Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

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:

27 April 2018 to 29 June 2018

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)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 23 (Series on testing and assessment)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

EC Number:

944-892-8

Molecular formula:

not applicable

IUPAC Name:

Reaction mass of butyl palmitate and butyl oleate and butyl (9Z,12Z)-octadeca-9,12-dienoate and 482-680-2

Test material form:

liquid: viscous

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Twenty daphnids were exposed to butyl avocadate distillated at saturation concentration in test media. Saturation concentration solution was prepared in test medium and was divided in 4 replicates. A control (4 replicates) was performed at the same time with only test medium. the test was conducted in 125 mL glass flasks with 50 mL solution per flask. Test solutions were replaced by freshly prepared solutions after 24 hours. Five daphnids were introduced into each replicate. The number of immobilised daphnids was recorded after 24h and 48h in all replicates.

Test solutions

Vehicle:

yes

Details on test solutions:

The test item solution was prepared by dissolution of 10.4 mg of butyl avocadate distillated in 500 mL of the test medium to obtain a nominal concentration higher than the saturation concnetration in test media. The solution was prepared in 1 L glass bottle and shaken during about 24 hours. Then this preparation was filtered through 0.2 µm filter (Whatman cellulose nitrate membrane filters). This solution was used for exposure and identified as saturation concentration. This preparation was repeated to renewall the exposure solution after 24h (10.1 mg of butyl avocadate distillated in 500 mL of the test medium).

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Culture conditions: Temperature at 20°C +/- 2°C, light/dark cycle 16/8 hours, freshwater (reconstituted from salts).
Age at the beginning of the test: Daphnids less than 24 hours old and produced from parthenogenically reproducing brood female population.
Origin: Culture at SGS France from Rouen Laboratory.

Study design

Test type:

semi-static

Water media type:

freshwater

Remarks:

reconstituted from salts

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

Value: 19.8 to 20.4

Criteria:20°C +/- 2°C

Dissolved oxygen:

Value: 8.7

Criteria: > 3

Details on test conditions:

Test item preparation was repeated at 24h and alive daphnids were transferred in newly prepared solutions.
The test solutions at T0 and 24h (fresh solutions) were sampled (volume: 100 mL), extracted and quantified immediately according to the validated method.
The test was carried out at 20°C +/- 2°C in the dark (temperature was recorded automatically by Evisense Temperature Center).
The number of immobilised daphnids was recorded after 24h and 48h in all replicates.
After 24 and 48 hours, the 4 replicates of tested concentrations were respectively mixed. These test solutions were sampled (volume: 100 mL) and quantified immediately according to the validated method.
The pH and dissolved O2 values for each conditions were recorded at T0, T24 and T48h.

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.47 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

See section "Any other information on results incl. tables" below

Any other information on results incl. tables

Data at 24h :

Test Condition	Daphnids immobilised per glass flask
	replicate A	Replicate B	Replicate C	Replicate D	Total of immobilised daphnids	Percentage of immobilisation	pH	Dissolved O2 (mg/L)
Control	0	0	0	0	0	0%	7.4	8.7
Saturation	1	0	0	1	2	10%	7.6	8.8

Data at 48h :

Test Condition	Daphnids immobilised per glass flask
	replicate A	Replicate B	Replicate C	Replicate D	Total of immobilised daphnids	Percentage of immobilisation	pH	Dissolved O2 (mg/L)
Control	0	0	1	0	1	5%	7.4	8.8
Saturation	1	1	0	1	3	15%	7.5	8.7

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Ecotoxicity test of Butyl avocadate distillated on Daphnia magna fulfils the requirements of OECD Guideline No. 202 to determine EC50-48h > 0.47 mg/L (saturation concentration)

Executive summary:

Objective:

The scope of this study was, in compliance with the principles of Good Laboratory Practice (GLP), to determine the acute toxicity of butyl avocadate distillated on Daphnia magna in a 48 -hour semi-static test.

Method Summary:

Twenty daphnids were exposed to butyl avocadate distillated at saturation concentration in test medium. Four replicates were tested per concentration. Test solutions were replaced by freshly prepared solutions after 24 hours.

The number of immobilised daphnids was recorded 24h and 48h in all replicates.

Results:

	Butyl avocadate distillated Based on measured concentration
EC50 -48h	> 0.47 mg/L
Immobilisation at the saturation concentration in test media (0.47 mg/L)	15%

Conclusion:

Ecotoxicity test of butyl avocadate distillated on Daphnia magna fulfils the requirements of OECD Guideline No. 202 to determine EC50 -48h > 0.47 mg/L (saturation concentration).