Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-05-11 to 2015-11-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
as Limit-test
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L (saturated solution)
- Sampling method: The limit concentration and the control were diluted (factor 2) with acetonitrile directly after sampling and were measured without further dilution.
- Sample storage conditions before analysis: All samples were stored at room temperature before and after preparation, if necessary.

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: a saturated solution with a nominal loading of 100 mg/L of the test item was prepared with ISO test water (acc. to OECD 202, Annex 3) by stirring with approximately 1100 rpm for 48 hours at room temperature followed by filtration with a membrane filter (0.2 µm, RC, MACHEREY-NAGEL) to achieve the saturated solution.
- Limit loading rate: 100 mg/l
- Control: ISO test water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): No vehicle used.
- Concentration of vehicle in test medium (stock solution and final test solution): No vehicle used.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None observed.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna.
- Source: In-house culture.
- Age at study initiation (range): 2-24 hours.
- Feeding during test: No.


ACCLIMATION
- Acclimation period: 2 hours in dilution water
- Acclimation conditions (same as test or not): Same as test.
- Type and amount of food: a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with an algae cell density of > 1000000 cells/mL. The algae were cultured at the test facility.
- Feeding frequency: at least 5 times per week ad libitum
- Health during acclimation (any mortality observed): No.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
Not applicable.
Hardness:
262 mg CaCO3/L
Test temperature:
20.8 °C
pH:
7.85-7.99
Dissolved oxygen:
6.53 - 8.77 mg/l (after 48 h exposure period)
Salinity:
Not applicable.
Nominal and measured concentrations:
Nominal: 100 mg/l (Limit-test)
measured: < LOQ of 40 µg test item/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses.
- Fill volume: 20 ml in each replicate
- Aeration: No.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Dilution water: ISO Test water, according to OECD 202, Annex 3.
- Intervals of water quality measurement: At the beginning and end of the exposure (0h and 48 h).

OTHER TEST CONDITIONS
- Adjustment of pH: No.
- Photoperiod: 16/8 h light/dark cycle.
- Light intensity: Diffuse light, light intensity of max. 20 µE m-2 s-1.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility after 24h and 48h of exposure.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable.
- Justification for using less concentrations than requested by guideline: Range finding study.
- Range finding study loading rates: 100 mg/l (static) nominal; 60 µg/L measured concentration
- Results used to determine the conditions for the definitive study: No effects observed.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate (historic (monthly data) of test institute)
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: loading rate (Water Accommodated Fraction )
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.
Remarks:
loading rate (water accomodated fraction)
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: None reported.
- Observations on body length and weight: None reported.
- Other biological observations: None reported.
- Mortality of control: No.
- Other adverse effects control: None reported.
- Abnormal responses: None reported.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No.
- Effect concentrations exceeding solubility of substance in test medium: Not applicable (WAF was tested).
Results with reference substance (positive control):
Historic (monthly) reference data of test institute for potassium dichromate:
0.6 mg/L < EC50 (24 h) < 2.4 mg/L, according to AQS P 9/2 (clone 5)
0.6 mg/L < EC50 (24 h) < 2.1 mg/L, according to OECD 202 (clone A)
Validity criteria fulfilled:
yes
Conclusions:
At the saturated solution with a nominal loading of 100 mg/L of the test item 1,2,3-Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-C13-branched-alkyl)ester, no effects were observed on Daphnia magna. Thus, the test item is not toxic in the range of the water solubility.
Executive summary:

In the acute immobilisation test with Daphnia magna (STRAUS), the effects of a saturated solution with a nominal loading of 100 mg/L of the test item 1,2,3 -Propanetricarboxylic acid, 2 -Hydroxy-, tris(C12 -C13 -branched-alkyl)ester were determined according to OECD 202 (2004) from 2015-06-01 to 2015-06-05, with the definitive exposure phase from 2015-06-03 to 2015-06-05. The limit test was conducted under static conditions over a period of 48 hours. The test item is a clear and colourless liquid with a negligible solubility in water. Therefore, a saturated solution with a nominal loading of 100 mg/L of the test item was prepared with ISO test water (acc. to OECD 202, Annex 3) by stirring with approximately 1100 rpm for 48 hours at room temperature followed by filtration with a membrane filter (0.2 µm, RC, MACHEREY-NAGEL) to achieve the saturated solution. The saturated solution was visually clear throughout the exposure phase of 48 hours. Twenty daphnids each were exposed to the limit concentration and the control. The concentrations of 1,2,3 -Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-C13-branched-alkyl)ester were analytically verified via LC-MS/MS at the start of the exposure (0 hours) and at the end of the exposure (48 hours) in the saturated solution and the control. With regard to the measured concentrations in samples of the non GLP preliminary range finding test with measured concentrations of 60 µg/L and sensitivity of the analytical method, the limit of quantification (LOQ) was set to 40 µg test item /L. However, the measured concentrations of the test item at the start (0 hours) and at the end of the exposure (48 hours) were below LOQ in the definitive study. This can be attributed to the fact, that the water solubility of the test item is very low (≤ 0.739 ng/L), lower than the LOQ. Since no effects on daphnia magna were observed, the analytical results were acceptable. The effect levels given are based on the nominal loading of the test item 1,2,3 -Propanetricarboxylic acid, 2 -Hydroxy-, tris(C12-C13-branched-alkyl)ester. The water quality parameters (i.e. pH-value and dissolved oxygen concentration), measured at the start (0 hours) and at the end of the exposure (48 hours), were within the acceptable limits. The validity criteria of the test guideline were fulfilled. At the saturated solution with a nominal loading of 100 mg/L of the test item 1,2,3-Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-C13-branched-alkyl)ester, no effects were observed on Daphnia magna. Thus, the test item is not toxic in the range of the water solubility.

Description of key information

In the acute immobilisation test on the target substance 1,2,3 -Propanetricarboxylic acid, 2 -Hydroxy-, tris(C12 -C13 -branched-alkyl)ester, with Daphnia magna (STRAUS), the effects of a saturated solution with a nominal loading of 100 mg/L of the test item 1,2,3 -Propanetricarboxylic acid, 2 -Hydroxy-, tris(C12 -C13 -branched-alkyl)ester were determined according to OECD 202. At the saturated solution with a nominal loading of 100 mg/L of the test item, no effects were observed on Daphnia magna. Thus, the test item is not toxic in the range of the water solubility. Also the source substance,  Tri (hexyl, octyl, decyl) citrate, was not toxic up to the limit of water solubility.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information

In the acute immobilisation test with Daphnia magna (STRAUS), the effects of a saturated solution with a nominal loading of 100 mg/L of the test item 1,2,3 -Propanetricarboxylic acid, 2 -Hydroxy-, tris(C12 -C13 -branched-alkyl)ester were determined according to OECD 202 (2004) from 2015-06-01 to 2015-06-05, with the definitive exposure phase from 2015-06-03 to 2015-06-05. The limit test was conducted under static conditions over a period of 48 hours. The test item is a clear and colourless liquid with a negligible solubility in water. Therefore, a saturated solution with a nominal loading of 100 mg/L of the test item was prepared with ISO test water (acc. to OECD 202, Annex 3) by stirring with approximately 1100 rpm for 48 hours at room temperature followed by filtration with a membrane filter (0.2 µm, RC, MACHEREY-NAGEL) to achieve the saturated solution. The saturated solution was visually clear throughout the exposure phase of 48 hours. Twenty daphnids each were exposed to the limit concentration and the control. The concentrations of 1,2,3 -Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-C13-branched-alkyl)ester were analytically verified via LC-MS/MS at the start of the exposure (0 hours) and at the end of the exposure (48 hours) in the saturated solution and the control. With regard to the measured concentrations in samples of the non GLP preliminary range finding test with measured concentrations of 60 µg/L and sensitivity of the analytical method, the limit of quantification (LOQ) was set to 40 µg test item /L. However, the measured concentrations of the test item at the start (0 hours) and at the end of the exposure (48 hours) were below LOQ in the definitive study. This can be attributed to the fact, that the water solubility of the test item is very low (≤ 0.739 ng/L), lower than the LOQ. Since no effects on daphnia magna were observed, the analytical results were acceptable. The effect levels given are based on the nominal loading of the test item 1,2,3 -Propanetricarboxylic acid, 2 -Hydroxy-, tris(C12-C13-branched-alkyl)ester. The water quality parameters (i.e. pH-value and dissolved oxygen concentration), measured at the start (0 hours) and at the end of the exposure (48 hours), were within the acceptable limits. The validity criteria of the test guideline were fulfilled. At the saturated solution with a nominal loading of 100 mg/L of the test item 1,2,3-Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-C13-branched-alkyl)ester, no effects were observed on Daphnia magna. Thus, the test item is not toxic in the range of the water solubility.

The influence of the source substance Tri (hexyl, octyl, decyl) citrate, on the growth of the green algal species Scenedesmus subspicatus CHODAT was investigated in a 72 -hour static test according to the OECD Guideline No. 201, adopted June 7, 1984. The test was performed in compliance with GLP. Due to the low water solubility of the test substance a filtrate of a supersaturated stock suspension of nominal 100 mg/L was tested. Thus, no concentrations above the solubility limit of the test substance in the used test water were tested. Also due to the low water solubility no analytical verification could be done in the present test. Therefore, the biological results could not be related to a specific concentration of the test substance but only to the water solubility limit in the test medium.

The 72-hour NOEC was determined to be at least up to the solubility limit of the test substance. The NOEC might even be higher than this concentration, but concentrations in excess of the solubility limit had not been tested. The 72-hour LOEC and the 72-hour EC50 were clearly higher than the solubility limit.