2,3-Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol

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:

16 Oct 2017 - 20 Oct 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

The batch of Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol tested was a clear yellow resin with a purity of 97.2% and visually completely soluble in test medium at the concentration tested. No correction was made for the purity/composition of the test item.

Analytical monitoring:

yes

Details on sampling:

During the test, 4.0 mL samples were taken from the approximate centre of the test vessels for analysis. Sampling frequency was:
1) At the start of the test and after 72 hours from the freshly prepared solutions.
2) At the first renewal (t=24h) and the end of the test from the 24-hour old solutions.

Samples were analysed on the day of sampling.

Vehicle:

no

Details on test solutions:

Water solubility of the test item was determined in Test Facility Study no. 517600 and was 2.0 ¿g/L at a loading of 10 mg/L and 10 ¿g/L at a loading rate of 200 mg/L. As determined in 517599, the test item is slightly surface active, potentially causing an overestimation of the water solubility.

The batch of Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol tested was visually completely soluble in test medium at the limit test concentration tested.

No correction was made for the purity/composition of the test item. Preparation of the test solution started with a stock solution of 10 mg/L in acetone. No other treatment than vigorous shaking was needed to completely dissolve the test item. Thereafter, 500 ¿L of the stock was spiked into 5 litres of medium to reach a test item concentration of 10 ¿g/L and a 18-minute period of magnetic stirring was applied to ensure homogenous distribution. All test solutions were clear and colourless at the end of the preparation procedure. Any residual volumes were discarded.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Test species source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.
Mean length: 3.0 ± 0.5 cm
Mean weight: 0.37 ± 0.15 g
Characteristics: F1 from a single parent-pair bred in UV-treated water.
Reason for selection: The test species are an internationally accepted test species.
Total fish used: 15

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

180 mg CaCO3 per litre.

Test temperature:

22 ± 2°C

pH:

7.7 ± 0.3

Dissolved oxygen:

6.8 ¿ 10 mg/L dissolved oxygen

Salinity:

NA

Conductivity:

NA

Nominal and measured concentrations:

Fish were exposed to a solvent-control and a limit concentration of test item.

Although the measured concentration at the start of the test was equal to nominal (10 ¿g/L) and remained stable during the first 24 hours of exposure (91% of initial), in the last renewal the initially measured concentration was 5.5 ¿g/L in freshly prepared solution and 7.3 ¿g/L in spent solution. Based on these results, the calculated average test item exposure concentration was 8.0 ¿g/L.

Details on test conditions:

Test vessels: 6 litres, all-glass, containing 5 litres of test solution.
Test medium: Adjusted ISO medium with a hardness of 180 mg CaCO3 per litre and a pH of 7.7 ± 0.3.
Number of fish: 7 fish in the control, 8 fish in the limit concentration.
Loading:
- Control: 0.52 g fish/Litre, i.e. 7 fish per 5 litres of test medium.
- Limit concentration: 0.59 g fish/Litre, i.e. 8 fish per 5 litres of test medium.
Illumination: 16 hours photoperiod daily
Aeration: The test media were not aerated during the test.
Feeding: No feeding from 24 hours prior to the test and during the total test period.
Introduction of fish: Within 4 minutes after preparation of the test media from a holding tank with comparable water quality parameters and pH and temperature differences between test and holding tank media of less than 0.5 unit and 1.0°C.

Mortality and other effects were measured at 3, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from day 0 to observe for any dead or severely distressed fish. Dead fish were removed when observed. Dissolved oxygen content, pH and temperature were measured daily in all vessels with surviving fish, beginning at the start of the test (day 0).

Reference substance (positive control):

yes

Remarks:

pentachlorophenol (PCP) (Concentrations: 0.10, 0.22 and 0.46 mg/L in ISO-medium)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 8 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence interval could not be determined

Details on results:

No mortality or other effects were observed in the control and the limit concentration during the exposure period, thereby indicating that the test item was not toxic to fish at the average exposure concentration of 8.0 ¿g/L.

Results with reference substance (positive control):

All carp exposed to the reference substance (PCP) at a concentration of 0.46 mg/L died within 24 hours, while no mortality occurred at 0.10 and 0.22 mg/L. The 96h-LC50 for carp exposed to PCP was 0.32 mg/L (95 % confidence interval between 0.22 and 0.46 mg/L). The range of the 96h-LC50 for carp is generally between 0.10 and 0.46 mg/L, hence the sensitivity of carp originating from the present batch for PCP falls within the range of sensitivities generally observed and is considered valid.

Sublethal observations / clinical signs:

Incidence of mortality and total mortalty

Average exposure concentration Test item^1(¿g/L)	Initial number of fish	Cumulative mortality					Total mortality (%)
		3h	24h	48h	72h	96h
Solvent control	7	0	0	0	0	0	0
8.0	8	0	0	0	0	0	0

1 Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol

Validity criteria fulfilled:

yes

Remarks:

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

Conclusions:

The 96h-LC50 was beyond the concentration range tested, i.e. exceeded the average exposure concentration of 8.0 ¿g/L (this concentration was considered to exceed solubility of the test item in water) and is therefore concluded to be >8.0 ¿g/L.

Executive summary:

A study investigating the short-term toxicity of Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2 -dicarboxylic anhydride and propylidenetrimethanol to the freshwater species Cyprinus carpio was conducted according to the OECD Guideline No. 203 at a GLP accredited laboratory. The study met the acceptability criteria prescribed by the study plan and was considered valid.

Fish were exposed to either a solvent control or a limit concentration of 10 ¿g/L test substance. Total exposure duration was 96 hours and test solutions were renewed daily. Samples for concentration analysis were taken from freshly prepared and spent solutions during the first and last renewal period.

Analysis of test samples at the start of the test showed a measured concentrtion equal to nominal (10 ¿g/L). Further test samples were taken for analysis throughout the duration of the test and although the measured concentration was shown to remain stable during the first 24 hours of exposure (91% of initial), in the last renewal the initially measured concentration was 5.5 ¿g/L in freshly prepared solution and 7.3 ¿g/L in spent solution. The reason for the lower concentration in the freshly prepared solution is not known, but could have resulted from low solubility of test item and/or inhomogenous distribution. Based on these results, the average exposure concentration of the limit test was 8.0 ¿g/L.

The 96h-LC50 was beyond the concentration range tested, i.e. exceeded the average exposure concentration of 8.0 ¿g/L (the limit of solubility of the test substance) and is therefore concluded to be >8.0 ¿g/L.

Description of key information

A study investigating the short-term toxicity of Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2 -dicarboxylic anhydride and propylidenetrimethanolst to fish using the freshwater species Cyprinus carpio, was conducted according to the OECD Guideline No. 203 at a GLP accredited laboratory. The study met the acceptablity criteria presvribed by the study plan and was considered valid.

Fish were exposed to either a solvent control or a nominal limit concentration of 10 ¿g/L test substance. Total exposure duration was 96 hours and test solutions were renewed daily. Samples for concentration analysis were taken from freshly prepared and spent solutions during the first and last renewal period.

Analysis of test samples at the start of the test showed a measured concentration equal to nominal (10 ¿g/L). Further test samples were taken for analysis throughout the duration of the test and although the measured concentration was shown to remain stable during the first 24 hours of exposure (91% of initial), in the last renewal the initially measured concentration was 5.5 ¿g/L in freshly prepared solution and 7.3 ¿g/L in spent solution. The reason for the lower concentration in the freshly prepared solution is not known, but could have resulted from low solubility of test item and/or inhomogenous distribution. Based on these results, the average exposure concentration of the limit test was 8.0 ¿g/L.

The 96h-LC50 was beyond the concentration range tested, i.e. exceeded the average exposure concentration of 8.0 ¿g/L (the limit of solubility of the test substance) and is therefore concluded to be >8.0 ¿g/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

8 µg/L