Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide

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:

02/06/2020 - 04/09/2020

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)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch: 2018060002
pH: 7.60
moisture content: 30.29%

Analytical monitoring:

yes

Details on sampling:

Solutions at T=0h were taken directly from the starting solutions without daphnids. Solutions at T=48h were pooled from two test tubes with daphnids.

Vehicle:

no

Details on test solutions:

The medium was prepared according to M4 Elendt composition.
Test solutions of required concentrations were prepared by direct addition (by weighing) from the test item with the daphnids medium. The prepared samples were stirred 10 minutes at 20 ± 2°C, darkness. After this step, the samples were filtrated on cellulose acetate filter (porosity: 0.45 µm) after a settling period of 10 minutes.

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna Straus, clone number 5, from at least the third generation (i.e. the third brood) obtained with a non-cyclic parthenogenesis reproduction.
The daphnids breeding was carried out in closed bottles placed in a climatic chamber free from any toxic vapour and in medium M4.
Daphnids used in this experimentation were previously filtered in order to obtain animals from a size between 560 µm and 800 µm (corresponding to daphnids less than 24 hours old).

Test type:

static

Water media type:

not specified

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

Observation at 24 and 48 h

Hardness:

260 mg/L of CaCO3

Test temperature:

19.8-20.0°C

pH:

7.5 - 8.1

Dissolved oxygen:

8.4 - 9.1 mg/L

Nominal and measured concentrations:

nominal: 0 (control), 10, 18, 32, 58, 104 and 188 mg test item/L
measured (time weighted average): 0 (control), 5.3, 13.7, 22.6, 42.0, 88.3 and 131.0 mg test item/L

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

113 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Remarks:

Based on total carbon measurement

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

31 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Remarks:

Based on total carbon measurement

Basis for effect:

mobility

Results with reference substance (positive control):

The last toxic response obtained on the reference item K2Cr2O7 (May 27, 2020) indicates an EC50-24h of 1.20 mg/L (1.09 – 1.31), indicating that the daphnids sensitivity is correct (within the accepted interval of 0.6–2.1 mg/L fixed by the International Standard ISO 6341 December 2012 as mentioned in the OECD 202 Guideline) and in accordance with historical data obtained by the laboratory

Nominal test item concentration (mg/L)	Time-weighted mean measured concentations (mg/L)	Number of daphnids exposed at the start	Immobilised daphnids (%)
			at 24h	at 48h
Control	0	20	0 (0%)	0 (0%)
10	5.3	20	0 (0%)	0 (0%)
18	13.7	20	0 (0%)	0 (0%)
32	22.6	20	1 (5%)	3 (15%)
58	42.0	20	6 (30%)	17 (85%)
104	88.3	20	8 (40%)	20 (100%)
188	131.0	20	10 (50%)	20 (100%)

Validity criteria fulfilled:

yes

Conclusions:

The results obtained for the test item “RICOIL EN” on the toxicological endpoint “immobilisation” give an EC50-48h = 31 mg/L [27 - 36], based on Time-weighted mean measured test item concentration.

These values are based on Time-weighted mean measured test item “RICOIL EN” concentration.

Executive summary:

The aim of this study was to determine the acute toxicity of the test item “RICOIL EN” on the daphnids Daphnia magna, according to the OECD guideline 202 [7], Limit test 100 mg/L with semi-static-conditions.

 

Following the results of preliminary tests (non GLP), a final test, at six nominal test item concentration was performed, in order to evaluate the concentration which immobilise X% of the daphnids exposed to the test item after 24 and 48 hours, reported as EC_X-24h and EC_X-48h, relative to tested concentration.

The immobility of the daphnids was determined in a closed static 48-hours test by visual observation after 24 and 48 hours.

The results obtained for the test item “RICOIL EN” on the toxicological endpoint “immobilisation” give an EC₅₀-48h = 31 mg/L [27 - 36], based on Time-weighted mean measured test item concentration.

 

These values are based onTime-weighted mean measuredtest item“RICOIL EN”concentration.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

131 mg/L