Fatty acids, C16-18 and C18-unsatd., reaction products with glycidyl neodecanoate and 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate

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:

18 April 2016 to 21 April 2016

Reliability:

1 (reliable without restriction)

Reason / purpose for cross-reference:

other: Basis for representation of test solution concentrations

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

The test substance is listed as ZEF 6099/100. The test substance, a brown liquid, is the reaction product of C16-C18 and C18 unsaturated fatty acids, with (3,4-epoxycyclohexyl) methyl 3,4-epoxycyclohexylcarboxylate and neodecanoic fatty acid, oxiranylmethylester. The test substance was obtained from the sponsor and was stored at room temperature (15.2 – 20.9°C) in a closed vessel dark and dry.

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

The content of the test item in the test solutions was estimated based on the organic carbon content of the test item and dissolved organic carbon (DOC) measurement. DOC was determined as total carbon (TC) minus IC (inorganic carbon) in the filtrated (0.45 µm) test solutions. Analyses were made using the carbon analyser TOC multi N/C 2100S, Analytik Jena.

Test organisms (species):

Daphnia magna

Details on test organisms:

The test species, Daphnia magna STRAUS, were from the in-house laboratory breeding culture since 27 September 2007. Young female daphnids selected for the test were an age of <24 h.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

The hardness of the deionised dilution water was 2.502 mmol/L or 250 mg CaCO3/L.

Test temperature:

The temperature of the test medium was 20.1°C to 21.9 °C and complied with the requirements of the protocol (18-22°C, constant within 2°C).

pH:

The pH during the test measured between 7.6 and 7.7 and complied with the requirements of the protocol (6.0-8.5, not varying by more than 1.5 unit).

Dissolved oxygen:

The oxygen concentrations measured during the test were between 8.6 and 9.9 mg/L and complied with the requirements of the protocol (≥3 mg/L at the end of the test).

Salinity:

No information provided.

Conductivity:

No information provided.

Nominal and measured concentrations:

The experimental test was performed with one nominal ZEF 6099/100 concentration of 100 mg/L; the test solution was prepared using the water-accommodated fraction. The decision to test one nominal concentration was based on the results of the algae study (Muckle, 2016). Analytical monitoring was conducted on the basis of dissolved organic carbon (DOC). Because of the low solubility of the test item in the test medium, the measured DOC concentrations at the beginning of the study in the treatment were in a similar low range as the blank control. At the end of the test, the measure DOC concentrations in the treatment and in the control were much higher than at the beginning. This was caused by a not explainable contamination and not by the test item. Because no toxicity could be observed, this can be stated as uncritical for the outcome of the study. Because of the low solubility in the test medium, no calculation from carbon content of the test item (72.42%) and DOC measurement was possible. The measured DOC concentrations in the treatment were in a similar range as the blank control. Therefore, the determination of the biological results was based on the nominal concentration. In an algal test with the same test item (Muckle 2016), the measured DOC concentrations were also in the same range as in the blank control. However, toxicity was observed at the nominal concentration of 100 mg/L and the presence of dissolved test item in the test solutions is thus proven by this biological result. The algal test medium contains more minerals and trace elements than the Daphnia test medium. Therefore, it can be concluded that the Daphnia were exposed to the test item at the nominal concentration of 100 mg/L.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as a positive control in the reference study.

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

Key result

Duration:

24 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:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

One valid experiment was performed. The study was performed using one nominal concentration containing 100 mg/L. For the test concentration, 20 Daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted. None of the animals were immobilised in the control and in the treatment. Potassium dichromate K2Cr2O7 was used as a positive control in the reference study

Results with reference substance (positive control):

The 24 h EC50 was 1.6 mg/L lying within the required range of 0.6 mg/L and 1.7 mg/L. For the estimation of the EC50 of the positive control, the fit showed sufficient statistical correspondence of the data with the dose-response equation.

Validity criteria fulfilled:

yes

Conclusions:

The test substance did not induce acute immobilisation of Daphnia magna at a nominal concentration of 100 mg/L after 48 h of exposure. The 48 h NOEC was ≥ 100 mg/L based on one nominal concentration. The 48 h EC50 was > 100 mg/L based on one nominal concentration of 100 mg/L.

Description of key information

The key study was a static acute invertebrate toxicity test on the effects of ZEF 6099/100 on the freshwater daphnid, Daphnia magna, following OECD Guideline 202. Toxicity of the substance to the daphnids was not observed; the 48-h NOEC was reported as ≥ 100 mg/L (based on the water-accommodated fraction); the 48-h LOEC and 48-h EC50 were each reported as > 100 mg/L (based on the water-accommodated fraction).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L