Fatty acids, linseed-oil, reaction products with bisphenol A-epichlorohydrin polymer and glycidyl neodecanoate

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 May 23, 2016 to May 26, 2016

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:

other: OECD guidance document no. 23

Version / remarks:

Guidance document on aquatic toxicity testing of difficult substances and mixtures (adopted Dec. 2000)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch no.: #210162718
Composition: Reaction products of linseed-oil fatty acids, 4,4'-methylendiphenyldiglycidylether with neodecanoic fatty acid, oxiranylmethylester
Purity: 100 % as per definition of UVCB
Appearance: brown liquid

Analytical monitoring:

yes

Remarks:

DOC

Details on sampling:

At the start and at the end of the test, the content of the test substance in the test solutions was determined using measurement of dissolved organic carbon (DOC). The measured concentration based on DOC measurement was very low caused by the low solubility of the test substance. Nevertheless, the increase of DOC showed the presence of the test substance in the test solutions. Therefore, the determination of the biological results was based on the geometric mean of the measured concentrations. Geometric mean is calculated by multiplicationof the n participating concentrations and taking the nth root. Additionally the determination of the biological results was based on nominal concentration.

Details on test solutions:

The water-accommodated fraction (WAF) prepared for the test was done by weighing the nominal load 100.6 mg/L, adding the corresponding amount of dilution water and shaking vigorously for 25 hours. The resulting solution was filtrated through 0.45 μm nylon filters.

Test organisms (species):

Daphnia magna

Details on test organisms:

- Species: Daphnia magna; Variety: STRAUS; Strain: Berlin; Sex: female; Age: between 0 and 24 hours
- Vessels: preserving glasses, nominal volume 2 L; Medium M4-Medium (recipe of ELENDT); Food: unicellular 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:

250 mg CaCO3/L

Test temperature:

19.1 – 21.3 °C

pH:

7.8

Dissolved oxygen:

8.3 (O2-Concentration in mg/L)

Salinity:

-

Conductivity:

-

Nominal and measured concentrations:

100 mg/L (nominal)
3.26 mg/L (measured)

Details on test conditions:

- Treatments: 4 vessels, each containing 20 mL test solution and 5 Daphnia
- Blank control: 4 vessels, each containing 20 mL dilution water and 5 Daphnia

Reference substance (positive control):

yes

Remarks:

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9)

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 3.3 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: limit of solubility during this study

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 3.3 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: limit of solubility during this study

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 3.3 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: limit of solubility during this study

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

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Because no toxicity was observed, no calculation of the biological with the help of validated software was performed. The results based on the mean of the measured concentrations which represent the limit of solubility during the conditions of this study and additionally on the nominal concentration.
- One valid experiment was performed. 20 Daphnia were exposed to the test substance for the treatment for 48 hours in a static test system. None of the animals were immobilised in the blank control and in the treatment of 100 mg/L (nominal).

Results with reference substance (positive control):

The 24h-EC50 value was determined as1.6 mg/L, lying within the demanded range of 0.6 – 1.7 mg/L stated in the guideline.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, none of the animals were immobilised after a 48 h exposure to the test substance at a concentration of 100 mg/L (nominal) or 3.3 mg/L (measured). Therefore, the 48hEC50 and NOEC (in Daphnia magna) were established at >3.3 and ≥3.3 mg/L (measured).

Executive summary:

A study was conducted to determine the short-term toxicity to aquatic invertebrates of the test substance according to OECD Guideline 202, EU Method C.2. Daphnia magna were exposed for 48 h to water accommodated fractions (WAFs) prepared at loading rates of 0 (control) and 100 mg/L (limit test) under static conditions. Mobility of the Daphnia was evaluated after 24 and 48 h and samples for analytical dose verification were taken from the test groups at test start and end. Analysis of the samples indicated very low dissolved organic carbon (DOC) concentrations due to low water solubility, which increased after 48 h. Therefore, the determination of the results was based on the geometric mean of the measured concentrations. None of the animals were immobilised after a 48 h exposure to the test substance at the limit concentration. The EC50 value of the positive control was also found to be within the range stated in the guideline. All other validity criteria were met. Therefore, under the study conditions, the 48h EC50 and NOEC for Daphnia magna was determined to be >3.3 and 3.3 mg/L (measured concentration), which corresponds to a nominal concentration of 100 mg/L (Muckle, 2016).

Description of key information

The 48h EC50 and NOEC for Daphnia magna were established at >3.3 and 3.3 mg/L, based on mean measured concentration.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

3.3 mg/L

Additional information

A study was conducted to determine the short-term toxicity to aquatic invertebrates of the test substance according to OECD Guideline 202, EU Method C.2.Daphnia magna were exposed for 48 h to water accommodated fractions (WAFs) prepared at loading rates of 0 (control) and 100 mg/L (limit test) under static conditions. Mobility of the Daphnia was evaluated after 24 and 48 h and samples for analytical dose verification were taken from the test groups at test start and end. Analysis of the samples indicated very low dissolved organic carbon (DOC) concentrations due to low water solubility, which increased after 48 h.Therefore, the determination of the results was based on the geometric mean of the measured concentrations. None of the animals were immobilised after a 48 h exposure to the test substance at the limit concentration. The EC50 value of the positive control was also found to be within the range stated in the guideline. All other validity criteria were met. Therefore, under the study conditions, the 48h EC50 and NOEC for Daphnia magna were determined to be >3.3 and 3.3 mg/L (measured concentration) respectively, which corresponds to a nominal concentration of 100 mg/L (Muckle, 2016).