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

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

Study period:

48 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

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes

Analytical monitoring:

no

Details on sampling:

Substance known to be stable in water (supplied in solution).

Test organisms (species):

Daphnia magna

Details on test organisms:

Test organism: Daphnia magna
Source: Shell Research Laboratories

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

The stocks of animals were cultured, and the tests performed, in dechlorinated mains tap water, of typical hardness 280 mg/l CaC03

Test temperature:

The water was adjusted to 20 ± 1°C

pH:

pH stabilised between 7.0 and 8.0

Dissolved oxygen:

Aerated until the dissolved oxygen concentration reached a minimum of 60% air saturation

Nominal and measured concentrations:

A preliminary study had indicated the 48 hour ECso was approximately 100 mg/l (as supplied, 30 mg/l actives) and therefore definitive test concentrations were prepared as 10, 25, 63, 160, 400 and 1000 mg/I of material supplied

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

ca. 7.5 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 3 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

ca. 55 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 29 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

The 48 hour ECso value of Lakeland AMA to Daphnia magna was estimated as 97.7 mg/l as supplied (29 mg/l actives). The highest no-observed effect concentration (HNEC) after 48 hours was 10 mg/l (3 mg/l actives). The lowest test concentration which immobilised all twenty Daphnia (LOEC) within 48 hours was 400 mg/l (120 mg/l actives).

The water quality measurements of the test solutions are given in Table 1 and were within acceptable limits. None of the twenty control Daphnia, maintained in dilution water, was immobilised during the study and this indicates an acceptable level of "health" of the test organisms cultured under the test conditions.

Validity criteria fulfilled:

yes

Conclusions:

Wide range of concentrations between those showing no effect and those leading to 100% immobilisation with increase in immobility over time.
A Daphnia reproduction study has been commissioned to look for potential chronic effects.

Executive summary:

The 48 hour ECso value of Lakeland AMA to Daphnia magna was estimated as 97.7 mg/l as supplied (29 mg/l actives).

The highest no-observed effect concentration (HNEC) after 48 hours was 10 mg/l (3 mg/l actives).

The lowest test concentration which immobilised all twenty Daphnia (LOEC) within 48 hours was 400 mg/l (120 mg/l actives).

Description of key information

Acute Daphnia study performed, but no supporting analysis. However, substance known to be stable in water (supplied in solution).

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 invertebrates

Fresh water invertebrates

Effect concentration:

29 mg/L

Additional information

The 48 hour ECso value of Lakeland AMA to Daphnia magna was estimated as 97.7 mg/l as supplied (29 mg/l actives). The highest no-observed effect concentration (HNEC) after 48 hours was 10 mg/l (3 mg/l actives). The lowest test concentration which immobilised all twenty Daphnia (LOEC) within 48 hours was 400 mg/l (120 mg/l actives).

Note that in a subsequent Daphnia reproduction study (2013), the NOAEC was 10 mg/l actives (the highest concentration tested), showing a very narrow threshold between acute and chronic toxicity. Supporting analysis confirmed stability of the substance in the test system.