Reaction mass of L-valine and ethanesulphonic acid and octadecan-1-ol and docosan-1-ol and eicosan-1-ol

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:

7/6/18 - 27/7/18

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of L-valine and ethanesulphonic acid and octadecan-1-ol and docosan-1-ol and eicosan-1-ol

Cas Number:

2125692-22-8

Molecular formula:

C25-31H54-66NO5S

IUPAC Name:

Reaction mass of L-valine and ethanesulphonic acid and octadecan-1-ol and docosan-1-ol and eicosan-1-ol

Test material form:

solid

Sampling and analysis

Details on sampling:

The test was performed with Elendt M4 medium according to OECD 202 (2004).

Test solutions

Vehicle:

yes

Details on test solutions:

The stock solution was prepared as water saturated solution by adding 400.3 mg test item to 1000 mL test medium and shaking for 24.2 h using an overhead shaker at 22.9 – 23.7 °C in diffuse light. The water saturated solution was filtered through a fibre glass filter with a retaining range till 0.6 μm. The filter was prepared by rinsing with purified water and preconditioning with ca. 50 mL stock solution (which was discarded) to reduce adsorption of the test item. This filtered stock solution was used as highest test item loading rate in the test. The negative control (NC; test medium) was treated in the same way as the test item solution. Four replicates, with five daphnids each, were prepared for each test item treatment and the negative control.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

The test organism Daphnia magna Straus originates from the clone breeding of the Federal Environment Agency, department IV 2.4, Berlin, and has been cultivated at Hydrotox GmbH since October 2012. The daphnids are cultured at 20 ± 2 °C with 16 h light : 8 h dark and placed into fresh Elendt M4 medium twice a week. They are kept at approx. 10 animals / 200 mL and fed on workdays with Desmodesmus subspicatus algae corresponding to 0.1 mg C × daphnid-1 × day-1. The test organisms used were 2.5 – 24 h old at the start of the test.
Quality assurance takes place at regular intervals by testing the sensitivity of the test organisms to the reference item potassium dichromate (Sigma, Steinheim, Germany; Lot no.: MKBF2111V). The recent quality testing was performed in April 2018 with EC50 (24h) = 1.8 mg/L (CL 95 %: 1.64 – 2.02 mg/L), which is in the declared range of 0.6 – 2.1 mg/L (24 h) according to OECD 202.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

specified temperature 18 – 22 °C, constant within ± 1 °C

pH:

7.7

Dissolved oxygen:

7.7 mg/L

Conductivity:

701 μS/cm

Nominal and measured concentrations:

Nominal test item loading rate [mg/L] * 0 25 50 100 200 400
Test vessels (replicates) 4
Test solution / Test medium [mL] 40

Details on test conditions:

The test vessels are kept in an incubator (specified temperature 18 – 22 °C, constant within ± 1 °C) with 16 h light : 8 h dark. The pH as well as the O2-concentrations were measured at the start (0 h) and at the end of the test (48 h) and the temperature was measured continuously.

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

63.83 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

19.08 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 34.86 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

34.86 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Reported statistics and error estimates:

With the statistical software ToxRat Professional 3.2.1 (ToxRat Solutions GmbH, Alsdorf, Germany),

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

EC50 (48hr) = 63.83 mg/L

Executive summary:

Study: Daphnia magna Acute Immobilisation Test according to

OECD 202 (13 April 2004)

Sponsor: INOLEX Inc.

Test item: Brassicyl Valinate Esylate

Chemical name: Brassicyl Valinate Esylate

Molecular formula: Not available

CAS number: 2125692-22-8

Batch/Lot number: HC9430

Purity: 100 %

Test organism: Daphnia magna Straus

Test duration: 48 h

Application of test item: 25 – 400 mg/L nominal

Experimental phase: 12 – 14 June 2018

Study initial / completion date: 07 June 2018 / 27 July 2018

Results:

As the measured test item concentrations are not within ± 20 % of the nominal loading rates,

according to OECD 202 (2004), all results are given in relation to the analytically measured test

item concentrations (geometric mean concentrations).

(Lowest/No Observed) Effect Concentration Measured test item concentration [mg/L]

95 % Confidence Limits (CL) 48 h

EC50 63.83

CL 36.63 – 1401.26

EC10 19.08

CL 7.85 – 30.94

LOEC ˃ 34.86

NOEC ≥ 34.86

The test is valid according to OECD Test Guideline 202 (13 April 2004).

The measured TOC concentrations in the test item treatments were 6.05 – 12.31 % of the nominal TOC concentrations.