Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs.

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

OECD Guideline 203. "Fish, Acute Toxicity Test", 2019

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs.

EC Number:

614-257-7

Cas Number:

68071-40-9

Molecular formula:

C18H34O4, C20H38O4 and C22H42O4 (mainly)

IUPAC Name:

Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs.

Specific details on test material used for the study:

Identification: Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs. Batch (Lot) Number: 190708588, Expiry date: 31 July 2020, Physical Description: Transparent liquid, Purity/Composition: See Certificate of Analysis, UVCB, Storage Conditions: At room temperature protected from light

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Seven fish per group were exposed to WSFs individually prepared at loading rates of 0.43, 0.94, 2.1, 4.5 and 10 mg/L. The total exposure period was 96 hours. Samples for analytical confirmation of actual exposure concentrations were taken during two renewal intervals from freshly prepared and 24-hour old solutions.
No mortality was observed in the control and at any of the test concentrations throughout the exposure period.
Samples taken from the control and all test concentrations were analysed. The concentrations measured in the freshly prepared solutions increased with increasing loading rates indicating proper preparation of the test solutions. However, the concentrations measured at the start of the first and the third renewal periods also indicated that the preparation of the test solutions was not reproducible with the current protocol. During the subsequent 24-hour intervals the measured concentrations decreased and were partly below the limit of detection or at 1-60% of the initially measured concentration. Based on the obtained results, the average exposure concentration was calculated to be 1.1 mg/L for the highest WSF and used to express effect parameters.

Test solutions

Details on test solutions:

The batch of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs tested was a transparent liquid UVCB and not completely soluble in test medium at the loading rates initially prepared.
For the saturation test, a loading rate of 100 mg/L was prepared and continuously stirred for three days while samples for possible chemical analysis were taken approximately every 24 hours.
Preparation of test solutions started with loading rates individually prepared at loading rates of 0.43 to 100 mg/L. In the range-finding test, a three-day period of magnetic stirring was applied to ensure maximum dissolution of the test item in medium. Thereafter, the aqueous Water Soluble Fractions (WSFs) were collected by means of siphoning and used as test concentrations. Based on the results of the preceding saturation and range-finding tests, a 24-hour period of magnetic stirring was applied to ensure maximum dissolution of the test item in medium in the final test. The obtained mixtures were allowed to settle for a period of
approximately 2-3 hours. Thereafter, the aqueous WSFs were collected by means of siphoning and used as test concentrations.
All test solutions were clear and colorless at the end of the preparation procedure except for the 100 mg/L WSF which was slightly hazy.

Test organisms

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Source ‘De Haar Vissen’, Zodiac proefacc. Wageningen University and Research Centre, The Netherlands.
Mean length: Range-finding test: 2.6 ± 0.3 cm
Final test: 2.8 ± 0.2 cm
Mean weight: Range-finding test: 0.24 ± 0.12 g
Final test: 0.28 ± 0.07 g
Characteristics F1 from a single parent-pair bred in UV-treated water.

Study design

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

96 h

Test conditions

Hardness:

The hardness of test medium expressed as CaCO3: 180 mg/L.

Test temperature:

20-22°C

pH:

7.4-7.8

Dissolved oxygen:

6.4-9.4 mg/L

Nominal and measured concentrations:

The batch of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs tested was a transparent liquid UVCB and not completely soluble in test medium at the loading rates initially prepared. Water Soluble Fractions (WSFs) were individually prepared at loading rates of 0.43, 0.94, 1.0, 2.1, 4.5, 10 and 100 mg/L and used as test concentrations.

Results and discussion

Effect concentrations

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: the 96h-LC50 was beyond the range test, i.e. exceeded an average exposure concentration of 1.1 mg/L being considered the maximum solubility of the test item in test medium.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

1. No mortality was observed in the control throughout the test.
2. The dissolved oxygen concentration has been at least 60% of the air saturation value throughout the test (>5 mg/L at 22°C).
3. Test concentrations were analytically determined.

Executive summary:

The objective of the study was to evaluate Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs for its ability to generate acute toxic effects in Cyprinus carpio during an exposure period of 96 hours and, if possible, to determine the LC50 at all observation times.

The study procedure described in this report was based on the OECD guideline No. 203,1992. In addition, procedures were based on the test methods described in the OECD series on testing and assessment number 23, 2019.

The batch of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16 -alkyloxy)methyl] derivs tested was a transparent liquid UVCB and not completely soluble in test medium at the loading rates initially prepared. Water Soluble Fractions (WSFs) were individually prepared at loading rates of 0.43, 0.94, 1.0, 2.1, 4.5, 10 and 100 mg/L and used as test concentrations.

A final test was performed based on the results of a preceding range-finding test. Seven fish per group were exposed to WSFs individually prepared at loading rates of 0.43, 0.94, 2.1, 4.5 and 10 mg/L. The total exposure period was 96 hours. Samples for analytical confirmation of actual exposure concentrations were taken during two renewal intervals from freshly prepared and 24-hour old solutions.

No mortality was observed in the control and at any of the test concentrations throughout the exposure period.

Samples taken from the control and all test concentrations were analysed. The concentrations measured in the freshly prepared solutions increased with increasing loading rates indicating proper preparation of the test solutions. However, the concentrations measured at the start of the first and the third renewal periods also indicated that the preparation of the test solutions was not reproducible with the current protocol. During the subsequent 24-hour intervals the measured concentrations decreased and were partly below the limit of detection or at 1-60% of the initially measured concentration. Based on the obtained results, the average exposure concentration was calculated to be 1.1 mg/L for the highest WSF and used to express effect parameters.

The study met the acceptability criteria prescribed by the study plan and was considered valid.

The 96h-LC50 was beyond the range test, i.e. exceeded an average exposure concentration of 1.1 mg/L being considered the maximum solubility of the test item in test medium.