Phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol]

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:

23/01/2006 - 28/04/06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: PARCOM 1995. Protocol for a Fish Acute Toxicity Test. Oslo and Paris Commission Protocol

Version / remarks:

adapted from the OECD 203 Guideline

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Details on sampling:

- Concentrations: 0 and 10 mg/L test substance.
- Sampling method: Sampling population mortality percentage

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Fish were transferred from a holding tank to the test tank containing a prepared solution of the test substance
- Controls: 5 mortality controls, one per exposure period
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No, test material soluble.

Test organisms (species):

other: Scophthalmus maximus

Details on test organisms:

TEST ORGANISM
- Common name: Scophthalmus maximus
- Strain: SM06001
- Source: France Turbot, L'Epine, France

Test type:

semi-static

Water media type:

saltwater

Limit test:

yes

Total exposure duration:

96 h

Remarks on exposure duration:

Exposure measurements taken at 0, 24, 48, 72 and 96 hours

Test temperature:

14.6 °C

pH:

pH 8.06 - 8.13

Dissolved oxygen:

99.6 - 100.0 % air saturation

Salinity:

31.6 %

Nominal and measured concentrations:

Nominal, 25 % test substance (M-528-7) - 10 mg/ L

Details on test conditions:

TEST SYSTEM
- Material, size, headspace, fill volume: 10 L
- Renewal rate of test solution (frequency/flow rate): 48 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 5


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Artificial seawater (Coral Reef, Kent Sea Salt, Red Sea Fish Pharm)
- Alkalinity: pH 8.06 - 8.13
- Intervals of water quality measurement: 24 intervals

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, measured at 0, 24, 48, 72 and 96 hours.

TEST CONCENTRATIONS
- Test concentrations: 0 and 10 mg / L test substance
- Results used to determine the conditions for the definitive study: 0 and 10 mg / L test substance

Reference substance (positive control):

no

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No, test material dissolved completely
- Effect concentrations exceeding solubility of substance in test medium: Effect concentration was higher that maximum dissolved mass of test substance

Validity criteria fulfilled:

yes

Conclusions:

The LC50 value for 0, 24, 48, 72 and 96 hours was determined to be > 10 mg/ L.

Executive summary:

The study assessed the acute toxicity of 25 % M-528 -7, identified as the registered substance. The test specis was Scophthalmus maximus. This study was performed under GLP in accordance with PARCOM 1995: Protocol for a Fish Acute Toxicity Test. All validity criteria were complied with. The time limit test performed used one concentration of the test substance to show an LC50 value of >10 mg/L for 0, 24, 48, 72 and 96 hours. A mortality control was performed, containing 0 mg/L for 0, 24, 48, 72 and 96 hours with 0% mortality in the fish test populations. For both the definitive test and mortality control one replicate was used per concentration with 7 organisms per vessel.

Description of key information

The study assessed the acute toxicity of 25 % M-528 -7, identified as the registered substance. The test specis was Scophthalmus maximus. This study was performed under GLP in accordance with PARCOM 1995: Protocol for a Fish Acute Toxicity Test. All validity criteria were complied with. The time limit test performed used one concentration of the test substance to show an LC50 value of >10 mg/L for 0, 24, 48, 72 and 96 hours. A mortality control was performed, containing 0 mg/L for 0, 24, 48, 72 and 96 hours with 0% mortality in the fish test populations. For both the definitive test and mortality control one replicate was used per concentration with 7 organisms per vessel.

Key value for chemical safety assessment

Marine water fish

Marine water fish

Effect concentration:

10 mg/L