Sodium hydrogen N-(1-oxododecyl)-L-glutamate

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:

From 04, April 2011 to 08, April 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Quality Assesment is on page 4 of the attched report

Specific details on test material used for the study:

Batch no.: 4231685 supplied by the sponsor
Aspect: white-yellowish, grainy, sticky
Purity: 95%
Solubility: soluble in water
Storage condition of test material: room temperature (15 °C - 25 °C), stable for at least 24 months
Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium): stable for 12 months minimum
Solubility: soluble and stable in water
Reactivity of the test material with the incubation material used (e.g. plastic ware): not reactive
More information can be found on the attached report

Analytical monitoring:

yes

Details on sampling:

A stock solution of containing 1500 mg/L in dilution water was prepared. This was accomplished by solving the nominal load in dilution water with the help of ultrasonic. The resulting solution showed frothing. The stock solution then was used to prepare solutions of the concentrations to be tested.

Vehicle:

yes

Details on test solutions:

A stock solution of containing 1500 mg/L in dilution water was prepared. Water characteristic are detailed on attached report.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Sexually immature young fish, lenght 2 +/- 1 cm. Animals were obtained by Dehner Garten Center and arrived in January 2011. Before using for the test, fish were kept for 14 days under test conditions. During this period mortality didn't surpass 5%.
Vessels were polyethylene aquaria, with chlorine free tap water.
Feeding was done three times a day with warmwater fishfoodand daphnia, totalling to about 1-2% of body weight per day.
Photo period :12/12 hours using neon tubes
Temperature : 23 ± 2°C

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Remarks on exposure duration:

Observations were made every 24 h

Hardness:

0.79 mmol/l (water used)

Test temperature:

Temperature range was 22.0 - 23.3 °C.

pH:

The pH values in the test media and the control ranged from 7.5 to 8.4.

Dissolved oxygen:

The concentration of dissolved oxygen stayed above 6.1 mg/L or 69% throughout the test.

Conductivity:

172 microS/cm at 20 °C (water used)

Nominal and measured concentrations:

The correlation between nominal and measured concentration was good. The geometric mean of the measured concentrations was in a range of 78 - 80 % of the nominal concentration. Therefore, the geometric means of the measured concentrations were used for the determination of the biological results.

Details on test conditions:

24 hours before the start of the test, food was withheld from the designated test fish.
Test Design semi-static
Medium renewal every 24 ± 1
Duration 96 hours
Loading 1 fish/L
Vessels glass aquaria, maximal volume 10 L
Aeration accomplished with glass tubes, frequency of bubbles 1/s
Feeding none
Photo period 12/12 hours using neon tubes
Temperature 23 ± 2°C (deviation within on test ± 1°C)
pH adjustment none
Replicates one vessel for each treatment and for the control
Observations were made every 24 hours, measuring pH and O2-concentration of the old and new test solution in each vessel and documenting mortalities or abnormal behaviour.
The content of the test item in the test vessels was measured at the beginning and at the end of the test and at every medium renewal in the old and the new test solution.
A fish considered dead, if no visible movement could be observed, and if touching of the caudal peduncle produced no reaction.
On each day of the test, a stock solution containing 1500 mg/L test item was prepared. This stock solution was used to prepare a series of five concentrations in the range of 10 - 220 mg/L.
Date: 04. – 08. Apr. 2011
Treatments: 10 / 22 / 43 / 100 / 200 mg/L
Replicates: one vessel, each containing 7 L test solution and 7 fish
Control: one vessel, containing 7 L dilution water and 7 fish

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

37 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

39 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

MORTALITIES
The mortalities were recorded daily and can be found in the table 1 reported in the paragraph any other information.
As one dead fish was stated as not significant, the mortality in treatment 10 mg/L was not considered in evaluation of the results. No abnormal behaviour of the surviving fish was observed.
ANALYTICAL DETERMINATIONS
The concentration of the test item was calculated through measured DOC (dissolved organic carbon) divided by the content of organic carbon (60%) of the test item. The measured concentrations showed good correlation with the nominal concentrations. The geometric means of the measured concentrations were in a range of 78 - 80 % of the nominal concentrations. Therefore, the geometric mean of the measured concentrations was used for the determination of the results. The measured DOC-values in the control and the lowest concentrated treatment were in a similar range. The DOC-content in the control might be caused by excrements of the animals.
The measured concentrations of the test item can be found on page 15 of the attched report.
BIOLOGICAL RESULTS
The estimation of the EC50 was accomplished using the software OriginTM.
The data were evaluated using sigmoidal fit on a linear-logarithmic scale.
If a sigmoidal fit is used, no confidence interval can be calculated. Since there were only two values between 0% and 100% mortality, a linear fit with a probability-y-axis could not be performed. Formula and results are reported on page 18 of the attched report.
VALIDITY
 The mortality in the control may not exceed one fish at the end of the test.
No mortalities occurred in the control.
 The dissolved oxygen concentration must be at least 60% throughout the test.
The concentration of dissolved oxygen stayed above 6.1 mg/L or 69% throughout the test (100% at 101300 Pa equals 8.57 mg/L, following DIN 38408 part 22).
 The pH-value in the test solutions should not vary more than 1 unit during the test.
The highest variation was 0.9 units.
All validity criteria are therefore respected

Reported statistics and error estimates:

The estimation of the EC50 was accomplished using the software OriginTM.
The data were evaluated using sigmoidal fit on a linear-logarithmic scale.

Sublethal observations / clinical signs:

Table 1 Mortalities

Con mg/l	n° fish	dead fish 24 h new	dead fish 24 h cum	dead fish 48 h new	dead fish 48 h cum	dead fish 72 h new	dead fish 72 h cum	dead fish 96 h new	dead fish 96 h cum
0	7	0	0	0	0	0	0	0	0
10	7	0	0	0	0	0	0	1	1
22	7	0	0	0	0	0	0	0	0
46	7	0	0	1	1	0	1	0	1
100	7	0	0	6	6	1	7	0	7
200	7	7	7	0	7	0	7	0	7

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 96 h LC50 of the substance in Danio rerio was determined to be 39 mg/l

Executive summary:

The toxicity against Danio rerio was tested using a semi-static test design.The main study was performed using five concentrations ranging from 10 to 220 mg/L. Two concentrations showed significant mortality (100%). The content of test item was determined by calculation from content of organic carbon of the test item and DOC-measurement in the old and the new test solutions. DOC-measurements were performed at the beginning and at the end of the test and at every medium renewal in the old and in the freshly prepared test solutions. As the test item wasn’t stable under test conditions, the study was performed under semi-static conditions. The correlation between nominal and measured concentration was good. The geometric mean of the measured concentrations was in a range of 78 - 80 % of the nominal concentration. Therefore, the geometric means of the measured concentrations were used for the determination of the biological results.The following results for the test item were determined:

96h NOEC = 37 mg/L

96h LC50 = 39 mg/L

 

 

Description of key information

LC50 (96h) = 39 mg/L (measured concentrations, geometic mean) for Danio rerio (OECD 203nad EU-Method C.1, read across)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

39 mg/L

Additional information

No studies investigating the toxicity to fish of Sodium hydrogen N-(1-oxododecyl)-L-glutamate (CAS No. 29923-31-7) are available. Thus, available data for the source substance l-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS No. 68187-32-6) was used in a read-across approach. The read across is considered valid as the target substance is the major component, and the central member of an homologous series of components, of the source substances, possessing identical functional groups and extremely similar structures.  It is reasonable to expect that the toxicological properties of the target and source substances will not be markedly different.  On this basis, experimental data on the source substances are expected to be directly applicable to the target substance, and can be used to adequately predict its properties. Further details are provided in the in the chapter 13 of Iuclid. In the test used the toxicity against Danio rerio was tested using a semi-static test design.The main study was performed using five concentrations ranging from 10 to 220 mg/L. Two concentrations showed significant mortality (100%). The content of test item was determined by calculation from content of organic carbon of the test item and DOC-measurement in the old and the new test solutions. DOC-measurements were performed at the beginning and at the end of the test and at every medium renewal in the old and in the freshly prepared test solutions. As the test item wasn’t stable under test conditions, the study was performed under semi-static conditions. The correlation between nominal and measured concentration was good. The geometric mean of the measured concentrations was in a range of 78 - 80 % of the nominal concentration. Therefore, the geometric means of the measured concentrations were used for the determination of the biological results.The following results for the test item were determined:

96h NOEC = 37 mg/L

96h LC50 = 39 mg/L