L-Glutamic acid, N-coco acyl derivs., monosodium salts

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Principles of method if other than guideline:

WoE report is based on two short term toxicity to aquatic invertebrate studies as-
WoE 2 and WoE 3.

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

WoE 2: - Concentrations: Test chemical concentration used for the study was control (0), 100 mg/l (nominal concentration) and 83.14 mg/l (measured concentration).
WoE 3: - Concentrations: Test chemical concentration used for the study was 100% v/v saturated solution (nominal concentrations).

Vehicle:

not specified

Test organisms (species):

Daphnia magna

Details on test organisms:

WoE 2:
TEST ORGANISM
- Common name: Water flea
- Source: Test organism Daphnia magna was obtained from National Institute of Agricultural Science & Tech. Twenty five daphnids were kept in a glass beaker with 800 mL of dilution water.
- Age at study initiation (mean and range, SD): 7 days old
- Other: Young daphnids, which are bone from not less than 14 days old daphnids that were above third brood progeny and less than 24 hours old, were used for this study.

WoE 3:
TEST ORGANISM
- Common name: Water flea

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

WoE 2 and WoE 3: 250 mg/l as CaCO3

Test temperature:

WoE 2: 20.0 to 20.6°C
WoE 3: no data available

pH:

WoE 2: 7.24 to 7.87
WoE 3: no data available

Dissolved oxygen:

WoE 2: 6.88 to 7.41 mg/l
WoE 3: no data available

Nominal and measured concentrations:

WoE 2:
Nominal concentration – control (0), 100 mg/l
Measured concentration – control (0), 83.14 mg/l

Details on test conditions:

WoE 2:
TEST SYSTEM
- Test vessel: Glass beaker
- No. of organisms per vessel: 20 daphnids
- Aeration: No aeration was provided during the study.
- Feeding: Test organisms were not fed during the 48 hr exposure period.

OTHER TEST CONDITIONS
- Photoperiod: 16 hours of continuous artificial light and 8 hours of continuous darkness with 30 minutes dawn and dusk transition period between light and darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : After the exposure period of 48 hrs, the numbers of immobile daphnia were noted.

TEST CONCENTRATIONS
- Test concentrations: Test chemical concentration used for the study was 100 mg/l (nominal concentration) and 83.14 mg/l (measured concentration).

WoE 3:
TEST SYSTEM
- No. of organisms per vessel: 20 daphnids

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : After the exposure period of 48 hrs, the numbers of immobile daphnia were noted.

TEST CONCENTRATIONS
- Test concentrations: Test chemical concentration used for the study was 100% v/v saturated solution (1000000 mg/l).

Reference substance (positive control):

yes

Remarks:

WoE 2: potassium dichromate was used as a reference substance during the study and WoE 3: no data available

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

83.14 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: WoE 2

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: WoE 2

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 83.14 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: WoE 2

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: WoE 2

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 other: % v/v

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: WoE 3

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 other: % v/v

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: WoE 3

Details on results:

WoE 2: During the exposure period, no immobilisation and abnormal sings were found in the control group and the treatment group at 83.14 mg/L measured concentration.

WoE 2: The concentration of the test substance was analyzed in the test solution with 100 mg/L nominal concentration. The concentrations at initial exposure (0 hours) and at the end of exposure (after 48 hours) were determined as 100 and 69.12 mg/L (measured concentration), respectively. The concentration at the end of exposure exceeded ±20% of the measured initial values (0 hours). Therefore, all test results were determined as the geometric means.

 

Table: Cumulative immobility of Daphnia magna.

 

Nominal concentration (mg/L)	Mean measured conc. of test substance (mg/L)	Number of organisms tested	Cumulative number of organisms immobilised
			24 hours	48 hours
Control	-	20	0	0
100	83.14	20	0	0

 

Table:General symptoms of Daphnia magna.

 

Nominal concentration (mg/L)	Mean measured conc. of test substance (mg/L)	General symptoms
		24 hours	48 hours
Control	-	Normal	Normal
100	83.14	Normal	Normal

 

During the exposure period, the percentage of immobilisation in the control group was below 10%, and no abnormal signs were foundsuchas trapping at watersurface.Inthe definitive test, the percentage of immobilisation was less than 50% in the highest concentration treatment group during the exposure period.

WoE 3:

Analysis of the test solutions at 0 and 48 hours showed measured test concentrations to be less than the limit of quantitation (LOQ) of the analytical method. The concentration of the test chemical could not be determined in the test media (at the highest attainable test concentration of 1.7 mg/l, no immobilisation or adverse reactions to exposure were observed). Therefore the results are based on concentration as % v/v saturated solution.

 

Table:Effect of test chemical on test organismD. magna.

 

Nominal concentration (mg/l)	Number ofDaphnia magna	Number Immobilised
		24 hr (acute)	48 hr (acute)
>100% v/v saturation	20	0	0

 

Validity criteria fulfilled:

not specified

Conclusions:

On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the 48 hr EC50/LC50 value can be expected to be > 100 mg/l.

Executive summary:

Data available of the read across chemicals has been reviewed to determine the effect of the test chemical on aquatic invertebrates. The studies are as mentioned below:

An acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical.The test was performed following the principles of the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test).Daphnia magna (Water flea) (7 days old) obtained from National Institute of Agricultural Science & Tech was used as a test organism. Twenty five daphnids were kept in a glass beaker with 800 mL of dilution water. Young daphnids, which are bone from not less than 14 days old daphnids that were above third brood progeny and less than 24 hours old, were used for this study. Test chemical concentration used for the study was control (0), 100 mg/l (nominal concentration) and 83.14 mg/l (measured concentration). Thus, in a definitive test, a limit test was performed. Test chemical concentrations were determined analytically.The concentrations of test chemical were analyzed using HPLC in all test solutions at the beginning (0 hour) and at the end (48 hours) of the study. The samples from each one dish of the control and treatment groups were collected twice, and then each sample was analyzed.The concentrations at initial exposure (0 hours) and at the end of exposure (after 48 hours) were determined as 100 and 69.12 mg/L (measured concentration), respectively. Test daphnids (total 20 daphnids) were exposed to the test chemical conc. in a glass beaker under static conditions for an exposure period of 48 hrs. Test conditions during the study were hardness of 250 mg/l as CaCO3, temperature of 20.0 to 20.6°C, pH of 7.24 to 7.87 and dissolved oxygen of 6.88 to 7.41 mg/l under a photoperiod of 16 hours of continuous artificial light and 8 hours of continuous darkness with 30 minutes dawn and dusk transition period between light and darkness respectively. No aeration was provided in the test vessel during the study. Test organisms were not fed during the 48 hr exposure period. After the exposure period of 48 hrs, the numbers of immobile daphnia were noted. Potassium dichromate was used as a reference substance during the study. The results of this study were confirmed within the range permitted for the test (mean ± 2SD) by historical control data in this laboratory of Biotoxtech Co., Ltd. Exposure conditions for the positive control study were in the same conditions as the definitive test. The concentration at the end of exposure exceeded ±20% of the measured initial values (0 hours). Therefore, all test results were determined as the geometric means.During the exposure period, the percentage of immobilisation in the control group was below 10%, and no abnormal signs were foundsuchas trapping at watersurface.Inthe definitive test, the percentage of immobilisation was less than 50% in the highest concentration treatment group during the exposure period.The dissolved oxygen concentration at the end of the test should be 3 mg/l in control and test vessels. Thus, the validity criteria has been fulfilled.On the basis of the effect of the test chemical on mobility of the test organism Daphnia magna,the 48 hr NOEC value was determined to be 100 mg/l (nominal conc.) and 83.14 mg/l (measured conc.). The median effect concentration (EC50) value was determined to be>100 mg/l (nominal conc.) and>83.14 mg/l (measured conc.), respectively.

Another short term toxicity to aquatic invertebrate study was conducted for 48 hrs for assessing the effect of test chemical.The test was performed following the principles of the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) and EC Council Regulation No 440/2008 C.2 Acute Toxicity for Daphnia, respectively.Daphnia magna (Water flea) was used as a test organism.Test chemical concentration used for the study was 100% v/v saturated solution (nominal concentrations).Test chemical concentrations were determined analytically.The concentrations of test chemical were analyzed using High performance liquid chromatography with mass spectrometry (HPLC-MS) at 0 and 48 hours. The study was performed under static conditions using total 20 daphnids under test conditions with hardness of 250 mg/l CaCO3 for 48 hrs. The effect measured was immobilization of the daphnids. After the exposure period of 48 hrs, the numbers of immobile daphnia were noted. Analysis of the test solutions at 0 and 48 hours showed measured test concentrations to be less than the limit of quantitation (LOQ) of the analytical method. The concentration of the test chemical could not be determined in the test media (at the highest attainable test concentration of 1.7 mg/l, no immobilisation or adverse reactions to exposure were observed). Therefore the results are based on concentration as % v/v saturated solution. On the basis of the toxic effect of the test chemical on mobility of the test organism Daphnia magna, the 48 hr NOEC value was determined to be 100% v/v (saturated solution) and the median lethal concentration (LC50) value was determined to be > 100% v/v (saturated solution), respectively. Thus, test chemical was considered as non-toxic to aquatic invertebrates at environmental relevant concentrations and hence, considered to be ‘not classified’ as per the CLP classification criteria.

On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the 48 hr EC50/LC50 value can be expected to be > 100 mg/l. Thus, test chemical was considered as non-toxic to aquatic invertebrates at environmental relevant concentrations and hence, considered to be ‘not classified’ as per the CLP classification criteria.

Description of key information

On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the 48 hr EC50/LC50 value can be expected to be > 100 mg/l.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

Data available of the read across chemicals has been reviewed to determine the effect of the test chemical on aquatic invertebrates. The studies are as mentioned below:

An acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical.The test was performed following the principles of the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test).Daphnia magna (Water flea) (7 days old) obtained from National Institute of Agricultural Science & Tech was used as a test organism. Twenty five daphnids were kept in a glass beaker with 800 mL of dilution water. Young daphnids, which are bone from not less than 14 days old daphnids that were above third brood progeny and less than 24 hours old, were used for this study. Test chemical concentration used for the study was control (0), 100 mg/l (nominal concentration) and 83.14 mg/l (measured concentration). Thus, in a definitive test, a limit test was performed. Test chemical concentrations were determined analytically.The concentrations of test chemical were analyzed using HPLC in all test solutions at the beginning (0 hour) and at the end (48 hours) of the study. The samples from each one dish of the control and treatment groups were collected twice, and then each sample was analyzed.The concentrations at initial exposure (0 hours) and at the end of exposure (after 48 hours) were determined as 100 and 69.12 mg/L (measured concentration), respectively. Test daphnids (total 20 daphnids) were exposed to the test chemical conc. in a glass beaker under static conditions for an exposure period of 48 hrs. Test conditions during the study were hardness of 250 mg/l as CaCO3, temperature of 20.0 to 20.6°C, pH of 7.24 to 7.87 and dissolved oxygen of 6.88 to 7.41 mg/l under a photoperiod of 16 hours of continuous artificial light and 8 hours of continuous darkness with 30 minutes dawn and dusk transition period between light and darkness respectively. No aeration was provided in the test vessel during the study. Test organisms were not fed during the 48 hr exposure period. After the exposure period of 48 hrs, the numbers of immobile daphnia were noted. Potassium dichromate was used as a reference substance during the study. The results of this study were confirmed within the range permitted for the test (mean ± 2SD) by historical control data in this laboratory of Biotoxtech Co., Ltd. Exposure conditions for the positive control study were in the same conditions as the definitive test. The concentration at the end of exposure exceeded ±20% of the measured initial values (0 hours). Therefore, all test results were determined as the geometric means.During the exposure period, the percentage of immobilisation in the control group was below 10%, and no abnormal signs were foundsuchas trapping at watersurface.Inthe definitive test, the percentage of immobilisation was less than 50% in the highest concentration treatment group during the exposure period.The dissolved oxygen concentration at the end of the test should be 3 mg/l in control and test vessels. Thus, the validity criteria has been fulfilled.On the basis of the effect of the test chemical on mobility of the test organism Daphnia magna,the 48 hr NOEC value was determined to be 100 mg/l (nominal conc.) and 83.14 mg/l (measured conc.). The median effect concentration (EC50) value was determined to be>100 mg/l (nominal conc.) and>83.14 mg/l (measured conc.), respectively.

Another short term toxicity to aquatic invertebrate study was conducted for 48 hrs for assessing the effect of test chemical.The test was performed following the principles of the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) and EC Council Regulation No 440/2008 C.2 Acute Toxicity for Daphnia, respectively.Daphnia magna (Water flea) was used as a test organism.Test chemical concentration used for the study was 100% v/v saturated solution (nominal concentrations).Test chemical concentrations were determined analytically.The concentrations of test chemical were analyzed using High performance liquid chromatography with mass spectrometry (HPLC-MS) at 0 and 48 hours. The study was performed under static conditions using total 20 daphnids under test conditions with hardness of 250 mg/l CaCO3 for 48 hrs. The effect measured was immobilization of the daphnids. After the exposure period of 48 hrs, the numbers of immobile daphnia were noted. Analysis of the test solutions at 0 and 48 hours showed measured test concentrations to be less than the limit of quantitation (LOQ) of the analytical method. The concentration of the test chemical could not be determined in the test media (at the highest attainable test concentration of 1.7 mg/l, no immobilisation or adverse reactions to exposure were observed). Therefore the results are based on concentration as % v/v saturated solution. On the basis of the toxic effect of the test chemical on mobility of the test organism Daphnia magna, the 48 hr NOEC value was determined to be 100% v/v (saturated solution) and the median lethal concentration (LC50) value was determined to be > 100% v/v (saturated solution), respectively. Thus, test chemical was considered as non-toxic to aquatic invertebrates at environmental relevant concentrations and hence, considered to be ‘not classified’ as per the CLP classification criteria.

On the basis of the experimental studies of the read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the 48 hr EC50/LC50 value can be expected to be > 100 mg/l. Thus, test chemical was considered as non-toxic to aquatic invertebrates at environmental relevant concentrations and hence, considered to be ‘not classified’ as per the CLP classification criteria.