- Amount: 0.5E7 cells/daphnid from day 0 to day 6; 1.0E7 cells/daphnid from day 7 to day 21
- Frequency: daily
- Age of test organisms: < 24 hours

HOUSING
- Housing medium: M4-medium (Elendt, 1990)
- Housing conditions: each test organism were kept separate in 60 mL test water

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Test temperature:

20 °C

pH:

7.8 - 8.6

Dissolved oxygen:

94 - 107 mg/L

Nominal and measured concentrations:

Nominal test concentrations: 0.5, 1.0, 2.0 mg/L
Measured concentrations: 0.19, 0.39, 0.77 mg/L (geometric mean, biological active)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, total volume, fill volume: glass beakers, 150 mL, 100 mL
- Renewal rate of test solution (frequency): after 2, 6, 7, 9, 12, 14, 16, 19 days
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- No. of vessels per vehicle control (replicates): 10
- Biomass loading rate: 1 daphnid/100 mL

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic freshwater according to Elendt (M4-medium)
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH-value and oxygen content of the new test solutions at day 2, 12, 16 and of the old test solutions at day 6, 14, 19.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness
- Light intensity: approx. 450 and 95 lux

EFFECT PARAMETERS MEASURED: mortality and reporduction after 2, 6, 7 9, 12, 14, 16, 19, 21 days

VEHICLE CONTROL PERFORMED: yes

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 0.77 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

> 0.77 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Details on results:

Toxic effects on the reproduction and mortality of the adult daphnids, respectively, are above the water solubility of the test material.

Validity criteria fulfilled:

not specified

Conclusions:

Under the conditions of the study, the No Oberved Effect Concentration was determined to be greater than or equal to 0.77 mg/L.

Executive summary:

The long term toxicity of the test material to aquatic invertebrates was investigated in a GLP study which was conducted in accordance with the standardised guideline OECD 211 under semi-static conditions. Under the conditions of the study, the No Oberved Effect Concentration was determined to be greater than or equal to 0.77 mg/L.

Description of key information

Study conducted to recognised testing guideline with acceptable restrictions.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.77 mg/L

Additional information

The long term toxicity of the test material to aquatic invertebrates was investigated in a GLP study which was conducted in accordance with the standardised guideline OECD 211 under semi-static conditions. Under the conditions of the study, the No Observed Effect Concentration was determined to be greater than or equal to 0.77 mg/L.

The study was conducted to GLP and a standardised guideline. Since the study was conducted with the structural analogue, bis(2-ethylhexyl) adipate, it was assigned a reliability score of 2 and considered suitable for assessment as an accurate reflection of the test substance.

The available data are considered to be complete and the result determined, 21 d NOEC value of ≥ 0.77 mg/L, was taken forward for risk assessment.