Reaction mass of 1,1'-(2,2,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione and 1H-Pyrrole-2,5-dione, 1,1'-(2,4,4-trimethyl-1,6-hexanediyl)bis-

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:

2008-09-23 to 2008-09-25

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:

adpted 13 April 2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

December 1992

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all concentrations at test start and test termination.
- Sampling method: 2 mL from the approximate centre of the test vessels.
- Sample storage conditions before analysis: no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solutions were prepared separately for each loading rate at concentrations 10,000 higher than the target test concentrations. No special treatment other than careful shaking was applied to dissolve the stocks
- Eluate: no
- Differential loading: no
- Controls: yes, test medium control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Acetone

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: ln-house Iaboratory culture with a known history.
- Age at study initiation (mean and range, SD): young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old.
- Feeding during test: no


Breeding:
Start of each batch: With newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture
vessel.
Maximum age of the cultures: 4 weeks
Renewal of the cultures: After 7 days of cultivation half of the medium twice a week.
Temperature of medium: 18 - 22°C
Feeding: Daily, a suspension of fresh water algae.
Medium: M7, as prescribed by Dr. Elendt-Schneider (Eiendt, B.-P., 1990: Selenium deficiency in Crustacea. An ultrastructural approach to antennal
damage in Daphnia magna Straus. Protoplasma 154, 25-33).

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

180 mg/L as CaCO3

Test temperature:

21.3 - 21.6 °C

pH:

7.8 - 8.0

Dissolved oxygen:

8.9 - 9.1 mg/L

Nominal and measured concentrations:

Nominal test substance concentrations: 0.10, 0.18, 0.32, 0.56 and 1.0 mg/L
Measured test substance concentration after 48 h: 0.11, 0.204,. 0,336. 0.548, and 0.952 mg/L (95 - 109% of nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel: stainless steel vessels (1.5 L nominal volume)
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): diluter
- Renewal rate of test solution (frequency/flow rate): flow rate ca 6 L/h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per vehicle control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: adjusted ISO medium
- Intervals of water quality measurement: pH and oxygen after 0 and 48 h, termperature continously

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 h day- night cycle

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mobility after 24 and 48 hours

VEHICLE CONTROL PERFORMED: yes

RANGE-FINDING STUDY
Limit/range finding test
- Test concentrations: 1.0, 10, 100 mg/L
- Results used to determine the conditions for the definitive study: 90% immobilised at 10 mg/L after 48 h

Range finding test (flow-through)
- Test concentrations: 0.05, 0.2 and 0.8 mg/L
- Results used to determine the conditions for the definitive study: 100% immobilised at 0.8 mg/L after 48 h

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.18 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: confidence interval: 0.16 to 0.21 mg/L

Details on results:

- Immobilisation of control: no

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Relevant effect levels:
The EC50 (24 h) was 0.77 mg/L with a 95% confidence interval between 0.68 and 0.91 mg/L.
The EC50 (48 h) was 0.62 mg/L with a 95% confidence interval between 0.53 and 0.77 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present flow-through study MATMD did not induce acute immobilisation of Daphnia magna at 0.10 mg/L after 48 h of exposure (NOEC). The EC50 (48 h) was calculated to be 0.18 mg/L (nominal, 95% confidence interval between 0.16 and 0.21 mg/L).

Description of key information

EC50 (48 h): 0.18 mg/L (nominal, OECD 202)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

0.18 mg/L

Additional information

A study on Daphnia magna has been performed according to OECD guideline 202 in compliance with GLP, applying flow-through conditions. The test animals were exposed to nominal test substance concentrations of 0.10, 0.18, 0.32, 0.56 and 1.0 mg/L. Analytical dose verification determined measured substance concentrations within 95 – 109% of nominal. Thus, all results were based on nominal concentrations. An EC50 (48 h) of 0.18 mg/L was determined.