Undecanolactone

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:

Experimental dates 29 May to 22 June 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Undecanolactone

EC Number:

254-399-3

EC Name:

Undecanolactone

Cas Number:

39282-36-5

Molecular formula:

C11H20O2

IUPAC Name:

(5E,13E)-icosa-5,13-dienoic acid; 6-tetradecyloxan-2-one

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Elementis Specialties, Batch ref: 1383Q12001
- Expiration date of the batch: 30/08/2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
- Stability under test conditions: No data

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Control and 100 mg/L loading rate
- Sampling method: 0h - duplicate samples teken from freshly prepared bulk test preparation, 48h - duplicate samples taken from pooled replicates
- Sample storage conditions before analysis: Samples stored frozen prior to analysis

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Known amount of test item was added to the surface of 2L test water, to give nominal 100 mg/L loading rate. Test water was stirred by magnetic stirrer such that a dimple vortex was formed. Stirring was for 23 hours, the test solutions were allowed to stand for 1 hour. Water accomodated fraction (WAF) was filtered through glass wool plug.
- Eluate: Test medium
- Differential loading: No
- Controls: Test medium only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): Visual observation showed dispersed test item in the water column after stirring and settling. Microscopic observation after filtering showed no undissolved test item

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: Not specified
- Source: in-house laboratory culture
- Age of parental stock (mean and range, SD): Not specified
- Feeding during test: Not fed during the test

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

No data

Test temperature:

22-23oC

pH:

7.6 to 7.8

Dissolved oxygen:

8.6 to 8.8 mg O2/L

Salinity:

No data

Conductivity:

No data

Nominal and measured concentrations:

Nominal concentration: control and 100 mg/L WAF
Measured concentration:

Details on test conditions:

Study plan stated water temperature should be maintained at 18 - 22oC with a maximum deviation of 1oC. At the start of the definitive test the temperature was 23oC, but this did not coincide with any immobilisation or sub-lethal effects and was not considered to have affected study integrity.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate tested at 0.32, 0.56, 1.8 and 3.2 mg/L under simiilar conditions to definitive test. Results were within normal range for this reference substance

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EL50

Effect conc.:

> 0.1 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other: EC50 exceeded test item solubility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 0.1 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat. (dissolved fraction)

Basis for effect:

mobility

Remarks on result:

other: EC50 exceeded test item solubility

Any other information on results incl. tables

Nominal loading rate (mg/L	Measured concn (mg/L)	Total no. organisms tested	Total no. immobilised		Observations		% effect
			24h	48h	24h	48h
Control	<LoD	20	0	0	1T 19N	20N	0
100	<LoD	20	0	0	20N	20N	0

T            Trapped at surface

N           No sub-lethal effects observed

LoQ       Limit of Quantification (0.1 mg/L)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 48-hour EL50, based on immobility, was determined to be >100 mg/L loading rate WAF. The toxicity of the test item can be considered as being beyond the range tested and exceeded the maximum soluble concentration of the test item in the test medium used for the test i.e. the EL50 exceeded the limit of quantification (LoQ). The LoQ was calculated to be 0.1 mg/L. EL is the Effective Loading Rate.

Executive summary:

In a 48-hour acute toxicity study the aquatic invertebrate,Daphnia magna, was conducted in accordance with the OECD test guideline 202 and in compliance with GLP. 

The test was performed as a limit test at a nominal loading rate of 100 mg/L WAF (Water Accommodated Fraction), with the single test solution prepared from a 100 mg/L saturated solution. The measured concentrations at 0 and 48-hour were below the LoQ (Limit of Quantification) of the analytical method. The LoQ was calculated to be 0.1 mg/L.

Under the conditions of the test, the EL50 (immobility) was determined to be >100 mg/L loading rate WAF. EL is the Effective Loading Rate.

This acute toxicity study is considered acceptable and satisfies the guideline requirements for a short-term toxicity study to aquatic invertebrates.