1,3-Propanediol, 2,2-bis(hydroxymethyl)-, polymer with 2-(chloromethyl)oxirane, 2-propenoate

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

January-February 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD guideline 202 and under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Pentaerythritol, ethoxylated, esters with acrylic acid

EC Number:

500-111-9

EC Name:

Pentaerythritol, ethoxylated, esters with acrylic acid

Cas Number:

51728-26-8

IUPAC Name:

51728-26-8

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Pentaerythritol, ethoxylated, esters with acrylic acid
- Substance type: UVCB
- Physical state: clear, yellowisch liquid
- Lot/batch No.: 0008190677
- Expiration date of the lot/batch: 21 February 2013
- Storage condition of test material: room temperature

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

The concentration of Pentaerythritol, ethoxylated, esters with acrylic acid was measured at all of the test concentrations daily during the test.
At aEach occasion, three replicate samples were taken from the test solution and one sample was taken from the control solution.

Analytical measurements were be performed by TOC analysis.

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

Because the test item is very poorly soluble in water, and it was not a single chemical substance, test solutions were prepared using a saturated solution method, WAF method according to the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD No. 23.

Two supersaturated test item stock solutions (nominal loading rates of 100 mg/L) were prepared by dispersing/dissolving the appropriate amount of test item into the test medium (ISO medium) two days before the start of the experiment. These solutions were shaken for about 24 hours at approximately 30°C and then equilibrated for about 24 hours at the test temperature. The non-dissolved test materials were removed by filtration through a fine (0.22 µm) filter to give the 100 % v/v saturated solutions. Stock solution 1 was used as highest test concentration solution, the other test solutions were prepared by appropriate diluting of stock solution 2, just before introduction of the Daphnia (start of the experiment).

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Species and strain: Daphnia magna (Straus)
- Source: National Institute of Public Health, 1097 Budapest Gyáli u. 2-6. Hungary
- Justification of strain: Daphnia magna is the standard species of the acute immobilisation test.
- Number of animals: 20 animals in test and control groups respectively, divided into 4 replicates (5 animals/replicate)
- Age of the animals: less than 24 h old at the beginning of the test
- Feeding during test: no feeding during the test
- Food type: concentrated algal suspension of Pseudokirchneriella subcapitata during the holding

ACCLIMATION
- Acclimation period: no acclimation period because the water used was similar to the culture water.
- Acclimation conditions: same

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

None.

Test conditions

Hardness:

The reconstituted water (ISO medium) had an approximate theoretical total hardness of 249 mg/L (as CaCO3).

Test temperature:

The water temperature was measured at the start of the tests and 24-hour intervals thereafter in each test vessel. The test temperature was in the range of 20.2 – 20.7 °C measured in the test vessels. The additionally measured temperature in the climate chamber was between 20.1 and 20.8 °C.

pH:

The pH of the test solution was not adjusted and not varied by more than 1.5 units in any one test. The pH was measured in each test vessel daily in the case of old and fresh media where was possible. The values were in the range of 7.26 – 7.92.

Dissolved oxygen:

The dissolved oxygen concentration was measured in each test vessel daily in the case of old and fresh media where was possible. The values were in the range of 7.9 – 8.7 mg/L.

Salinity:

No data.

Nominal and measured concentrations:

The following nominal concentrations were tested: 6.25; 12.5; 25; 50 and 100 mg/l. Concentration of the test item was measured daily during the test.The corresponding calculated geometric mean test item concentrations were: 6.34; 11.97; 22.89; 44.87 and 88.54 mg/l.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers
- Material, size, headspace, fill volume: t 5 ml test solution/animal
- Aeration: yes
- Type of flow-through (e.g. peristaltic or proportional diluter): semi-static
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms in control: 20
- No. of organisms per concentration: 20
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

OTHER TEST CONDITIONS
- Adjustment of pH: the pH will not vary by more than 1.5 units in any one test
- Photoperiod:: 16 hours light (artificial illumination) and 8 hours darkness;

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The immobility or mortality of the Daphnia will be determined by visual observation after 24 and 48 hours. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile. Also, other visible abnormalities in appearance or behaviour will be recorded. The number of immobilised animals and the percentage of immobility will be determined at 24 and 48 hours.

TEST CONCENTRATIONS
Range-finding study:
- Test concentrations: 0.1, 1, 10 and 100 mg/l (nominal)
- Results used to determine the conditions for the definitive study:

Concentrations (mg/l): 0 0.1 1 10 100
Number of
treated / immobilised animals 10 / 0 10 / 1 10 / 0 10 / 1 10 /7

Definitive study:
The following nominal concentrations were tested: 6.25; 12.5; 25; 50 and 100 mg/l.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

135.82 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 103.87-1202.81 mg/L

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

90.94 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 77.35-108.89 mg/L

Effect concentrations 3

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

100

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

50

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

The number of immobilised animals and the percentage of immobility were determined at the 24th and 48th hour (for results, see Table). There were no immobilized animals in the control group. The dissolved oxygen concentration at the end of the test in control and test vessels was more than 3 mg/L. All validity criteria were within acceptable limits and therefore the study can be considered as valid.

The following nominal concentrations were tested: 6.25; 12.5; 25; 50 and 100 mg/l. Concentration of the test item was measured daily during the test.The corresponding calculated geometric mean test item concentrations were: 6.34; 11.97; 22.89; 44.87 and 88.54 mg/L. As the measured concentration deviated notdid not deviate more than 20 per cent from the nominal in all cases, biological results are based on the nominal concentrations.

Results with reference substance (positive control):

For the evaluation of the quality of the Daphnia clone and the experimental conditions, Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions. The date of the last study with reference item Potassium dichromate (batch no.: 0769128) is: 09-10 August 2012. The 24h EC50: 0.98 mg/L, (95 % confidence limits: 0.92 – 1.06 mg/L).

Any other information on results incl. tables

Table: Number and percentage of immobilised animals

	Number of treated animals	Immobilised animals
Nominalconcentration mg/L		24 hours		48 hours
		number	percent	number	percent
Control	20	0	0	0	0
6.25	20	0	0	0	0
12.5	20	0	0	0	0
25	20	0	0	0	0
50	20	0	0	0	0
100	20	5	25	13	65

 

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 24h EC50 value:  135.82 mg/L(with 95 % conf. limits: 103.87–1202.81 mg/L)
The 48h EC50 value:   90.94 mg/L(with 95 % conf. limits: 77.35–108.89 mg/L)

Executive summary:

The acute toxicity of Pentaerythritol, ethoxylated, esters with acrylic acidwas assessed with acute immobilisation test on Daphnia magna, over an exposure period of 48 hours in a semi-static system. Based on the results of the preliminary range-finding test five test concentrations in a geometric series with a separation factor of 2 and one untreated control were tested in the main experiment.The nominal concentrations of the test item used in the main experiment were: 6.25, 12.5, 25,50 and 100 mg/L. Test concentrations were analytically determined daily during the test. As the measured concentration did not deviate more than 20 per cent from the nominal in all cases, biological results are based on the nominal concentrations. Twenty animals, divided into four groups (glass beaker) of five animals each were used for the test and for the control groups.

 

Under the conditions of this Daphnia magnaacute immobilisation study the calculated and observed endpoints for the effect of Pentaerythritol, ethoxylated, esters with acrylic acidwere the followings:

The 24h EC₅₀value:     135.82 mg/L(with 95 % conf. limits: 103.87–1202.81 mg/L)

The 48h EC₅₀value:     90.94 mg/L(with 95 % conf. limits: 77.35–108.89 mg/L)

 

The 48h No-Observed Effect Concentration (NOEC):            50 mg/L

The 48h Lowest Observed Effect Concentration (LOEC):     100 mg/L