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 fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 June 2016 to 20 June 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 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

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 – 23.3°C) in a closed vessel dark and dry.

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The original animals of the test species of Danio raerio HAMILTON-BUCHANAN were originally obtained in March 2009 from Umweltbundesamt (UBA) and used for breeding and production of eggs. Sexually immature offspring (length 2± 1 cm) were used in the test.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

The hardness of the drinking water used in the test was 1.03 mmol/L.

Test temperature:

The temperature of the test medium was 22.2°C to 24.8 °C.

pH:

The pH during the test measured between 7.6 and 7.9 and complied with the requirements of the protocol (not varying by more than 1 unit).

Dissolved oxygen:

The dissolved oxygen during the test measured between 6.5 and 9.0 mg/L (at least 80%) and complied with the requirements of the protocol (at least 60% throughout the test).

Salinity:

No information provided.

Conductivity:

The conductivity of the drinking water used in the test measured 242 µS/cm at 25°C.

Nominal and measured concentrations:

The experimental test was performed with one nominal ZEF 6099/100 limit 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. 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, but toxicity at the nominal concentration of 100 mg/L showed the presence of dissolved test item in the test solutions. The concentration of minerals in the algal test medium and fish test medium is similar. Therefore, it can be concluded that the fishes were exposed to the test item at the nominal concentration of 100 mg/L.

Details on test conditions:

The content of the test item in the test solutions was calculated 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.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The toxicity against Danio rerio was tested using a static design for 96 hr. No mortality was observed in the blank control and in the treatment at the one nominal limit concentration of 100 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

No mortality was observed in the blank control and in the treatment at the one nominal limit concentration of 100 mg/L. The 96 h NOEC was ≥ 100 mg/L and the 96 hr LC50 was > 100 mg/L for mortality based on the nominal concentration.

Description of key information

The key study was a static acute fish toxicity test on the effects of ZEF 6099/100 on the freshwater fish Danio rerio.The 96-h NOEC was ≥100 mg/L (based on the water-accommodated fraction); the 96-h LOEC was >100 mg/L (based on the water-accommodated fraction); and the 96-h LC50 was >100 mg/L (based on the water-accommodated fraction).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L