Decanoic acid, mixed diesters with octanoic acid and propylene glycol

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:

28 Aug - 01 Sep 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: filtered stock solution of 1000 mg/L

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 1000 mg test substance was added to 1 L drinking water, stirred for approx. 18 h and filtered. Stock solution was prepared daily.
- Eluate: No
- Differential loading: No
- Controls: yes, water control
- Evidence of undissolved material: After 72 and 96 h oily drops were observed on top of the test solution in the test vessels.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: West Aquarium, Bad Lauterbach, Germany
- Length at study initiation (length definition, mean, range and SD): 3 cm ± 0.5 cm
- Feeding during test: none

ACCLIMATION
- Type and amount of food: Tetramin in an amount of approx. 1% of the body weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): Fish were healthy without any behavioural abnormalities. The mortality was <= 5% 7 d prior to test initiation.
- Other: Fish were treated with malachite green three times a week with a 14-day quarantine.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

approx. 12 °dH

Test temperature:

19 - 20 °C

pH:

7.8 - 8.5

Dissolved oxygen:

86 - 108%

Nominal and measured concentrations:

nominal: control, 1000 mg/L
measured: 4.1 mg/L (0 h), 4.7 mg/L (24 h), 68 mg/L (48 h), 81 mg/L (72 h)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass aquaria, 20 L, headspace: 10 L, fill volume: 10 L
- Aeration: continuous aeration
- Renewal rate of test solution: every day
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water from the Gelsenwasser AG

OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark

EFFECT PARAMETERS MEASURED: mortality was observed every day

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LL0

Effect conc.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 39 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Oily drops on the water surface after 72 h and 96 h of exposure.

Sublethal observations / clinical signs:

The effect concentration is based on the nominal concentration because great differences were found in the measured concentrations (Table 1). Oily drops were observed after 72 and 96 h indicating an oversaturated solution. Stability testing of the test substance resulted in a deviation of < 20% from the concentration at the beginning. The test substance was biologically available.

Table 1: Measured concentrations in filtered stock solution (TOC analysis)

	Concentration [mg/L]				Mean [mg/L]
	0 h	24 h	72 h	96 h
Filtered stock solution	4.1	4.7	68*	81*	39

*) oversaturated solution, oily drops on the surface of test solutions

Table 2: Validity criteria for OECD 203 (2019)

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	The mortality in the control(s) at the end of the test was <10%.	yes
The dissolved oxygen concentration must have been at least 60% of the air saturation value throughout the test	The dissolved oxygen concentration was >89% of the air saturation value 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% of the nominal concentration throughout the test. If the deviation from the nominal concentration is greater than 20%, results should be based on the measured concentration.	The deviation from the nominal concentration greater than 20% at the end of the test.	no

 

 

Validity criteria fulfilled:

no

Remarks:

See Table 2 in "Any other information on results incl. tables".

Description of key information

The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546495-41-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 19 October 2022 and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Additional information

The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546495-41-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 19 October 2022 and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

One experimental study investigating the short-term toxicity of decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) to fish is available. The limit test was performed according to the EU Method C.1 (GLP) with the zebrafish Brachydanio rerio under semi-static conditions. A Water Accommodated Fraction (WAF) of 1000 mg/L did not result in any effects although oily drops were visible after 72 and 96 h. The analytical determination of the test substance based on TOC-analysis resulted in very different values since the test solutions were determined to be oversaturated, hence the effect concentration was based on the nominal values. Thus, a LL50 of > 1000 mg/L was determined and used for the chemical safety assessment.