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

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Four samples were taken from the freshly prepared control and test media at 0 and 72 hours, respectively. Four samples were taken from the expired control and test media at 24 and 96 hours.
Samples were stored frozen until analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water accommodated fraction (WAF)
The test material was dispersed in dechlorinated water in a glass aspirator at a nominal concentration of 100 mg/L. The contents were stirred for approximately 24 hours and then left to stand for approximately 24 hours in the dark. An aliquot was then removed from the mid-vessel region to provide the Water Accommodated Fraction (WAF).

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source:commercial fish farm in the UK
- Length at study initiation: 5.85 cm (mean total length)
- Weight at study initiation: 1.64 g (mean wet weight)
- Feeding during test: none

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: commercial fish food (TROUW (UK) Ltd. Nutra Fry 02); amount equivalent to 1% of the total wet-weight of fish in the holding tank; no food was given during the 24-hour period immediately before exposure.
- Health during acclimation: no medication, no mortality

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

170 mg/L as CaCO3

Test temperature:

14 ± 1 °C, constant to within ± 1°C during the study

pH:

7.8-8.3

Dissolved oxygen:

90-103% air saturation value

Nominal and measured concentrations:

nominal loading rate: 100 mg test material/L as WAF
mean measured TOC levels (after background correction):
in fresh media: 42.3-45.4 mg C/L (control mean: 1.2-1.4 mg C/L)
in expired media (24 h): 42.9-47.6 mg C/L (control mean: 1.5-1.8 mg C/L)
overall geometric mean value: 44.2 mg C/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria, containing 20 litres of medium to a depth of 19 cm.
- Type: open
- Aeration: yes
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10 (During the test, one fish was found outside of the control vessel at 24 hours; this animal was removed from the study data so the number of fish exposed in the control vessel was nine.)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.82 g body weight/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water, dechlorinated and softened by passage through a water purification system consisting of activated carbon filter, water softener and reverse osmosis treatment.
Total organic carbon: 1.2-1.4 mg C/L
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h 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) : mortality and sub-lethal effects; recorded at approx. 2, 4, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Range finding study
- Test concentrations: nominal loading rates 0.1, 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: no mortality or sub-lethal effects were noted after 96 hours

Reference substance (positive control):

not required

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: results are expressed in terms of loading rates

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality and sub-lethal effects

Remarks on result:

other: results are expressed in terms of loading rates

Details on results:

- Other biological observations: none
- Mortality of control: zero
- Other adverse effects control: none

The test medium was a off-white hazy dispersion.

Reported statistics and error estimates:

The “no observed effect loading rate” (NOELR) was derived by direct inspection of the data for lethal and sub-lethal effects. An incidence rate of more than 10% was considered to be significant.

Validity criteria fulfilled:

yes

Remarks:

mortality of control animals <10%; concentration of dissolved oxygen in all test vessels >60% saturation

Description of key information

96-h LC50 (based on loading rates) >100 mg/L for Oncorhynchus mykiss (OECD TG 203, EU C.1)

Additional information

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