Fatty acids, vegetable-oil, Me esters, sulfurized

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

FROM 16 NOV 2018 TO 19 FEB 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

The difference of the temperature in the test was more than 2 °C (21.2 – 24.9 °C). As no mortality occurred in the test, this was stated as uncritical.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, vegetable-oil, Me esters, sulfurized

EC Number:

276-337-4

EC Name:

Fatty acids, vegetable-oil, Me esters, sulfurized

Cas Number:

72102-30-8

IUPAC Name:

Fatty Acids, vegetable-oil, Me-Esters, sulfurized

Test material form:

liquid

Details on test material:

- Density: 0.95 g/mL
- Batch no.: 71012767

Sampling and analysis

Analytical monitoring:

yes

Remarks:

The method is fully described in validation report VB17091901G926.

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Strain: Danio rerio HAMILTON-BUCHANAN
- Source: The batch of the fish was a mixture fish from a commercial supplier (Dehner Garten Center, 67433 Neustadt) and the offspring of the original animals, obtained from Umweltbundesamt (UBA) and used for breeding and production of eggs.
- Age at study initiation: sexually immature young fish
- Length at study initiation: length 2 ± 1 cm
- Method of breeding: not specified
- Maintenance of the brood fish: not speficied

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: warmwater fishfood, amount not specified
- Feeding frequency during acclimation: three times a day
- Health during acclimation: no mortality occurred

FEEDING DURING TEST
- Food type: none

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Remarks on exposure duration:

none

Post exposure observation period:

none

Test conditions

Hardness:

0.88 mmol

Test temperature:

Nominal Concentration Temperatures in ° C (old/new test solution)
in mg/L 0 h 24 h 48 h 72 h 96 h
new old new old new old new old
Blank Control 21.8 23.6 21.2 23.6 23.4 23.6 22.0 23.6
100 23.5 24.9 23.3 24.5 23.1 24.5 22.7 24.2

pH:

Nominal Concentration pH at t in h (old/new test solution)
in mg/L 0 h 24 h 48 h 72 h 96 h
new old new old new old new old
Blank control 8.1 8.2 8.1 8.2 8.0 8.3 8.2 8.2
100 8.0 8.1 8.1 8.2 8.0 8.3 8.1 8.3

Dissolved oxygen:

Nominal Concentration O2 in mg/L at t in h (old/new test solution)
in mg/L 0 h 24 h 48 h 72 h 96 h
new old new old new old new old
Blank control 9.0 7.9 9.8 7.9 9.4 7.9 9.0 8.2
100 8.0 6.9 8.6 7.6 8.3 7.6 8.3 8.1

Salinity:

not applicable

Conductivity:

210 µS/cm

Nominal and measured concentrations:

The study was performed as a limit-test at the nominal concentration 100 mg/L using a semi-static test design and daily medium renewal.

Details on test conditions:

TEST SYSTEM
- Test vessel: aquaria
- Type: open
- Material: glass, 10L maximal volume
- Aeration: accomplished with glass tubes
- Type of flow-through: not applicable
- Renewal rate of test solution: daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: not stated

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Wasserwerk Maikammer/tap water
- Total organic carbon: < 0.5 mg/L
- Particulate matter: not stated
- Metals:
sodium 4.4 mg/L; potassium 2.5 mg/L; calcium 32 mg/L; magnesium 2.1 mg/L; aluminium 0.007 mg/L; iron <0.005 mg/L; manganese <0.005 mg/L; antimony <0.001 mg/L; arsenic <0.001 mg/L; lead <0.001 mg/L; cadmium <0.0001 mg/L; chromium <0.0005 mg/L; copper 0.002 mg/L; nickel <0.001 mg/L; mercury <0.0001 mg/L; selenium <0.001 mg/L; bor <0.01 mg/L;
- Pesticides and biocides: < LOD µg/L
- Chlorine: as chloride 9.2 mg/L; as chlorinated organic compounds < 1 µg/L
- Alkalinity: not stated
- Ca/Mg ratio: 15.24:1 (m/m)
- Culture medium different from test medium: no
- Intervals of water quality measurement: yearly

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 12/12
- Light intensity: not stated

EFFECT PARAMETERS MEASURED: Observations were made every 24 hours, measuring pH and O2-concentration of the old and new test solution in each vessel and documenting mortalities.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Key result

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

not applicable

Reported statistics and error estimates:

none

Applicant's summary and conclusion

Conclusions:

One valid experiment was performed.
The study was performed as a limit-test at the nominal concentration 100 mg/L. Because of insufficient stability of the test item in test medium under test conditions, the study was performed under semi-static conditions and daily medium renewal. The concentration and the blank control showed no mortality.
In two other studies, an alga test and a daphnia test (GLP studies performed at LAUS GmbH), test item was only detectable in the fresh prepared solutions, but in presence of the test organism no test item was detectable. In this study, the content of the test item in the test vessels was measured at the beginning, at each medium renewal in the fresh prepared test solutions and the end of the test. Despite identical handling, the measured concentrations were scattering but test item was detectable in each fresh prepared solution and at the end of the test in small quantities. Therefore, the determination of the results was based on the nominal concentration. No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met.
The result of the test is considered valid.