Fatty acids, C16-18 tridecyl esters

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:

2012

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyl oleate

EC Number:

252-862-4

EC Name:

Dodecyl oleate

Cas Number:

36078-10-1

Molecular formula:

C30H58O2

IUPAC Name:

9-Octadecenoic acid (9Z)-, dodecyl ester

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: K120424B
- Expiration date of the lot/batch: April 2013
STABIILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature
- Stability under test conditions: Stable

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Samples were taken from the control and the exposure vessel (100 mg/L).
- Sampling method: Sampling at start (0 h) and end (96 h), 4.8 mL were taken from the test and the control aquarium for chemical analysis.
- Sample storage conditions before analysis: Sample storage in 4 mL brown glass vials (filled up to the brim to avoid oxidative processes), maximum storage period of 8 d at 5 °C ± 3 °C before analysis.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Due to sparingly soluble properties of the test item, the study was performed with the water accommodated fraction (WAF) prepared with synthetic fish water according to OECD 203. The test solutions were withdrawn from the middle of the suspension of the beakers after 1 h settling using a glass tube and transferred into the test vessels (aquarium).
Two beakers were prepared like this and stirred for a period of 48 h at 12-22 °C in diffuse light. For stirring an overhead high-grade stainless steel radial impeller was used (about 500 rpm). The impeller was placed about 5 cm above the bottom of the beakers. The depth of the vortex was about 10% of the total height of the liquid. The test item is very mobile and was therefore added by pipetting. According to the density indicated by the sponsor of 0.8529 g/cm3 the amount to be added was converted into volume.
The filtration of the WAF to obtain the water soluble fraction (WSF) was not taken into consideration to avoid unwanted impacts of the filtration process and to have a worst case scenario.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): Slightly whitish oily spots were still floating on the surface of the solutions. The test solutions were withdrawn from the middle of the suspension on the beakers using a glass tube and transferred into the test vessels (aquarium).

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
Common name: zebra fish
- Source: Aquarium Dietzenbach Fischzucht, Dietzenbach, Germany, delivery date: 20 Nov 2012
- Length at study initiation (length definition, mean, range and SD): 2 ± 1 cm
- Feeding during test: none

ACCLIMATION
- Acclimation period: 8 days before the test started.
- Acclimation conditions (same as test or not): same as test
- Feeding frequency: 2 x every working day.
- Health during acclimation (any mortality observed): No mortality, the fish behaved normally.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Test temperature:

22.3 - 23.9°C

pH:

8 - 8.1

Dissolved oxygen:

Control: 7.9 - 8.6 mg O2/L
100 mg/L: 7.9 - 8.7 mg O2/L

Nominal and measured concentrations:

Nominal: control, 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel : Size: 8 L aquarium
- Aeration: yes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
Source/preparation of dilution water: according to guideline
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 14 h light / 10 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality every 24 h (and 6 h after study initiation); behavioural abnormalities

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accomodated Fraction (WAF)

Basis for effect:

mortality (fish)

Effect concentrations 2

Key result

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: WAF

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no

Applicant's summary and conclusion

Validity criteria fulfilled:

no

Conclusions:

No fish died or showed any abnormal behaviour during the 96 h exposure period.
For Lauryl Oleate, LL50 (96h) > 100 mg/L and NOELR >= 100 mg/L, the substance is not considered harmful to fish.