Icosyl acrylate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

from 2012-02-17 to 2012-05-22

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)

Version / remarks:

2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Determination of the water quality parameters in the fresh media (0 h) and in the old media (48 h)
- Determination of the TOC at 0 h (fresh media) and 48 h (old media)

Vehicle:

no

Details on test solutions:

- PREPARATION OF TEST SOLUTIONS: A single water accommodated fraction (WAF) with a nominal loading of 100 mg/L was prepared with dilution water three days prior to the application. The test item dispersion was stirred with approximately 1100 rpm for 72 hours at room temperature. After a separation phase of 1 h, the WAF was taken from the homogeneaus liquid phase.
The limit loading level of 100 mg/L was based on the results of a preliminary range finding test, showing no effects at this loading level of the test item.

- CONTROL: Dilution water without test item, tested under the same conditions as the test groups.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBolu).
- Breeder: DR.U.NOACK-LABORATORIEN, Sarstedt, Germany
- Age at study initiation (mean and range, SD): 2 -24 hours old
- Feed: none

ACCLIMATATION:
- Culture: ln glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 ± 2 °C, in an incubator, 16 h illumination, light intensity of max. 20 µE·mexp-2*sexp-1.
- Culture medium: Elendt M4, according to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L.
- Culture feeding: At least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata, Desmodesmus subspicatus and Chlorella vulgaris, with an algae cell density of > 10exp6 cells/mL.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

176 mg CaCO3/L

Test temperature:

18 -22 °C +/- 1°C constant

pH:

8.06

Dissolved oxygen:

9.12

Nominal and measured concentrations:

The single water accommodated fraction (WAF) had a nominal concentration of 100 mg/L.
The measured TOC concentrations in the definitive test were 3.84 mg/L (fresh media, 0 h) and 4.19 mg/L at the control

Details on test conditions:

- Test vessels: Glass beakers (4 cm ID x 7 cm H), 50 ml capacity.
- Test volume per vessel 20 mL.
- Dilution water: Same as for culture.
- Number of daphnids and replicates: 20 daphnids, divided into 4 replicates, each with 5 daphnids per WAF and control.
- Age of daphnids at experimental starting: 2 to 24 h old daphnids were used for the study. They were obtained by removing the mother animals twice within 22 h.
- Application: Per replicate 20 g of each test solution each was weighed out into the test vessel. The daphnids were inserted with a small amount of dilution water by a pipette
- Test temperature18 - 22°C, ± 1 °C constant

OTHER TEST CONDITIONS
- Photoperiod: 16:8 light/dark cycle
- Light intensity: Diffuse light

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EL10

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EL100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

other: NOEL

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

other: LOEL

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Biological data: There was no effect observed, neither in the WAF, nor in the control group in all test item and control groups after 24 and 48 h under static conditions.

- Measured TOC Concentrations: The tested water accommodated fraction of the test item was visually clear throughout exposure. The WAF and the control were analytically verified by analysis of organic carbon (TOC, according to DIN EN 1484) at the start of the exposure (fresh media, 0 h) and at the end of the exposure (old media, 48 h). All effect values given are based on the nominal loading of the test item Acrylate 22 45% (Behenylacrylate).
- Nominal loading of the test item (mg/L) 100WAF = 3.84 mg/L measured concentration (fresh media, 0h) and 3.95 mg/L (old media, 48h)
- Nominal loading of the test item (mg/L) Control = 4.19 mg/L measured concentration (fresh media, 0h) and 3.52 mg/L (old media, 48h)

Results with reference substance (positive control):

The percentage immobility for the reference item was determined after 24 h. The EC50-value with 95 % confidence interval (Cl) was calculated by sigmoidal dose-response regression. The EC50-value for the most recent of the monthly performed reference tests was:
EC50 : 1.64 mg/L (Cl 1.59 - 1.69 mg/L)
The EC50-value of the reference item potassium dichromate after 24 h is within the prescribed concentration range of 1.0 - 2.5 mg/L of quality criteria according to AQS P 9/2 (05/1996) for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item is also within the recommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202.

Reported statistics and error estimates:

STATISTICAL METHODS OF EVALUATION.
- EL10/50/100-values after 24 and 48 h and the NOEL and LOEL after 48 h were deduced directly from the Observation data, without mathematical calculation.
- EC-values and statistical An EC50-value was calculated only for the reference item by analyses for reference item sigmoidal dose-response regression. The confidence interval for EC50 was calculated from the best-fit values, the standard error and the t-distribution with the software GraphPad prism.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2012-09-21 to 2012-10-22

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)

Version / remarks:

(13th April 2004)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Water solubility (under test conditions): <0.02 mg/L

Analytical monitoring:

yes

Details on sampling:

Analysis of the test substance loading rates was conducted immediately after the test substance loading was freshly prepared. Only the stock solutions were measured. No measurement was performed after 24 h, since a considerably high sample volume (10 mL) was needed for the chemical analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Water accommodated fraction (WAF) approach
The test loading was prepared by adding the respective amount of an acetonic stock solution to an empty glass vessel. After complete evaporation of the solvent, the aerated Daphnia medium was added, moderately stirred for 96 h, followed by filtration (MILLIPORE AP15 glass fibre filter). The resulting water soluble fraction at a loading rate of 100 mg/L was used in the test.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Age at study initiation: Less than 24 h
- Method of breeding: Held in 4 L glass aquaria (3 L medium) at 20 ± 2 °C

Feeding during test
- Food type: Suspension of Desmodesmus subspicatus in Elendt M4 medium with an optical density OD680 of about 15 units
- Amount: 400 μL
- Frequency: Per day, except on weekends

ACCLIMATION
- Acclimation period: 1 h
- Acclimation conditions (same as test): Yes
- 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:

None

Hardness:

Carbonat: 0.32 mmol/L

Test temperature:

20 ± 2°C (temperature-controlled room), constant within ± 1°C

pH:

7-7.6

Dissolved oxygen:

5.9- 6.7 mg/L

Nominal and measured concentrations:

Nominal: 100 mg/L
Measured: <0.02 mg/L (below the quantification limit)

Details on test conditions:

TEST SYSTEM
- Test vessel: Flasks, all-glass, with 50 mL of test medium
- Type: Closed
- Material, size, headspace, fill volume: Glass, 100 mL
- Aeration: Yes
- No. of organisms per vessel: 20 per vessel
- No. of vessels per concentration: 2
- No. of vessels per control: 3

TEST MEDIUM / WATER PARAMETERS
- Conductivity in test: 617- 939 µS/cm
- Culture medium different from test medium: No
- Medium: Continuously aerated Elendt M4 medium; Daphnia magna was cultivated in Elendt M4 medium prepared with deionised water (conductivity <1.5 µS/cm)


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h per day
- Light intensity: White fluorescent tubes with a light intensity of 400-500 lux.

EFFECT PARAMETERS MEASURED:
Temperature. Determined in an additional flask without Daphnia at the start and at the end of the exposure
Oxygen, pH: Determined in all solutions at the beginning and in the combined test solutions at the end of the exposure
Conductivity: Determined in all solutions at the beginning of the exposure

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study:
Loading rate (mg/l) and corresponding % immobile Daphnia after exposure
0 mg/L; 48 h exposure; 3.3% immobilisation
1 mg/L; 48 h exposure; 7.5% immobilisation
10 mg/L; 48 h exposure; 0% immobilisation
100 mg/L; 48 h exposure; 0% immobilisation

Reference substance (positive control):

yes

Remarks:

Acute reference test with potassium dichromate conducted twice a year.

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

Loading rate

Basis for effect:

mortality

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

Loading rate

Basis for effect:

behaviour

Details on results:

- Behavioural abnormalities: No
- Other biological observations: No
- Mortality of control: No
- Other adverse effects control: No
- Abnormal responses: No

Results with reference substance (positive control):

The EC50 for the control of sensitivity for 24 h of exposure with potassium dichromate was estimated to be 0.8 mg/L (data from 16 July 2012). The resulting EC50 value of the reference item was within the recommended range of 0.6 - 2.1 mg/L .

Reported statistics and error estimates:

No

Description of key information

The short-term toxicity to aquatic invertebrates is assessed based on data available for2-Propenoic acid, C16-18-alkyl esters (CAS 90530-21-5) and 2-Propenoic acid, C18-22-alkyl esters.

 

Table 1 . Results on short-term toxicity to aquatic invertebrates

Ester	Method	Species	EC50[48hrs]	Reference
2-Propenoic acid, C16-18-alkyl esters [90530-21-5]	OECD 202	Daphnia magna	100 mg/l	BASF SE 2012
2-Propenoic acid, C18-22-alkyl esters [85085-17-2]	OECD 202	Daphnia magna	> 100 mg/l	BASF SE 2012

 

Conclusion

The absence of a short-term toxic potential to aquatic invertebrates was demonstrated by in vivo assays for2-Propenoic acid, C16-18-alkyl esters (90530-21-5) and 2-Propenoic acid, C18-22-alkyl esters (85085-17-2). With regard to the observed EC50 [48 h] values of > 100 mg/L (WAF),it can be concluded that all members of the category are not toxic to aquatic invertebrates.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

The median effective concentration (EC50) of 2-Propenoic acid, C16-18-alkyl esters (CAS 90530-21-5), toDaphnia magnawas investigated for the water accommodated fraction (WAF) at a loading rate of 100 mg/L under static exposure conditions over a period of 48 h. 40 individual Daphnia divided into 2 test vessels were exposed to the test substance. GC-FID chemical analysis of the test substance showed that the dissolved test substance concentration was below the quantification limit (0.02 mg/L). Thus, evaluation was made based on the loading rate. No significant effects (≤10% immobilization out of a total of 40 Daphnia) were observed after 24 and 48 h of exposure. Based on these results, the 24 and 48 h EC50 values of the test substance, were >100 mg/L with respect to the loading rate. The no-observed-effect concentrations (NOEC) for 24 and 48 h of exposure were ≥100 mg/L. 100% immobilization was not detected within 48 h of exposure (BASF SE, 2012).

 

ln the acute immobilization test toDaphnia magna(STRAUS), the effects of the water accommodated fraction (WAF) of the test substance2-Propenoic acid, C18-22-alkyl esters (85085-17-2)with a nominal loading of 100 mg/L were determined according to OECD 202 (2004) and Council Regulation (EC) No. 440/2008 Method C.2 (2008) in a Iimit test. The Iimit test was conducted under static conditions over a period of 48 hours. Twenty daphnids were exposed to the water accommodated fraction and the control. The WAF and the control were analytically verified by analysis of organic carbon (TOC, according to DIN EN 1484) at the start of the exposure (fresh media, 0 h) and at the end of the exposure (old media, 48 h). The measured concentrations of organic carbon in the fresh media (0 h) were 4.19 mg Carbon/L in the control and 3.84 mg Carbon/L in the WAF. The measured concentrations of organic carbon in the old media (48 h) were 3.52 mg Carbon/L in the control and 3.95 mg Carbon/L in the WAF. All effect values given are based on the nominal loading of the test item. Water quality parameters (pH-value and dissolved oxygen concentration), measured in the fresh (0 h) and old media (48 h), were determined to be within the acceptable Iimits. The validity criteria of the test guidelines were fulfilled.

The LL50/EC50 after 48 hours was > 100 mg/L. All effect levels are given based on the nominal level of the test item. Therefore the test substance was found to cause no toxic effects to Daphnia magna after 48 hours when tested with a loading level of 100 mg/L (BASF SE, 2012).