Mixed esters of fatty acids C16 and C16-C18 unsatd. with adipic acid and pentaerythritol

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:

2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

- direct weighing: the test item was added to 5 litres of dilution water
- then stirred for 24 hrs on a magnetic stirrer
- removing of undissolved particles of the test item by filtration using a folded filter of pore size 7-12 μm and an aseptic filter
- pH: 7.5 - 7.7

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

- mean standard body length (n=14): 3.5 cm (S.D. = 0.11 cm)
- Supplier: Aqua KlöGer (Germany) - loading: 0.62 g body weight (wet weight) per liter
- medication: none
- mortalities during acclimatisation period : < 5 %
- temperature: 20 - 24 °C
- feeding: commercial fish food (daily) and discontinued 24 h prior to test
- keeping water: synthetic fresh water in accordance with ISO 7346

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

13.9 °dH (= 248 mg/L CaCO3)

Test temperature:

22.4 to 23.3 °C (daily monitoring)

pH:

7.5 - 7.7

Dissolved oxygen:

7.5 - 8.7 mg/l

Salinity:

No data

Nominal and measured concentrations:

100 mg/L (nominal) plus control

Details on test conditions:

TEST SYSTEM:
- keeping water: synthetic fresh water according to ISO 7346
- photoperiod: 16 hours light, 8 hours dark
- temperature: 20 - 24 °C
- aeration: gentle aeration via narrow glass tubes
- no feeding during test
- test vessel: glass aquaria holding 5 L of test media covered with glass plates
- number of fish per test vessel: 7
- method of administration: direct weighing
- solubilizer or other auxiliaries: ultra-Turrax, magnetic stirrer, folded filter
- test concentration: 100 mg/l plus one control
- Method of initiation: animals were placed in prepared media
- test parameter: mortality (recorded daily)

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:

Some test fish had a somewhat larger size than the one recommended in the test guideline for the zebra fish. This deviation is not regarded to be relevant to the results.

Validity criteria fulfilled:

yes

Remarks:

(mortality in the controls < 10% by the end of the test; dissolved oxygen concentration above 60% of the air-saturation value throughout the exposure period; pH did not vary by more than 1 unit.)

Conclusions:

In a semi-static test a LC50 of > 100 mg/l (n) after 96 h was obtained for the test item against fish (Danio rerio). No toxic effects against fish were observed at a limit test concentration of 100 mg/L under exposure conditions.

Executive summary:

The study was conducted under semi static conditions in accordance with Council Regulation (EC) No 440/2008, Method C.1 which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203. A group of seven fish of the recommended size was exposed to a limit test concentration of nominally 100 mg/L of the test item dissolved in dilution water. Auxiliaries used to prepare the test media were a magnetic stirrer, folded filters and an aseptic filter of pore size 0.2 μm. Observations were made on the number of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure. No toxic effects against fish were observed at a limit test concentration of 100 mg/L under exposure conditions. The quantification of the test item was performed by DOC determination.

Description of key information

In a semi-static test  a LC50 of higher than 100 mg/l after 96 h was obtained for the test item against fish (Danio rerio). The result is expressed in terms of nominal concentrations. No toxic effects against fish were observed at a limit test concentration of 100 mg/L under exposure conditions. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

"Should read: > 100 mg/L"

Toxicity to fish was conducted in a study under semi static conditions in accordance with Council Regulation (EC) No 440/2008, Method C.1 which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203. A group of seven fish of the recommended size was exposed to a limit test concentration of nominally 100 mg/L of the test item dissolved in dilution water. Auxiliaries used to prepare the test media were a magnetic stirrer, folded filters and an aseptic filter of pore size 0.2 μm. Observations were made on the number of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure. No toxic effects against fish were observed at a limit test concentration of 100 mg/L under exposure conditions. The quantification of the substance was performed by DOC determination.

The substance is insoluble or only poorly soluble in water. A suitable selective and sensitive chromatographical method for the determination of the test item in aqueous solutions could not be established. Therefore an accompanying analysis by means of a chromatographical method could not be performed. The quantification of the substance was performed by DOC determination.