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 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:

2013-09-12 to 2013-09-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all, daily
- Sample storage conditions before analysis: stored at 6 ± 2 °C

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solutions were prepared and mixed the the dilution water in a mixing chamber
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Dimethyl sulfoxide (DMSO)
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): 0.100 mL/L

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Source: Umweltbundesamt, Berlin, Germany
- Length at study initiation (length definition, mean): 2 ± 1 cm
- Weight at study initiation (mean): 0.41 g
- Feeding during test: no

ACCLIMATION
- Acclimation period: Zebrafish with at least 12 days of acclimatisation
- Acclimation conditions: same as test conditions
- Type and amount of food: Sera Vipan; SERA GMBH, Heinsberg, Germany, 4% of fish body weight
- Feeding frequency: 3 times a week
- Health during acclimation (any mortality observed): no

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

Total hardness: 43 mg CaCO3/L

Test temperature:

23.2 - 23.5 °C

pH:

7.79 - 8.39

Dissolved oxygen:

100% saturation

Nominal and measured concentrations:

Nominal test item concentrations: 0.550, 0.250, 0.114, 0.0518, 0.0235 mg/L
Geometric mean meassured concentrations: 0.315, 0.114, 0.0606, 0.0314, 0.0156 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria
- Fill volume: 7.6 L
- Type of flow-through (e.g. peristaltic or proportional diluter): membrane piston pumps
- Renewal rate of test solution (frequency/flow rate): 6.88 L/h (mean first order), 6.59 /meand, second order)
- Aeration: No aeration will be provided in the test vessels. The dilution water supply tank will be aerated.
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.02 g fish/L at maximum

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: double distilled water
- Intervals of water quality measurement: after 0, 24, 48, 72 and 96 h

OTHER TEST CONDITIONS
- Photoperiod: light/dark cycle was 12 to 12 h
- Light intensity: 3.14 - 5.74 µmol/m²s

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and visible abnormalities (e.g. loss of equilibrium,swimming behaviour, respiratory function, pigmentation, etc.) after 24, 48, 72 and 96 hours.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Range finding study: yes
- Test concentrations: 1.0 , 0.1, 0.01 mg/L
- Results used to determine the conditions for the definitive study: 100% mortality at 1.0 mg/L after 48 h

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.06 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: confidence interval: 0.0314 - 0.114 mg/L

Details on results:

- Behavioural abnormalities: starting at 0.0314 mg/L: slowed escape reflex, abnormal swimming motions, remaining unusually long at the surface, remaining unusually long on the ground.
- Mortality of control: no
- Other adverse effects control: no

Validity criteria fulfilled:

yes

Conclusions:

The study resulted in a LC50 (96 h) of 0.0602 mg/L (geometric mean measured concentration).

Description of key information

LC50 (96 h): 0.0602 mg/L (geometric mean, OECD 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.06 mg/L

Additional information

An acute toxicity study under flow-through conditions was carried out according to OECD guideline 203 in compliance with GLP with Danio rerio as test organism. The test was conducted with nominal test substance concentrations of 0.550, 0.250, 0.114, 0.0518, and 0.0235 mg/L. The measured concentrations ranged from 39-78% of the nominal values during exposure, therefore the geometric mean measured concentrations were determined. A LC50 (96 h) of 0.0602 mg/L based on geometric mean measured concentrations was determined.