[No public or meaningful name is available]

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:

25 -27 Spet 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Adopted April 13, 2004

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, 2000.

Principles of method if other than guideline:

A combined limit/range-finding test was performed.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, vegetable-oil, polymd., esters with 1,2-hexadecanediol

Cas Number:

68910-99-6

Molecular formula:

Not applicable (i.e., UVCB substance)

IUPAC Name:

Fatty acids, vegetable-oil, polymd., esters with 1,2-hexadecanediol

Test material form:

other: paste

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solution was prepared by adding the required amount of test material to the test medium. The solution was stirred for three days. Subsequently the solution was filtered (0.45 µm membrane filter, RC55, Whatman).
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): The test solution was clear and colorless at the end of the preparation procedure.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: in-house laboratory culture
- Age of parental stock: > 2 weeks
- Age of test animals: <24 h
- Feeding during test: none

ACCLIMATION
- Acclimation period: With newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 5 litres of medium in an all-glass culture vessel.
- Type and amount of food: Daily, a suspension of freshwater algae.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

180 mg/L (CaCO3)

Test temperature:

20 °C

pH:

7.8 - 7.9

Dissolved oxygen:

8.4 - 9.1 mg O2/L

Nominal and measured concentrations:

WAF prepared at a loading rate of 100 mg/L (nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel: glass vessels, 60 mL (nominal volume)
- Fill volume: 50 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 h day-night regime

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mobility after 24 and 48 h, measurement: pH and dissolved oxygen were measured at the start and end of the study. Temperature was measured continuously.


RANGE-FINDING STUDY
- Test concentrations: WAFs prepared at loading rates of 1.0 and 10 mg/L
- Results used to determine the conditions for the definitive study: no immobilised specimen observed

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mobility

Results with reference substance (positive control):

The 48 h-EC50 was 0.41 mg/L with a 95% confidence interval between 0.34 and 0.46 mg/L (tested September 2017)

Any other information on results incl. tables

Table 1: Number of Introduced Daphnids and Incidence of Immobility

Time (h)	Replicate	Loading rates (mg/L)
		Control	100
0	A	5	5
	B	5	5
	C	5	5
	D	5	5
	Total introduced	20	20
24	A	0	0
	B	0	0
	C	0	0
	D	0	0
	Total immobilised	0	0
	Effect %	0	0
48	A	0	0
	B	0	0
	C	0	0
	D	0	0
	Total immobilised	0	0
	Effect %	0	0

Table 2: Validity criteria for OECD 202.

Criterion from the guideline	Outcome	Validity criterion fulfilled
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.	0%	yes
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.	8.5 mg/L	yes

 

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

For further details please refer to “Any other information on results incl. tables”.