Reaction mass of linolenate methyl and linoleate methyl and oleate methyl

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:

2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Methyl (9Z,12Z,15Z)-9,12,15-octadecatrienoate

EC Number:

206-102-3

EC Name:

Methyl (9Z,12Z,15Z)-9,12,15-octadecatrienoate

Cas Number:

301-00-8

Molecular formula:

C19H32O2

IUPAC Name:

methyl octadeca-9,12,15-trienoate

Constituent 2

Reference substance name:

Methyl linoleate

EC Number:

203-993-0

EC Name:

Methyl linoleate

Cas Number:

112-63-0

Molecular formula:

C19H34O2

IUPAC Name:

methyl octadeca-9,12-dienoate

Constituent 3

Reference substance name:

Methyl oleate

EC Number:

203-992-5

EC Name:

Methyl oleate

Cas Number:

112-62-9

Molecular formula:

C19H36O2

IUPAC Name:

methyl (Z)-octadec-9-enoate

impurity 1

Reference substance name:

Methyl palmitate

EC Number:

203-966-3

EC Name:

Methyl palmitate

Cas Number:

112-39-0

Molecular formula:

C17H34O2

IUPAC Name:

methyl palmitate

Test material form:

liquid

Specific details on test material used for the study:

Name Reaction mass of methyl linolenate and methyl linoleate and methyl oleate
Batch no. 18010144
Appearance colourless to pale yellow liquid
Composition METHYL OLEATE [CAS 112-62-9] 17 - 23 %;
METHYL LINOLEATE [CAS 112-63-0] 12 - 20 %;
METHYL LINOLENATE [CAS 301-00-8] 47-53 %;
OTHER METHYL ESTERS 4 - 16 %
EC-No. 907-284-3
Purity GC - 50.25 % linolenate methyle
Homogeneity: homogeneous
Production date 15. Feb. 2018
Expiry date 15. Feb. 2020
Storage Room Temperature (20 ± 5°C)
Specific gravity 0.8872

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

Temperature 19.6 – 20.1 °C
Duration 48 hours
Observation times 24 and 48 hours
Medium renewal none
Test vessels glass beakers, nominal volume 100 mL, tall shape
Replicates (Treatments) 4 vessels, each containing 50 ± 5 mL test solution and 5 daphnia
Replicates (Blank control) 4 vessels, each containing 50 ± 5 mL dilution water and 5 daphnia

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Species Daphnia magna
Authority STRAUS
Strain Berlin
Sex female
Age between 0 and 24 hours
Origin Umweltbundesamt Berlin
In-house breeding since 27. September 2007
Selection of the test system was made following the proposal of the guidelines.



Animal Husbandry
Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical. The keeping is performed similar to the method described in the OECD guideline, following SOP 115 002 01 („Zucht und Hälterung von Daphnia magna STRAUS“), version 12 from 02. Feb. 2015.
Vessels preserving glasses, nominal volume 2 L
Medium M4-Medium (recipe of ELENDT)
Food green algae (Desmodesmus subspicatus)
Medium renewal twice a week
Photo period 16/8 hours, using neon tubes
Temperature 20  2 °C

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

19.6 – 20.1 °C

pH:

7.8

Dissolved oxygen:

8.6mg/l

Nominal and measured concentrations:

nominal concentration: 100mg/L

Details on test conditions:

Using a glass tube, the daphnia were caught and lifted from the beaker. They were put on a small sieve, and the medium surrounding the animals was sucked off using absorbent paper. Immediately after that, the animals were put into the respective test solution.
The test vessels were left to stand for 48 hours. After 24 and 48 hours, the immobilised daphnia were counted. Daphnia are considered immobilised when they do not perform any movements or are only able to move their antennae when the beaker is gently agitated. Daphnia which are trapped at the surface of the test solution are also considered immobilised.
The pH and the concentration of dissolved oxygen in the test vessels were measured at the beginning and at the end of the test. The content of the test item in the test vessels was measured at the beginning of the test.


--> Experimental Conditions
Date of performance 07. – 09. Mai 2019
Treatments 100 mg/L (nominal concentration)
The concentrations to be tested are based on the result of a non-GLP pre-test.
Temperature 19.6 – 20.1 °C
Duration 48 hours
Observation times 24 and 48 hours
Medium renewal none
Test vessels glass beakers, nominal volume 100 mL, tall shape
Replicates (Treatments) 4 vessels, each containing 50 ± 5 mL test solution and 5 daphnia
Replicates (Blank control) 4 vessels, each containing 50 ± 5 mL dilution water and 5 daphnia

Reference substance (positive control):

yes

Remarks:

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9)

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Executive summary:

The short-term toxicity to aquatic invertebrates was performed according to the OECD 202 guideline.

The results were the following:

24h EC50	> 100 mg/L
48h EC50	> 100 mg/L
48h NOEC	≥100 mg/L
48h LOEC	> 100 mg/L