Fatty acids, coco, esters with 1,3-butanediol

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

Study period:

20 Mar - 09 Apr 2020

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

2019

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Control and 100 mg/L (nominal loading)
- Sampling method: samples were analyzed at the beginning and in the end of the test

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Because of the very poorly solubility in water of the test item an extraction has been performed to better solubilize the soluble components of the test item in water, according to OECD Guidance N. 23. After the range finding test the test item has been prepared at 100 mg/L in tap water (saturated solution exceeding the maximum solubility of the test item). The solution has been extracted for 72 h, at 10 rpm, at room temperature. From extract the solution have been prepared understirring. The test has been performed on the nominal solution so obtained.
- Controls: 1

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Universita’ Milano Bicocca, Univerity of Milan, Milan, Italy
- Length at study initiation (length definition, mean, range and SD): 1-2 cm


ACCLIMATION
- Acclimation period: 11 days for range-finding test, 14 days for definitive test
- Acclimation conditions (same as test or not): yes
- Type and amount of food during acclimation: Feedstuff in flakes and granules
- Feeding frequency during acclimation: 3 times a week with suspension 24 hours before the beginning of the test
- Health during acclimation (any mortality observed): No abnormalities were observed


FEEDING DURING TEST
- Food type: no feeding during test

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

40 - 250 mg CaCO3/L

Test temperature:

23.9 - 24.1 °C

pH:

7.60 - 7.83

Dissolved oxygen:

76 - 79% saturation of dissolved oxygen

Nominal and measured concentrations:

- nominal: control, 100 mg/L
- measured (0 h): -, 10.26 mg/L
- measured (96 h): -, 10.38 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 10L glass tanks
- Type (delete if not applicable): open
- Aeration: continuous with porous stones
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: < 0.8 g/L.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: To reduce the eventual presence of chlorine, the tap water used for the assay has been allowed to stabilize for 48 hours. Tanks have been kept under control for temperature and oxygen for approximately 1 hour before introducing fish.
- Culture medium different from test medium: no
- Intervals of water quality measurement: every 24 hours

OTHER TEST CONDITIONS
- Photoperiod: 12 hours of light and 12 hours of darkness, tanks have been lighted with white light lamps

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Visible abnormalities such as equilibrium loss, irregular swimming, difficulties in respiratory functions and variation of pigmentation have been observed after 2 h + 0.5h and 5 h +1 h from the beginning of the test and twice per day until the end of the test and recorded.

TEST CONCENTRATIONS
- Range finding study : Yes
- Test concentrations: 100, 10, 10, 1, 0.1 mg/L

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10.26 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No abnormalities were observed during the test

Sublethal observations / clinical signs:

Table 1: Measured concentrations of the test item

Nominal concentration	Measured concentration 0 h (mg/L)	Measured concentration 96 h (mg/L)	% Stability of measured concentration
100 mg/L	10.26	10.38	101.15

 

Table 2: Number of dead fish in control and treated groups during the test (n = 7)

	2 h	5 h	1 d	1 d	2 d	2 d	3 d	3 d	4 d	4 d
Check No.	-	-	1^st	2^nd	1^st	2^nd	1^st	2^nd	1^st	2^nd
Control	0	0	0	0	0	0	0	0	0	0
100 mg/L	0	0	0	0	0	0	0	0	0	0

 

Table 3: Validity criteria for OECD 203.

Criterion from the guideline	Outcome	Validity criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test	0%	Yes
The dissolved oxygen concentration must have been at least 60 per cent of the air saturation value throughout the test	76 - 79% air saturation throughout the test	Yes
There must be evidence that the concentration of the substance being tested has been satisfactorily maintained, and preferably it should be at least 80 per cent of the nominal concentration throughout the test. If the deviation from the nominal concentration is greater than 20 per cent, results should be based on the measured concentration.	The concentration at the end of the test showed a recovery of 101.15% of the initial tested concentration	Yes

 

Validity criteria fulfilled:

yes

Remarks:

See Table 3 at 'any other informations on results incl. tables'

Description of key information

LC50 (96 h) > 10.26 mg/L (initial measured concentration) (OECD 203, 2019)

LC50 (96 h) > 100 mg/L (nominal concentration) (OECD 203, 2019)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

10.26 mg/L

Additional information

One GLP study is available, in which the short-term toxicity (96 h) of the UVCB substance fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3) to fish was investigated. This study was conducted according to OECD guideline 203 (2019). After a previous range-finding study, the test was conducted as a limit test with a nominal concentration of 100 mg/L. The initial measured concentration was 10.26 mg/L test item, and at the end of the test 10.38 mg/L test item. Thus, the test item was stable over the time of exposure. The results were based on the initial measured concentration. At the end of the test no mortality and no abnormalities were observed in treated and control fish. The 96-h LC50 was determined as > 10.26 mg /L based on the initial measured concentration (LC50 (96 h) > 100 mg/L (nominal)). All validity criteria were met and the test is considered valid.