Condensation products of triethanolamine with addition products of fatty acids, C18 (unsaturated) alkyl with maleic anhydride

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

At the start of the test, two samples (50 mL) were taken from freshly prepared control and test media.
After 48 hours, the contents of the test vessels from each group were pooled and two samples (50 mL) were taken.
Samples were stored in a freezer prior to analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water accommodated fractions (WAFs)
100 mg test material was dispersed in 1L dilution medium (Elendt M4 medium) in a glass vessel. The contents of the vessel were stirred for approximately 24 hours and then left to stand for approximately 46 hours in the dark. An aliquot was then removed mid-vessel to provide the Water Accommodated Fraction (WAF).

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: in-house culture originating from a strain supplied by the National Institute for Applied Chemical Research (IRCHA), France
- Age at study initiation: < 24 h
- Method of breeding: Stock cultures of Daphnia magna were maintained in glass vessels containing approximately 0.5 to 0.8 litres of Elendt M4 culture medium in a temperature-controlled laboratory at nominally 20 ± 2°C. A photoperiod of 16 hours light : 8 hours dark was maintained, with periods of subdued lighting at the beginning and end of each light phase. The culture medium was renewed three times each week.
Cultures were fed daily with a suspension of the unicellular green algae, Pseudokirchneriella subcapitata, to provide nominally 0.1 to 0.2 mg carbon per daphnid, per day, except during the initial three days when a slightly lower ration was given. Culture conditions ensure that the stock animals reproduce by parthenogenesis.
The day before the start of the study, all juvenile Daphnia were removed from the laboratory cultures. The following morning, juveniles produced by the gravid (egg-bearing) adult Daphnia were removed from the culture vessels and held in a separate holding vessel.
- Feeding during test: none

ACCLIMATION
- Acclimation period: not relevant, conditions were the same for maintenance and testing

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

260 mg/L as CaCO3

Test temperature:

20-21 °C

pH:

7.6-8.2

Dissolved oxygen:

83-102 % air saturation value

Nominal and measured concentrations:

nominal loading rate: 100 mg test material/L
measured levels at test start: 46.3 mgC/L
measured levels at test end: 37.5 mgC/L

Details on test conditions:

TEST SYSTEM
- Test vessel: covered glass dishes containing approx. 100 mL of medium
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 20 mL medium per organism

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: deionised, reverse osmosis water
- Total organic carbon: 1.0 mg C/L
- Alkalinity: 50 mg /L as CaCO3
- Ca/Mg ratio: 3.7:1
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light : 8 hours dark with periods of subdued lighting at the beginning and end of each light phase

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : numbers of mobile, immobile and floating Daphnia counted approx. 24 and 48 hours after the start of the study

RANGE FINDING STUDY
- Test concentrations: nominal loading rates of 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: no immobility after 48 hours.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: results are expressed in terms of loading rates

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: results are expressed in terms of loading rates

Details on results:

- Behavioural abnormalities: none
- Mortality of control: none
- Other adverse effects control: none
- Abnormal responses: none

The test medium was colourless.

Results with reference substance (positive control):

- 48-hour EC50: 1.3 mg/L (within the range typically obtained in this laboratory)

Reported statistics and error estimates:

The “no observed effect loading rate” (NOELR) was derived by direct inspection of the data on the immobility of the animals. An incidence rate of more than 10% was considered to be significant.

Validity criteria fulfilled:

yes

Remarks:

In the control, no Daphnia have been immobilised or trapped at the surface of the water. The dissolved oxygen concentration at the end of the test was ≥60% of the air saturation value at the temperature used.

Conclusions:

The results indicate that the test material is not toxic to daphnia up to the limits of its water solubility.

Description of key information

48-h EC50 (based on loading rates) >100 mg/L for Daphnia magna (OECD TG 202, EU C.2)

Additional information

LC50 for freshwater invertebrates: > 100 mg/L
The results indicate that the test material is not toxic to daphnia up to the limits of its water solubility and a NOEC and thus a PNEC cannot be determined.