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

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:

2 Oct 2017 - 4 Oct 2017

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

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 completely soluble in test medium at the concentrations 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 for possible analysis from the test concentration and controls from the approximate centre of the test vessels for analysis. Sampling frequency was at the start of the test (0 hours) and at the end of the test (48 hours). Samples were analysed on the day of sampling. At the end of the exposure period, the replicates were pooled at each concentration before 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 500 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 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 0.10 mg/mL in acetone. No other treatment than vigorous shaking was needed to completely dissolve the test item. Thereafter, 50 ¿L of the stock was spiked into 500 mL of medium to reach a test item concentration of 10 ¿g/L and a 15-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):

Daphnia magna

Details on test organisms:

Species: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by a cyclical parthenogenesis under specified breeding conditions.
Test species source: In-house laboratory culture with a known history (Charles River Laboratories Den Bosch BV, Hambakenwetering 7, 5231 DD ¿s-Hertogenbosch, The Netherlands).
Reason for selection: The test species are an internationally accepted invertebrate species.
Validity of batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

not specified

Test temperature:

19 - 20°C

pH:

7.9 - 8.0

Dissolved oxygen:

8.6 - 9.8 mg/L dissolved oxygen

Salinity:

NA

Conductivity:

NA

Nominal and measured concentrations:

Test organism exposures included a blank control, a solvent control and an analytically confirmed nominal limit concentration of 10 ¿g/L test item.

Details on test conditions:

Test vessels: 60 mL, all-glass.
Test medium: Adjusted ISO medium.
Number of daphnids: 20 per concentration.
Loading: 5 per vessel containing 60 mL of test solution.
Light: 16 hours photoperiod daily.
Feeding: No feeding
Aeration: No aeration of the test solutions.
Introduction of daphnids: Within 10 minutes after preparation of the test solution.

Immobility (including mortality) was measured at 24 and 48 hours following the start of exposure. Dissolved oxygen content and pH were measured at the beginning and at the end of the test for the test concentration and the controls. Temperature of the test medium were measured continuously in a temperature control vessel, beginning at the start of the test.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (Concentrations: 0.10, 0.18, 0.32, 0.56, 1.0, 1.8 mg/L and a control)

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 10 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

Analysis of the samples showed measured concentrations being at the level of nominal throughout the exposure period, i.e. 101-108%. Therefore, the effect parameters were expressed in terms of analytically confirmed nominal concentrations. No immobilisation was observed in the controls and at the limit concentration throughout the exposure period.

Results with reference substance (positive control):

Daphnia magna that were exposed to reference substance (potassium dichromate) concentrations of 0.10, 0.18, 0.32, 0.56, 1.0 and 1.8 mg/L and to a control for a maximum of 48 hours showed responses within the ranges of the expected responses at the different concentrations, i.e. the 48h-EC50 was between 0.3 and 1.0 mg/L. The sensitivity of the batch of D. magna was therefore in agreement with historical data collected at the testing laboratory and is considered valid. The 24h-EC50 was 0.59 mg/L with a 95% confidence interval between 0.52 and 0.68 mg/L. The 48h-EC50 was 0.41 mg/L with a 95% confidence interval between 0.34 and 0.46 mg/L.

Number of Introduced Daphnids and Incidence of Immobility

Time (h)	Replicate	Test item*; Nominal concentration (¿g/L)
		Blank-control	Solvent-control	10
0	A	5	5	5
	B	5	5	5
	C	5	5	5
	D	5	5	5
	Total introduced	20	20	20
24	A	0	0	0
	B	0	0	0
	C	0	0	0
	D	0	0	0
	Total immobilised	0	0	0
	Effect %	0	0	0
48	A	0	0	0
	B	0	0	0
	C	0	0	0
	D	0	0	0
	Total immobilised	0	0	0
	Effect %	0	0	0

*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 48h-EC50 for Daphnia magna exposed to Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol was beyond the range tested, i.e. exceeded an analytically confirmed nominal concentration of 10 ¿g/L (considered the maximum soluble concentration in test medium) and is therefore concluded to be >10 ¿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 aquatic freshwater invertebrate, Daphnia magna, was conducted according to the OECD Guideline No. 202 at a GLP accredited laboratory. The study met the acceptability criteria prescribed by the study plan and was considered valid.

 

A limit test was performed. Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to a blank control, a solvent control and to a limit concentration, i.e. 10 ¿g/L. The total exposure period was 48 hours and samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test. Analysis of the samples showed measured concentrations being at the level of nominal throughout the exposure period, i.e. 101-108%. Therefore, the effect parameters were expressed in terms of analytically confirmed nominal concentrations.

 

No immobilisation was observed in the controls and at the limit concentration throughout the exposure period, therefore the 48h-EC50 for D. magna was concluded to be >10 µg/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 propylidenetrimethanol to the aquatic freshwater invertebrate, Daphnia magna, was conducted according to the OECD Guideline No. 202 at a GLP accredited laboratory. The study met the acceptability criteria prescribed by the study and was considered valid.

 

A limit test was performed. Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to a blank control, a solvent control and to a limit concentration, i.e. 10 ¿g/L. The total exposure period was 48 hours and samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test. Analysis of the samples showed measured concentrations being at the level of nominal throughout the exposure period, i.e. 101-108%. Therefore, the effect parameters were expressed in terms of analytically confirmed nominal concentrations.

 

No immobilisation was observed in the controls and at the limit concentration throughout the exposure period, therefore the 48h-EC50 for D. magnawas concluded to be >10 ¿g/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

10 µg/L