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Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the analogue justification attached to IUCLID section 13.
Reason / purpose:
read-across source
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 294.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 294.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 294.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 294.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Validity criteria fulfilled:
yes
Remarks:
- Immobilisation in the controls may not exceed 10 % (Immobilisation in the controls was 0 %) - The concentration of dissolved oxygen at the end of the test must be at least 3 mg/L (measured: 8.6 mg/L)
Conclusions:
None of the animals was immobilised in the blank control and the treatment.
The following results were determined for the test item (species: Daphnia magna) (OECD 202, Limit test):
48h-NOEC ≥ 294.6 μg/L
48h-LOEC > 294.6 μg/L
24h-EC50 > 294.6 μg/L
48h-EC50 > 294.6 μg/L
Executive summary:

One valid experiment was performed.

The study was performed as a limit test at 100 mg/L (nominal). For each test concentration and the blank control, 20 Daphnia were exposed to the test item for 48 hours in a static test system.

After 24 and 48 hours, the immobilised Daphnia were counted.

None of the animals was immobilised in the blank control and the treatment. Therefore no statistical evaluation was performed and the EC50 (48h) was determined to be > 294.6 µg/L (> 100 mg/L nominal concentration).

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 06 NOV 2018 to 08 NOV 2018
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:
OECD Guideline for Testing of Chemicals No. 202, adopted 13. Apr. 2004:
”Daphnia sp., Acute Immobilisation Test“
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
Council Regulation (EC) No. 440/2008, Method C.2. “Daphnia sp. Acute Immobilisation
Test”, adopted 30. May 2008
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD guidance document no. 23, GUIDANCE DOCUMENT ON AQUATIC TOXICITY TESTING OF DIFFICULT SUBSTANCES AND MIXTURES,
Version / remarks:
adopted 14. Dec. 2000
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 585542
- Expiration date of the lot/batch: May 2019
- Purity test date: 16 May 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test item was stored in a closed vessel at room temperature (20 ± 5°C) protected from light and humidity.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The water-accommodated fraction (WAF) was prepared for the test. This was done by weighing the real load of 100.8 mg/L, adding the corresponding amount of dilution water and shaking vigorously for 24 hours. The resulting solution was centrifuged to remove nonsoluble particles because a higher recovery could be achieved by centrifugation than by membrane filtration.
- Preliminary purification step (if any): centrifugation

FORM AS APPLIED IN THE TEST (if different from that of starting material): Water-accomodated fraction (WAF)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L (nominal)
- Sampling method: At the beginning (0 h) and at the end of the test (48 h), the content of phosphate as part of the test item in the test solutions was determined using photometric determination.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The water-accommodated fraction (WAF) was prepared for the test. This was done by
weighing the real load of 100.8 mg/L, adding the corresponding amount of dilution water
and shaking vigorously for 24 hours. The resulting solution was centrifuged to remove nonsoluble
particles because a higher recovery could be achieved by centrifugation than by membrane filtration.
- Controls: yes, Daphnia medium
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): yes during preparation; nonsoluble particles were removed by centrifugation prior to treatment.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Species: Daphnia magna
- Authority: STRAUS
- Strain: Berlin
- Sex: female
- Age: between 0 and 24 hours
- Origin: Umweltbundesamt Berlin
- In-house breeding since: 27. September 2007
- Vessels: preserving glasses, nominal volume 2 L
- Medium: M4-Medium (recipe of ELENDT)
- Food: green algae (Desmodesmus subspicatus)
- Medium renewal: twice a week
- Photo period: 16/8 hours, using neon tubes
- Temperature: 20 ± 2 °C
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
Resulting hardness in mg CaCO3/L: 250
Test temperature:
20.4 – 21.6 °C
pH:
- Blank control:
0 h: pH 7.7
48 h: pH 7.8
- treatment (100 mg/L nominal concentration):
0 h: pH 8.1
48 h: pH 7.9
Dissolved oxygen:
- Blank control:
0 h: 8.7 mg/L oxygen
48 h: 8.7 mg/L oxygen
- treatment (100 mg/L nominal concentration):
0 h: 8.6 mg/L oxygen
48 h: 8.6 mg/L oxygen
Salinity:
n.a.
Conductivity:
see "Any other information on materials and methods incl. tables"
Nominal and measured concentrations:
100 mg/L (nominal)
294.6 µg/L (measured, geometric mean)
Details on test conditions:
- Treatments: 100 mg/L (nominal) The concentrations to be tested are based on the result of
a non-GLP pre-test.
- Temperature: 20.4 – 21.6 °C
- Duration: 48 hours
- Observation times: 24 and 48 hours
- Medium renewal: none
- Test vessels: glass beakers, nominal volume 50 mL, tall shape
- Replicates (Treatments): 4 vessels, each containing 20 ± 5 mL test solution and 5
daphnia
- Replicates (Blank control): 4 vessels, each containing 20 ± 5 mL dilution water and 5
daphnia
Reference substance (positive control):
yes
Remarks:
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study (201714R201).
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 294.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 294.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 294.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 294.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: none
- Observations on body length and weight: none
- Other biological observations: none
- Immobilisation of control: no
- Effect concentrations exceeding solubility of substance in test medium: yes
Results with reference substance (positive control):
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a
current reference study (201714R201). The 24h-EC50i value was determined as 1.9 mg/L.
The value was within the requested range for the 24h-EC50 between 0.6 - 2.1 mg/L of potassium
dichromate K2Cr2O7 as specified in the OECD guideline.
Reported statistics and error estimates:
None of the animals was immobilised in the blank control and the treatment. Therefore no
statistical evaluation was performed.

FINDINGS

Immobility

In the blank control and the treatment, none of the Daphnia was immobilised (see table

below).

Table Immobility

Nominal Concentration in mg/L

Immobility 24 hours

Immobility 48 hours

absolute

in %

absolute

in %

Blank control

0

0

0

0

0

0

0

0

0

0

100

0

0

0

0

0

0

0

0

0

0


Analytical Determinations

At the beginning and at the end of the test, the content of phosphate as part of the test item in the test solutions was determined using photometric determination. The concentration

of phosphate was used to calculate back to the concentration of test item in the test solutions. The theoretical content of phosphate in the test item is 47 %, which results from

the total P content of 15.32 % (given by the sponsor). The measured concentrations in the blank value are below the LOQ. For evaluation, the geometric mean was determined from

the concentrations at the beginning and end of the test.

The measured concentrations for treatment and blank control are given in the following table:

Table Measured Concentrations Phosphate as part of the test item

Nominal
Concentration Test Item

Measured

concentrations
 t = 0 h

Measured

concentrations
 t = 48 h

mg/L

µg/L

µg/L

Blank control

< LOQ

< LOQ

100

165.83

115.60

Table Calculated concentration test item

Nominal
Concentration Test Item

Calculated concentration test item
 t = 0 h

Calculated concentration test item
 t =48 h

mg/L

µg/L

µg/L

Blank control

--

--

100

352.84

245.97

Table Geometric Mean

Nominal Concentration Test Item

Geometric Mean of measured concentrations

mg/L

µg/L

Blank control

--

100

294.6

RESULTS AND STATISTICS

None of the animals was immobilised in the blank control and the treatment. Therefore no statistical evaluation was performed.


Biological Results Test Item

The biological results are presented in the following table:

Table Biological Results Test Item

Parameter

Value

24h EC50

> 294.6 µg/L

48h EC50

> 294.6 µg/L

48h NOEC

≥294.6 µg/L

48h LOEC

> 294.6 µg/L

Validity criteria fulfilled:
yes
Remarks:
- Immobilisation in the controls may not exceed 10 % (Immobilisation in the controls was 0 %) - The concentration of dissolved oxygen at the end of the test must be at least 3 mg/L (measured: 8.6 mg/L)
Conclusions:
None of the animals was immobilised in the blank control and the treatment.
The following results were determined for the test item (species: Daphnia magna) (OECD 202, Limit test):
48h-NOEC ≥ 294.6 μg/L
48h-LOEC > 294.6 μg/L
24h-EC50 > 294.6 μg/L
48h-EC50 > 294.6 μg/L
Executive summary:

One valid experiment was performed.

The study was performed as a limit test at 100 mg/L (nominal). For each test concentration and the blank control, 20 Daphnia were exposed to the test item for 48 hours in a static test system.

After 24 and 48 hours, the immobilised Daphnia were counted.

None of the animals was immobilised in the blank control and the treatment. Therefore no statistical evaluation was performed and the EC50 (48h) was determined to be > 294.6 µg/L (> 100 mg/L nominal concentration).

Description of key information

48h-NOEC ≥ 294.6 μg/L (Daphnia magna, OECD 202, Limit test, read-across)

48h-LOEC > 294.6 μg/L (Daphnia magna, OECD 202, Limit test, read-across)

48h-EC50 > 294.6 μg/L (Daphnia magna, OECD 202, Limit test, read-across)

24h-EC50 > 294.6 μg/L (Daphnia magna, OECD 202, Limit test, read-across)

Key value for chemical safety assessment

Additional information

No data are available on the short-term toxicity towards aquatic invertebrates of Esters of phosphoric acid with myo-Inositol, plant-derived (CAS No. 83-86-3). Therefore data from the analogue substance "Esters of sodium phosphate with myo-Inositol, plant-derived" (CAS 17211-15-3; EC 241-253-9) were used for read across. This read-across is in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment. This read-across is justified in within the analogue justification in IUCLID Section 13.

One valid experiment was performed.

The study was performed as a limit test at 100 mg/L (nominal). For each test concentration and the blank control, 20 Daphnia were exposed to the test item for 48 hours in a static test system.

After 24 and 48 hours, the immobilised Daphnia were counted. None of the animals was immobilised in the blank control and the treatment. Therefore no statistical evaluation was performed and the EC50 (48h) was determined to be > 294.6 µg/L (> 100 mg/L nominal concentration).