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

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.20 (Daphnia magna Reproduction Test)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Sampling schedule:
- Control: on day 2 and 19 in the old media
- Test concentrations: on day 0 and 16 in the freshly prepared media; on day 2 and 19 in the old media
- Stability of test concentration/s during exposure : Ensured by renewal of test media three times per week and checked by chemical analysis (DOC)

The biological test solutions were routinely measured on the day of sampling. If this was exceptionally not possible, the samples were stored in a refrigerator at 4 °C until the analysis was carried out. The biological test solutions were analysed in the same way as the calibration samples.

Vehicle:

no

Details on test solutions:

- Three times a week direct weighings were prepared to produce the desired test concentrations.
- The test item was weighed out, added to 2 litres of dilution water for each concentration and treated for 24 h on a magnetic stirrer.
- Finally undissolved particles of the test item were removed by filtration using an aseptic filter with a pore size of 0.45 + 0.2 μm (Sartobran 150 Sterile Capsule). The pH was measured and ranged between 7.7 and 8.0.
- For each test item concentration and the control 10 replicates were prepared.

Test organisms (species):

Daphnia magna

Details on test organisms:

- Daphnia magna STRAUS, parthenogenetic females, laboratory bred at CURRENTA, Leverkusen, cloned at the Federal Health Office (BGA), Berlin Germany
- feeding: unicellular green algae (Desmodesmus subspicatus) 'ad libitum'
- separation of neonates from their parent Daphnia: by filtration prior to the acute test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Hardness:

In the range of 14.8 °dH to 15.6 °dH (concerning the highest test concentration)

Test temperature:

In the range of 20.1 and 20.5 °C (concerning the highest test concentration)

pH:

In the range of 7.9 and 8.3 (concerning the highest test concentration)

Dissolved oxygen:

In the range of 8.2 and 10.0 mg/l (concerning the highest test concentration)

Nominal and measured concentrations:

Water Accommodated Fractions (WAFs) were produced to test the effects at different loading rates and all results are expressed in terms of Effective Loadings (EL). Effective Loadings were below the detection limit of the DOC determination (< 2 mg/L) on 2011-10-19, 2011-10-21 and on 2011-11-04 and between < 2 and 2.11 mg/L DOC on 2011-11-07 according to the semi-static conditions, respectively.

Details on test conditions:

TEST SYSTEM:
- Test vessels: 150 mL glass beakers holding 1 neonate in 100 mL of test medium
- Experimental design: 2 test concentrations plus 1 control, 1 neonate per vessel, 10 replicates per concentration/control
- Renewal of the test media: Monday, Wednesday and Friday
- Method of initiation: neonates were placed in prepared media
- Photoperiod: 16 h light: 8 h dark
- Light intensity: not exceeding 20 μE x m-2 x s-1
- Temperature of incubation unit: 19.6 to 20.4 °C
- Aeration: none
- Test item concentration/s: 3 and 10 mg/L
- Food source and feeding rate: Desmodesmus subspicatus; day 0-7: 0.1 mg C / Daphnia / day; day 8-21: 0.2 mg C / Daphnia / day

Reference substance (positive control):

no

Duration:

21 d

Dose descriptor:

NOELR

Effect conc.:

>= 10 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: according to Williams / Dunnett`s Multiple Sequential t-Test Procedure

Duration:

21 d

Dose descriptor:

LOELR

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: according to Williams / Dunnett`s Multiple Sequential t-Test Procedure

Duration:

21 d

Dose descriptor:

other: NOEL

Effect conc.:

>= 10 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: according to Williams / Dunnett`s Multiple Sequential t-Test Procedure

Duration:

21 d

Dose descriptor:

other: LOEL

Effect conc.:

> 10 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: according to Williams / Dunnett`s Multiple Sequential t-Test Procedure

Details on results:

No toxic effects on reproduction and mortality against Daphnia were observed up to three-fold of the water solubility (< 0.003 g/L) under exposure conditions.

Validity criteria fulfilled:

yes

Remarks:

- mortality rate in the controls did not exceed 20 % by the end; Living offspring produced per parent Daphnia surviving at the end of the test was ≥ 60 in the controls; Diss. oxygen conc. remained above 3 mg/L throughout the exposure period

Conclusions:

After a 21d-exposure period under semi static conditions no toxic effects on reproduction and mortality against Daphnia were observed up to three-fold of the water solubility (< 0.003 g/L).

Executive summary:

A study was performed to assess the effects of the substance on the reproductive output of parthenogenetic Daphnia magna STRAUS under semi static conditions. The study was conducted in accordance with Council Regulation (EC) No 440/2008, Method C.20 'Daphnia magna Reproduction Test'' (2008), which equals in all relevant parts to the OECD Test guideline 211 (Daphnia magna Reproduction Test; adopted: Oct. 03, 2008). Young female Daphnia, aged less than 24 hours at the start of the test, were exposed to two concentrations, nominally 3 and 10 mg/L of the test item dissolved in water. Auxiliaries used to prepare the test media were on a magnetic stirrer and an aseptic filter. After a 21d-exposure period, the total number of living offspring produced per parent animal alive at the end of the test was assessed. The reproductive output of the Daphnia exposed to the test item was compared to that of the control in order to determine the Lowest Observed Effect Loading (LOEL) and the No Observed Effect Loading (NOEL) according to Williams / Dunnett's Multiple Sequential t-Test Procedure. Additionally, the survival of the parent Daphnia and the time to production of first brood was determined.

No toxic effects on reproduction and mortality against Daphnia were observed up to three-fold of the water solubility under exposure conditions. The test item 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 the means of a chromatographical method cannot be performed. The quantification of the test item was performed by DOC determination.

Description of key information

After a 21d-exposure period under semi static conditions no toxic effects on reproduction and mortality against Daphnia were observed up to three-fold of the water solubility (NOEL > 10 mg/l).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

10 mg/L

Additional information

"Should read: NOEL > 10 mg/L"

A study was performed to assess the effects of the substance on the reproductive output of parthenogenetic Daphnia magna STRAUS under semi static conditions. The study was conducted in accordance with Council Regulation (EC) No 440/2008, Method C.20 'Daphnia magna Reproduction Test'' (2008), which equals in all relevant parts to the OECD Test guideline 211 (Daphnia magna Reproduction Test; adopted: Oct. 03, 2008). Young female Daphnia, aged less than 24 hours at the start of the test, were exposed to two concentrations, nominally 3 and 10 mg/L of the test item dissolved in water. Auxiliaries used to prepare the test media were on a magnetic stirrer and an aseptic filter. After a 21d-exposure period, the total number of living offspring produced per parent animal alive at the end of the test was assessed. The reproductive output of the Daphnia exposed to the test item was compared to that of the control in order to determine the Lowest Observed Effect Loading (LOEL) and the No Observed Effect Loading (NOEL) according to Williams / Dunnett's Multiple Sequential t-Test Procedure. Additionally, the survival of the parent Daphnia and the time to production of first brood was determined.

No toxic effects on reproduction and mortality against Daphnia were observed up to three-fold of the water solubility under exposure conditions. The test item 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 the means of a chromatographical method cannot be performed. The quantification of the test item was performed by DOC determination.