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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No full study report, only summarised results
Principles of method if other than guideline:
No data concerning used method.
GLP compliance:
not specified
Analytical monitoring:
not specified
Vehicle:
yes
Details on test solutions:
The test sample (1 mg/L) was introduced in acetone solution with a nominal acetone concentration of 500 ppm (v/v) in the test.
Test organisms (species):
Daphnia magna
Limit test:
yes
Total exposure duration:
48 h
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 1 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
As would be expected for water insoluble lipophilic materials tested above their solubility limit most of the daphnia became trapped in a surface film ("floaters") and this place a stress on them. As time 24 hour the floating daphnia were re-submerged. After 24 and 48 h 0% Daphnia were immobilised.
Validity criteria fulfilled:
not specified
Conclusions:
The LC50 after 48 h to Daphnia magna was greater than 1 mg/L under the conditions described.
Executive summary:

The LC50 after 48 h of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was greater than 1 mg/L, tested with Daphnia magna.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted according to internationally recognised test methods.
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes
Specific details on test material used for the study:
- Lot/batch No.: 001101TMO
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 and 100 mg/L
- Sampling method: 0.5 - 1.0 mL sampled from each vessel
- Sample storage conditions before analysis: No data
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test substance at 3000 mg/L (with solubilizer HCO-50 100 mg/L) added to diluting water (Elendt M4) to give the required nominal test concentration
- Eluate: dilution water (Elendt M4)
- Controls: yes - dilution water and test medium with dispersant
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): solubilizer HCO-50 100 mg/L
- Concentration of vehicle in test medium (stock solution and final test solution): 100 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Test solutions observed to be cloudy (white, turbid)
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Source:NIES Japan
- Age at study initiation (mean and range, SD): within 24h old
- Feeding during test: No
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
No
Hardness:
228 mg/l as CaCO3
Test temperature:
19.5-20.0 °C.
pH:
7.2-7.4
Dissolved oxygen:
8.5-8.9 mg/l
Salinity:
N/A fresh water
Nominal and measured concentrations:
Nominal Concentrations: 0 and 100 mg/L
Mean measured concentrations: 0 and 96.4 mg/L (See Results table below)
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beaker
- Material, size, headspace, fill volume: 100 ml
- Renewal rate of test solution (frequency/flow rate): N/A static
- No. of organisms per vessel: 5 (to give 20/concentration)
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4(OECD guideline No.211 Annex 2)
- Intervals of water quality measurement: 48 hours

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16h light / 8h dark
- Light intensity: room light

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

TEST CONCENTRATIONS
- Spacing factor for test concentrations: N/A
- Justification for using less concentrations than requested by guideline: N/A
- Range finding study: Yes
- Test concentrations: up to at least 100 mg/l in immobilisation test
- Results used to determine the conditions for the definitive study: Yes - 48h-EC50 was >100 mg/L.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: A single daphnid exposed at 100 mg/L was found dead/immobile after 24 hours
- Other biological observations: No
- Mortality of control: No mortality observed during test period
- Other adverse effects control: No
- Abnormal responses: No other abnormal responses observed during test period
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test solution was cloudy - Effect concentrations exceeding solubility of substance in test medium: No
Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50/LC50: 0.90 mg/L (48h)
Reported statistics and error estimates:
Not applied for EC50 - No concentration related effects observed
Method of calculating mean measured concentrations: Geometric mean

Measured Concentrations of test chemicals during a 48h exposure period

Nominal Concentration      Measured concentration(mg/L)   Percent of nominal

           (mg/L)                                   0hr          48hr       Mean                  0hr      48hr

          Control                            < 0.006      < 0.006           -                     -            -

 Disp.Cont.                          < 0.006      < 0.006           -                     -            -

    100                                  103.6      89.7       96.4                  103.6     89.7

                   Mortality or immobility of Daphnia magna exposed to the test chemicals

                       Nominal concentration (mg/L)     Cumulative number of dead or immobilized Daphnia

                                                                                      (Percent Mortality or Immobility)

                                                                                      24 hour                  48 hour

                                    Control                                       0(0)                         0(0)

                          Dispersant Control                              0(0)                         0(0)

                                      100                                           1(5)                         1(5)

 

·               

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of this test the EC50 (48h) > 100mg/L and NOEC (48h) = 100mg/L for Daphnia magna exposed to Trioctyl benzene-1,2,4-tricarboxylate for 48 hours
Executive summary:

Acute immobilisation in Daphnia has been investigated in a 48 hour test according to OECD test methods. Dissolution/dispersion agents were used to increase concentration of the substance in the test medium. The EC50 (48h) was determined to be >100 mg/L and the NOEC was 100 mg/L, the highest concentration investigated.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
1994-04-13 to 1994-04-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. For read-across justification see Section 13.
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Samples of the freshly prepared stock solution and the dilution for testing after 0 and 48 hours were taken, no further details mentioned
Vehicle:
no
Details on test solutions:
As the test substance is poorly soluble in water, a 1 g/L mixture with synthetic freshwater was prepared. This mixture was stirred for 18 hours and filtrated afterwards. The filtrate was analyzed and showed an initial content of 7.4 mg/L DOC. The filtrate was used as Stock solution.
The analytical determination of stock and test solutions showed that they were not stable within 48 hours (deviation > 20%), therefore the geometric mean of the measured values after 0 and 48 hours were used for evaluation.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain: Daphnia magna Straus, clone 5
- Source: laboratory breed
- Age at study initiation: not older than 24 hours
- Method of breeding: The females were maintained in M4 medium in 1 L beakers. A reddish dark-brown coloration of the animals indicated that they were healthy. At two to three day intervals, the exuviae were siphoned off and the water was changed. In the course of this, the offspring was removed from the breeding vessels. At regular intervals of approx. 4 weeks, offspring were isolated from the vessels. They served as a basis for further breeding.
- Feeding during test: none



ACCLIMATION
- Acclimation period: Females were separated from the offspring 24 hours before the start of the test. The offspring produced overnight were transferred into test water and were used for the test.
- Type and amount of food: Scenedesmus subspicatus, the amount of food added is such that it is consumed by the animals
- Feeding frequency: daily
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
none
Hardness:
2.5 mmol
Test temperature:
20 °C ± 1 °C
pH:
7.9 - 8.2
Dissolved oxygen:
8.0 - 8.2 mg/L
Salinity:
CaCl2 x 2 H2O: 294 mg/L; MgSO4 x 7 H2O: 123 mg/L; NaHCO3: 63 mg/L; KCl: 5.5 mg/L
Ca/Mg ratio: 4:1
Na/K ratio: 10:1
Nominal and measured concentrations:
Nominal: 6.6 mg/L
Measured: 3.2 mg/L (geometric mean of measured concentrations after 0 and 48 hours)
Details on test conditions:
TEST SYSTEM
- Test vessel: Round-bottom test tubes
- Material, size, headspace, fill volume: glass, calibrated to 10 mL
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic fresh water
- Ca/mg ratio: 4:1
- Conductivity: not mentioned
- Culture medium different from test medium: yes
- Intervals of water quality measurement: not mentioned


OTHER TEST CONDITIONS
- Adjustment of pH: not adjusted
- Photoperiod: not applicable
- Light intensity: no light during test


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilisation after 24 and 48 hours; O2 concentration, pH at the end of the test


TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Range finding study: not applicable, tested at solubility limit
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 4.4 mg/L
Nominal / measured:
estimated
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 4.4 mg/L
Nominal / measured:
estimated
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
>= 4.4 mg/L
Nominal / measured:
estimated
Conc. based on:
dissolved
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 4.4 mg/L
Nominal / measured:
estimated
Conc. based on:
dissolved
Basis for effect:
mobility
Details on results:
The given concentrations were calculated from the estimated concentration of DOC. An estimation was necessary, as the DOC value was decreasing in the progress of the test.
Results with reference substance (positive control):
- Results with reference substance valid? yes, historical control (not tested in parallel to the test substance)
- Concentrations: 1 and 2 mg/L potassium dichromate
- Results: 15% and 100% immobilised daphnia after 24 h
Reported statistics and error estimates:
Due to the low mortality up to the solubility limit, no statistics were performed.

Table #1: Effect of 1,2,4 -Benzenetricarboxylic acid, decyl octyl ester on immobilisation of Daphnia magna

  concentration [mg/L]        24 hour values        48 hour values
      number  %  number   
   mobile  immobile  immobile  mobile  immobile immobile 
 0 (control)  19  1  5  19  1  5
 3.2  20  0  0  19  1  5

The given concentration refers to the estimated content of DOC.

Remark: In the DOC-determination it was not possible to distinguish between carbon from the test substance and carbon from the impurities (2,5%)

Validity criteria fulfilled:
yes
Conclusions:
Not toxic under test conditions in the range of water solubility.
Executive summary:

The effect of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters on the immobilisation of Daphnia magna had been studied in accordance with OECD Guideline for Testing of Chemicals No. 202 part I and EEC Methods for Determination of Ecotoxicity, Annex to Directive 92/69/EEC.

Daphnia magna was exposed to 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters for an exposure time of 48 hours. As the test substance is poorly soluble in water, a 1 g/L mixture with synthetic freshwater was prepared. This mixture was stirred for 18 hours and filtrated afterwards. The filtrate was analyzed by means of DOC analysis and showed an initial content of 7.4 mg/L DOC. The filtrate was used as stock solution. The analytical determination of stock and test solution showed that they were not stable within 48 hours (deviation > 20%), therefore the geometric mean of the measured values after 0 and 48 hours for the test solution (3.2 mg/L) were used for evaluation.

No lethality or immobilisation of Daphnia magna > 5% was observed at the tested concentration after 48 hours exposure.

Description of key information

Short-term toxicity to Daphnia: EC50 - >100 mg/L; NOEC - 100 mg/L

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information

Acute immobilisation in Daphnia has been investigated in a 48 hour test according to OECD test methods. Dissolution/dispersion agents were used to increase concentration of the substance in the test medium. The EC50 (48h) was determined to be >100 mg/L and the NOEC was 100 mg/L, the highest concentration investigated.

Tests with a structural analogue of the registered substance, a trimellitate ester with mixed C8 -C10 side chains, showed no toxicity when tested at, or above, the limits of water solubility.