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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 - 27 April 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
13 April 2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
30 May 2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
The following test vessels were set up:
- Test solution (Tn); containing Daphnia medium with test item (two replicates with 20 Daphnia each)
- Blank control (Bn); containing pure Daphnia medium (three replicates with 20 Daphnia each)
- Since the test item is soluble, the test solution was prepared by directly dissolving the test item in Daphnia medium. The resulting solution was used as the test solution in the toxicity test. Pure Daphnia medium served as blank controls.
- O2 concentration and pH were measured in the test medium for each concentration including the blank control. If the O2 concentration was too low (>5.0 mg/l required) the media was aerated by stirring. Afterwards, the media were filled into the test vessels (50 ml per vessel).
- Daphnia, aged less than 24 h and already acclimatized to the Daphnia medium, were then introduced into the test media, and the vessels were covered with a glass plate. The Daphnia were not fed during the test and the test vessels were not aerated.
- static exposure conditions
- Evidence of undissolved material: Not relevant. Since the test item is soluble, the test solution was prepared by directly dissolving the test item in Daphnia medium.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISMS
- Test organism: Daphnia magna (Straus, 1820), derived from a healthy stock and not first brood progeny
- Breeding: Parental and young Daphnia held in 4 l glass aquaria (3 l medium) at 20±2°C
- Illumination: 16 h per day
- Medium: Continuously aerated Elendt M4 medium prepared with ultra-pure water (conductivity <1.5 µS/cm)
- Feed: Suspension of Desmodesmus subspicatus in Elendt M4 medium with an optical density OD680 of about 15 units
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
not reported
Test temperature:
18–22°C, controlled at ±1 °C
pH:
6.5 to 7.5
Dissolved oxygen:
The minimum dissolved oxygen concentration in the controls and the test vessels at the end of each 24h-period was >=6.9 mg O2/l (required >=3 mg O2/l).
Salinity:
not reported
Conductivity:
683 to 705 µS cm-1
Nominal and measured concentrations:
The concentrations of p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) in the test medium were determined by HPLC analysis at the beginning and after 24 and 48 h of exposure. The quantification was based on the analysis of p-nitrobenzoic acid. Subsequently, the corresponding test item content was calculated using the content of p-nitrobenzoic acid in the test item.
These analyses revealed that the concentration of p-nitrobenzoic acid was stable over the whole 48 h period and was within the 80-120% of the nominal concentration. The measured concentration of p-nitrobenzoic acid at the beginning of the test was 52.1 mg/l and 52.9 mg/l (i.e. 102% of the initial value) after 48 hours of exposure. Considering a p-nitrobenzoic acid content of 52.8%, this corresponds to 98.7 mg/l and 100 mg/l of the test item, respectively, assuming the nitrilotriethanol component was stable too.
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 ml beakers, all-glass, with 50 ml of test medium,covered with a glass plate to avoid evaporation and contamination of the test solutions with dust
- Test medium: Elendt M4 medium; prepared with ultra-pure water (conductivity <1.5 µS/cm)
- Number of Daphnia: 40 individuals per test concentration, 20 per vessel
- Age: Less than 24 h
- Light: 16 h photoperiod a day, supplied by overhead white fluorescent tubes
- Temperature: 18–22 °C, controlled at ±1 °C
- pH: 6 to 9. The pH should normally not vary by more than 1.5units in one test.
- Feed: The Daphnia are not fed during the test
- Aeration: The test vessels were not aerated during the test.
- Test type: static exposure conditions
- Test duration: 48 h

RANGE-FINDING STUDY
Prior to the definitive test a non-GLP range finding test with nominal concentrations of 1, 10 and 100 mg/l of p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) was performed. The HPLC determinations indicate that the test item concentrations are stable. Static conditions were therefore applied in the definitive test.

EFFECT PARAMETERS MEASURED
Observed immobility (inability to swim) of the daphnids: Observations of immobile Daphnia were made after 24 and 48 h of exposure. Any abnormal behaviour or appearance was reported.
Reference substance (positive control):
yes
Remarks:
Acute reference test with potassium dichromate conducted twice a year
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
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
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
No significant effects (<=10% immobilization) were observed at 100 mg/l nominal concentration or in the blank controls, neither after 24 h of exposure nor after 48 h.
Therefore, the median effect concentrations (EC50) of p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) (CAS no. 7394-38-9) on Daphnia magna after 24 h as well as after 48 h of exposure were estimated to be >100 mg/l nominal concentration.
The NOEC values after 24 h and after 48 h of exposure were both 100 mg/l nominal concentration.
Results with reference substance (positive control):
Acute ref. test with K2Cr2O7 conducted twice a year. The EC50 value for the control of sensitivity for 24 h of exposure with K2Cr2O7 was estimated to be 0.89 mg/l (29.6.2016), which lies within the recomm. range of 0.6–2.1 mg/l acc. to OECD Guideline 202.
Reported statistics and error estimates:
The effective concentrations ECx were assessed based on the nominal concentration of the test item.
No statistical analysis was performed.
Validity criteria fulfilled:
yes
Remarks:
All validity criteria i.e. immobilization in the controls <=10% and O2 concentrations at the end of the test >=3 mg/L were fulfilled.
Conclusions:
The acute toxicity of p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) (CAS no. 7394-38-9) to Daphnia magna was determined in a 48 hour static test according to OECD guideline 202. The median effect concentrations (EC50) of p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) on Daphnia magna were estimated to be >100 mg/l nominal concentration after 24 h as well as after 48 h of exposure. The NOEC values were determined to be 100 mg/l nominal concentration after 24 h as well as after 48 h of exposure. The results of the test can be considered reliable without restriction.
Executive summary:

The median effect concentration (EC50) and the no-effect concentration (NOEC) of p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) (CAS no. 7394-38-9) to Daphnia magna were investigated under static exposure conditions over a period of 48 h, following guideline OECD 202.

The test item p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) is solid, has a high solubility (>=782 g/l at pH 6 and at 23 °C) and is 98% pure. The test media were prepared by directly dissolving the test item in Daphnia medium.

The single investigated nominal concentration was 100 mg/l.

40 individual Daphnia divided into 2 test vessels were exposed to the test item, and 60 Daphnia divided into 3 test vessels were used as blank controls.

The concentration of p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) in the test medium were measured by HPLC analysis at the beginning and after 24 and 48 h of exposure. These measures were based on the determination of the test item component p-nitrobenzoic acid, and assuming a 52.8% share. These analyses revealed that the concentration of test item was stable over the whole 48 h period and remained within 80-120% of the nominal concentration. Therefore, the effective concentrations ECx were assessed based on the nominal concentration of the test item.

No significant effects (<=10% immobilization) were observed at 100 mg/l nominal concentration or in the blank controls, neither after 24 h of exposure nor after 48 h. Therefore, the median effect concentrations (EC50) of p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) (CAS no. 7394-38-9) on Daphnia magna after 24 h as well as after 48 h of exposure were estimated to be >100 mg/l nominal concentration.

The NOEC values after 24 h and after 48 h of exposure were both 100 mg/l nominal concentration.

All validity criteria were fulfilled.

Description of key information

The acute toxicity of p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) (CAS no. 7394-38-9) to Daphnia magna was determined in a 48 hour static test according to OECD guideline 202. The median effect concentrations (EC50) of p-Nitrobenzoic acid, compound with 2,2’,2’’-nitrilotriethanol (1:1) on Daphnia magna were estimated to be >100 mg/l nominal concentration after 24 h as well as after 48 h of exposure. The NOEC values were determined to be 100 mg/l nominal concentration after 24 h as well as after 48 h of exposure. The results of the test can be considered reliable without restriction.

Key value for chemical safety assessment

Additional information