Reaction products of acrylic acid with 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]

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:

From 16 July, 2012 to 18 July, 2012

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:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Qualifier:

according to guideline

Guideline:

ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Samples for possible analysis were taken from all test concentrations and the control according to the schedule below.
Frequency: At t=0 h and t=48 h
Volume: 1.5 mL from the approximate centre of the test vessels
Storage: Samples were stored in a freezer until analysis.
At the end of the exposure period, the replicates were pooled at each concentration before sampling. Additionally, reserve samples of 1.5 mL were taken for possible analysis. If not used, these samples were stored in a freezer for a maximum of three months after delivery of the draft report pending on the decision of the sponsor for additional analysis.

Vehicle:

no

Details on test solutions:

Ebecryl 140 radiation curing resins, a UVCB substance, was not completely soluble in test medium at the loading rates initially prepared. Weighing of test substance and preparation of test solutions was performed under dimmed light conditions. All test concentrations were prepared separately and started with loading rates of 1.0, 10 and 100 mg/L applying 2 d of magnetic stirring in the dark to reach maximum solubility of the test substance in the test medium. The resulting aqueous mixtures were left to stabilize for 3 h where after the clear and colourless Water Accommodated Fractions (WAFs) were siphoned off and used as test concentrations.

Test organisms (species):

Daphnia magna

Details on test organisms:

Species: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions.
Source: In-house laboratory culture with a known history.
Reason for selection: This system has been selected as an internationally accepted invertebrate species.
Validity of batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Characteristics: For the test selection of young daphnids with an age of < 24 h, from parental daphnids of more than two weeks old.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

180 mg/L expressed as CaCO3

Test temperature:

Between 19.4 and 20.6°C

pH:

Between 7.9 and 8.0

Dissolved oxygen:

Between 8.4 and 9.0 mg O2/L

Nominal and measured concentrations:

Nominal concentrations: WAFs prepared at loading rates of 1.0, 10 and 100 mg/L
Measured concentrations: Analysis of the sample taken from the highest test concentration at the start of the test showed an initial concentration of 10 mg/L. This concentration remained stable during the test period (82% of initial at the end of the test). Given this result, the effect parameters were based on the initial exposure

Details on test conditions:

Test duration: 48 h
Test type: Static
Test vessels: 100 mL, all-glass
Medium: Adjusted ISO medium
Number of daphnids: 20 each for the highest test concentration and the control; 10 for each lower test concentration
Loading: 5 per vessel containing 80 mL of test solution
Light: No illumination
Feeding: No feeding
Aeration: No aeration of the test solutions.
- Source/preparation of dilution water: Adjusted ISO medium: the following chemicals (analytical grade) are dissolved in tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands):
Macro salts:
CaCl2.2H2O : 211.5 mg/L
MgSO4.7H2O: 88.8 mg/L
NaHCO3 : 46.7 mg/L
KCl : 4.2 mg/L
The hardness: 180 mg/L expressed as CaCO3 and the pH: 7.7 ± 0.3 after aeration.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
EC50 at t=24, 48 h

Reference substance (positive control):

yes

Remarks:

potassium dichromate (K2Cr2O7)

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 10 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Behavioural abnormalities: No
- Immobility of control: No immobility was observed.
- Other adverse effects control: No

Results with reference substance (positive control):

The 24h-EC50 was 0.49 mg/L with a 95% confidence interval between 0.45 and 0.55 mg/L.
The 48h-EC50 was 0.28 mg/L with a 95% confidence interval between 0.14 and 0.65 mg/L.

Reported statistics and error estimates:

No EC50 could be calculated because the test substance proved to be of low toxicity (EC50 > maximum soluble concentration tested).

Measured concentrations: Analysis of the sample taken from the highest test concentration at the start of the test showed aninitial concentration of 10 mg/L. This concentration remained stable during the test period (82% of initialat the end of the test). Given this result, the effect parameters were based on the initial exposureconcentration.

Immobility: After 48 h of exposure 20% immobility was observed at the highest testconcentration. No immobility was observed at any of the lower test concentrations and the control.

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, the 48 h EC50 of di-TMPTTA to Daphnia magna was > 10 mg/L (WAF).

Executive summary:

A study was conducted to assess the acute toxicity of di-TMPTTA to Daphnia magna in accordance with OECD Guideline 202, EU Method C.2, 2008 and the ISO 6341, 1996, in compliance with GLP. A combined limit/range-finding test was performed, exposing twenty daphnids per concentration (four replicates, five daphnids per replicate) to a WAF prepared at a loading rate of 100 mg/L and a control. In addition, ten daphnids per concentration (two replicates, five daphnids per replicate) were exposed to WAFs prepared at loading rates of 1.0 and 10 mg/L. The total test period was 48 h and samples for analytical confirmation of actual exposure concentrations were taken at the start and the end of the test. Analysis of the sample taken from the highest test concentration at the start of the test showed an initial concentration of 10 mg/L. This concentration remained stable during the test period (82% of initial at the end of the test). Given this result, the effect parameters were based on the initial exposure concentration. Under the test conditions, the test substance induced 20% immobility of Daphnia magna at the maximum solubility level in test medium. Hence, the 48 h EC50 was considered as > 10 mg/L (Bouwman, 2013).

Description of key information

Based on the study conditions, the 48 h EC50 of the test substance toDaphnia magnawas >10 mg/L (measured; WAF).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

10 mg/L

Additional information

A study was conducted to assess the acute toxicity of the test substance toDaphnia magnain accordance with OECD Guideline 202, Commission Regulation (EC) No 440/2008, Part C.2, 2008 and the ISO International Standard 6341, 1996. A combined limit/range-finding test was performed, exposing twenty daphnids per concentration (four replicates, five daphnids per replicate) to a WAF prepared at a loading rate of 100 mg/L and a control. In addition, ten daphnids per concentration (two replicates, five daphnids per replicate) were exposed to WAFs prepared at loading rates of 1.0 and 10 mg/L. The total test period was 48 h and samples for analytical confirmation of actual exposure concentrations were taken at the start and the end of the test. Analysis of the sample from the highest test concentration at the start of the test showed an initial concentration of 10 mg/L. This concentration remained stable during the test period (82% of initial at the end of the test). Given this result, the effect parameters were based on the initial exposure concentration. Under the test conditions, the test substance induced 20% immobility ofDaphnia magnaat the maximum solubility level in test medium. Hence, the 48 h EC50 was > 10 mg/L.