N-dodecyl-β-alanine, compound with 2,2',2''-nitrilotriethanol (1:1)

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:

96 hours

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

Data refers to sodium salt.
Triethanolamine is not classified as hazarodus in the environment and the sodium salt is considered a suitable surrogate for read-across
No further animal testing can be justified.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Analytical monitoring:

not required

Vehicle:

no

Details on test solutions:

Dilutions in water

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

The fish were fed daily to repletion with commercial trout pellets but food was not given during the 24 hour period immediately prior to exposure or during the exposure period itself.
No medication was given during the acclimatisation period and mortalities were recorded as < 1 % in the 7 days prior to the test.
The size of the fish used in the test was determined by measuring the control fish at the end of the exposure period.
The mean standard length was found to be 4.7 cm (SD = 0.4 cm) and the mea.'1 weight determined as 1.3 g (SD = 0.4 g).

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

Chlorine levels remained below the limit of detection throughout the acclimatisation and exposure periods
The mean hardness level, calculated from daily measurements during the same period, was determined as 154 mgCaC03/1.

Test temperature:

14 C (+/- 1C)

pH:

7.7 - 7.7 during the study

Dissolved oxygen:

9.85 - 9.97 mg/O2 / litre
The mean values lowered from starting levels of 9.97 to the final figure at 96 hours of 9.85.

Nominal and measured concentrations:

Nominal test concentrations: 0.56, 1.0, 1.8, 3.2, 5.6, 10 mg actives/litre

Details on test conditions:

Treatment and control groups were maintained at 14 ± I°C throughout the exposure period.
Supplementary aeration was provided via narrow bore glass tubes.
A photoperiod of 16 h light: 8 h dark was established and daily records of temperature, pH and dissolved oxygen were maintained for each control and test vessel
The fish were not fed during the 96 hour exposure period.

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 3.2 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

ca. 3.2 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC100

Effect conc.:

ca. 5.6 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

ca. 5.6 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 4.2 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

There were no mortalities at 3.2 mg/l actives or lower, but the next highest test concentration, 5.6 mg/l, resulted in 100% mortality.
Loss of equilibrium was observed in fish before death. None of the surviving fish showed adverse effects.

Validity criteria fulfilled:

yes

Conclusions:

Appears toxic to aquatic orgnaisms. Stable in water.

Executive summary:

Very narrow concentration range showing no effect or 100% mortality.

Even without full analysis, the known stability of the substance in water and the ease to dilute an aqueous solution led to the conclusion that analysis was not required. The study is considered valid without analysis and repeating the study on vertebrates is not appropriate.

It is predicted that the triethanolamine salt will have a lower toxicity in view of the low biological effect of triethanolamine and the molecular weight difference between triethanolamine and sodium; however, due to uncetainty factors in read-across, it is assumed that the toxicity of the triethanolamine salt will be equivalent to that of the sodium salt.

Description of key information

Considered toxic to fish

Data refers to sodium salt.

Triethanolamine is not classified as hazarodus in the environment and the sodium salt is considered a suitable surrogate for read-across

No further animal testing can be justified.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

4.2 mg/L

Additional information

Key study showed 100% mortality at 3.2 mg/l and no observed effect at 5.6 mg/l