Amines, N-coco alkyltrimethylenedi-, acetates

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:

12 August 2002 to 16 August 2002

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

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

other: Scophthalmus maximus

Details on test organisms:

TEST SPECIES
- Supplier: France Turbot, L’Epine, France.
- Batch history: Juvenile turbot were received on 03 July 2002 free of malformations and in good health. The fish were assigned a batch number of SM02015.
- Holding conditions: Animals were fed and maintained as detailed in STL Runcorn SOP I.16. Stock juvenile turbot were held in artificial seawater (STL Runcorn SOP III.12) maintained at 15 ± 2 °C by a chiller unit and aerated via air diffusers attached to the laboratory air supply system. Feeding was stopped when juvenile turbot were transferred to test tanks 24 hours before the start of the tests.

Test type:

semi-static

Water media type:

saltwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

Not applicable

Hardness:

Not reported

Test temperature:

15 +/- 1.5 °C (see Appendix 3, attached)

pH:

Mean pH 7.83 to 8.28 (see Appendix 2, attached)

Dissolved oxygen:

Mean 90.7 to 98.1 % air saturation value (see Appendix 1, attached)

Salinity:

Mean 30.9 to 34.9 unit not specified (see Appendix 4, attached)

Conductivity:

Not reported

Nominal and measured concentrations:

Nominal test item concentrations of 0.1, 0.178, 0.316, 0.562 and 1.0 mg/L in artificial seawater.

Details on test conditions:

TEST CONDITIONS
- Dilution media: Artificial seawater (Coral Reef, Kent Sea Salt, Red Sea Fish Pharm).
- Test vessels: Approximately 20 L plastic aquaria.
- Behaviour in seawater: The sample was described as soluble in water. After addition to seawater, the sample dispersed well throughout the vessels.
- Test conditions: Single replicates of 10 L at each test concentration and control media were prepared. Seven animals were added to each test vessel and exposures were conducted under semi-static conditions with replacement of media every 48 hours. Test duration was 96 hours at a nominal temperature of 15 ± 1.5 °C.
- Parameters: Dissolved oxygen, pH, temperature and salinity values were recorded prior to (old) and after (new) media renewal. Mean values and standard deviations were calculated and recorded for each parameter (see Appendices 1, 2, 3 and 4, attached).
- Photoperiod: Ambient laboratory lighting with a daily 10-hour photoperiod.
- Aeration: Air bubbled directly into test media.
- Observations: Animals were observed twice every 24 hours. Numbers of mortalities and animals exhibiting abnormal behaviour were recorded (see Appendix 5, attached). At the end of the test, a sample of juvenile turbot was weighed and measured. The mean values and standard deviations were calculated and recorded (see Appendix 6, attached).
- Endpoint: Cessation of movement and failure to respond to tactile stimulation.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.84 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.562 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

RESULTS
- All animals in the control vessels survived the 96-hour test period.
- After 96 hours exposure to the specified test concentrations, the LC50 was determined to be 0.84 mg/L.
- The 72-hour LC50 value was determined to be 0.93 mg/L.
- The 24 and 48-hour LC50 values were both determined to be > 1.0 mg/L.
- The concentration of test material producing no observable effect (NOEC) was determined to be 0.562 mg/L after 96 hours.
- The concentration of test item producing the Lowest Observed Effect (LOEC) was determined to be 1.0 mg/L after 96 hours.
- None of the test concentrations produced 100 % mortality in the study.

Reported statistics and error estimates:

ANALYSIS OF STUDY DATA
- The mortality data at each observation period was processed using the statistical computer programme Toxcalc supplied by Tidepool Scientific (STL Runcorn SOP V.1).
- Toxcalc was used to derive the median effect concentration (LC50), which kills (immobilises) 50 % of the animals exposed to the test material, together with 95 % fiducial limits and a No Observed Effect Concentration (NOEC).

Validity criteria fulfilled:

not specified

Conclusions:

All animals in the control vessels survived the 96-hour test period. After 96 hours exposure to the specified test concentrations, the LC50 was determined to be 0.84 mg/L. The 72-hour LC50 value was determined to be 0.93 mg/L. The 24 and 48-hour LC50 values were both determined to be > 1.0 mg/L. The concentration of test material producing no observable effect (NOEC) was determined to be 0.562 mg/L after 96 hours. The concentration of test item producing the Lowest Observed Effect (LOEC) was determined to be 1.0 mg/L after 96 hours.

Executive summary:

The study was undertaken in accordance with PARCOM Method 1995 and OECD 203 (1992) “Fish, Acute Toxicity Test” to determine the toxicity of the test item to juvenile turbot, Scophthalmus maximus, which is the test organism recommended by the Paris Commission for studies on the effects of test chemicals on marine vertebrates.

 

Single replicates of 10 L at nominal test concentrations of 0.1, 0.178, 0.316, 0.562 and 1.0 mg/L in artificial seawater and control media were prepared. Seven animals were added to each test vessel and exposures were conducted under semi-static conditions with replacement of media every 48 hours. Test duration was 96 hours at a nominal temperature of 15±1.5°C. Animals were observed twice every 24 hours. Numbers of mortalities and animals exhibiting abnormal behaviour were recorded. At the end of the test, a sample of juvenile turbot was weighed and measured. The mean values and standard deviations were calculated and recorded.

 

All animals in the control vessels survived the 96-hour test period. After 96 hours exposure to the specified test concentrations, the LC50 was determined to be 0.84 mg/L. The 72-hour LC50 value was determined to be 0.93 mg/L. The 24 and 48-hour LC50 values were both determined to be > 1.0 mg/L.

 

The concentration of test material producing no observable effect (NOEC) was determined to be 0.562 mg/L after 96 hours. The concentration of test item producing the Lowest Observed Effect (LOEC) was determined to be 1.0 mg/L after 96 hours.

Description of key information

After 96 hours exposure of juvenile turbot to specified test concentrations, the LC50 was determined to be 0.84 mg/L (OECD 203).

Key value for chemical safety assessment

Marine water fish

Marine water fish

Effect concentration:

0.84 mg/L

Additional information

The study was undertaken in accordance with PARCOM Method 1995 and OECD 203 (1992) “Fish, Acute Toxicity Test” to determine the toxicity of the test item to juvenile turbot, Scophthalmus maximus, which is the test organism recommended by the Paris Commission for studies on the effects of test chemicals on marine vertebrates.

 

Single replicates of 10 L at nominal test concentrations of 0.1, 0.178, 0.316, 0.562 and 1.0 mg/L in artificial seawater and control media were prepared. Seven animals were added to each test vessel and exposures were conducted under semi-static conditions with replacement of media every 48 hours. Test duration was 96 hours at a nominal temperature of 15±1.5°C. Animals were observed twice every 24 hours. Numbers of mortalities and animals exhibiting abnormal behaviour were recorded. At the end of the test, a sample of juvenile turbot was weighed and measured. The mean values and standard deviations were calculated and recorded.

 

All animals in the control vessels survived the 96-hour test period. After 96 hours exposure to the specified test concentrations, the LC50 was determined to be 0.84 mg/L. The 72-hour LC50 value was determined to be 0.93 mg/L. The 24 and 48-hour LC50 values were both determined to be > 1.0 mg/L.

 

The concentration of test material producing no observable effect (NOEC) was determined to be 0.562 mg/L after 96 hours. The concentration of test item producing the Lowest Observed Effect (LOEC) was determined to be 1.0 mg/L after 96 hours.