Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 Dec - 07 Dec 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

LUBW Landesanstalt für Umwelt, Messungen und Naturschutz, Baden-Württemberg, Germany

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.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- 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 The test solutions were withdrawn from the middle of the suspension og the beakers after 1 h settling using a glass tube and transferred into the test vessels (aquarium).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 (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.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

22.3 - 23.9 °C

pH:

8.0 - 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

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no

Sublethal observations / clinical signs:

No fish died or showed any abnormal behaviour during the 96 h exposure period.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to the analogue justification provided in IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source: RA-A, CAS 36078-10-1, Dako, 2013, D. rerio, 96 h

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Water Accommodated Fraction (WAF)

Basis for effect:

mortality (fish)

Remarks on result:

other:

Remarks:

Source: RA-A, CAS 36078-10-1, Dako, 2013, D. rerio, 96 h

Conclusions:

The effect concentration retained for the short-term toxicity to fish is an LL50 (96 h) of > 100 mg/L (nominal), based on an experimental study with a structurally and chemically closely related source substance (OECD 203, D. rerio); read-across

Description of key information

No effects up to the limit of water solubility (OECD 203, D. rerio); read-across

Additional information

There is no study available, in which the short-term toxicity of Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters to fish was assessed. Therefore, read-across to the structurally and chemically closely related source substance Dodecyl oleate (CAS 36078-10-1) was performed in accordance with Regulation (EC) No 1907/2006 Annex XI, section 1.5 in order to fulfill the data requirements for this substance. The source substance is characterized by similar fatty acid chain lengths and alcohol components as the target substance and is therefore considered a suitable representative for the assessment of the short-term toxicity of the target substance to fish. A detailed read-across justification in provided in IUCLID section 13.

The available study with the source substance Dodecyl oleate was conducted according to OECD guideline 203 and in compliance with GLP. A limit test was performed in which the zebrafish Danio rerio was exposed to a Water Accommodate Fraction with a nominal loading level of 100 mg/L test item for 96 h. After 96 h, no mortality was observed and an LL50 (96 h) of > 100 mg/L was derived based on nominal concentrations. The chemical analysis of the test solution resulted in concentrations below the analytical detection limit of 0.005 mg/L reflecting the very low water solubility of the test item. Thus, it is concluded that Dodecyl oleate does not cause short-term effects to fish up to the limit of water solubility.

Based on the high degree of structural and chemical similarity between the target and the selected source substance, the target substance is expected to exhibit a similar ecotoxicological profile as the source substance. Therefore, it can be concluded that the target substance Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters does not cause short-term toxic effects to fish up to its limit of water solubility (< 6.57 µg/L at 20 °C, pH 6.3, OECD 105).