1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from handbook

Qualifier:

according to guideline

Guideline:

other: Protocol number 202, part I, 24 h EC50 Acute Immobilization Test, of the 4th of April 1984, from the OECD Guideline for Testing of Chemicals

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

other: (50% dechlorinated water and 50% distilled water

Limit test:

no

Total exposure duration:

48 h

Test temperature:

21.9 – 22.4 °C

pH:

8.33 – 8.49

Dissolved oxygen:

67 – 100%.

Nominal and measured concentrations:

0 (control), 0.5, 1, 2, 4, 8 and 16 mg/l

Details on test conditions:

No. of organisms per vessel: 20

Reference substance (positive control):

not specified

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

6.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: confidence limit 4.57 – 8.96).

Details on results:

The test chemical caused 0% immobilization at the 0.5 mg/l concentration. At concentrations of 1 mg/l and 2 mg/l, 2 and 3 daphnia, respectively, out of a total of 40, wereobserved immobile. The 4 mg/l and 8 mg/l concentrations caused immobilization in 5 and 9 daphnia, respectively, out of a total of 20. All the animals treated at the 16 mg/l concentration were found immobile. 1.7% immobilization was recorded in the Control group.

Reported statistics and error estimates:

Litchfield and Wilcoxon Method was used

Validity criteria fulfilled:

not specified

Conclusions:

The effect concentration at which 50% immobilization (EC50) of daphnia was observed was determined to be 6.40 mg/l (confidence limit 4.57-8.96).

Executive summary:

An experiment was conducted to determine the short term toxicity of test chemical to aquatic invertebrates according to theProtocol number 202, part I, 24 h EC50 Acute Immobilization Test, of the 4th of April 1984, from the OECD Guideline for Testing of Chemicals. The test organisms used in the study was Daphnia magna. The experiment was conducted in static condition and waster used was 50% dechlorinated water and 50% distilled water. The nominal concentrations of test chemical used were 0 (control), 0.5, 1, 2, 4, 8 and 16 mg/l. The test chemicalwas administered in a single dose per concentration level, dissolved in the water held in the test tubes, which was similar to that used in the breeding period. The daphnia were then transferred to the vessels.

The dilution water was aerated to saturation level prior to introduction of the test substance to ensure that the oxygen level did not fall below 60% of the saturation value.Values for pH ranged from 8.33 –8.49, temperature ranged between 21.9 – 22.4°C and dissolved oxygen ranged between 67 – 100%.The Daphnia were observed at the initiation of study and after 24 and 48 hours exposure. Observations included a determination of the number of immobilized animals. The test chemical caused 0% immobilization at the 0.5 mg/l concentration. At concentrations of 1 mg/l and 2 mg/l, 2 and 3 daphnia, respectively, out of a total of 40, were found immobile. The 4 mg/l and 8 mg/l concentrations caused immobilization in 5 and 9 daphnia, respectively, out of a total of 20. All the animals treated at the 16 mg/l concentration were observed to be immobile. 1.7% immobilization was recorded in the Control group.

The statistical method used in this study was Litchfield and Wilcoxon Method.

The effect concentration at which 50% immobilization (EC50) of daphnia was observed was determined to be 6.40 mg/l (confidence limit 4.57-8.96). Since the test chemical is readily biodegradable in nature test chemical is considered to be non toxic and cannot be classified as per CLP regulation.

Description of key information

An experiment was conducted to determine the short term toxicity of test chemical to aquatic invertebrates according to theProtocol number 202, part I, 24 h EC50 Acute Immobilization Test, of the 4th of April 1984, from theOECD Guideline for Testing of Chemicals. The test organisms used in the study was Daphnia magna. The experiment was conducted in static condition and waster used was 50% dechlorinated water and 50% distilled water. The nominal concentrations of test chemical used were 0 (control), 0.5, 1, 2, 4, 8 and 16 mg/l. The test chemicalwas administered in a single dose per concentration level, dissolved in the water held in the test tubes, which was similar to that used in the breeding period. The daphnia were then transferred to the vessels.

The dilution water was aerated to saturation level prior to introduction of the test substance to ensure that the oxygen level did not fall below 60% of the saturation value.Values for pH ranged from 8.33 –8.49, temperature ranged between 21.9 – 22.4°C and dissolved oxygen ranged between 67 – 100%.The Daphnia were observed at the initiation of study and after 24 and 48 hours exposure. Observations included a determination of the number of immobilized animals.The test chemical caused 0% immobilization at the 0.5 mg/l concentration. At concentrations of 1 mg/l and 2 mg/l, 2 and 3 daphnia, respectively, out of a total of 40, were found immobile. The 4 mg/l and 8 mg/l concentrations caused immobilization in 5 and 9 daphnia, respectively, out of a total of 20. All the animals treated at the 16 mg/l concentration were observed to be immobile. 1.7% immobilization was recorded in the Control group.

The statistical method used in this study was Litchfield and Wilcoxon Method.

The effect concentration at which 50% immobilization (EC50) of daphnia was observed was determined to be 6.40 mg/l (confidence limit 4.57-8.96). Since the test chemical is readily biodegradable in nature test chemical is considered to be non toxic and cannot be classified as per CLP regulation.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

6.4 mg/L

Additional information

Different studies have been conducted to determine the toxicity of test chemical to aquatic invertebrates from various sources and their results are summarized below. 

 

In first study an experiment was conducted to determine the short term toxicity of test chemical to aquatic invertebrates according to the Protocol number 202, part I, 24 h EC50 Acute Immobilization Test, of the 4th of April 1984, from the OECD Guideline for Testing of Chemicals. The test organisms used in the study was Daphnia magna. The experiment was conducted in static condition and waster used was 50% dechlorinated water and 50% distilled water. The nominal concentrations of test chemical used were 0 (control), 0.5, 1, 2, 4, 8 and 16 mg/l. The test chemical was administered in a single dose per concentration level, dissolved in the water held in the test tubes, which was similar to that used in the breeding period. The daphnia were then transferred to the vessels.

The dilution water was aerated to saturation level prior to introduction of the test substance to ensure that the oxygen level did not fall below 60% of the saturation value. Values for pH ranged from 8.33 –8.49, temperature ranged between 21.9 – 22.4°C and dissolved oxygen ranged between 67 – 100%.The Daphnia were observed at the initiation of study and after 24 and 48 hours exposure. Observations included a determination of the number of immobilized animals. The test chemical caused 0% immobilization at the 0.5 mg/l concentration. At concentrations of 1 mg/l and 2 mg/l, 2 and 3 daphnia, respectively, out of a total of 40, were found immobile. The 4 mg/l and 8 mg/l concentrations caused immobilization in 5 and 9 daphnia, respectively, out of a total of 20. All the animals treated at the 16 mg/l concentration were observed to be immobile. 1.7% immobilization was recorded in the Control group.

The statistical method used in this study was Litchfield and Wilcoxon Method.

The effect concentration at which 50% immobilization (EC50) of daphnia was observed was determined to be 6.40 mg/l (confidence limit 4.57-8.96).

 

In another study an experiment was conducted to determine the short term toxicity of test chemical to aquatic invertebrates according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) and EU Method C.2 (Acute Toxicity for Daphnia). The test organism used in the study was Daphnia Magna which were laboratory bred and less than 24 hours old at test initiation. The nominal concentrations of test chemical were0 (control), 6.25, 12.5, 25, 50 and 100 mg/l. Dilution water was reconstituted water prepared according to the EEC Directive. The pH of the water was adjusted to 8.1 and the dissolved oxygen was 8.1 mg/l. The experiment was conducted in static condition in50-ml beakers containing 20 ml of test solution with 10 Daphnia Magna per beaker. Experiments were run in duplicate. The concentration of the test chemicals at the beginning and at the end of the test was analyzed for the control and for the 6.25, 25, and 100 mg/l test solutions. In addition, stability analyses gave values 95.5 and 85.2% of nominal for a 100 mg/l solution at the beginning and end of the test. The statistical method used in this study was Logit model described by Cox, D. R. 1977. Analysis of binary data. Methuen & Co., Ltd. Daphnids in the control group showed no adverse effects during the exposure.

After 48 h exposure of test chemical to Daphnia magna was the Effect concentration (EC50) at which 50 % immobilization observed was determined to be 21.5 mg/l (95% confidence limits: 16.1 – 28.1 mg/l). EC0 and EC100 value were determined to be 5.3 mg/l and 89.3 mg/l respectively after exposure of test chemical to Daphnia magna for 48 h.

 

By considering results of all the studies mentioned above the EC50 value was determined to be in range 6.40 mg/L to 21.5 mg/l. Since the test chemical is readily biodegradable in nature test chemical is considered to be non toxic and cannot be classified as per CLP regulation.