Glycerol, propoxylated, esters with acrylic acid, reaction products with diethylamine

Short-term toxicity to aquatic invertebrates

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:

2017-02-07 to

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)

Deviations:

yes

Remarks:

Recorded test temperatures were between 20.3 and 23.4°C (mean: 20.4°C) and thus not maintained in the 20°C ± 1°C range. This deviation was not considered to have affected the outcome or the achievement of the study objectives.

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

By decision of the sponsor’s representative, the test item concentrations were only determined at the beginning of the test in all test solutions. However, an additional analysis on old solutions at 48h were conducted to confirm the test item analysis difficulties.

Vehicle:

no

Details on test solutions:

For both range-finding and definitive tests, tests solutions were prepared from dilutions of a stock solution prepared at 1 g/L (nominal concentration): a known volume of test item (98 µL) was poured into a volumetric flask, the volume was then made up to 100 mL with test medium. The solution was kept under high speed stirring at ambient temperature during approximately 1 hour with a magnetic stir bar. The solutions were slightly opalescent but homogeneous.

The pH of the test solutions was not adjusted.

Test organisms (species):

Daphnia magna

Details on test organisms:

The test organism used for this study was Daphnia magna Straus (Cladocera, Crustacea), clone 5, bred within the laboratory by acyclical parthenogenesis in a synthetic medium. Daphnia magna cultures were fed with a mixture of the microalgae Chlorella vulgaris and Pseudokirchneriella subcapitata. The neonates used were less than 24h old at test initiation (selected by filtration) and they were not first brood progeny.

Test animals were not fed during the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

• Preliminary test: range from 20.0 to 20.1°C (mean 20.0°C)
• Definitive test: range from 20.3 to 23.4°C (mean 20.4°C)

pH:

PRELIMINARY TEST
0h: 8.0 - 8.6
48h: 7.6 - 7.7

DEFINITIVE TEST
0h (fresh solution): 8.1 - 8.4
24h (old solution): 7.8 - 7.9
24h (fresh solution): 8.0 - 8.5
48h (old solution): 7.9

Dissolved oxygen:

PRELIMINARY TEST
0h: 8.8 - 8.9 mg/L
48h: 8.1 - 8.3 mg/L

DEFINITIVE TEST
0h (fresh solution): 8.6 - 8.8 mg/L
24h (old solution): 8.6 - 9.2 mg/L
24h (fresh solution): 9.3 mg/L
48h (old solution): 8.7 - 8.9 mg/L

Nominal and measured concentrations:

PRELIMINARY TEST
Daphnids were exposed under static conditions (i.e. without test solutions renewal) to a series of the following nominal test concentrations: 4.25, 9.50, 20.50, 45.50 and 100.00 mg/L.

DEFINITIVE TEST
Due to results obtained from the preliminary range-finding test, the definitive test was conducted over a 48 hours period under semi-static conditions, meaning that test solutions were renewed at 24h from a fresh stock solution. The same nominal test concentrations (i.e. 4.25, 9.50, 20.50, 45.50 and 100.00 mg/L) were tested.

Details on test conditions:

Culture and test vessels containing D. magna (20 daphnids per tested concentration) were incubated with a photo period of 8 hours of darkness per 24h at a temperature ranging from 18°C to 22°C but remaining constant within ± 1°C during the test.

Test vessels were made of clear glass tubes (around 20 mL capacity) and covered to minimise evaporation and avoid the entry of dust into the solutions. At least 3 mL of exposure solution was provided for each neonate.

The control treatment was maintained under the same conditions as the treated groups, except it did not contain any test item. No auxiliary substance was used.

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

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Reference Item Test

The sensitivity of the test system and the methodology are evaluated monthly by performing an acute Daphnia magna toxicity test on potassium dichromate. The most recent value of 24h-EC50, obtained in February 2017, was equal to 0.8 mg/L.

 

The ISO 6341 norm has a validity criterion specifying that reference item EC50 values must be in the 0.6 to 2.1 mg/L range.

Range-finding and definitive test

No significant immobilization was recorded (only 1 daphnid was found immobile at the highest tested concentration during the definitive test).

 

As expected with this test item, many discrepancies are reported with regards to measured test item concentration results: recovery rates are aberrant and the RSD values high. The analysis of this substance is known to be complicated because of its behavior in aqueous media. These data should thus be disregarded.

Environmental Conditions

The appearance of the test solutions was visually checked at the beginning and at the end of the test. Solutions were found to be clear, no precipitation was observed at the end of the test.

Validity criteria fulfilled:

yes

Conclusions:

The test item has no effect on Daphnia magna up to the highest tested concentration of 100 mg/L.: The NOEC is thus = 100 mg/L and the EC50 is estimated to be > 100 mg/L.

Executive summary:

This study was designed to determine the effects of the test item to Daphnia magna over a 48h period according to the OECD 202 Guideline.

 

Due to results obtained in the preliminary range-finding test,the definitive test was conducted over a 48 hours period under semi-static conditions: the tests solutions were prepared from dilutions of a stock solution prepared at 1 g/L (nominal concentration) and renewed 24h after the beginning of the trial (a fresh stock solution was used for the test solutions renewal).

 

As the test item analysis was known to be complicated and by decision of the sponsor’s representative, the test item concentrations were only determinedat the beginning of the testin all test solutions. However, the test facility conducted an additional analysis on old solutions at 48h to confirm the test item analysis difficulties.

No significant immobilisation was recorded throughout both tests. Consequently, the test item should be considered to have no effect on Daphnia magna up to the highest tested concentration of 100 mg/L. The NOEC is thus = 100 mg/L and the EC50 is estimated to be > 100 mg/L.

 

The definitive test met the validity criteria of the test guideline detailed as follows:

§ The immobilisation in the control did not exceed 10% at the end of the test (0% in the definitive test),

§ The dissolved oxygen concentrations remained above 3 mg/L over the test period (above 8.6 mg/L in the definitive test).

Description of key information

An acute daphnia toxicity test according to the OECD Test Guideline 202 was conducted with Glycerol, propoxylated, esters with acrylic acid, reaction products with diethylamine (CAS 162492-10-6) under semi-static conditions.

As the test item analysis in water is complex and unreliable, recovery rates in the test solutions were highly inconsistent, although they confirmed sufficient exposure to the test item in fresh solutions. Up to the highest test item concentration tested (100 mg/L), no significant immobilisation was observed. Therefore, the EC50 is considered to be greater than this tested concentration.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

As a conservative approach for the chemical safety assessment, the LE50 is considered to be equal to the highest concentration tested (100mg/L), although no significant immobilisation was observed up to this concentration.