Ibuprofen

Long-term toxicity to fish

Administrative data

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

April 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable GLP guideline study; poster publication, acceptable for assessment. The reliability is also given in a draft study report by 'Wildlife Int. Ltd.'.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Ibuprofen: an early life-stage toxicity test with the Fathead minnow (Pimephales promelas)

Author:

Maack, G., Gallagher, S. P., Krueger, H. O., Leopold, A., Rechenberg, B.

Year:

2011

Bibliographic source:

Poster publication by the UBA (Umweltbundesamt)

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ibuprofen

EC Number:

239-784-6

EC Name:

Ibuprofen

Cas Number:

15687-27-1

Molecular formula:

C13H18O2

IUPAC Name:

2-(4-isobutylphenyl)propanoic acid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Arcos Organics: lot 1) A0286876 (purity: 99.2%); lot 2) A0157934 (purity: 99.9%)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all treatments (from one replicate), samples of primary stock solutions,
- Sampling method: Days 0, 7, 14, 21, 28 and 33 (test termination), all samples were collected at mid-depth in the test chambers
- Sample storage conditions before analysis: not applicable, samples processed immediately for analysis

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: primary stock solution at 0.019 mg/mL; preparation of secondary stock solution (0.003, 0.0010, 0.0031, 0.010, 0.0313 mg/mL) by proportional dilution using the primary stock solution; preparation of stock solutions was performed 10 times during the exposure period
- Controls: negative control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)):
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): primary stock solution was clear and colorless with white precipitate flowting on the solution surface; secondary stock solutions were clear and colorless

Test organisms

Test organisms (species):

Pimephales promelas

Details on test organisms:

TEST ORGANISM
- Common name: fathead minnow
- Source: Chesapeake Cultures, Inc., Hayes Virginia 23072, USA

METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Method of collection of fertilised eggs: Fathead minnow embryos (< 24 h old) were received on spawning substrate from source

POST-HATCH FEEDING
Live brine shrimp nauplii (Artemia sp.) three times per day during the first seven days of post-hatch. Thereafter, they were fed live brine shrimp nauplii three times per day on weekdays and at least two times per day on weekends. Fish were not fed for approximately 48 hours prior to the
termination of the test to allow for clearance of the digestive tracts before weight measurements were made.

Study design

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

33 d

Remarks on exposure duration:

5-d embryo hatching period + 28 days post-hatch juvenile growth

Test conditions

Hardness:

control: 142±3 mg/L as CaCO3
highest test concentration: 138±2 mg/L as CaCO3

Test temperature:

25 °C ± 1 °C

pH:

8.0 to 8.2

Dissolved oxygen:

7.2 mg/L (≥ 88%)

Conductivity:

control: 382 µmhos/cm
highest test concentration: 378±24 µmhos/cm

Nominal and measured concentrations:

Nominal: 0.010, 0.032, 0.10, 0.32, 1.0 and 3.2 mg/L
Mean measured concentrations: 0 (control), 0.0091, 0.029, 0.092, 0.3, 0.93, 3.0 mg/L
Recovery: 91, 91, 92, 94, 93 and 94%

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass tanks (max. volume: 9 L)
- Fill volume: 7 L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): 6 exchanges per day
- No. of fertilized eggs/embryos per vessel: 20
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 (L:D)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- hatching success
- time to hatch
- larval survival
- growth

POST-HATCH DETAILS
- Begin of post-hatch period: after 5 days (hatching period)

Reference substance (positive control):

not specified

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

33 d

Dose descriptor:

NOEC

Effect conc.:

>= 3 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

act. ingr.

Basis for effect:

number hatched

Remarks:

+ time to hatch, larval mortality and growth

Remarks on result:

other: NOEC = highest tested concentration

Effect concentrations 2

Duration:

33 d

Dose descriptor:

LOEC

Effect conc.:

> 3 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

act. ingr.

Basis for effect:

number hatched

Remarks:

+ time to hatch, larval mortality and growth

Details on results:

As no effects could be observed up to the highest concentration tested (3 mg/L), the NOECs were set to be ≥ 3 mg/L and the LOEC values are derived to be > 3 mg/L.

Any other information on results incl. tables

Summary of hatching success, larval survival and growth parameters

Mean measured concentrations (mg/L)	Hatching success (%)	Survival to day 28 posthatch (%)	Growth parameters at day 28 posthatch
			Mean total length ± SD (mm)	Mean wet weight ± SD (mg)	Mean dry weight ± SD (mg)
negative control	100	76	24.2±0.66	108.3±2.88	21.9±0.92
0.0091	99	87	25.1±0.42	123.2±6.63	26.1±1.02
0.029	98	82	24.7±0.57	123.1±10.49	24.7±2.29
0.092	100	83	24.6±0.54	114.2±4.35	22.9±0.38
0.30	99	85	24.0±0.61	100.5±7.25	20.7±1.85
0.93	99	80	24.9±0.39	115.7±4.79	24.1±1.16
3	99	76	24.4±0.44	109.1±6.23	22.1±1.47

There were no statistically significant differences for any parameter measured in comparison to the negative control (p> 0.05).