Fatty acids C16-18 (even numbered), mono and di esters with Sucrose

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

1992

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control, 2.2 and 5 mg/L
- Sampling method: 20 mL samples were taken from exposure vessels (at test start, after 48 and 96 h).

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test item was directly weighed into a beaker. Diluation water was added and the mixture was homogenized using an Ultra-Turrax and poured into the chamber under stirring with a glass rod.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Source: Charles River Aquatics, Broekman Instituut B.V., Somere, The Netherlands (delivery date: 22 Apr 1996; date of hatching: 31 Jan 1996)
- Length at study initiation (length definition, mean, range and SD): 2.8 - 3.0 cm (mean: 2.9 cm; n=21)

ACCLIMATION
- Acclimation period: 12 d
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: Tetra Min, Melle, Germany
- Feeding frequency during acclimation: twice daily ad libitum

FEEDING DURING TEST
- None

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

2.3 - 2.5 mmol Ca2+ + Mg2+/L

Test temperature:

21.2 - 22.2 °C

pH:

7.6 - 8.2

Dissolved oxygen:

7.5 - 9.9 mg O2/L

Nominal and measured concentrations:

Nominal: control, 1.0, 2.2, 5.5 mg/L
measured: < 1, not analysed, 1.87, 4.67 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria (length: 30 cm, width: 22 cm, height: 24 cm); calibrated to 10 L
- Aeration: no
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1 (three in total: see "Any other information on materials and methods incl. tables")

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (composition according to ISO/DIS 7346/1)
- Culture medium different from test medium: same as test

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 h light/12 h dark
- Light intensity: approx. 700 lux

EFFECT PARAMETERS MEASURED
- Letahlity and visible changes in appearance and behaviour were assessed after 3, 6, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: approx. 2.2
- Range finding study: A range-finding study was conducted but the details were not reported.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Remarks:

Geometric mean of LC0 and LC100

Effect conc.:

3.3 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

2.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No behavioural changes in the control were observed. At 1 mg/L some fish showed increased fright reaction, projecting opercula and were observed swimming posture tail-heavy at the beginning of the study (3+6 h). At 2.2 mg/L some fish showed projecting opercula, increased respiration rate, irregular respiration, hypoactivity and were observed swimming posture tail-heavy throughout exposure. At 5 mg/L some fish showed projecting opercula, dark colored integument, irregular respiration, hypoactivity and were observed swimming posture tail-heavy at the beginning of the study (3+6 h) before they were observed dead.
- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Test solutions were clear and colorless with particulate matter at the water surface and on the bottom.

Reported statistics and error estimates:

Probit analysis could not be performed in order to derive the LC50. Thus, the LC50 was calculated based on the geometric mean of LC0 and LC100.

Sublethal observations / clinical signs:

Table 1: Lethality of fish during exposure

Concentration [mg/L]	Lethality after x h
	3 h	6 h	24 h	48 h	72 h	96 h
0	0/7	0/7	0/7	0/7	0/7	0/7
1	0/7	0/7	0/7	0/7	0/7	0/7
0	0/7	0/7	0/7	0/7	0/7	0/7
2.2	0/7	0/7	0/7	0/7	0/7	0/7
0	0/7	0/7	0/7	0/7	0/7	0/7
5	0/7	0/7	7/7	7/7	7/7	7/7

Description of key information

LC50 (96 h): 3.3 mg/L (arithmetic mean measured, OECD 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

3.3 mg/L

Additional information

One experimental study is available investigating the short-term toxicity of Fatty acids C16-18 (even numbered), mono and diesters with sucrose (no CAS) to fish. The study was performed according to OECD 203 (GLP) with the zebrafish Danio rerio. Nominal concentrations of 1.0, 2.2 and 5.5 mg/L were tested in a static exposure regime. Analysis by HPLC/UV revealed that the substance concentrations remained stable during exposure (within 80-120% of nominal). Thus, the effect concentrations were based on nominal concentrations. 100% mortality was recorded at 5.5 mg/L whereas 0% mortality was recorded at 2.2 mg/L. Thus, the LC50 (96 h) of 3.3 mg/L (geometric mean of nominal substance concentration) was derived as the geometric mean of the LC0 (1.88 mg/L) and LC100 (4.67 mg/L).