ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4th September- 6th September 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to guidelines and GLP.

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Principles of method if other than guideline:

N/A

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol

EC Number:

500-099-5

EC Name:

ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol

Cas Number:

37625-56-2

Molecular formula:

(C6H14O3)x.C6H10O2 (x=0-6)

IUPAC Name:

2-Oxepanone, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

Clear, colourless liquid

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
N/A

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

pH and dissolved oxygen was monitored at the start and end of the test period (0 and 48h) in all of the test solutions. The test substance concentration was monitored for stability using the lowest and highest test concentrations at the start and at the end of the test (at 0 and 48h). A sample from the stock solution was also taken at test initiation. Immobilization was determined at 24h and 48h.

Test solutions

Vehicle:

no

Details on test solutions:

A fresh stock solution was prepared on the day of the test start. 1000 mg of the test item was added to 1000 ml aerated reconstituted water and stirred for 10 minutes. To remove the nonwater soluble fraction of the test item from the test solution, the solution was filtered through a 0.45 um cellulose acetate filter (pre-boiled in order to remove any traces of external carbon). The acquired water phase (loading rate 1000 mg/l) was then used as a stock solution, from which the test concentrations were diluted using aerated M7-media. M7-media alone was used as the control solution.
M7-media was prepared according to OECD TG no. 202 (table 2 and 3). The M7-media had a pH of 7.8±0.2 and a theoretical hardness of 250±25 mg/I (expressed as CaC03).

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

The Daphnia magna culture is a Clone-A originating from the Norwegian Institute of Water Research (NIVA), Norway. The Clone-A has been identified by genotyping.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

N/A

Test conditions

Hardness:

250±25 mg/I theoretical

Test temperature:

20± 1 deg C

pH:

7.7-7.9

Dissolved oxygen:

85-101 %

Salinity:

N/A

Nominal and measured concentrations:

Nominal loading rate 28, 56, 113, 225, 450 and 900 mg/l. Measured concentrations at 0 hours for the stock solution, 28 and 900 mg/l were 230, 18, 200 mg/l respectively, at 28 hours measured concentrations were 17 and 200 mg/l (stock solution was not analysed).

Details on test conditions:

The animals were incubated in glass petri dishes (50 ml) with 25 ml test solution. Four replicates were used, both for the control and for the test concentrations, with 5 animals in each. The Petri dishes were placed in a thermo constant room at a temperature of 20± 1.0 C and with a light rhythm of 16 hours light: 8 hours darkness.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 900 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: N/A

Effect concentrations 2

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 900 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: N/A

Effect concentrations 3

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

900 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: N/A

Effect concentrations 4

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

113 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: N/A

Details on results:

The criteria for validity of the tests according to OECD 202 were met.

Results with reference substance (positive control):

A reference test carried out with potassium dichrominate gave an EC50 of 1.3 mg/I, which confirmed that the culture was suitable as a test organism according to OECD guideline 202.

Reported statistics and error estimates:

None reported.

Any other information on results incl. tables

Table 1. Imobilised Daphnia magna at 24 and 48 hours

Conc. Loading rate/mg/l	Number of immobilised Daphnia magna
	24 and 48 hours
	1		2		3		4		total	total	% immobilised	% immobilised
	24	48	24	48	24	48	24	48	24	48	24	48
Control	0	2	0	0	0	0	0	0	0	2	0	10
28	0	0	0	1	1	1	0	0	1	2	5	10
56	0	2	0	0	0	1	1	1	1	4	5	20
113	0	0	0	0	0	0	0	0	0	0	0	0
225	1	1	0	0	0	0	0	2	1	3	5	15
450	0	1	0	1	0	1	0	0	0	3	0	15
900	0	0	1	4	0	1	0	1	1	6	5	30

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The toxicity of Capa 3050 to the water flea was determined in a static 48 hour study. Daphnia magna were exposed to nominal loading rates of Capa 3050 between 28 and 900 mg/l . The 48 hour EC50 was >900 mg/l based on nominal exposure loading rates.

Executive summary:

The toxicity of Capa 3050 to the water flea, Daphnia magna, was determined in a 48 hour static acute immobilisation test conducted according to OECD guideline 202. The daphnids were exposed to Capa 3050 at nominal loading rates of 28, 56, 113, 225, 450 and 900mg/l. Stability of Capa 3050 in the test media was confirmed by TOC analysis at the lowest and highest concentration at the start and end of test period. The 48 hour EC50 was >900 mg/l based on nominal loading rates.