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Long-term toxicity to fish

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Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
other: Method described by Harries et al. (2000): "Development of a reproductive performance Test for endocrine-disrupting chemicals using pair-breeding Fathead minnows. Environmental Science and Technology 34, 3003-3011.
Principles of method if other than guideline:
This publication is a discussion document for a future OECD guideline.
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: control, 1, 5, 50, 500 µg/L
- Sampling time: day -1, 0, 1, 2, 8, 15, 16, 22 and 23
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A 300 mg/L stock solution was prepared by dissolving 1.8 g test substances in 6 L of dechlorinated water. The concentrate was stirred overnight to provide a clear and colourless solution. A series of stock solutions was prepared by addition of the required volume of stock concentrate to 10 L glass jars.
Test organisms (species):
Pimephales promelas
Details on test organisms:
TEST ORGANISM
- Common name: fathead minnow
- Source: brood stock held at Brixham Environmental Laboratory
- Length at study initiation:
- 62.8 -64.5 (male)
- 48.0 - 51.3 (female)

HOLDING CONDITIONS
- Holding period: 6 month
- Holding conditions: same as test, except that water was only filtered through a 10 µm filter before use
- Holding temperature: 25 ± 1 °C
- Type and amount of food: high protein pelleted fish food, supplemented with frozen brine shrimp
- Feeding frequency: daily
- Mortality: none within seven days prior test start

ACCLIMATION
- Acclimation period: 11 days
- Acclimation conditions: same as test


Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
40.0 - 49.7 mg/L as CaCO3
Test temperature:
24.7 - 25.5 °C
pH:
7.3 - 7.8
Dissolved oxygen:
6.4 - 8.8 mg/L
Nominal and measured concentrations:
Nominal test concentrations: control, 1, 5, 50, 500 µg a.i./L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- Material, nominal volume, fill volume: glass vessels, 12 L, 9.5 L
- Type of flow-through: peristaltic diluter
- No. of organisms per vessel: pair of fish (1 male and 1 female)
- No. of vessels per concentration (replicates): 8 (6 adult and 2 progeny tanks)
- No. of vessels per control (replicates): 8 (6 adult and 2 progeny tanks)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water resevoir with an average retention time of 24 h. Passed through activated carbon, coarsly filtered to remove particulate material, dechlorinated with sodium thiosulphate and salts added, as required, to maintain minimum hardness levels. The treated water was held in a secondary resevoir with a capacity of 36 m³ and an average retention time of 8 h. The water was passed through an ultra violet steriliser to a second set of filters (25 and 10 µm mesh size) and then to a third storage tank with a capacity of 13.5 m³.
- Total organic carbon: 21.8 mg/L
- Alkalinity: 28.7 mg/L as CaCO3
- Ca/mg ratio: 12/3.2 mg/L
- Conductivity: 244 µS/cm
- Intervals of water quality measurement: Dissolved oxygen, pH and temperature measurements once per week in all test vessels; temperature measurements twice weekly

OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h dark, with a 10 min. dawn/dusk transition period
- Light intensity: 320-460 lux

EFFECT PARAMETERS MEASURED: fecundity (number of spawnings, total number of eggs spawned, number of eggs per spawning (egg batch size) and percent hatchability of eggs determination of plasma vittelogenin, (VTG), gonadosomatic index (GSI), histopathology


Reference substance (positive control):
yes
Remarks:
17α-ethynylestradiol
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.036 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.293 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
reproduction

 

 

Biological parameter

Effect concentration (µg a.i./L)

Nominal

Mean measured

NOEC

LOEC

NOEC

LOEC

F0 Number of spawnings

50

500

36

293

F0 Egg production

50

500

36

293

F0 Egg batch size

50

500

36

293

F0 GSI (male)

500

>500

293

>293

F0 GSI (female)

500

>500

293

>293

F0 Vitellogenin (male)

500

>500

293

>293

F0 Vitellogenin (male)

500

>500

293

>293

F1 Egg hatch

50

500

36

293

Endpoint:
adult fish: sub(lethal) effects
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 analogue justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.036 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.293 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
reproduction

Description of key information

NOEC (21 d): 0.036 mg a.i./L (measured, arithm. mean); read across

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.036 mg/L

Additional information

Data on the chronic toxicity of sodium 2-biphenylate (CAS 132-27-4) to fish are not available. The assessment was therefore based on a study conducted with the analogue substance 2-phenylphenol (CAS 90-43-7) as part of a read across approach, which is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Further justification is given within the overall summary chapter 6.1 and within the analogue justification in IUCLID section 13.

The chronic toxicity of 2-phenylphenol to fathead minnow (Pimephales promelas) was tested in a reproductive performance test based on the method described by Harries et al. (2000) with GLP compliance. The test was set up as a flow-through system. The fish were exposed for 21 days to nominal test substance concentrations of 1, 5, 50, 500 µg a.i./L. The test substance concentrations were analytically verified at day -1, 0, 1, 2, 8, 15, 16, 22 and 23 and ranged from 59-81% of the nominal. The fecundity of test fish was assessed daily. Viability of resultant embryos was assessed in animals held in the same treatment regime to which the adults were exposed. A suite of histological and biological endpoints, that potentially are directly reflective of effects associated with endocrine disrupting chemicals, was also evaluated.

Based on arithmetic mean meas. concentration the overall NOEC (21 d) was determined as 0.036 mg a.i./L and the overall LOEC (21 d) as 0.293 mg a.i./L (measured, arithm. mean).